Stem Cell Clinic

Stem Cell Banking Market to Surge at a Robust Pace in Terms of Revenue Over 2018 2028 – Montana Ledger

By Stem Cell Medicine

Global Stem Cell Banking Market: Overview

The demand within the global stem cell banking market is growing on account of advancements in the field of regenerative medicine. The medical fraternity has become extremely focused towards the development of artificial tissues that can infuse with the human body. Furthermore, medical analysis and testing has gathered momentum across biological laboratories and research institutes. Henceforth, it is integral to develop stem cell samples and repositories that hold relevance in modern-day research. The need for regenerative medicine emerges from the growing incidence of internal tissue rupture. Certain types of tissues do not recover for several years, and may even be damaged permanently. Therefore, the need for stem cell banking is expected to grow at a significant pace.

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In a custom report, TMR Research digs into the factors that have aided the growth of the global stem cell banking market. The global stem cell banking market can be segmented on the basis of bank size, application, and region. The commendable developments that have incepted across the US healthcare industry has given a thrust to the growth of the North America stem cell banking market.

Global Stem Cell Banking Market: Notable Developments

The need for improved regenerative medication and anatomy has played an integral role in driving fresh developments within the stem cell banking market.

Gallant has emerged as a notable market entity that has remained as the torchbearer of innovation within the global stem cell banking market. The company has recently launched stem cell banking for dogs, and has attracted the attention of the masses. As people become increasingly concerned about their pets, the new move by Gallant shall help the company in earning the trust of the consumers. Moreover, it can move several notches higher on the innovation index.

Cells4Life has also remained at the forefront of developments within the global stem cell banking market. After suffering backlash for its error in cord blood stem cell promotion, the company is expected to use effective public relation strategies to regain its value in the market.

Global Stem Cell Banking Market: Growth Drivers

Development of improved facilities for storage of stem cells has played an integral role in driving market demand. Furthermore, the unprecedented demand for improved analysis of regenerative medications has also created new opportunities within the global stem cell banking market. Medical research has attracted investments from global investors and stakeholders. The tremendous level of resilience shown by biological researchers to develop stem cell samples has aided market growth. Henceforth, the total volume of revenues within the global stem cell banking market is slated to multiply.

Commercialization of stem cell banks has emerged as matter of concern for the healthcare industry. However, this trend has also helped in easy storage and procurement of cells stored during the yester years of children. Presence of sound procedures to register at stem cell banks, and the safety offered by these entities, has generated fresh demand within the global market. New regional territories are opening to the idea of stem cell banking. Several factors are responsible for the growth of this trend. Primarily, improvements in stem cell banking can have favourable impact on the growth of the healthcare industry. Moreover, the opportunities for revenue generation associated with the development of functional stem cell banks has aided regional market growth.

The global stem cell banking market is segmented on the basis of:

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Stem Cell Banking Market to Surge at a Robust Pace in Terms of Revenue Over 2018 2028 - Montana Ledger

Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020 – JD Supra

By Stem Cell Clinics

Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA teams second year-end post will provide an overview of 2019 with a focus on the drug, biologic, and regenerative medicine programs at the agency. In many ways, the past year could be called a business as usual year for the FDAs drugs and biologics centers in that they continued to make progress on all of large-scale programs and priorities initiated by former-Commissioner Scott Gottlieb, who left the agency in April. FDA has been under the leadership of an Acting Commissioner since that time, although Texas radiation oncologist Dr. Stephen Hahn will be taking the reins soon following his confirmation by the full Senate in a 72-18 vote on December 12, 2019. (The Senate HELP Committee advanced the nominee on December 3, 2019; see our blog post just prior to that committee vote here.)

At the same time, however, the final months of 2019 have exposed several challenges for various FDA programs that operate under the extensive drug and biologic authorities contained in the Food Drug & Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act), respectively. The agency will be forced to grapple with many of these issues directly and deliberately in 2020as a result of deadlines of the agencys own making as well as external pressures coming from other parts of D.C. and from the rapidly changing nature of the U.S. health care system.

Business as Usual When Getting New Drugs, Generic Drugs, and Biosimilars to Market and Promoting Competition under Various Action Plans But Challenges Are Emerging Related to Accelerated Approval and Breakthrough Products

According to data presented by the Office of New Drugs in early December (see ONDs slides here), FDA had another extremely productive year when it comes to its approval of new molecular entities that address a unique blend of therapeutic areas. The agency approved 45 new molecular entities in FY 2019 (October1, 2018 to September30, 2019), of which 71%, or 32 products, received priority review status and 23 were designated as orphan drugs intended to treat rare diseases. As OND emphasized in the presentation, several of those new product approvals are notable for their uniqueness and therefore, in the agencys view, 2019 reflects not only quantity but [also] quality. The OND presentation also highlights a significant amount of other information on new molecular entity approvals and may be of interest to those readers who want to take a deeper dive into the data.

In addition to advancing important new drugs and biologics to market, former Commissioner Gottlieb is well-known for having spearheaded to development of a Drug Competition Action Plan (DCAP) and a Biosimilars Action Plan (BAP) during his nearly two-year tenure as head of the agency. Some of our prior coverage of the DCAP and BAP is available here. In general terms, the DCAP encourages market competition for generic drugs and helps to bring greater efficiency and transparency to the generic drug review process; the BAP aims to achieve similar goals for biosimilar products as the agency continues its implementation of the 2010 Biologics Price Competition and Innovation Act (BPCIA), including the critical drug-to-biologic transition that will occur by operation of law in March of 2020.

FDA continued to make progress on its various goals under these two initiatives during 2019. Some examples of this progress can be captured with these two data points:

With all of these wins, however, FDA still faces its fair share of challenges related to its expedited drug and biologic programs, especially as it appears to have accelerated its review of products intended for diseases with an unmet need to breakneck speed. Indeed, the OND presentation from early December also added that for FY 2020 and as of November 21, 2019, the agency had already approved 13 such drugs, suggesting that next year could be a record-breaking one in terms of innovative drug product approvals. A recent Bloomberg Law article (available here) used the phrase breakneck speed to describe the agencys actions in this space based on several recent FDA approvals of new molecular entities that have come months in advance of their assigned target dates. The Bloomberg Law article highlights that in response to FDAs speediness in reaching approval decisions on new drugs and biologics for diseases with unmet needs, patient advocates and, increasingly, insurers that have to pay for those treatments are starting to raise concerns that these products lack sufficient safety or effectiveness data.

Relatedly, there has been increasing pressure on FDA to remove certain accelerated approval drugs from the market following a failure by the drug product sponsor to confirm the efficacy or clinical benefits of the product in the required post-marketing confirmatory clinical trial. The most visible example of this regulatory challenge came in October 2019 when FDA convened an advisory committee to recommend whether it should withdraw accelerated approval from hydroxyprogesterone caproate injection (marketed under the brand name Makena for the prevention of preterm birth in pregnant women). FDAs Bone, Reproductive and Urologic Drugs Advisory Committee voted 9-7 to withdraw approval, with the dissenters favoring leaving Makena on the market while requiring the sponsor to conduct a new confirmatory trial. (Notably, no one voted for the option of leaving it on the market without requiring a new confirmatory trial.)Among the concerns of some members who voted to leave the product on the market with a new clinical trial obligation was that the drugs withdrawal would leave no safe treatment options for pregnant women at high risk of preterm birth. FDA will have to make a final decision regarding what to do about Makena in 2020, and it undoubtedly will face intense criticism (and potentially legal challenge) no matter what route it chooses to take for this public health quandary in which it finds itself.

In a similar vein, FDA official Dr. Richard Pazdur participated in a Senate briefing on December 10, 2019, in which he and other speakers defended the Breakthrough Therapy Designation program. FDA insisted again that the designation was intended to let the agency have earlier interactions with drug sponsorsand that it was not meant to be an early rating system for drugs or a signal of how they might do commercially. Given that the Breakthrough program was created in 2012 and is considered to be wildly successful, some speakers at the briefing expressed surprise that there was still any confusion about its purpose and function. Whether Congress picks up any of these emerging areas for consideration as part of FDAs 2022 user fee reauthorization packages remains to be seenas those negotiations will begin in earnest after the New Year, but the issues certainly are complex enough to allow for robust policy discussions to occur.

Finally, there are expected to be bumps in the road with the upcoming March 2020 transition of proteins previously approved under New Drug Applications (NDAs) to Biologics License Applications (BLAs)for which FDA only finalized its guidance for industry last year. The March 2020 transition date was established under the BPCIA and the agency does not have discretion in getting the transition done (only in how it handles the logistical and administrative issues created by transitioning approved products in this way). Check out our prior blog post on the final deemed to be a license transition guidance.

Business as Usual with the Rapid Pace of FDAs Issuance of Agency Guidance But Challenges Are Emerging Related to Judicial Deference to FDA Decision-Making

FDA guidance documents for all regulated product categories continued to be released on a regular basis this year, including several related to areas of agency priorities under the DCAP and BAP including the final biosimilar interchangeability guidance issued in May (see our blog post here) and a draft guidance on insulin interchangeability issued in November 2019. The latter also relates to the March 2020 NDA-to-BLA transition, as insulins are one of the largest class of products that will be transitioning into regulation as biologics, making them open to what is expected to be more efficient competition through the BPCIAs biosimilar pathway than what was possible in the past as insulin NDAs.

Despite the accelerated pace of the issuance of Agency guidance, however, FDA is beginning to face more challenges related to its decision-making and the scope of its exercise of agency discretion. In particular, a significant District Court for the District of Columbia ruling issued on December 6, 2019, Genus Medical Technologies, LLC v. FDA, provides hints of a potential shift in judicial deference to certain agency actions. The court vacated FDAs classification of a medical imaging liquid as a drug rather than as a device after determining that FDA did not have discretion to decide how to regulate a product merely because the definitions of drug and device overlap in the FD&C Act.

According to the district court judge, FDA was not interpreting the drug/device definitions in the statute properly, and Congress did not intend to allow the agency unfettered discretion to pick between the two categories. Rather, the court found that the text of the definitions are clear and do not create a gap or any ambiguity for FDA to fill with an exercise of agency discretion. This recently issued decision may indicate a potential shift in how courts are going to apply long-standing precedents related to judicial deference to agency decisions. If FDA decides to appeal the Genus ruling, it may end up at the Supreme Court as one of many expected challenges to the doctrines that established our current framework for judicial deference of an administrative agencys interpretation of an ambiguous statute.

Business as Usual with FDAs Comprehensive Regenerative Medicine Framework and Stepped up Enforcement Against Stem Cell Clinics Offering Unlawful Products But What Happens in November 2020 When the Enforcement Discretion Period Ends?

One of the first FDA press releases for 2019 was co-authored by former Commissioner Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks and was focused on the agencys new policies aiming to advance the development of safe and effective cell and gene therapies. In the press release, the agency leaders predicted that by 2020, FDA would receive more than 200 Investigational New Drug Applications (INDs) for cell and gene therapies each year. The agency has continued to work diligently to increase its staff in CBER to conduct clinical reviews for such INDs and to try to keep pace with the industrys development of these innovative technologies.

As we discussed in our update on FDAs Comprehensive Regenerative Medicine Policy Framework earlier this year, the agency is prioritizing two parallel goals: (1) clarifying the regulatory criteria for product marketing and providing support and guidance to legitimate product developers; and (2) removing unapproved, unproven, and potentially unsafe products from the U.S. market. The second prong of this comprehensive plan for regenerative medicine products was the topic of one of Dr. Gottliebs very last statements as Commissioner before he left the agency, issued on April 3, 2019 in conjunction with CBER Director Dr. Marks, indicating how important this area is to the agencys current public health priorities.

In the April 2019 statement, Drs. Gottlieb and Marks acknowledged FDAs challenges and efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, citing several Warning Letters issued to manufacturers that violated current good manufacturing practices (CGMPs) for human cells and tissue products. They noted that it was of particular concern given that the industry was nearly halfway through the period during which the FDA intends to exercise enforcement discretion for certain regenerative medicine products with respect to INDs and premarket approval requirements. Now that it is December 2019, that deadline is even closer with less than one year left. November 2020 is the end of the three-year period of enforcement discretion announced by FDA when it first articulated the policies and goals of this comprehensive framework in 2017. See our prior posts on the topic here and here.

Under the Comprehensive Regenerative Medicine Policy Framework, FDA appears to have stepped up the pace of issuing Warning and Untitled Letters to sellers of unapproved stem cell products during the second half of 2019. In conjunction with a Warning Letter issued on December 5, 2019 to two related companies for processing and marketing unapproved umbilical cord blood-derived cellular products, Dr. Marks of CBER reiterated the agencys concerns about safety and reminded the public of the upcoming compliance deadline: As evidenced by the number of actions that the agency has taken this month alone, there are still many companies that have failed to come into compliance with the [FD&C Act] and FDAs regulations.

Dr. Marks was referring to two Untitled Letters that were issued to stem cell product distributors on November 20 and November 25, 2019, respectively. The press release cited above also added that the agency had also recently sent 20 letters to manufacturers and health care providers noting that it has come to [FDAs] attention that they may be offering unapproved stem cell products, reiterating the FDAs compliance and enforcement policy.

FDA also prevailed this year in the U.S. District Court of the Southern District of Florida against a stem cell clinic charged with violating the FD&C Act and the PHS Act. In June 2019, the court held that the defendants adulterated and misbranded a stem cell drug product made from a patients adipose tissue without FDA approval and for significant deviations from CGMPs, issuing a permanent injunction as requested by the Department of Justice on FDAs behalf. The agencys statement on that important court win by the government is available here.

Lastly, on December 6, 2019, FDA issued a Public Safety Notification on Exosome Products. The safety notification informed the public of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes, which came to FDAs attention through the Centers for Disease Control and Prevention, the Nebraska Department of Health and Human Services, and others. There are currently no FDA-approved exosome products and, to be honest, we are not even sure what such a product would be since an exome consists of all the sequenced exons within a single human genome after the introns are removed. (So were the clinics administering complete exomes to patients? that seems unlikely.)But what we found noteworthy about this public safety notice is the forceful and direct language FDA used when describing the unscrupulous conduct of the sellers of these products:

Certain clinics across the country, including some that manufacture or market violative stem cell products, are now also offering exosome products to patients. They deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions. They may claim that they these products do not fall under the regulatory provisions for drugs and biological products that is simply untrue. As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the [PHS Act] and the [FD&C Act] and are subject to premarket review and approval requirements.

The clinics currently offering these products outside of FDAs review process are taking advantage of patients and flouting federal statutes and FDA regulations. This ultimately puts at risk the very patients that these clinics claim to want to help, by either delaying treatment with legitimate and scientifically sound treatment options, or worse, posing harm to patients, as evidenced by these recent reports of adverse events.

As we enter the final year of FDAs enforcement discretion period, perhaps these public notices and Warning/Untitled Letters will become even more frequent and the agency will become even more frustrated by the ongoing violations and medical practitioners who flout federal law. This area will see substantial activity in 2020 and we will be watching closely to see what changes, if anything, about FDAs approach in November when the deadline to come into compliance ends. Will there be widespread FBI raids on stem cell clinics engaged in this kind of bad behavior? Only time will tell.

Final Thoughts: A Few Other Business as Usual Activities in the Therapeutic Product Areas and Prescription Drug Advertising Enforcement

Although we have highlighted what we view as some important challenges for the FDA to address in the coming months, other areas continue to be business as usual without anything very new to report. FDA continues to invest significant resources into improving the quality of compounded drugs and ensuring compliance with Sections 503A and 503B of the FD&C Act. Drug compounding was another topic of one of Dr. Gottliebs very last statements as Commissioner on April 3, 2019, in which he laid out the 2019 compounding priorities that included maintaining quality manufacturing and compliance and regulating compounding from bulk drug substances.

Notwithstanding all the efforts by FDA and State regulators in this area over the past several years, the agency continues to see concerning activity when it comes to compounded drugs, such as problems related to the condition under which compounded sterile medicines are made, which raisesignificant risks to patients. As a result, FDA has made it an intense area of focus to take enforcement actions against compounders who fail to produce sterile drugs in compliance with the law. During the past year, for example, FDA has won at least four permanent injunctions against various compounders after the agency identified behavior that posed a significant risk to public health and safety.

In addition, in 2019 FDA also increased its activities towards reducing and mitigating the impact of drug shortages on the health care system. See our prior blog post on Drug Shortages.

Finally, after a fairly slow year of enforcement in the prescription drug advertising space, the last two months of 2019, at least as of December 12th, have given us three (!) letters two untitled and one warning from the FDAs Office of Prescription Drug Promotion (OPDP). Most interestingly, the Warning Letter issued on December 2, 2019 for omitting warnings about the most serious risks associated with [a medication-assisted treatment] drug from promotional materials was announced to the public via FDA press release, which is not a typical action for normal-course OPDP letters to industry. The drug in question, approved for the prevention of relapse to opioid dependence following opioid detoxification, is associated with several significant risks including potential opioid overdose. Given the countrys public health emergency that is the opioid epidemic, FDA appears to have felt the need to make the deficiencies in the advertisement and those risks more widely publicized. So another thing we will be watching for in the New Year is whether this OPDP action represents the beginning of a new trend by the agency to publicize these Warning Letters more directly, or whether its advertising enforcement activities may be picking up due to industrys evolving approaches to promoting therapeutic products.

If you made it to the end of this post, thank you for reading our tome, and we hope you found it helpful and interesting! Stay tuned next week for our third and final FDA year-end blog post.

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Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020 - JD Supra

This was the best health news over the last decade – USA TODAY

By Gene Therapy Clinics

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The 2010s will go down in history as a decade of many newsworthy health-related stories, many of which were not good news -- Ebola, measles, antibiotic resistance. But in the years since 2010 there were also many promising discoveries in medicine, life-saving drugs approved, and great strides taken addressing national health crises. Some of these stories will have lasting effects for generations to come.

24/7 Tempo reviewed multiple news archives and dozens of articles published since 2010 to select 15 of the most positive health news stories that made headlines.

Some of the most talked about stories over the last few years have influenced health guidelines, treatment of serious disease, and even government policy.

Reports of significant research developments in the treatment and prevention of chronic and other conditions gave hope to millions of Americans. Some of the good news broke as recently as just a few months ago these are the 15 biggest health topics of 2019.

Click here for 15 of the best health news over the last decade.

CT scans in high risk patients can reduce overall lung cancer mortality

Year: 2011

Category: Diseases

The tremendous effort by researchers and health institutions to develop a cure for cancer over the decades since the legislation for the War on Cancer was enacted in 1971 will likely continue. Any good news on developments are worth noting. The 2011 National Lung Screening Trial showed a reduction in lung cancer mortality of 20% in high risk patients receiving low-dose CT (LDCT) compared to chest X-ray. The CDC recommends that people at high risk of developing lung cancer -- heavy smokers, people who have smoked as recently as 15 years, and people who are 55 years or older -- undergo annual LDCT scans because of potential risks.

In 2016, there were 218,229 new cases of lung cancer, and 148,869 people died from the disease in the United States, according to the CDC. The American Cancer Society estimates 142,670 deaths from lung cancer in 2019. A major reason for the disease's high mortality rate is that the tumor does not typically cause symptoms until it spreads, making early screening especially crucial to improving survival rates.

Blame SUVs: These 9 cars will be killed in 2020

Pass the ketchup, hold the beef: Americans crave Impossible Burger, Beyond Meat in 2020

Melanoma drug approved

Year: 2011

Category: Treatment

After more than a decade of no new potential drugs for melanoma, the deadliest form of skin cancer, the FDA approved vemurafenib, sold under the brand name Zelboraf, in 2011 for patients with metastatic melanoma with the BRAF(V600E) mutation or for those who have tumors that cannot be surgically removed.

Zelboraf was seen as a major development because it can improve melanoma patients' quality of life -- the drug is a simple pill taken twice a day -- and it may extend survival rate. In a trial, the length of time melanoma patients who received Zelboraf lived without the cancer getting worse was almost double the length of patients who did not take the drug.

Since 2011 several drugs have been approved to treat melanoma, and survival rates of this deadly cancer have improved.

Gene editing is now possible

Year: 2012

Category: Technology

Gene editing is the process of changing an organisms DNA. After decades of research around the world, scientists made a major breakthrough with the discovery of clustered repeats of DNA sequences, known as CRISPR.

First described in 2012, CRISPR, or Clustered Regularly Interspaced Short Palindromic Repeats, is the basis for potentially world-changing gene editing technology, or, as some might say, DNA hacking. It may be used to develop treatments for a range of diseases, including cancer and genetic disorders. In 2015, CRISPR was successfully used for the first time to save a life. Two baby girls, 11-month and a 16-month-old, received gene editing treatment to help them fight leukemia.

While the gene-altering tool is bringing revolutionary change to health fields, it has also raised serious ethical concerns. Misuses and inadvertently harmful uses of CRISPR include those for creating designer babies, and causing environmental ripple effects by eliminating disease-spreading insects.

FDA says trans fat should not be considered 'safe'

Year: 2013

Category: Eating

Trans fats, or partially hydrogenated oils, have been widely used for years, most notably in fast foods. Trans fats can raise the levels of "bad" LDL cholesterol, lower the levels of good-for-you HDL cholesterol, and increase the risk of heart disease, the No. 1 killer in the United States. And now they are on their way out.

In 2013, the FDA officially announced trans fats should not be considered safe in human food. In 2015, the agency gave food manufacturers three years to phase out the use of trans fats in their products. The deadline was June 18, 2018, although the FDA granted a one-year extension in the use of artificial trans fats in some cases. The ban will be fully implemented in Jan. 1, 2020.

HIV prevention pill

Year: 2014

Category: Diseases

About 50,000 Americans are diagnosed with HIV every year, according to the CDC. Despite advancements in treatment and years of research into the infection, HIV does not have a cure. In 2014, the CDC issued new guidelines that recommend a pill to people at high risk of HIV as a prevention method. High risk people include gay or bisexual men, injection drug users, and women with an HIV+ partner.

The agency said that the pill, sold under the brand name Truvada, may lower the risk by as much as 90% when taken consistently. Truvada has been used to treat HIV since 2012 when the FDA approved the drug. Truvada contains tenofovir and emtricitabine, which when used in combination with other antiviral medication may keep the HIV virus from establishing a permanent infection.

A new way to treat cavities

Year: 2015

Category: Treatment

In 2015, the FDA approved a painless new way to treat tooth decay called silver diamine fluoride (SDF). It's a liquid that is applied directly to cavities to stop the decay. The FDA gave it a "breakthrough therapy designation" two years later.

As a non-invasive and fairly cheap method (it costs about $20-$25 per tooth), SDF treatment, which must be prescribed by a dentist, can save people a lot of money. About 91% of American adults have dental decay, and about 27% have untreated tooth decay, according to the CDC. Tooth decay is common among kids as well -- it's the most common chronic disease in children between 6 and 11 years of age.

3D printing of human organs

Year: 2015

Category: Technology

3D printing technology has improved considerably over the past few years. (Today, low-budget 3D printers are available for anyone who can spare $100.) The technology has advanced so much that producing fully functional replacement organs from a person's own cells seems like a not-so-distant possibility. Scientists at Harvard's Wyss Institute have grown a heart tissue that beats just like a normal human heart.

Production for treatment is still years away, however. The technique, called sacrificial writing into functional tissue (SWIFT), has not even been tested on mice yet. But if it works, it can be used to print other organs, too, potentially saving the lives of thousands of people who are waiting for an organ transplant.

Immunotherapy and cancer

Year: 2016

Category: Treatment

Cancer immunotherapy was named the 2016 Advance of the Year by the American Society of Clinical Oncology. The therapy is designed to support and boost the immune systems response to cancer cells, rather than targeting the cancer itself. One of the most successful immunotherapies so far is the checkpoint inhibition. It makes the immune response stronger by keeping immune cells activated, which does not normally happen when a person has cancer.

It may take decades until immunotherapy could replace the current standards in cancer treatment of surgery, chemotherapy, and radiation, but currently hundreds of immunotherapy drugs are being tested in clinical trials on people.

Some benefits of immunotherapy include fewer side effects than radiation or chemotherapy, lower risk of relapse, and making other cancer treatments more effective.

Opioid crisis recognized as national public health emergency

Year: 2017

Category: Public health

Every day over 130 people in the United States die from opioid overdose, including pain medication, heroin, and synthetic opioids such as fentanyl, according to the National Institutes of Health. In 2017, President Donald Trump declared the opioid crisis a national public health emergency, giving hope that the federal government's involvement could help fight the worst drug crisis in U.S. history.

The official designation removed certain administrative requirements for accessing federal funds to fight the epidemic, including the use of taxpayers' money to make addiction treatments and naloxone, a life-saving medication that can reverse an opioid overdose, drug, more accessible.

The Department of Health and Human Services has renewed the opioid crisis' status as a national emergency several times since 2017. Money has been used to speed up a survey on whether and how often doctors prescribe opioids and help launch anti-addiction programs quicker, according to the a 2018 report by the Government Accountability Office.

Early-stage Alzheimer's treatment

Year: 2019

Category: Diseases

Currently, there is no treatment for Alzheimer's disease, the sixth leading cause of death in the United States. Pharmaceutical companies and universities have tried to tackle different aspects of the neurodegenerative disorder, but to no avail. Until just a few months ago.

Biogen, a biotechnology company, announced in October 2019 it would ask the FDA to approve its Aducanumab drug as first treatment for early Alzheimer's disease. The company said that patients in the early stages of the disease who were treated with a high dose of the drug experienced significant improvements in memory, orientation, and language. If Aducanumab is approved, it will be one of a handful of drugs approved to treat the disease.

Smoking rates at all-time low

Year: 2018

Category: Habits

The short and long-term health problems smoking causes have been well-documented for decades. Today cigarette smoking among U.S. adults is at an all-time low -- 13.7% in 2018, according to the CDC.

While smoking regular cigarettes is down, smoking e-cigarettes is on the rise. About 37% of 12th graders reported vaping in 2018, compared with 28% in 2017. A recent Gallup survey found that 20% of 18- to 29-year-olds vape regularly, more than twice the national average for all age groups.

There has been a recent outbreak of lung injury associated with the use of e-cigarettes. At least 47 deaths and 2,290 lung injuries have been confirmed by the CDC as a result of vaping as of Nov. 20, 2019. The agency has identified vitamin E acetate, an additive in some THC-containing e-cigarettes, as the likely cause for the lung injuries.

Cystic fibrosis treatment approved by FDA

Year: 2019

Category: Treatment

About 30,000 Americans live with cystic fibrosis, a fairly common genetic disease that affects the lungs and other organs, limiting one's ability to breathe as the disease progresses. About 1,000 new cases are diagnosed every year.

The FDA approved in 2019 what it called a "new breakthrough" therapy to treat the condition. The medication, sold under the name Trikafta, is available to patients who are 12 years or older and have the F508del mutation, the most common cystic fibrosis mutation. It is found in 90% of the people living with the disease. The treatment can increase the life expectancy of patients, which is now around 44 years.

Second HIV patient goes into remission

Year: 2019

Category: Diseases

A second person since HIV was identified in the 1980s has been said to be in sustained remission. The patient, who was treated in London, has not been given antiretroviral therapy for 18 months, and the virus has remained undetectable. The good news comes more than a decade after the Berlin patient, known as the first person to have been cured from the infection. Both patients received a stem cell transplant.

HIV, the virus that causes AIDS, is one of the most serious global health challenges. Almost 38 million people live with HIV worldwide, according to the World Health Organization. Just over 60% are receiving treatment.

Blood test detects breast cancer 5 years early

Year: 2019

Category: Diagnoses

Even though deaths from breast cancer have declined, the disease remains the second leading cause of cancer death among women in the United States, according to the CDC. More than 40,000 women die from it a year.

Improved rates of early detection have helped drive up survival rates. A recent British study offers hope that the condition could now be detected five years before there are any clinical signs of it. The new method is a blood test that identifies the body's immune response to antigens produced by tumor cells. The test may be available in clinics in about five years.

Finding a cure for arthritis

Year: 2019

Category: Treatment

2019 has been an exciting year in the field of health technology and scientific research. In addition to such technological developments as organ printing and gene editing, recent research has shown promise for a cure for arthritis. Millions of people suffering from joint inflammation -- from osteoarthritis, for example, which is the most common form of arthritis -- may be helped.

A recent study published in the Science Advances journal has found that "cartilage in human joints can repair itself [...] to regenerate limbs." The body was previously believed to be unable to do so. People have a molecule that helps with joint tissue repair, and that molecule is more active in ankles and less active in knees and hips. The findings can help develop treatments that may prevent, slow, or even reverse arthritis.

24/7 Wall Street is a USA TODAY content partner offering financial news and commentary. Its content is produced independently of USA TODAY.

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Platelet-Rich Plasma Injection Procedure

By Platelet Rich Plasma Injections

Platelet-rich plasma injections are outpatient procedures. Because the patient's blood must be drawn and prepared for injection, a typical procedure may take anywhere from 45 to 90 minutes.

Whether the patient has a one-time injection or a series of injections spaced over weeks or months is up to the individual patient and doctor. If a series of injections is planned, a doctor may recommend a single blood draw during the first visit and use fresh PRP in the first injection and freezing and thaw the remaining PRP as needed for future injections. However, some experts believe freezing and thawing PRP negatively affects its usefulness and prefer to do a separate blood draw for each PRP injection.1

An experienced physician should perform the injections. The use of imaging technology (e.g., ultrasound guidance) ensures a precise injection.

Precision is important because, like viscosupplementation treatments, platelet-rich plasma injections must be made directly into the joint capsule.

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The American Academy of Orthopaedic Surgeons recommends patients adhere to the following pre-injection guidelines:

Although the American Academy of Orthopaedic Surgeons published these pre-injection guidelines, the organization does not advocate for or against platelet-rich plasma treatment for osteoarthritis.2

See Stem Cell Therapy for Arthritis

This is an in-office procedure that involves a blood draw, preparation of the PRP, and the injection:

The platelet-rich plasma typically stimulates a series of biological responses, and the injection site may be swollen and painful for about 3 days.

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Patients are advised to take it easy for a few days and avoid putting strain on the affected joint.

Doctors may require or suggest that a patient:

Patients who do not have physically demanding jobs can usually go back to work the next day. Patients can resume normal activities when swelling and pain decrease, typically a few days after the injections. Patients should not begin taking anti-inflammatory medications until approved by the doctor.

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Platelet-Rich Plasma Injection Procedure

Attractive Market Opportunities in the Cord Blood Stem Cell Market By 2029 – Sound On Sound Fest

By Stell Cell Research

New York City, NY: December 2019 Published via (Wired Release) The Cord Blood Stem Cell Market reviews offer thorough statistics about the worldwide enterprise comprising of valuable figures and stats. Further, the report provides facts starting from the bottom year (2019) and stretches till the forecast length (2020-2029). Moreover, research completed by professional experts in their domains strives tough to make the Cord Blood Stem Cell marketplace report successful. The document is essential for normal for the key contributors as well as for the brand new entrants inside the marketplace that gives in-intensity market insights. This Cord Blood Stem Cell research file has set a bench-marking example for this type of dynamic marketplace that explores several recommendations and sensible growth strategies when it comes to the marketplace.

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The international Cord Blood Stem Cell marketplace file is offered in a precise style based totally on the analysis with the aid of industry professionals or specialists. The research document produced covers numerous boom prospects in recent times with linkage in the coming decades. The assumptions are made by the panels and key vendors. The Cord Blood Stem Cell marketplace on a severe note specializes in the numerous evaluation viewpoints, marketplace rankings, enterprise fore points, and business profiles that integrate together and shape a platform. The platform consists of an open dialogue panel where industry experts from variable sectors share reviews to narrow down the issues and provide you with the solutions with regards to import/export data, global sales, market rivalry, price chain analysis, and lots of more.

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Competitive Landscape:

Key players profile in the report include

Cord Blood Registry Systems, Inc.Viacord Inc.China Cord Blood Corporation.Cord Blood America, Inc.Cryo-Cell International, Inc.Cryo-Save AG.Cordlife Group Ltd.Vita 34 AG.Lifecell International Pvt. Ltd.Stemcyte Inc.

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Attractive Market Opportunities in the Cord Blood Stem Cell Market By 2029 - Sound On Sound Fest

Attractive Market Opportunities in the Stem Cell Cartilage Regeneration Market By 2029 – Sound On Sound Fest

By Stell Cell Research

New York City, NY: December 2019 Published via (Wired Release) The Stem Cell Cartilage Regeneration Market reviews offer thorough statistics about the worldwide enterprise comprising of valuable figures and stats. Further, the report provides facts starting from the bottom year (2019) and stretches till the forecast length (2020-2029). Moreover, research completed by professional experts in their domains strives tough to make the Stem Cell Cartilage Regeneration marketplace report successful. The document is essential for normal for the key contributors as well as for the brand new entrants inside the marketplace that gives in-intensity market insights. This Stem Cell Cartilage Regeneration research file has set a bench-marking example for this type of dynamic marketplace that explores several recommendations and sensible growth strategies when it comes to the marketplace.

The Stem Cell Cartilage Regeneration marketplace record documented is a rolling dice for the competition to layout strategies and become barely extra decisive to perform extra profitability by way of prioritizing the imaginative and prescient of the employer.[ Download Free PDF Sample Of This Report ]

Our Free sample report provides a brief introduction to the research report overview, TOC, list of tables and figures, an overview of major market players and key regions included.

The international Stem Cell Cartilage Regeneration marketplace file is offered in a precise style based totally on the analysis with the aid of industry professionals or specialists. The research document produced covers numerous boom prospects in recent times with linkage in the coming decades. The assumptions are made by the panels and key vendors. The Stem Cell Cartilage Regeneration marketplace on a severe note specializes in the numerous evaluation viewpoints, marketplace rankings, enterprise fore points, and business profiles that integrate together and shape a platform. The platform consists of an open dialogue panel where industry experts from variable sectors share reviews to narrow down the issues and provide you with the solutions with regards to import/export data, global sales, market rivalry, price chain analysis, and lots of more.

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Competitive Landscape:

Key players profile in the report include

Theracell (Laboratories)Orthocell LimitedXintela AB (publ)CellGenix GmbHMerck KGaAOsiris Therapeutics, Inc.BioTissue Technologies GmbHVericel CorporationSmith & Nephew plcEMD Serono, Inc.

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We have also done the product classification of the same on the basis ofstem cell type, treatment, end user, and region.

Key benefits for the stakeholders:

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2. The research file gives a qualitative and quantitative evaluation of the Stem Cell Cartilage Regeneration industry via offering accurate market length and forecast from 2020-2029.

3. The Stem Cell Cartilage Regeneration research provides benefits for the stakeholders to discover market opportunities and contemporary trends.

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5. Stem Cell Cartilage Regeneration market report throws mild at the key players and strategies to make recognize the competitive environment of the industry.

Contact Us:

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Attractive Market Opportunities in the Stem Cell Cartilage Regeneration Market By 2029 - Sound On Sound Fest

Global Stem Cell Media Market |2018-2023| Qualitative & Quantitative Analysis, Key Vendors Analysis, Reliability, Growth Innovation in Technology…

By Stell Cell Research

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The Global Stem Cell Media Market report highlights the most recent market trends. Stem Cell Media report unveils vulnerabilities that may emerge because of changes in business activities or presentation of another item in this report. It is designed in such a way that it provides an evident understanding of an industry. This Stem Cell Media market report is comprised of the combination of best industry insight, practical explanation and talent solutions. It explains research of the existing scenario of the global market, which takes into consideration numerous market dynamics. Stem Cell Media report also perceives the different drivers and limitations affecting the market amid the estimate time frame.

Stem Cell Media Market Segmentation By Type, Applications & Regions

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The global Stem Cell Media market was valued at $XX million in 2018, and analysts expect the global market size will touch $XX million by the end of 2023, growing at a CAGR of XX% between 2019 and 2023. This report runs detailed bygone analysis of global market for Stem Cell Media from 2013-2018, and offers widespread market forecasts from 2019-2023 by regions and subsectors. It covers the sales size, price, revenue, gross margin, ancient growth and future perspectives in the Stem Cell Media market.

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The Stem Cell Media market report offers key statistics information on the market situation of the Stem Cell Media Stem Cell Media companies and person involved in the industry. A Stem Cell Media Market serves an exhaustive view of size, trends and aspect have been included in this report to analyze factors that will perform a significant impact in propelling the sales of Stem Cell Media Market in the upcoming years.

A chapter-wise format in the form of numbers, graphical representations are given. The Stem Cell Media leading companies all around the world are recognized to help in-process state and direction of the business. In addition, complete Stem Cell Media information of these manufacturers and their market share by various regions, with the company and product introduction. The Stem Cell Media is a crucial source for each market segment, speculator, and other players.

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Competitive study of the major Stem Cell Media market players will help in analyzing the market driving and business strategies.

Analysis of necessary trends impacting to the build-up of the market.

The deep research study of market-based development possibilities, growth limiting factors and feasibility of investment will forecast the market growth.

Analysis of trending factors will be influencing the Market shares in the next few years.

The forecast extent for geographical divisions (regions), as well as sub-areas, will develop at the most elevated rate.

An overview of the global market for Global,Stem Cell Media Market and related technologies.

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In conclusion, it is a deep research report on Global Stem Cell Media industry. This Stem Cell Media market report covers all the aspects of market vendors, product, its multiple applications, offer clients the scope to classify feasible market possibilities to expand markets. In addition to this, the trends and revenue analysis of the global Stem Cell Media market has been mentioned in this report.

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Global Stem Cell Media Market |2018-2023| Qualitative & Quantitative Analysis, Key Vendors Analysis, Reliability, Growth Innovation in Technology...

Global Stem Cell Therapy Market to Become a Worth US$ 4759.27 Million By 2024 – E-Industry News

By Stell Cell Research

The Global Stem Cell Therapy Market Set For Rapid Growth, To Reach Around USD 4759.27 Million By 2024Research Report provides the newest industry data and industry future trends, allowing you to identify the products and end users driving Revenue growth and profitability.The global Stem Cell Therapy Market report is a systematic study of the globalStem Cell Therapy Marketintroducing the advanced state of affairs in the market as well as schemes that aid in its enlargement in the coming years. The report evaluates several factors determining the market expansion as well as the volume of the whole Stem Cell Therapy Market. The report states the aggressive vendor scenery of the market together with the profiles of some of the leading market players. The most important players in the Stem Cell Therapy Market are also discussed in the report.

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Some of the Major Stem Cell Therapy Market Players Are:

The report covers the product contributions, revenue generated, segmentation, and business summarization of the foremost players. The report provides data taking into consideration the latest improvements in the global Stem Cell Therapy Market while estimating the contribution in the market of the most important players in the near future. The report estimates the limitation and power of the leading players via SWOT analysis and assesses their growth in the market. Additionally, the key product categories and segments as well as the sub-segments of the global market are clarified in the report.

The market assessment is also estimated throughout the research as well as concludes the data using Porters five analysis on the market enlargement.Further, the report also scrutinizes the Stem Cell Therapy Market based on the manufactured goods categories and customer segments as well as the development of each segment is calculated over the predicted time.

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The report collects information accumulated from various authoritarian organizations to estimate the growth of the segments. Additionally, the study also evaluates the global Stem Cell Therapy Market on the basis of the topography and analyzes the macro- and microeconomic features determining the market expansion in every area. Furthermore, the Stem Cell Therapy Market is classified on the basis of various regions.

The Stem Cell Therapy Market segmented by regions/countries:

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1) Global Stem Cell Therapy Market share & sales assessments on the basis of regional and country level segments.

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5) Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations).

6) Competitive landscaping mapping the key trends.

7) Company profiles with their strategies, financials, and recent developments.

8) Production Supply chain trends analysis latest technological advancements.

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Objective of Studies:

1. To provide detailed analysis of the market structure along with forecast of the various segments and sub-segments of the global Stem Cell Therapy Market.

2. To provide insights about factors affecting the market growth. To analyse the Stem Cell Therapy Market based on various factors- price analysis, supply chain analysis, Porte five force analysis etc.

3. To provide historical and forecast revenue of the market segments and sub-segments with respect to four main geographies and their countries- North America, Europe, Asia, Latin America and Rest of the World.

4. To provide country level analysis of the market with respect to the current market size and future prospective.

5. To provide country level analysis of the market for segment by application, product type and sub-segments.

6. To provide strategic profiling of key players in the market, comprehensively analysing their core competencies, and drawing a competitive landscape for the market.

7. To track and analyse competitive developments such as joint ventures, strategic alliances, mergers and acquisitions, new product developments, and research and developments in the global Stem Cell Therapy Market.

Why Trust ZMRs Analytical Insights?

Target Audience of Stem Cell Therapy Market:

Manufacturer / Potential Investors

Traders, Distributors, Wholesalers, Retailers, Importers and Exporters

Association and government bodies

Also, Research Report Examines:

Thanks for reading this article; you can also get individual chapter wise section or region wise report version like North America, Europe or Asia.

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Global Stem Cell Therapy Market to Become a Worth US$ 4759.27 Million By 2024 - E-Industry News

Stem Cell Market to 2025 Analysis by Top Vendors – Space Market Research

By Stell Cell Research

OG Analysis, a global market research firm, has announced the release of their Stem Cell market outlook to 2025 report includes the latest predictions of global Stem Cell market along with geography, therapy area and applications. The report specifically focuses on different types of Stem Cell with a special attention of their emergence over the forecast period to 2025.

Browse Stem Cell Market Research Report https://www.oganalysis.com/industry-reports/217751/stem-cell-market

The research report provides objective measures to tap into the future opportunities that will be available over the next six years. It also highlights key areas to watch over the future along with detailed insights into drivers and challenges across different Stem Cell applications and products.

The Stem Cell market report aggregates the current market size based on volume and average price data. It also includes six year outlook to 2025 on the basis of anticipated growth rates for each sub segment and industry as a whole.

The base case outlook in the next six years for different types of Stem Cell, across different verticals and countries is provided. It additionally examines the key dynamics around companies, markets, along with key trends, drivers and challenges facing the Stem Cell worldwide.

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The report covers a broad region from Asia Pacific, North America, Europe, Latin America and Middle East Africa for the period of 2018 to 2025. 12 countries across these regions are analyzed independently in the Stem Cell report. Impact of domestic market conditions, price variations, competition, government policies, healthcare spending, technological and local market conditions are assessed for country level forecasts.

Global spending on healthcare continues to increase significantly with ageing population, increased access to treatment and ongoing advancements in technology. This provides strong support for Stem Cell market growth in the medium to long term future. While growth will remain steady in the developed markets, Asian and other emerging markets will be key for Stem Cell market growth from 2019 to 2025.

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To address the expanding need for advanced Stem Cell products, companies are rapidly embracing the new market dynamics, primarily focusing on new launches, specifically to suit local and regional demand patterns. Accordingly, detailed discussion about broader implications of key strategies, product launches and other latest Stem Cell market developments are included in the research work.

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OG Analysis has been a trusted research partner for 10+ years delivering most reliable analysis, information and innovative solutions. OG Analysis is one of the leading players in market research industry serving 980+ companies across multiple industry verticals. Our core client centric approach comprehends client requirements and provides actionable insights that enable users to take informed decisions.

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Stem Cell Market to 2025 Analysis by Top Vendors - Space Market Research

Aspen Neuroscience Receives $6.5M for Parkinson’s Stem Cell Therapy – Parkinson’s News Today

By Stem Cell Treatment

Aspen Neuroscience, a new biotech company, has raised $6.5 million to develop cell therapies for Parkinsons disease using patients own cells.

The company was co-founded by renowned stem cell scientists Jeanne F. Loring, PhD, and Andres Bratt-Leal, PhD, and initially supported by Summit for Stem Cell, a non-profit organization that provides a variety of services for Parkinsons patients.

Parkinsons hallmark motor symptomsinclude tremor, slowness of movement (bradykinesia), stiffness (rigidity), uncontrollable movements (dyskinesia), and poor balance.

As the disease progresses, patients typically need to gradually increase their dopaminergic therapeutic dose for maximum benefit. Even after that they might sometimes experience reappearance or worsening of symptoms due to diminishing effects of dopaminergic therapy, known was off periods.

Importantly, dopaminergic therapy is delivered to areas of the brain other than the striatum, a key motor control region severely affected in Parkinsons disease. Because of the therapys off-target behavior, patients also may experience side effects such as hallucinations or cognitive impairment.

Aspen wants to combine its expertise in stem cell biology, genomics and neurology and develop the first autologous (self) stem cell-based therapy for Parkinsons disease.

In this type of cell therapy, a patients own cells (usually skin cells) are reprogrammed back into a stem cell-like state, which allows the development of an unlimited source of almost any type of human cell needed, including dopamine-producing neurons, which are those mainly affected by this disorder.

Because these cells are derived from patients, they do not carry the risk of being rejected once re-implanted, eliminating the need for immunosuppressive complementary therapies, which carry serious side effects such as infections and possibly limiting therapeutic potential.

In theory, replacing lost dopaminergic neurons with new stem cell-derived dopamine-producing ones could potentially ease or reverse motor symptoms associated with the disease.

Aspen is developing a restorative, disease modifying autologous neuron therapy for people suffering from Parkinsons disease, Howard J. Federoff, MD, PhD, Aspens CEO, said in a press release.

We are fortunate to have such a high-caliber scientific and medical leadership team to make our treatments a reality. Our cell replacement therapy, which originated in the laboratory of Dr. Jeanne Loring and was later supported by Summit for Stem Cell and its President, Ms. Jenifer Raub, has the potential to release dopamine and reconstruct neural networks where no disease-modifying therapies exist, Federoff said.

The companys lead product (ANPD001) is undergoing investigational new drug (IND)-enabling studies for the treatment of sporadic Parkinsons disease. Aspen experts also are developing a gene-editing treatment (ANPD002) for familial forms of Parkinsons, starting with the most common genetic variant in the GBAgene, which provides instructions to make the enzyme beta-glucocerebrosidase.

The new seed funding round was led by Domain Associates and Axon Ventures, with additional participation from Alexandria Venture Investments, Arch Venture Partners, OrbiMed and Section 32, according to the press release.

With over three years of experience in the medical communications business, Catarina holds a BSc. in Biomedical Sciences and a MSc. in Neurosciences. Apart from writing, she has been involved in patient-oriented translational and clinical research.

Total Posts: 208

Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.

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