Two University of Chicago Medicine physicians elected to National Academy of Medicine for 2019 – Newswise

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Newswise Two University of Chicago faculty members,Vineet Arora, MD, MAPP, andErnst Lengyel, MD, PhD, have been elected tomembership in the National Academy of Medicine.

Election to the NAM is considered one of the highest honors in the fields of health and medicine, and acknowledges individuals who have demonstrated outstanding scientific and professional achievement in biology, medicine and related fields, saidKenneth S. Polonsky, MD, the Richard T. Crane Distinguished Service Professor, Dean of the Division of the Biological Sciences and the Pritzker School of Medicine, and Executive Vice President for Medical Affairs. With the results of the current election, there are now 19 current or emeritus University of Chicago faculty who are members of the NAM.

Arora is an academic hospitalist and medical educator who specializes in improving the learning environment for medical trainees and the quality, safety and experience of care delivered to hospitalized adults. She is a Professor in the Department of Medicine and serves as Associate Chief Medical Officer for the Clinical Learning Environment at the University of Chicago Medicine and Assistant Dean for Scholarship and Discovery at the Pritzker School of Medicine. She joined the UChicago faculty in 2004.

Aroras work bridges clinical medicine and medical education to transform the learning environment and the quality of care delivered in teaching hospitals. She is an internationally recognized expert on patient handoffs in health care and also has broad expertise in using technology, such as social media, to improve medical education. She has served as principal investigator of numerous federal and foundation grants that explore novel scientific approaches to improving patient care while also enhancing workplace learning in teaching hospitals.

Arora is an elected member to the American Society of Clinical Investigation, which recognizes physician-scientists for an outstanding record of scholarly achievement in biomedical research, and serves on the American Board of Internal Medicine Board of Directors. As an advocate for gender equity across health care, she has leadership roles in several organizations dedicated to advancing women leaders and combating sexual harassment in health care, including Women of Impact, TIME'S UP Healthcare and the National Academies of Science, Engineering, and Medicines Action Collaborative on Sexual Harassment in Higher Education.

Lengyel is a gynecologic oncologist and expert in the diagnosis and treatment of ovarian cancer. He is the Arthur L. and Lee G. Herbst Professor of Obstetrics and Gynecology and is Chair of the Department of Obstetrics and Gynecology at the University of Chicago. He joined the UChicago faculty in 2004.

Lengyel is a clinically active surgeon. His research is focused on understanding the biological basis of metastasis and in characterizing the metabolic changes that occur in ovarian cancer cells. His laboratory employs high throughput screening using sophisticated organotypic 3D models to evaluate the efficacy and mechanisms of action of new compounds in preclinical models to prepare for their translation to the clinic. His research team also applies advanced -omics techniques to characterize differences between primary and metastatic ovarian cancer in human tumor tissue to gain broad insights into ovarian cancer biology and develop a rationale for ovarian cancer treatments.

Ina 2019 study published inNature, Lengyel and his colleagues described a new treatment target that could prevent the rapid spread of high-grade serous carcinoma, the most common and deadly form of ovarian cancer, which originates in the fallopian tubes or ovaries and spreads throughout the abdominal cavity. This project is being further developed toward clinical testing by the NCI Experimental Therapeutics (NExT) program. His research team is also part of the Human Cell Atlas,a project supported by the Chan Zuckerberg Initiativeto map all of the cells in the human body. The team will characterize the different cell types in the female reproductive tract to understand the origins of gynecological diseases like fibroids, endometriosis or cancer.

TheNational Academy of Medicine, established in 1970 as the Institute of Medicine, is an independent organization of eminent professionals from diverse fields including health, biology, medicine and related fields. It serves alongside theNational Academy of Sciencesand theNational Academy of Engineeringas a scientific and policy adviser to the nation and the international community.

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Two University of Chicago Medicine physicians elected to National Academy of Medicine for 2019 - Newswise

Vertex Announces Reimbursement of Cystic Fibrosis Medicines SYMDEKO (tezacaftor/ivacaftor and ivacaftor) for Eligible Patients Ages 12 and Older, and…

LONDON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced that SYMDEKO (tezacaftor/ivacaftor and ivacaftor) is reimbursed in Australia for people with cystic fibrosis (CF) ages 12 years and older who are homozygous for the F508del mutation or who have one copy of the F508del mutation and another responsive residual function (RF) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. People with CF who have one copy of the F508del mutation and another responsive RF mutation in the CFTR gene will have access to a medicine for the cause of their CF for the first time. In addition, ORKAMBI (lumacaftor/ivacaftor) is now also reimbursed for the treatment of children with CF ages 2 to 5 who have two copies of the F508del mutation in the CFTR gene. Patients over the age of 6 have already been able to access ORKAMBI in Australia since October 2018.

Following previously received positive recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), eligible patients in Australia will be able to access both medicines immediately, and the medicines will be listed on the Pharmaceutical Benefits Scheme (PBS) from December 1st.

We are pleased that SYMDEKO and ORKAMBI will be made available immediately to eligible cystic fibrosis patients in Australia. We appreciate that the PBAC has recognized the value of these medicines to patients and thank the Department of Health and the Minister for Health in Australia for their strong engagement and collaboration to finalize the agreement, said Ludovic Fenaux, Senior Vice President, Vertex International.

Vertexs CF medicines are reimbursed in 17 countries around the world including Austria, Denmark, Germany, the Republic of Ireland, Italy, the Netherlands, Sweden and the U.S.

About CFCystic Fibrosis (CF) is a rare, life-shortening genetic disease affecting approximately 75,000 people worldwide. CF is a progressive, multi-system disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes one from each parent to have CF. While there are many different types of CFTR mutations that can cause the disease, the vast majority of all people with CF have at least one F508del mutation. These mutations, which can be determined by a genetic test, or genotyping test, lead to CF by creating non-working and/or too few CFTR proteins at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median age of death is in the early 30s.

About SYMDEKO (tezacaftor/ivacaftor) in combination with ivacaftorSome mutations result in CFTR protein that is not processed or folded normally within the cell, and that generally does not reach the cell surface. Tezacaftor is designed to address the trafficking and processing defect of the CFTR protein to enable it to reach the cell surface and ivacaftor is designed to enhance the function of the CFTR protein once it reaches the cell surface.

Mutations in the CFTR gene, responsive to SYMDEKO, that are currently registered in Australia include F508del/f and P67L, R117C, L206W, R352Q, A455E, D579G, 711+3AG, S945L, S977F, R1070W, D1152H, 2789+5GA, 3272-26AG, 3849+10kbCT, E56K, R74W, D110E, D110H, E193K, E831X, F1052V, K1060T, A1067T, F1074L and D1270N.

About ORKAMBI (lumacaftor/ivacaftor) and the F508del mutationIn people with two copies of the F508del mutation, the CFTR protein is not processed and trafficked normally within the cell, resulting in little-to-no CFTR protein at the cell surface. Patients with two copies of the F508del mutation are easily identified by a simple genetic test. Lumacaftor/ivacaftor is a combination of lumacaftor, which is designed to increase the amount of mature protein at the cell surface by targeting the processing and trafficking defect of the F508del-CFTR protein, and ivacaftor, which is designed to enhance the function of the CFTR protein once it reaches the cell surface.

About VertexVertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has three approved medicines that treat the underlying cause of cystic fibrosis (CF) a rare, life-threatening genetic disease and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational medicines in other serious diseases where it has deep insight into causal human biology, such as sickle cell disease, beta thalassemia, pain, alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy and APOL1-mediated kidney diseases.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London, UK. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including nine consecutive years on Science magazine's Top Employers list and top five on the 2019 Best Employers for Diversity list by Forbes.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, the statements in the second and third paragraphs of the press release. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy or other reasons, and other risks listed under Risk Factors in Vertex's annual report and subsequent quarterly reports filed with the Securities and Exchange Commission and available through the company's website at http://www.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

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Vertex Announces Reimbursement of Cystic Fibrosis Medicines SYMDEKO (tezacaftor/ivacaftor and ivacaftor) for Eligible Patients Ages 12 and Older, and...

FDA Approves TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older…

Today marks a milestone for CF patients, their families and Vertex. After a 20-year journey together, we have received FDA approval of TRIKAFTA: a single breakthrough medicine with the potential to treat up to 90% of all people with CF in the future. For approximately 6,000 people with CF in the U.S., TRIKAFTA is the first medicine that can treat the underlying cause of their disease, said Jeffrey Leiden, M.D., Ph.D., Vertex's Chairman, President and Chief Executive Officer. I want to personally thank the hundreds of Vertex scientists who have been working on this program for nearly 20 years many of whom have dedicated their entire careers to changing the course of this disease; the CF Foundation which has provided support, encouragement and help throughout the journey; and most importantly the thousands of patients, caregivers, doctors and advocates who have courageously and persistently worked side-by-side with us to get to where we are today.

Todays approval is a historic moment in cystic fibrosis care, with the potential for more people to benefit from CFTR modulator therapy to treat the basic defect of their disease, said Steven Rowe, M.D., Director, Gregory Fleming James Cystic Fibrosis Research Center, University of Alabama at Birmingham. In clinical trials, TRIKAFTA was generally well tolerated and demonstrated improvements in multiple outcome measures in CF, including improvements in FEV1, improvements in respiratory symptoms and, in the 24-week F/MF study, a reduced rate of pulmonary exacerbations and improvements in BMI.

The incredible speed of this approval underscores our shared sense of urgency with the FDA and the CF community for bringing this medicine to eligible people with CF, particularly those without a medicine targeting the underlying cause of their disease, said Reshma Kewalramani, M.D., Executive Vice President, Global Medicines Development and Medical Affairs and Chief Medical Officer at Vertex. We remain committed to relentlessly pursuing the development of transformative therapies for all people living with this disease.

Vertex has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the elexacaftor/tezacaftor/ivacaftor combination regimen. Vertex is currently evaluating elexacaftor/tezacaftor/ivacaftor in people ages 6 through 11 with F/MF and F/F CF mutations in an ongoing Phase 3 study and is committed to evaluating elexacaftor/tezacaftor/ivacaftor in children <6 years of age as part of planned future studies.

For more information on Vertexs patient assistance program, please visit VertexGPS.com.

About TRIKAFTA TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients ages 12 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if TRIKAFTA is safe and effective in children under 12 years of age. TRIKAFTA is designed to increase the quantity and function of the F508del-CFTR protein at the cell surface. The approval of TRIKAFTA was supported by positive results of two global Phase 3 studies in people ages 12 years and older with CF: a 24-week Phase 3 study in 403 people with one F508del mutation and one minimal function mutation (F/MF) and a 4-week Phase 3 study in 107 people with two F508del mutations (F/F).

Helping Patients Access TRIKAFTA The people who work at Vertex understand that medicines can only help people who can get them. The Vertex Guidance & Patient Support (Vertex GPS) program provides a team of Vertex employees dedicated to helping eligible people in the United States who have been prescribed our medicines understand their insurance benefits and the resources that are available to help them.

Vertex also offers a co-pay assistance program for eligible people with commercial insurance coverage and a free medicine program for qualifying people who meet certain income and other eligibility criteria. More information is available by visiting http://www.VertexGPS.com or by calling 1-877-752-5933.

About Cystic Fibrosis Cystic Fibrosis (CF) is a rare, life-shortening genetic disease affecting approximately 75,000 people worldwide. CF is a progressive, multi-system disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes one from each parent to have CF. While there are many different types of CFTR mutations that can cause the disease, the vast majority of all people with CF have at least one F508del mutation. These mutations, which can be determined by a genetic test, or genotyping test, lead to CF by creating non-working and/or too few CFTR proteins at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median age of death is in the early 30s.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) TABLETS TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if TRIKAFTA is safe and effective in children under 12 years of age.

Patients should not take TRIKAFTA if they take certain medicines, such as: antibiotics such as rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; St. Johns wort.

Before taking TRIKAFTA, patients should tell their doctor about all of their medical conditions, including if they: have kidney problems, have or have had liver problems, are pregnant or plan to become pregnant because it is not known if TRIKAFTA will harm an unborn baby, or are breastfeeding or planning to breastfeed because it is not known if TRIKAFTA passes into breast milk.

TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. Therefore, the dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Patients should especially tell their doctor if they take: antifungal medicines including ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; antibiotics including telithromycin, clarithromycin, or erythromycin; other medicines including rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. Johns wort.

TRIKAFTA may cause dizziness in some people who take it. Patients should not drive a car, operate machinery, or do anything that requires alertness until they know how TRIKAFTA affects them.

Patients should avoid food or drink that contains grapefruit while they are taking TRIKAFTA.

TRIKAFTA can cause serious side effects, including:

High liver enzymes in the blood, which is a common side effect in people treated with TRIKAFTA. These can be serious and may be a sign of liver injury. The patients doctor will do blood tests to check their liver before they start TRIKAFTA, every 3 months during the first year of taking TRIKAFTA, and every year while taking TRIKAFTA. Patients should call their doctor right away if they have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of the skin or the white part of the eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine.

Abnormality of the eye lens (cataract) in some children and adolescents treated with TRIKAFTA. If the patient is a child or adolescent, their doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts.

The most common side effects of TRIKAFTA include headache, diarrhea, upper respiratory tract infection (common cold) including stuffy and runny nose, stomach (abdominal) pain, inflamed sinuses, increase in liver enzymes, increase in a certain blood enzyme called creatine phosphokinase, rash, flu (influenza), and increase in blood bilirubin.

These are not all the possible side effects of TRIKAFTA. Please click here to see the full Prescribing Information for TRIKAFTA.

About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has four approved medicines that treat the underlying cause of cystic fibrosis (CF) - a rare, life-threatening genetic disease - and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational medicines in other serious diseases where it has deep insight into causal human biology, such as sickle cell disease, beta thalassemia, pain, alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy and APOL1-mediated kidney diseases.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London, UK. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including nine consecutive years on Science magazine's Top Employers list and top five on the 2019 Best Employers for Diversity list by Forbes. For company updates and to learn more about Vertex's history of innovation, visit http://www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.

Special Note Regarding Forward-looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, the statements by Dr. Leiden in the second paragraph, Dr. Rowe in the third paragraph, and Dr. Kewalramani in the fourth paragraph and statements regarding Vertexs current and future plans to study elexacaftor/tezacaftor/ivacaftor in the fifth paragraph of this press release. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy or other reasons, obtaining approval and commercializing elexacaftor/tezacaftor/ivacaftor in Europe, developing additional medicines to treat cystic fibrosis, and other risks listed under Risk Factors in Vertex's annual report and subsequent quarterly reports filed with the Securities and Exchange Commission and available through the company's website at http://www.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

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FDA Approves TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older...

Genentech’s Tecentriq in Combination With Avastin Increased Overall Survival and Progression-free Survival in People With Unresectable Hepatocellular…

Oct. 21, 2019 05:00 UTC

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMbrave150 study, evaluating Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as a treatment for people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy, met both of its co-primary endpoints demonstrating statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) compared with standard-of-care sorafenib.

Safety for the combination of Tecentriq and Avastin was consistent with the known safety profiles of the individual medicines, with no new safety signals identified. Data from the IMbrave150 study will be presented at an upcoming medical meeting.

We are very pleased with the results of our study testing the combination of Tecentriq and Avastin, which marks the first treatment in more than a decade to improve overall survival in people with unresectable hepatocellular carcinoma who have not received prior systemic therapy, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. HCC is a major cause of death globally and particularly in Asia, making this study an important step in our mission of addressing unmet medical needs for patients around the world. We will submit these data to global health authorities as soon as possible. Our hope is to bring a new treatment to people with this aggressive disease who currently have limited options.

In July 2018, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for Tecentriq in combination with Avastin in HCC based on data from an ongoing Phase Ib trial.

Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMbrave150 study

IMbrave150 is a global Phase III, multicenter, open-label study of 501 people with unresectable HCC who have not received prior systemic therapy. People were randomized 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq was administered intravenously, 1200 mg on day 1 of each 21-day cycle, and Avastin was administered intravenously, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib was administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle. People received the combination or the control arm treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Co-primary endpoints were OS and PFS by independent review facility (IRF) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Secondary efficacy endpoints included overall response rate (ORR), time to progression (TTP) and duration of response (DoR), as measured by RECIST v1.1 (investigator-assessed [INV] and IRF) and HCC mRECIST (IRF), as well as patient-reported outcomes (PROs), safety and pharmacokinetics.

About hepatocellular carcinoma

According to the American Cancer Society, it is estimated that more than 42,000 Americans will be diagnosed with liver cancer in 2019. Liver cancer incidence has more than tripled since 1980 and HCC accounts for approximately 75% of all liver cancer cases in the United States. HCC develops predominantly in people with cirrhosis due to chronic hepatitis (B and C) or alcohol consumption, and typically presents at an advanced stage where there are limited treatment options.

About the Tecentriq and Avastin combination

There is a strong scientific rationale to support further investigation of Tecentriq plus Avastin in combination. Avastin, in addition to its anti-angiogenic effects, may further enhance Tecentriqs ability to restore anti-cancer immunity by inhibiting vascular endothelial growth factor (VEGF)-related immunosuppression, promoting T-cell tumor infiltration and enabling priming and activation of T-cell responses against tumor antigens.

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

About Avastin (bevacizumab)

Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumors ability to grow and spread in the body (metastasize).

Tecentriq U.S. Indications

Tecentriq is a prescription medicine used to treat adults with:

A type of bladder and urinary tract cancer called urothelial carcinoma. Tecentriq may be used when your bladder cancer:

The approval of Tecentriq in these patients is based on a study that measured response rate and duration of response. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

A type of lung cancer called non-small cell lung cancer (NSCLC).

A type of breast cancer called triple-negative breast cancer (TNBC).

Tecentriq may be used with the medicine paclitaxel protein-bound when your breast cancer:

The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients disease worsened. Continued approval for this use may depend on results of an ongoing study to confirm benefit.

A type of lung cancer called small cell lung cancer (SCLC).

It is not known if Tecentriq is safe and effective in children.

Important Safety Information

What is the most important information about Tecentriq?

Tecentriq can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life threatening and can lead to death.

Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.

Tecentriq can cause serious side effects, including:

Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if patients have severe side effects.

Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used alone include:

The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

The most common side effects of Tecentriq when used in triple-negative breast cancer with paclitaxel protein-bound include:

Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects.

Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Report side effects to Genentech at 1-888-835-2555.

Please visit http://www.Tecentriq.com for the Tecentriq full Prescribing Information for additional Important Safety Information.

Avastin is approved for:

Avastin in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (prOC) in women who received no more than two prior chemotherapy treatments.

Avastin, either in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by Avastin alone, is approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (psOC)

Possible serious side effects

Everyone reacts differently to Avastin therapy. So, its important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Their doctor will stop treatment if any serious side effects occur. Patients should contact their health care team if there are any signs of these side effects.

Side effects seen most often

In clinical studies across different types of cancer, some patients experienced the following side effects:

Avastin is not for everyone

Patients should talk to their doctor if they are:

Patients should talk with their doctor if they have any questions about their condition or treatment.

Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Report side effects to Genentech at 1-888-835-2555.

For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com.

About Genentech in personalized cancer immunotherapy

For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, were investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer. The goal of PCI is to provide each person with a treatment tailored to harness his or her own immune system to fight cancer. Genentech is currently studying more than 10 cancer immunotherapy medicines across 70 clinical trials alone or in combination with other medicines. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visit http://www.gene.com/cancer-immunotherapy.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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Genentech's Tecentriq in Combination With Avastin Increased Overall Survival and Progression-free Survival in People With Unresectable Hepatocellular...

The global regenerative medicine market size is expected to reach USD 5.60 billion by 2025, expanding at a CAGR of 11.6% over the forecast period -…

NEW YORK, Oct. 21, 2019 /PRNewswire/ --

Regenerative Medicine Market Size, Share & Trends Analysis By Product (Primary Cell-based, Stem & Progenitor Cell-based), By Therapeutic Category (Dermatology, Oncology) And Segment Forecasts, 2019 - 2025

Read the full report: https://www.reportlinker.com/p05807250/?utm_source=PRN

The global regenerative medicine market size is expected to reach USD 5.60 billion by 2025, expanding at a CAGR of 11.6% over the forecast period. Regenerative medicines are expected to have a significant impact in healthcare to treat specific indications and chronic conditions. Therefore, high prevalence of cancer, neurodegenerative, orthopedic, and other aging-associated disorders coupled with increasing global geriatric population is driving the market growth. Moreover, rising prevalence of inheritable genetic diseases is anticipated to fuel the demand in the field of biotechnology field.

Market players are engaged in implementing novel protocols for the release of novel therapeutics. For instance, in July 2018, Convelo Therapeutics launched regenerative medicines for the treatment of various neurological diseases, such as multiple sclerosis.Agreements models initiated by the companies coupled with commercialization in emerging countries fuels the growth. For instance, in March 2018, Hitachi Chemical signed an agreement with the Daiichi Sankyo and SanBio Group to conduct clinical manufacturing of regenerative medicines developed by respective companies for Japanese and U.S. markets.

Regenerative medicine is anticipated to witness great attention in healthcare sector due to its wide range of applications and significant advancements tissue engineering, stem cells, gene therapy, drug discovery, and nanotechnology. For example, 3D printing is preferred over scaffold with stem cells to restore structure and functional characteristics of biological specimens.

Dermatology is estimated to hold the largest market share in terms of revenue in 2018, owing to the availability of various products and their application in simple and chronic wound healing. Oncology therapeutic category on the other hand, is projected to expand at the fastest CAGR during the forecast period owing to the presence of strong pipeline of regenerative medicines for cancer treatment.

North America held the largest regenerative medicine market share in terms of revenue in 2018 and is projected to continue its dominance in near future. A significant number of universities and research organizations investigating various stem cell-based approaches for regenerative apposition in U.S. is anticipated to propel the growth.

Further key findings from the report suggest: Therapeutics emerged dominant among product segments in 2018 due to high usage of primary cell-based therapies along with advances in stem cell and progenitor cell therapies Implementation of primary cell-based therapies in dermatological, musculoskeletal, and dental application results in highest share of this segment Stem cell and progenitor cell-based therapies are anticipated to witness rapid growth due to high investments in stem cell research and increasing number of stem cell banks With rise in R&D and clinical trials, key players are offering consulting services leading to lucrative growth of the services segment Asia Pacific is projected to witness the fastest CAGR during the forecast period due to rapid adoption of cell-based approaches in healthcare and emergence of key players Key players operating in the regenerative medicine market including AstraZeneca; F Hoffmann-La Roche Ltd.; Pfizer Inc.; Merck & Co., Inc.; Integra LifeSciences Corporation; and Eli Lilly and Company

Read the full report: https://www.reportlinker.com/p05807250/?utm_source=PRN

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15 Antiviral Herbs to Keep You Healthy – Healthline

Since ancient times, herbs have been used as natural treatments for various illnesses, including viral infections.

Due to their concentration of potent plant compounds, many herbs help fight viruses and are favored by practitioners of natural medicine.

At the same time, the benefits of some herbs are only supported by limited human research, so you should take them with a grain of salt.

Here are 15 herbs with powerful antiviral activity.

Oregano is a popular herb in the mint family thats known for its impressive medicinal qualities. Its plant compounds, which include carvacrol, offer antiviral properties.

In a test-tube study, both oregano oil and isolated carvacrol reduced the activity of murine norovirus (MNV) within 15 minutes of exposure (1).

MNV is highly contagious and the primary cause of stomach flu in humans. It is very similar to human norovirus and used in scientific studies because human norovirus is notoriously difficult to grow in laboratory settings (2).

Oregano oil and carvacrol have also been shown to exhibit antiviral activity against herpes simplex virus type-1 (HSV-1); rotavirus, a common cause of diarrhea in infants and children; and respiratory syncytial virus (RSV), which causes respiratory infections (3, 4, 5).

Also a member of the mint family, sage is an aromatic herb that has long been used in traditional medicine to treat viral infections (6).

The antiviral properties of sage are mostly attributed to compounds called safficinolide and sage one, which are found in the leaves and stem of the plant (7).

Test-tube research indicates that this herb may fight human immunodeficiency virus type 1 (HIV-1), which can lead to AIDS. In one study, sage extract significantly inhibited HIV activity by preventing the virus from entering target cells (8).

Sage has also been shown to combat HSV-1 and Indiana vesiculovirus, which infects farm animals like horses, cows, and pigs (9, 10).

Many types of basil, including the sweet and holy varieties, may fight certain viral infections.

For example, one test-tube study found that sweet basil extracts, including compounds like apigenin and ursolic acid, exhibited potent effects against herpes viruses, hepatitis B, and enterovirus (11).

Holy basil, also known as tulsi, has been shown to increase immunity, which may help fight viral infections.

In a 4-week study in 24 healthy adults, supplementing with 300 mg of holy basil extract significantly increased levels of helper T cells and natural killer cells, both of which are immune cells that help protect and defend your body from viral infections (12).

Fennel is a licorice-flavored plant that may fight certain viruses.

A test-tube study showed that fennel extract exhibited strong antiviral effects against herpes viruses and parainfluenza type-3 (PI-3), which causes respiratory infections in cattle (13).

Whats more, trans-anethole, the main component of fennel essential oil, has demonstrated powerful antiviral effects against herpes viruses (14).

According to animal research, fennel may also boost your immune system and decrease inflammation, which may likewise help combat viral infections (15).

Garlic is a popular natural remedy for a wide array of conditions, including viral infections.

In a study in 23 adults with warts caused by human papillomavirus (HPV), applying garlic extract to affected areas twice daily eliminated the warts in all of them after 12 weeks (16, 17).

Additionally, older test-tube studies note that garlic may have antiviral activity against influenza A and B, HIV, HSV-1, viral pneumonia, and rhinovirus, which causes the common cold. However, current research is lacking (18).

Animal and test-tube studies indicate that garlic enhances immune system response by stimulating protective immune cells, which may safeguard against viral infections (19).

Lemon balm is a lemony plant thats commonly used in teas and seasonings. Its also celebrated for its medicinal qualities.

Lemon balm extract is a concentrated source of potent essential oils and plant compounds that have antiviral activity (20).

Test-tube research has shown that it has antiviral effects against avian influenza (bird flu), herpes viruses, HIV-1, and enterovirus 71, which can cause severe infections in infants and children (8, 20, 21, 22, 23).

Peppermint is known to have powerful antiviral qualities and commonly added to teas, extracts, and tinctures meant to naturally treat viral infections.

Its leaves and essential oils contain active components, including menthol and rosmarinic acid, which have antiviral and anti-inflammatory activity (24).

In a test-tube study, peppermint-leaf extract exhibited potent antiviral activity against respiratory syncytial virus (RSV) and significantly decreased levels of inflammatory compounds (25).

Rosemary is frequently used in cooking but likewise has therapeutic applications due to its numerous plant compounds, including oleanolic acid (26).

Oleanolic acid has displayed antiviral activity against herpes viruses, HIV, influenza, and hepatitis in animal and test-tube studies (27).

Plus, rosemary extract has demonstrated antiviral effects against herpes viruses and hepatitis A, which affects the liver (28, 29).

Echinacea is one of the most popularly used ingredients in herbal medicine due to its impressive health-promoting properties. Many parts of the plant, including its flowers, leaves, and roots, are used for natural remedies.

In fact, Echinacea purpurea, a variety that produces cone-shaped flowers, was used by Native Americans to treat a wide array of conditions, including viral infections (30).

Several test-tube studies suggest that certain varieties of echinacea, including E. pallida, E. angustifolia, and E. purpurea, are particularly effective at fighting viral infections like herpes and influenza (31).

Notably, E. purpurea is thought to have immune-boosting effects as well, making it particularly useful for treating viral infections (30).

Sambucus is a family of plants also called elder. Elderberries are made into a variety of products, such as elixirs and pills, that are used to naturally treat viral infections like the flu and common cold.

A study in mice determined that concentrated elderberry juice suppressed influenza virus replication and stimulated immune system response (32).

Whats more, in a review of 4 studies in 180 people, elderberry supplements were found to substantially reduce upper respiratory symptoms caused by viral infections (33).

Licorice has been used in traditional Chinese medicine and other natural practices for centuries.

Glycyrrhizin, liquiritigenin, and glabridin are just some of the active substances in licorice that have powerful antiviral properties (34).

Test-tube studies demonstrate that licorice root extract is effective against HIV, RSV, herpes viruses, and severe acute respiratory syndrome-related coronavirus (SARS-CoV), which causes a serious type of pneumonia (35, 36, 37).

Astragalus is a flowering herb popular in traditional Chinese medicine. It boasts Astragalus polysaccharide (APS), which has significant immune-enhancing and antiviral qualities (38).

Test-tube and animal studies show that astragalus combats herpes viruses, hepatitis C, and avian influenza H9 virus (39, 40, 41, 42).

Plus, test-tube studies suggest that APS may protect human astrocyte cells, the most abundant type of cell in the central nervous system, from infection with herpes (38).

Ginger products, such as elixirs, teas, and lozenges, are popular natural remedies and for good reason. Ginger has been shown to have impressive antiviral activity thanks to its high concentration of potent plant compounds.

Test-tube research demonstrates that ginger extract has antiviral effects against avian influenza, RSV, and feline calicivirus (FCV), which is comparable to human norovirus (43, 44, 45)

Additionally, specific compounds in ginger, such as gingerols and zingerone, have been found to inhibit viral replication and prevent viruses from entering host cells (46).

Ginseng, which can be found in Korean and American varieties, is the root of plants in the Panax family. Long used in traditional Chinese medicine, it has been shown to be particularly effective at fighting viruses.

In animal and test-tube studies, Korean red ginseng extract has exhibited significant effects against RSV, herpes viruses, and hepatitis A (47, 48, 49).

Plus, compounds in ginseng called ginsenosides have antiviral effects against hepatitis B, norovirus, and coxsackieviruses, which are associated with several serious diseases including an infection of the brain called meningoencephalitis (49).

Dandelions are widely regarded as weeds but have been studied for multiple medicinal properties, including potential antiviral effects.

Test-tube research indicates that dandelion may combat hepatitis B, HIV, and influenza (50, 51, 52).

Moreover, one test-tube study noted that dandelion extract inhibited the replication of dengue, a mosquito-borne virus that causes dengue fever. This disease, which can be fatal, triggers symptoms like high fever, vomiting, and muscle pain (53, 54).

Herbs have been used as natural remedies since ancient times.

Common kitchen herbs, such as basil, sage, and oregano, as well as lesser-known herbs like astragalus and sambucus, have powerful antiviral effects against numerous viruses that cause infections in humans.

Its easy to add these powerful herbs to your diet by using them in your favorite recipes or making them into teas.

However, keep in mind that most research has been conducted in test tubes and animals using concentrated extracts. Therefore, its unclear whether small doses of these herbs would have the same effects.

If you decide to supplement with extracts, tinctures, or other herbal products, consult your healthcare provider to ensure safe usage.

Continued here:
15 Antiviral Herbs to Keep You Healthy - Healthline

Kidney Cancer: What Is New in the Second-Line Treatment Setting? – Curetoday.com

Dr. Camillo Porta discussed what is new in kidney cancer beyond the first line of treatment at A Vision of Hope: A Kidney Cancer Educational Symposium.

BY Kristie L. Kahl

At A Vision of Hope: A Kidney Cancer Educational Symposium hosted by the Judy Nicholson Kidney Cancer Symposium and Penn Medicine Abramson Cancer Center Porta discussed what is new in kidney cancer beyond the first line of treatment.

Second-line treatment, he explained, occurs when the first line of therapy has failed in doing its job to control tumor progression. This is always a tough moment for patients with cancer, like the entire world is on the edge of falling on his/her head, Porta added. For the vast majority of you, fortunately, this is not true. This is an unpleasant, but obliged step in your personal war against cancer.

He noted that it has been clear that a benefit in overall survival has been seen among those treated with a sequence of active treatment, not just by a single agent. The number of patients receiving more than two lines of therapy is increasing and this often leads to long survival times, Porta explained.

Some treatments that have been evaluated for the second-line treatment of kidney cancer include Sutent (sunitinib), Votrient (pazopanib), Nexavar (sorafenib), Avastin (bevacizumab plus interferon, Inlyta (axitinib), Afinitor (everolimus), Lenvima (lenvatinib) plus Afinitor and Bevencio (avelumab) plus Inlyta. However, these therapeutic options have only shown a benefit in improving progression-free survival (the time from treatment to disease progression or worsening). In a subgroup of patients, Torisel (temsirolimus) monotherapy, Yervoy (ipilimumab) plus Opdivo (nivolumab) and Keytruda (pembrolizumab) plus Inlyta have prolonged overall survival in the first-line setting, while Opdivo and Cabometyx (cabozantinib) have also done so in the second-line setting.

With so many options, Porta noted that not all physicians are equal, but patients are. (Patients) simply want to live longer and better. Whatever better means to each of them, he said, adding that this is why physicians are focused on capturing quality of life in patient-reported outcomes.

The trade-off between benefits, like survival gain, and harms, like treatment-related toxicities, in the second-line setting is a trade-off a patient is willing to accept and is often different compared with things that are usually accepted by a newly diagnosed patient, Porta explained. Safety and quality of life are usually more important in later treatment lines, though. Of course, this is not a universal rule.

Therefore, the treatment experience in the second-line setting, like receiving a more gentle agent, is key in selecting which therapeutic option to use.

Luckily, renal cell carcinoma is an angiogenesis-driven tumor throughout the entirety of disease. Meaning that after the failure of an antiangiogenic agent, another can be active and continue to control disease progression, Porta said. This is a true paradigm shift from the era of cytotoxic chemotherapy.

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Kidney Cancer: What Is New in the Second-Line Treatment Setting? - Curetoday.com