MacroGenics to Participate in Upcoming Investor Conferences

ROCKVILLE, MD, Nov. 09, 2020 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences in November and December:

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MacroGenics to Participate in Upcoming Investor Conferences

Supernus Provides Regulatory Updates for SPN-812 and SPN-830

ROCKVILLE, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced regulatory updates for SPN-812 (viloxazine hydrochloride) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age, and SPN-830 (apomorphine infusion pump) for the continuous treatment of motor fluctuations (“on-off” episodes) in Parkinson’s disease (PD).

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Supernus Provides Regulatory Updates for SPN-812 and SPN-830

Praxis Precision Medicines Provides Regulatory Update On PRAX-114 Program

CAMBRIDGE, Mass., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance, today announced that it has received a response from the U.S. Food and Drug Administration (FDA) on the Investigational New Drug (IND) submission for PRAX-114 for the treatment of major depressive disorder (MDD).

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Praxis Precision Medicines Provides Regulatory Update On PRAX-114 Program

Minaris invests to triple capacity in Europe – Bioprocess Insider – BioProcess Insider

The cell and gene therapy CDMO will build additional facilities at its German and Japanese locations.

The contract development and manufacturing organization (CDMO) specializing in cell and gene therapies announced two separate investments of $40.7 million (34.2 million) into its Ottobrunn, Germany, site, and $23.8 million for its Yokohama, Japan, site.

Both regions now come under the umbrella of Minaris Regenerative Medicine, a subsidiary of Showa Denko Materials, after a rebrand in September to unify the name of its three businesses located in North America (previously, Hitachi Chemical Advanced Therapeutics Solutions (HCATS)), Europe (apceth Biopharma), and Japan (Hitachi Chemical).

Image: iStock/oatawa

The Japanese company acquired apceth last year for $86 million and will now add a 6,650-square-meter facility to the German site. The space will include additional clean rooms, quality control laboratories, warehousing, cryo-storage and office space.

Once operational in 2023, the facility will more than triple the current clean room capacity.

A spokesperson for Minaris explained that the facility will feature a modular design, which allows the company to combine two smaller units into one large ball room and to shift from a grade B to grade C to grade B environment according to our clients needs.

The European site became one of the first CDMOs to manufacture a commercial gene therapy, after agreeing a deal with bluebird bio to manufacture its Zynteglo (autologous CD34+ cells encoding A-T87Q-globin gene) product last year.

While the companys Japanese site will also receive an additional facility, which will cover 4,000-square-meters and is scheduled to start operations in October 2022.

The space will be used specifically for the commercial manufacture of regenerative medicine, particularly cancer immunotherapies and somatic stem cells, doubling the sites existing capacity.

Minaris global presence for a cell and gene specialist is unusual for an industry often concentrated in the US. However, the spokesperson for Minaris outlined that a global position confers an advantage to our clients that are seeking a global manufacturer to produce their product in different regions for example, clients with autologous cell products that need a manufacturing site close to the patients.

Additionally, We have regulatory expertise in Europe, Japan and the US and can leverage the expertise of one region to another, the spokesperson added.

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Minaris invests to triple capacity in Europe - Bioprocess Insider - BioProcess Insider

Cell Therapy Manufacturing Market: Applications and Regional Insights During the Forecasted Period 2020-2030 – PRnews Leader

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Australia, New Zealand, Rest of Asia-Pacific

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harmicell, Merck Group, Dickinson and Company, Thermo Fisher, Lonza Group, Miltenyi Biotec GmBH, Takara Bio Group, STEMCELL Technologies, Cellular Dynamics International, Becton, Osiris Therapeutics, Bio-Rad Laboratories, Inc., Anterogen, MEDIPOST, Holostem Terapie Avanazate, Pluristem Therapeutics, Brammer Bio, CELLforCURE, Gene Therapy Catapult EUFETS, MaSTherCell, PharmaCell, Cognate BioServices and WuXi AppTec.

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Human Embryonic Stem Cells (HESC) Market 2020 Manufacturer Analysis, Emerging Trends, Top Companies and Forecast to 2027 – TechnoWeekly

Human Embryonic Stem Cells (HESC) Market Size And Forecast

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Human Embryonic Stem Cells (HESC) Market 2020 Manufacturer Analysis, Emerging Trends, Top Companies and Forecast to 2027 - TechnoWeekly