​

 

BioPharma Global Welcomes Melanie Wexler
Biopharma Global gladly welcomes Melanie Wexler, our new Client Development Executive, to the team. At BPG, Melanie handles both HR Consulting and Talent Acquisition in the biotech and pharmaceutical space. Melanie has a strong background in successfully working with privately held companies, not-for-profit corporations and Fortune 500 clients alike. She is personally interested in the advancement of scientific studies, healthcare, biotech and medical research which gives her a unique edge when speaking with domestic and international clients both large and small.

Click here to contact Melanie for any hiring needs you might have.

Our Chat with Health Professional Radio
Biopharma Global Board Chair Carolyn Thompson and CEO James LaFLamme recently sat down with Neal Howard at Health Professional Radio to discuss orphan drugs, the FDA/EMA approval process, and rare disease research.

Click here to listen

Highlights from the Orphan Disease Space
FDA Outlines Innovation initiative

The FDA and its new Trump-picked commissioner Scott Gottlieb took to social media to talk up the agency’s plans to speed up the drug regulation process.

Full Article
Bluebird Bio Sees EU as its First Market

Bluebird Bio plans to bring its gene therapies to market in Europe before the U.S., thanks to a favorable regulatory pathway. Bluebird’s head of Europe, Andrew Obenshain, says the company is already in negotiations with the EMA and the MHRA on possible regulatory filings.

Full Article
Selvita and the LLS Announce Partnership


Selvita S.A. and The Leukemia & Lymphoma Society (LLS) announced a partnership to co-fund further preclinical and clinical development of a targeted therapy to treat patients with acute myeloid leukemia (AML).

Full Article
 

The First CAR-T Therapy Submitted to EMA

Kite Pharma, Inc. announced that it has submitted a Marketing Authorization Application (MAA) to the EMA for axicabtagene ciloleucel for severe forms of B-cell lymphoma. This application represents the first CAR-T therapy submitted to the EMA.

Full Article

Congratulations to the Following Companies who Recently Received an Orphan Drug Designation:
FDA:

Silvergate Pharmaceuticals, Inc., Bristol-Myers Squibb Company, BioMarin Pharmaceutical, Inc., Bayer HealthCare Pharmaceuticals, Inc., Horizon Pharma USA, Inc., Novartis, ARIAD Pharmaceuticals, Inc., Novatech SA, Mitsubishi Tanabe Pharma Corporation, NX Development Corporation, Janssen Biotech, Inc., Genentech, Inc., CSL Behring LLC, Arbor Pharmaceuticals, LLC, Emmaus Medical, Inc.

EMA:

Vall d’Hebron Institute of Research, Hôpital Foch, Sentinel Oncology Limited, PhaseRx Ireland, Mithra Pharmaceuticals S.A., Igenomix, S.L., Bluebird Bio France, IntraBio Ltd, GB Pharma Srl, NeoImmuneTech, Inc, Miragen Therapeutics Europe Ltd, Advicenne Pharma SA, Zealand Pharma A/S, Vale Pharmaceuticals Limited, ChemoCentryx Limited
Want to see your company’s name on these lists? Need Breakthrough Therapy designation, Fast Track Designation, RMAT Designation, FDA or EMA Orphan Designations? The BioPharma Global Regulatory Team can help – We are the #1 US based not-for-profit Global regulatory affairs firm with cost-effective, time-efficient solutions to chaperone your path through the regulatory affairs process. 

Contact us today: https://biopharmaglobal.com/contact or by phone +1(202)660-1826 

Biopharma Global |1934 Old Gallows Road, Suite 404 | Vienna, VA 22182