00:06 , Jul 24, 2019 |  BC Extra  |  Company News

July 23 Company Quick Takes: FDA approves Pfizer’s Rituxan biosimilar; plus Intra-Cellular, OTC Tamiflu, Cimzia and more

Pfizer’s Rituxan biosimilar approved in U.S.  FDA approved Ruxience rituximab-pvvr from Pfizer Inc. (NYSE:PFE) for non-Hodgkin lymphoma, chronic lymphocytic leukemia and granulomatosis with polyangitis and microscopic polyangitis. Ruxience is the second biosimilar of Rituxan, an...
00:04 , Jul 19, 2019 |  BC Extra  |  Financial News

Genmab’s plans after $500M NASDAQ debut

European bellwether Genmab plans to use a large chunk of the $505.9 million it raised through its listing on NASDAQ Thursday to fuel clinical development and commercialization of antibody-drug conjugate tisotumab vedotin (HuMax-TF-ADC). Two other...
02:23 , May 18, 2019 |  BioCentury  |  Product Development

AAVs on the brink: Charting the clinical landscape of in vivo gene therapies

Gene therapy is finally teetering on the edge of becoming a drug development mainstay, with at least nine AAV-based therapies in Phase III or II/III testing. An analysis of the AAV therapies in the clinic...
22:12 , May 3, 2019 |  BC Extra  |  Financial News

Junshi aims to list on Shanghai's new innovation board

Four months after its Hong Kong IPO, Junshi is looking to access a broader band of investors through a listing on the Shanghai stock exchange’s new science and technology innovation board. Junshi Biosciences Co. Ltd....
21:58 , Apr 26, 2019 |  BioCentury  |  Product Development

Rise of the independents, biotechs go to market

While product launch and commercialization has largely been the province of big biotech and big pharma, with smaller companies partnering to get their products over the finish line, BioCentury’s analysis of recent FDA approvals finds...
23:40 , Apr 8, 2019 |  BC Extra  |  Company News

Management tracks: WuXi AppTec, Kymab, Acceleron

WuXi AppTec Co. Ltd. (Shanghai:603259; HKSE:2359) hired Frederick Hausheer as CMO. He was CEO of Alpha Omega Oncology Services (San Antonio, Texas) and an associate partner at Alacrita Consulting (Waltham, Mass.). Antibody company Kymab Group...
15:46 , Jan 17, 2019 |  BC Extra  |  Politics & Policy

FDA removes a barrier to OTC naloxone development

To make it easier for drug manufacturers to develop over-the-counter naloxone, FDA released Thursday two model consumer-friendly Drug Facts labels that companies can use to gain OTC approval. This is the first time FDA has...
03:08 , Jan 5, 2019 |  BioCentury  |  Politics, Policy & Law

Budget woes may linger at FDA

The partial government shutdown is hurting patients and drug companies by preventing FDA from accepting most new drug applications, and the harm may not end when the budget stalemate is resolved. While it isn’t clear...
03:38 , Dec 8, 2018 |  BioCentury  |  Finance

Moderna’s land grab

A blockbuster IPO by Moderna Inc. (NASDAQ:MRNA) gives the company the opportunity to make the case for mRNA. With more money, and a broader and more advanced pipeline than other players in the mRNA space,...
13:51 , Nov 19, 2018 |  BioCentury  |  Regulation

FDA to apply light touch to biopharma apps

Concerned that regulatory uncertainty is preventing biopharma companies from developing digital tools that could help patients manage their health, FDA plans to exempt a broad range of apps and other software from premarket review. In...