BioSpace News Archive

Biotech manufacturing is the non-glamorous side of biopharma, although its impact on the economy shouldn’t be underestimated. Here’s everything you need to know.

Former XTuit Pharmaceuticals Chief Executive Officer Deborah Dunsire has been appointed head of Denmark-based H. Lundbeck A/S.

Miracles, it seems, have a high price tag. At least, if those miracles are miracle drugs. There’s no doubt that trends in gene therapy and immuno-oncology are producing drugs that are as close to miraculous as we’re likely to get, doing a great job, generally, in beating back diseases that to this point were untreatable or didn’t respond well to other therapies.

The U.S. Food and Drug Administration withdrew its draft guidance on statistical methods to evaluate the analytical similarity between branded drugs and biosimilars.

Adamis Pharmaceuticals is selling U.S. commercial rights to Symjepi, a competitor to Mylan’s EpiPen, to Novartis.

Athenex is kicking off the second half of 2018 with a bang. The company secured $100 million in investments from Perceptive Advisors, is making major inroads in China with a joint venture with Chinese biotech Xiangxue Life Sciences and an in-licensing agreement from Avalon PolyTom Limited.

Shares of MiMedx are down more than 31 percent this morning following the abrupt resignation of Board Chairman and Chief Executive Officer Parker H. “Pete” Petit. Additionally, William C. “Bill” Taylor resigned as president and chief operating officer.

Shares of Alkermes plc are climbing in premarket trading after the company announced the U.S. Food and Drug Administration approved Aristada Initio (aripiprazole lauroxil) as part of a combination treatment for schizophrenia.

It’s been a pretty good year for mergers and acquisitions in the biopharma industry. But the landscape for IPOs has been excellent as well, particularly in Massachusetts, which has recorded 13 IPOs since the beginning of the year.

Roche announced that its Phase III IMpassion130 clinical trial met its co-primary endpoint of progression-free survival (PFS) in triple-negative breast cancer (TNBC).