Protocols

Biogen snatches ex-Pfizer exec as new EVP, corporate development; Ionis/Akcea get thumbs up from EMA committee on inotersen

→ Biogen has snagged an ex-Pfizer executive to lead as their new executive vice president of corporate development, a newly created position designed to head up business development and strategy at Biogen. Daniel Karp was previously VP of worldwide business development and head of business dev for R&D at Pfizer, a company he’s been within varying roles for the past 13 years. There, he led a global team doing early science transactions, along with partnerships and acquisitions across Pfizer’s research portfolio.

Daniel Karp

“It’s a privilege to join Biogen, a true leader in neuroscience,” Karp said in a statement.  “I’m excited to work with Biogen’s innovative and talented team as we work to expand the company’s portfolio of therapies for people living with serious neurodegenerative diseases.”

At Biogen, he’ll be part of the executive committee, reporting to the CEO Michel Vounatsos. “Daniel’s solid experience from Pfizer combined with his scientific and business education will serve him well in this exciting position as we aim to further build our pipeline and portfolio to tackle unmet needs in neurological diseases,” Vounatsos said.

→ Ionis$IONS majority-owned spinout Akcea $AKCA got the thumbs up from the EMA’s Committee for Medicinal Products for Human Use on its bid for the approval of inotersen in Europe. The drug, now with the branded name Tegsedi, is meant to treat polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). With the committee’s blessing, Akcea will now be looking to the European Commission, which grants marketing authorization in the EU. Inotersen is also under regulatory review in Canada and the US. Its US PDUFA is in October, trailing a bit behind Alnylam’s August PDUFA on its rival drug patisiran.

→ Amgen is teaming up with researchers at MD Anderson in an effort to accelerate their development efforts on leukemia, myelodysplastic syndromes, multiple myeloma, small-cell lung cancer, and other non-lung cancers with small-cell histologies. Amgen is bringing their bispecific T cell engager (BiTE), CAR-T cell and small molecule programs to the table.

→ With growing evidence that immunotherapies may not be so effective in bladder cancer cases with low PD-L1 expression, the EMA is recommending that docs curtail their frontline use of Merck’s Keytruda and Roche’s Tecentriq. Chemo may be the best way to start.


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