Shire sets its peer group
With a $1.6 billion breakup fee in hand from erstwhile merger partner AbbVie Inc. (NYSE:ABBV), Shire plc (LSE:SHP; NASDAQ:SHPG) on Friday reiterated its prospects as an independent company focused on rare and specialty diseases, comparing its business development strategy to the paths taken by Gilead Sciences Inc. (NASDAQ:GILD), Biogen Idec Inc. (NASDAQ:BIIB) and Celgene Corp. (NASDAQ:CELG).
Unlike FDA panel, CHMP backs AZ's olaparib
EMA's CHMP recommended marketing authorization of Lynparza olaparib from AstraZeneca plc (LSE:AZN; NYSE:AZN) as maintenance treatment of platinum-sensitive relapsed ovarian, fallopian tube or peritoneal cancer in patients with germline breast cancer early onset (BRCA) mutations who are responding to platinum-based chemotherapy. If approved, the therapy would be the first poly(ADP-ribose) polymerase (PARP) inhibitor available in the indication.
CHMP wants more warnings for Ariad's Iclusig
EMA's CHMP recommended stronger warnings concerning risks of blood clots and arterial blockage with use of leukemia drug Iclusig ponatinib from Ariad Pharmaceuticals Inc. (NASDAQ:ARIA). CHMP's opinion endorses a similar recommendation from EMA's Pharmacovigilance Risk Assessment Committee (PRAC) earlier this month.
CHMP recommends Clinuvel's Scenesse
EMA's CHMP recommended marketing authorization under exceptional circumstances for Scenesse afamelanotide from Clinuvel Pharmaceuticals Ltd. (ASX:CUV; Xetra:UR9) to treat phototoxicity in patients with erythropoietic protoporphyria (EPP), a disorder characterized by extreme sensitivity to sunlight.
Baxter's Rixubis gets CHMP nod for hemophilia B
EMA's CHMP recommended marketing authorization of Rixubis (BAX 326) from Baxter International Inc. (NYSE:BAX) to treat and prevent bleeding in patients with hemophilia B. Approval will include a pharmacovigilance plan.
PureTech Ventures (Boston, Mass.) named Robert Horvitz, Joi Ito and Raju Kucherlapati as senior partners.
Coherus sets IPO terms
Biosimilars developer Coherus Biosciences Inc. (Redwood City, Calif.) set terms for its IPO on NASDAQ and plans to sell 6.3 million shares at $12-$15. At $13.50 Coherus would raise $85 million and be valued at $432.7 million. JPMorgan; Credit Suisse; and Cowen are underwriters.
Angion withdraws IPO
Angion Biomedica Corp. (Uniondale, N.Y.) withdrew its proposed IPO on NASDAQ, citing market conditions. In June, the company amended its IPO to sell 2.7 million shares at $10-$12. At $11, the company would have raised $30 million and been valued at $73.1 million. In April, Angion filed to raise up to $34.5 million. Aegis Capital was the sole underwriter.