21:45 , Sep 21, 2018 |  BC Extra  |  Company News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP Friday recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta Therapeutics (NASDAQ:SRPT) for...
15:21 , Sep 20, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Prostate cancer Patient sample and cell culture studies suggest inhibiting BDNF-TrkB signaling could help treat prostate cancer in African-American patients. In prostate fibroblasts isolated from four African-American patients, levels of BDNF were higher than in...
17:24 , Sep 14, 2018 |  BC Week In Review  |  Company News

Sanofi creating China/emerging markets and primary care units

Sanofi (Euronext:SAN; NYSE:SNY) said it will create two new global business units early next year, one focused on China and emerging markets and the other on primary care. The China and emerging markets unit will be...
22:44 , Sep 13, 2018 |  BC Week In Review  |  Financial News

Kodiak files for IPO

Ophthalmic company Kodiak Sciences Inc. (Palo Alto, Calif.) filed to raise $100 million in an IPO on NASDAQ underwritten by Morgan Stanley, BofA Merrill Lynch, Barclays and Chardan. Using its antibody biopolymer conjugate (ABC) platform, Kodiak...
22:19 , Sep 13, 2018 |  BC Extra  |  Company News

Sanofi creating China/emerging markets and primary care units

Sanofi (Euronext:SAN; NYSE:SNY) said it will create two new global business units early next year, one focused on China and emerging markets and the other on primary care. The China and emerging markets unit will be...
19:46 , Sep 12, 2018 |  BC Extra  |  Company News

Management tracks: Clearside, ImCheck

Clearside Biomedical Inc. (NASDAQ:CLSD) hired Leslie Zacks as general counsel and chief compliance officer. He was VP, general counsel and chief compliance officer at Arbor Pharmaceuticals Inc. (Atlanta, Ga.). Clearside plans to submit an NDA...
02:07 , Sep 10, 2018 |  BC Extra  |  Financial News

With anti-VEGF challenger in clinic, Kodiak files for IPO

Ophthalmic company Kodiak Sciences Inc. (Palo Alto, Calif.) filed to raise $100 million in an IPO on NASDAQ underwritten by Morgan Stanley, BofA Merrill Lynch, Barclays and Chardan. Using its antibody biopolymer conjugate (ABC) platform, Kodiak...
22:55 , Sep 7, 2018 |  BC Extra  |  Company News

Amid launch troubles, Portola commercial chief Fu resigns

With its stock price near its 52-week low amid a disappointing launch of anticoagulant Bevyxxa betrixaban, Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said EVP and Chief Commercial and Business Officer Tao Fu is resigning to pursue other...
18:51 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

J&J's Xarelto misses in pair of Phase III trials in acute medically ill and heart failure patients

Johnson & Johnson (NYSE:JNJ) reported that anticoagulant Xarelto rivaroxaban missed the primary endpoints in both the Phase III MARINER and COMMANDER HF trials. Data were presented at the European Society of Cardiology meeting in Munich...
18:02 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

FDA approves Bayer's recombinant Factor VIII for hemophilia A

FDA approved a BLA from Bayer AG (Xetra:BAYN) for Jivi damoctocog alfa pegol (BAY94-9027) to treat hemophilia A in patients ages 12 and older. Bayer told BioCentury the product will be launched the first week...