BioCentury | Aug 6, 2020
Regulation

GSK first across finish line in closely watched BCMA race

Despite toxicity concerns, FDA approved GSK’s BCMA-targeted antibody-drug conjugate Blenrep late Wednesday, making it the first in a new class of drugs for multiple myeloma. The accelerated approval for GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) didn’t come...
BioCentury | Jul 14, 2020
Deals

July 13 Quick Takes: Spudich, Rutter to lead start-up Kainomyx; plus deals for Ovid-Angelini, Dewpoint-Merck and Kiadis-Sanofi

Spudich, Rutter to lead start-up focused on parasitic diseases Kainomyx Inc. emerged from stealth Monday to discover and develop small molecules to treat malaria and other parasitic diseases. Co-founded in September by President and CEO...
BioCentury | Jun 23, 2020
Product Development

June 22 Quick Takes: Invitae acquiring ArcherDX; plus lymphoma approval for Karyopharm, Merck, Nabriva, Myovant, Assembly-AbbVie, Genentech and more

ArcherDX picks deal with Invitae over IPO Genetic testing company Invitae (NYSE:NVTA) is acquiring ArcherDX Inc., adding a cancer diagnostics platform to its precision oncology business. ArcherDX’s shareholders will receive $325 million in cash plus...
BioCentury | Jun 6, 2020
Product Development

June 5 Quick Takes: Merck, Tetraphase-Melinta, Apeiron, Neurasic, Jounce, Genmab-J&J

UCB buying Engage for $125M UCB S.A. (Euronext:UCB) acquired Engage Therapeutics Inc. Friday, gaining Staccato alprazolam, a drug-inhaler combo in Phase II testing for the rapid termination of epileptic seizures. Engage will receive $125 million...
BioCentury | Jun 2, 2020
Product Development

Sanofi makes case for why its first cancer drug in a decade can take on Darzalex

Carving a space in the crowded multiple myeloma market for recently approved Sarclisa is one of the four pillars of Sanofi’s strategy for re-entering oncology, and the company believes new data strengthen the case for...
BioCentury | May 13, 2020
Product Development

May 12 Quick Takes: Skyhawk, Merck expand deal; plus Sanofi’s Sarclisa and clinical updates drive gains for Gamida, CymaBay

Autoimmune, metabolic diseases added to Skyhawk-Merck deal Skyhawk Therapeutics Inc. expanded a collaboration with Merck & Co. Inc. (NYSE:MRK) to discover and develop small molecules that modulate RNA splicing for autoimmune and metabolic diseases; the...
BioCentury | May 1, 2020
Regulation

As first subcutaneous anti-CD38 mAb, Darzalex Faspro secures J&J’s lead in MM, shaves hours off infusion time

FDA’s approval of a subcutaneous form of Darzalex secures J&J’s leading position in the anti-CD38 market just two months after a new entrant threatened to cut into its market share. It’s also a game changer...
BioCentury | Mar 3, 2020
Product Development

Sanofi sees first fruit of renewed oncology commitment with Sarclisa approval

Sarclisa isatuximab will be the first oncology drug Sanofi launches in more than a decade, its approval Monday marking the pharma’s first cancer win after its re-entry into the space. The company’s next step is...
BioCentury | Mar 3, 2020
Product Development

Following Phase III readout, Karyopharm seeks approval of Xpovio for second-line MM

Karyopharm gained $11.38 (70%) to $27.72 on Monday, adding about $746 million in market value, after announcing that Xpovio selinexor met the primary endpoint of improving PFS in the confirmatory Phase III BOSTON trial to...
BioCentury | Jan 22, 2020
Company News

Jan. 21 Company Quick Takes: First BCMA-targeted therapy gets Priority Review from FDA; plus Roche-Seattle Genetics, AZ-Merck, Chi-Med

Priority Review for GSK's anti-BCMA therapy in MM GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said FDA granted Priority Review to a BLA for belantamab mafodotin to treat fourth-line relapsed or refractory multiple myeloma in patients who have...
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