BioCentury | Jul 24, 2020
Regulation

Data Bytes: CHMP’s July recommendations

Among the 11 new medicines recommended for approval by EMA’s CHMP is the first antibody-drug conjugate, and most advanced BCMA-targeted agent, for multiple myeloma patients: GSK’s Blenrep belantamab mafodotin. FDA’s Oncologic Drugs Advisory Committee unanimously...
BioCentury | Jun 24, 2020
Finance

Expect more company creation by BGV with its €105M fourth fund

BioGeneration Ventures is the latest in a string of European early-stage VCs raising upsized funds that give them the ability to commit more capital to portfolio companies and retain larger stakes longer. The firm also...
BioCentury | Jun 11, 2020
Product Development

J&J picks up pace for Warp Speed COVID-19 vaccine

One Operation Warp Speed finalist is advancing its COVID-19 vaccine into the clinic two months earlier than planned as the U.S. initiative looks to a 170-year-old company to produce glass packaging for countermeasures. Meanwhile, a...
BioCentury | Apr 30, 2020
Product Development

U.K.’s ACCORD platform trial to feed therapies into COVID-19 master protocols

The U.K. has launched the ACCORD platform trial to quickly test potential COVID-19 treatments that could be fast-tracked into larger master protocol trials. The Accelerating COVID-19 Research & Development platform (ACCORD) study is a nationwide...
BioCentury | Apr 15, 2020
Product Development

AZ targeting cytokine storms as ranks of repurposed agents for COVID-19 grow

AstraZeneca joins the growing list of companies targeting cytokine storms caused by COVID-19 with plans to start a trial of its Btk inhibitor to treat patients with severe disease. The announcement came Tuesday amid another...
BC Extra | Dec 9, 2019
Company News

With $2.7B ArQule buyout, Merck is latest pharma to jump into Btk race

With its proposed acquisition of ArQule, Merck will join the ranks of at least three other pharmas adding Btk inhibitors to their portfolios while appearing to pay much less than its peers. The $2.7 billion...
BC Extra | Nov 23, 2019
Company News

Nov. 22 Company Quick Takes: AZ’s Btk inhibitor gains expanded approval; plus WuXi Vaccines, SK Bio, ViiV, Horizon and Neon

Label expansion for AZ’s Calquence under Project ORBIS  FDA approved an sNDA for Calquence acalabrutinib from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat chronic lymphocytic leukemia and small lymphocytic leukemia under the agency’s Real-Time Oncology Review...
BC Extra | Nov 15, 2019
Company News

BeiGene enters U.S. market with first approval for in-house pipeline

With its first approval for an internally developed drug, BeiGene faces tough competition as it seeks to carve out a niche for Brukinsa. But the third-to-market Btk inhibitor could have an edge on efficacy without...
BC Extra | May 7, 2019
Clinical News

May 7 Clinical Quick Takes: AZ, Merck, Osmotica, AlzeCure

AZ's Calquence meets in Phase III for CLL  AstraZeneca plc (LSE:AZN; NYSE:AZN) said an interim analysis of the Phase III ASCEND trial to treat relapsed or refractory chronic lymphocytic leukemia showed that Calquence acalabrutinib as...
BioCentury | Jan 5, 2019
Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
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