BioCentury | Jun 25, 2020
Deals

June 24 Quick Takes: CSL pays $450M for uniQure’s hemophilia gene therapy; plus Merck-Yumanity, Editas, Compass-Olivia, Century-Empirica, Tetraphase-La Jolla

CSL gets global rights to uniQure gene therapy  CSL Ltd. (ASX:CSL) is paying $450 million up front for an exclusive, worldwide license to commercialize etranacogene dezaparvovec (AMT-061) from uniQure N.V. (NASDAQ:QURE), which is also eligible...
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 | May 8, 2020
Product Development

May 7 Quick Takes: Gaboxadol meets in Phase II for Fragile X; plus Innovent, Lilly, Tetraphase and more

Ovid’s gaboxadol meets in Phase II for Fragile X   Ovid Therapeutics Inc. (NASDAQ:OVID) said gaboxadol (OV101) met its primary safety endpoint and reduced behavioral and functional symptoms in the Phase II ROCKET trial to...
BioCentury | Mar 17, 2020
Product Development

March 16 Quick Takes: FDA raises efficacy questions for DBV allergy therapy; plus Novo, Provention, UCB, Pfizer-EMD Serono, Zai, AcelRx-Tetraphase, Medivir-Tan

DBV expects delay for peanut allergy product  DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) said the Aug. 5 PDUFA date for its peanut allergy therapy may be extended as FDA has raised questions on the long-term efficacy...
BC Extra | Aug 28, 2019
Company News

Aug. 28 Company Quick Takes: Amgen to appeal Repatha ruling and EcoR1 buys Woodford’s stake in Prothena; plus DarwinHealth-Celgene, CRISPR IP, Trevena and Shink

Repatha patents invalid, court finds  Amgen Inc. (NASDAQ:AMGN) said it will appeal after a federal court found that its patents covering anti-PCSK9 mAb Repatha evolocumab are invalid on the basis of lack of enablement. The...
BioCentury | Mar 9, 2019
Regulation

Gottlieb’s exit interview

FDA Commissioner Scott Gottlieb sat down with BioCentury after announcing his resignation to discuss his approach to promoting medical product innovation, the importance of strategic communications, and how a reorganization will bring FDA drug reviews...
BC Extra | Jan 15, 2019
Company News

Management tracks: Immunocore gains second ex-AZ exec

Immunocore Ltd. (Abingdon, U.K.) said it hired David Berman in September as head of R&D. Berman was SVP and head of immuno-oncology at AstraZeneca plc (LSE:AZN; NYSE:AZN), and before that was head of early stage...
BioCentury | Jan 12, 2019
Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
BC Week In Review | Nov 9, 2018
Clinical News

FDA approves AcelRx, Coherus, Pfizer Products, rebuffs Trevena's Olinvo

FDA approved products from Coherus Biosciences Inc. (NASDAQ:CHRS), AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) and Pfizer Inc. (NYSE:PFE) on Nov. 2, but issued a complete response letter to an NDA from Trevena Inc. (NASDAQ:TRVN). Coherus was up...
BC Extra | Nov 2, 2018
Company News

FDA approves AcelRx, Coherus, Pfizer products, rebuffs Trevena's Olinvo

FDA approved products from Coherus Biosciences Inc. (NASDAQ:CHRS), AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) and Pfizer Inc. (NYSE:PFE) on Friday, but issued a complete response letter to an NDA from Trevena Inc. (NASDAQ:TRVN). Coherus was up $0.70...
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BioCentury | Jun 25, 2020
Deals

June 24 Quick Takes: CSL pays $450M for uniQure’s hemophilia gene therapy; plus Merck-Yumanity, Editas, Compass-Olivia, Century-Empirica, Tetraphase-La Jolla

CSL gets global rights to uniQure gene therapy  CSL Ltd. (ASX:CSL) is paying $450 million up front for an exclusive, worldwide license to commercialize etranacogene dezaparvovec (AMT-061) from uniQure N.V. (NASDAQ:QURE), which is also eligible...
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 | May 8, 2020
Product Development

May 7 Quick Takes: Gaboxadol meets in Phase II for Fragile X; plus Innovent, Lilly, Tetraphase and more

Ovid’s gaboxadol meets in Phase II for Fragile X   Ovid Therapeutics Inc. (NASDAQ:OVID) said gaboxadol (OV101) met its primary safety endpoint and reduced behavioral and functional symptoms in the Phase II ROCKET trial to...
BioCentury | Mar 17, 2020
Product Development

March 16 Quick Takes: FDA raises efficacy questions for DBV allergy therapy; plus Novo, Provention, UCB, Pfizer-EMD Serono, Zai, AcelRx-Tetraphase, Medivir-Tan

DBV expects delay for peanut allergy product  DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) said the Aug. 5 PDUFA date for its peanut allergy therapy may be extended as FDA has raised questions on the long-term efficacy...
BC Extra | Aug 28, 2019
Company News

Aug. 28 Company Quick Takes: Amgen to appeal Repatha ruling and EcoR1 buys Woodford’s stake in Prothena; plus DarwinHealth-Celgene, CRISPR IP, Trevena and Shink

Repatha patents invalid, court finds  Amgen Inc. (NASDAQ:AMGN) said it will appeal after a federal court found that its patents covering anti-PCSK9 mAb Repatha evolocumab are invalid on the basis of lack of enablement. The...
BioCentury | Mar 9, 2019
Regulation

Gottlieb’s exit interview

FDA Commissioner Scott Gottlieb sat down with BioCentury after announcing his resignation to discuss his approach to promoting medical product innovation, the importance of strategic communications, and how a reorganization will bring FDA drug reviews...
BC Extra | Jan 15, 2019
Company News

Management tracks: Immunocore gains second ex-AZ exec

Immunocore Ltd. (Abingdon, U.K.) said it hired David Berman in September as head of R&D. Berman was SVP and head of immuno-oncology at AstraZeneca plc (LSE:AZN; NYSE:AZN), and before that was head of early stage...
BioCentury | Jan 12, 2019
Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
BC Week In Review | Nov 9, 2018
Clinical News

FDA approves AcelRx, Coherus, Pfizer Products, rebuffs Trevena's Olinvo

FDA approved products from Coherus Biosciences Inc. (NASDAQ:CHRS), AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) and Pfizer Inc. (NYSE:PFE) on Nov. 2, but issued a complete response letter to an NDA from Trevena Inc. (NASDAQ:TRVN). Coherus was up...
BC Extra | Nov 2, 2018
Company News

FDA approves AcelRx, Coherus, Pfizer products, rebuffs Trevena's Olinvo

FDA approved products from Coherus Biosciences Inc. (NASDAQ:CHRS), AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) and Pfizer Inc. (NYSE:PFE) on Friday, but issued a complete response letter to an NDA from Trevena Inc. (NASDAQ:TRVN). Coherus was up $0.70...
Items per page:
1 - 10 of 150