BioCentury | Jul 10, 2020
Product Development

Evive meets in Phase III for chemotherapy-induced neutropenia; plus regulatory updates for Biogen, Eisai, Merck, AZ

Evive planning BLA, MAA for neutropenia therapy following pivotal trial readout  Evive Biotech Inc. said efbemalenograstim alfa met the primary and secondary endpoints in a Phase III study to prevent chemotherapy-induced neutropenia in breast cancer...
BioCentury | Jul 6, 2020
Product Development

U.K. may be near 60M dose deal with Sanofi, GSK for second COVID-19 vaccine partnership

The U.K. is reportedly in talks to secure access to a second COVID-19 vaccine, this time from GlaxoSmithKline and Sanofi, as concerns grow over vaccine nationalism. The government has already partnered with AstraZeneca plc (LSE:AZN;...
BioCentury | Jul 2, 2020
Product Development

July 1 Quick Takes: Amgen gains on court win; plus Hua, J&J, argenx, Seattle Genetics-Genmab, Interprotein

Appeals court upholds Enbrel patents  Amgen Inc. (NASDAQ:AMGN) shares rose 8% Wednesday, adding more than $11 billion to the company’s market cap, after the U.S. Court of Appeals for the Federal Circuit upheld a 2019...
BioCentury | Jul 2, 2020
Finance

CRISPR, Acceleron follow-ons among year’s largest

A pair of biotechs priced upsized follow-on offerings late Tuesday, with CRISPR Therapeutics and Acceleron each raising $450 million, good for a tie for the year’s tenth-largest follow-on financing. CRISPR Therapeutics AG (NASDAQ:CRSP) sold 6.4...
BioCentury | Jul 1, 2020
Regulation

June 30 Quick Takes: Another first for Ultragenyx; plus approvals for Genentech’s Phesgo, Keytruda, Bavencio and Ultomiris

Ultragenyx’s Dojolvi wins FDA approval for rare disease FDA approved Dojolvi triheptanoin (UX007) from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat long-chain fatty acid oxidation disorders, making it the first drug approved for the indication. The...
BioCentury | Jun 30, 2020
Product Development

Vertex, NHS in deal to make CF triplet available in England once EC approves

It took four years for Vertex to reach an agreement with England’s NHS for access to its first combination cystic fibrosis therapy. But there won’t be any wait for the biotech’s highly anticipated triple therapy...
BioCentury | Jun 26, 2020
Regulation

Data Bytes: CHMP’s June opinions

A recommendation by EMA’s CHMP suggests remdesivir from Gilead Sciences Inc. (NASDAQ:GILD) could soon gain a speedy conditional approval to treat COVID-19. The committee announced the decision this week along with a basket of other...
BioCentury | Jun 26, 2020
Management Tracks

Saunders joins BridgeBio’s board; plus changes at BioXcel, FibroGen, Storm, Athenex, Seres, Chimerix and Catalyst

Brent Saunders has joined the the board of BridgeBio Pharma Inc. (NASDAQ:BBIO); he was chairman, president and CEO of Allergan plc in 2015-20 until its takeout by AbbVie Inc. (NYSE:ABBV) in May. The genetic diseases...
BioCentury | Jun 26, 2020
Product Development

Gilead goes for lung delivery of remdesivir, earlier COVID-19 disease stage

As European approval of IV remdesivir fast approaches, Gilead said it will begin evaluating an inhaled formulation of the antiviral drug -- a path that could take it out of the hospital. The move comes...
BioCentury | Jun 25, 2020
Regulation

With deep experience at the EC and WHO, Cooke primed to lead EMA amid pandemic

When Emer Cooke takes the reigns of EMA at year-end, she’ll be faced with navigating the agency through year two of the pandemic and the first full year of a post-Brexit relationship with the U.K....
Items per page:
1 - 10 of 2578
BioCentury | Jul 10, 2020
Product Development

Evive meets in Phase III for chemotherapy-induced neutropenia; plus regulatory updates for Biogen, Eisai, Merck, AZ

Evive planning BLA, MAA for neutropenia therapy following pivotal trial readout  Evive Biotech Inc. said efbemalenograstim alfa met the primary and secondary endpoints in a Phase III study to prevent chemotherapy-induced neutropenia in breast cancer...
BioCentury | Jul 6, 2020
Product Development

U.K. may be near 60M dose deal with Sanofi, GSK for second COVID-19 vaccine partnership

The U.K. is reportedly in talks to secure access to a second COVID-19 vaccine, this time from GlaxoSmithKline and Sanofi, as concerns grow over vaccine nationalism. The government has already partnered with AstraZeneca plc (LSE:AZN;...
BioCentury | Jul 2, 2020
Product Development

July 1 Quick Takes: Amgen gains on court win; plus Hua, J&J, argenx, Seattle Genetics-Genmab, Interprotein

Appeals court upholds Enbrel patents  Amgen Inc. (NASDAQ:AMGN) shares rose 8% Wednesday, adding more than $11 billion to the company’s market cap, after the U.S. Court of Appeals for the Federal Circuit upheld a 2019...
BioCentury | Jul 2, 2020
Finance

CRISPR, Acceleron follow-ons among year’s largest

A pair of biotechs priced upsized follow-on offerings late Tuesday, with CRISPR Therapeutics and Acceleron each raising $450 million, good for a tie for the year’s tenth-largest follow-on financing. CRISPR Therapeutics AG (NASDAQ:CRSP) sold 6.4...
BioCentury | Jul 1, 2020
Regulation

June 30 Quick Takes: Another first for Ultragenyx; plus approvals for Genentech’s Phesgo, Keytruda, Bavencio and Ultomiris

Ultragenyx’s Dojolvi wins FDA approval for rare disease FDA approved Dojolvi triheptanoin (UX007) from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat long-chain fatty acid oxidation disorders, making it the first drug approved for the indication. The...
BioCentury | Jun 30, 2020
Product Development

Vertex, NHS in deal to make CF triplet available in England once EC approves

It took four years for Vertex to reach an agreement with England’s NHS for access to its first combination cystic fibrosis therapy. But there won’t be any wait for the biotech’s highly anticipated triple therapy...
BioCentury | Jun 26, 2020
Regulation

Data Bytes: CHMP’s June opinions

A recommendation by EMA’s CHMP suggests remdesivir from Gilead Sciences Inc. (NASDAQ:GILD) could soon gain a speedy conditional approval to treat COVID-19. The committee announced the decision this week along with a basket of other...
BioCentury | Jun 26, 2020
Management Tracks

Saunders joins BridgeBio’s board; plus changes at BioXcel, FibroGen, Storm, Athenex, Seres, Chimerix and Catalyst

Brent Saunders has joined the the board of BridgeBio Pharma Inc. (NASDAQ:BBIO); he was chairman, president and CEO of Allergan plc in 2015-20 until its takeout by AbbVie Inc. (NYSE:ABBV) in May. The genetic diseases...
BioCentury | Jun 26, 2020
Product Development

Gilead goes for lung delivery of remdesivir, earlier COVID-19 disease stage

As European approval of IV remdesivir fast approaches, Gilead said it will begin evaluating an inhaled formulation of the antiviral drug -- a path that could take it out of the hospital. The move comes...
BioCentury | Jun 25, 2020
Regulation

With deep experience at the EC and WHO, Cooke primed to lead EMA amid pandemic

When Emer Cooke takes the reigns of EMA at year-end, she’ll be faced with navigating the agency through year two of the pandemic and the first full year of a post-Brexit relationship with the U.K....
Items per page:
1 - 10 of 2578