BioCentury | May 13, 2020
Product Development

Gilead secures global access to remdesivir via generic manufacturing deals

The first manufacturing deals for Gilead’s remdesivir, plus a series of grants for institutions across Europe to develop COVID-19 diagnostics and therapeutics, highlight the importance of global collaboration to tackle the pandemic. Gilead Sciences Inc....
BioCentury | Apr 23, 2020
Finance

Market recalibrates Biogen’s valuation as aducanumab filing is delayed

Biogen’s aducanumab roller-coaster ride continued Wednesday as investors reassessed the risk for the Alzheimer’s therapy following a roughly six-month delay for the company’s BLA submission. Biogen Inc. (NASDAQ:BIIB) disclosed Wednesday plans to push back an...
BioCentury | Mar 20, 2020
Product Development

Industry to boost supply of chloroquine, hydroxychloroquine despite limited data in COVID-19

Novartis and Teva join a growing list of pharmas with plans to ramp up supply of antimalarial drug hydroxychloroquine in the U.S. for COVID-19 despite sparse clinical data supporting the drug's efficacy in the indication....
BioCentury | Mar 19, 2020
Politics, Policy & Law

FDA urged to follow science, not hope, in quest for COVID-19 cures

Former FDA Commissioner Margaret Hamburg and FDA’s former Acting Chief Scientist Luciana Borio Thursday cautioned the agency to put science ahead of hope when responding to the COVID-19 pandemic. They spoke with BioCentury following public...
BioCentury | Mar 16, 2020
Product Development

Teva, Celltrion launch fourth U.S. Herceptin biosimilar at modest discount

Teva and Celltrion Monday launched Herzuma trastuzumab-pkrb, a biosimilar version of Genentech’s Herceptin trastuzumab, in the U.S. at a 10% discount to the original product. The launch price suggests that unlike generic drugs, the launch...
BioCentury | Mar 11, 2020
Product Development

Biocon, Mylan look ahead to U.S. launch of insulin glargine as last Lantus patent falls for Sanofi

A district court decision in favor of Biocon and Mylan sets the partners up to launch their version of insulin glargine in the U.S. midyear should the candidate get FDA approval in June. The partners...
BioCentury | Feb 6, 2020
Deals

Beyond Keytruda: How Merck envisions innovation and growth after a spinout

As Merck becomes the latest large pharma to split in two, separating its key growth drivers and innovative programs from its slower-growing businesses, the slimmed-down innovative company will rely on the fruits of recent and...
BioCentury | Feb 5, 2020
Product Development

Biogen investors look ahead to Alzheimer’s after Tecfidera IP win

The U.S. Patent Trial and Appeal Board removed a major overhang for Biogen investors on Wednesday after ruling to uphold the validity of a patent covering blockbuster MS therapy Tecfidera dimethyl fumarate. The news sent...
BC Extra | Jan 28, 2020
Company News

Bourla chooses BD over buybacks in 2020

CEO Albert Bourla outlined his vision for the new innovative business that will emerge from Pfizer after the spin-off of Upjohn, saying that the company would invest in business development and pipeline growth rather than...
BC Extra | Jan 28, 2020
Company News

Jan. 27 Company Quick Takes: Enhertu meets in pivotal gastric cancer study; plus Biocon-Mylan, CMS, Lilly-Boehringer, Ningbo-Genentech

Japan submission on horizon for AZ, Daiichi’s ADC  Daiichi Sankyo Co. Ltd. (Tokyo:4568) plans to seek approval of Enhertu for gastric cancer starting in Japan after the anti-HER2 antibody-drug conjugate met the primary and a...
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1 - 10 of 619
BioCentury | May 13, 2020
Product Development

Gilead secures global access to remdesivir via generic manufacturing deals

The first manufacturing deals for Gilead’s remdesivir, plus a series of grants for institutions across Europe to develop COVID-19 diagnostics and therapeutics, highlight the importance of global collaboration to tackle the pandemic. Gilead Sciences Inc....
BioCentury | Apr 23, 2020
Finance

Market recalibrates Biogen’s valuation as aducanumab filing is delayed

Biogen’s aducanumab roller-coaster ride continued Wednesday as investors reassessed the risk for the Alzheimer’s therapy following a roughly six-month delay for the company’s BLA submission. Biogen Inc. (NASDAQ:BIIB) disclosed Wednesday plans to push back an...
BioCentury | Mar 20, 2020
Product Development

Industry to boost supply of chloroquine, hydroxychloroquine despite limited data in COVID-19

Novartis and Teva join a growing list of pharmas with plans to ramp up supply of antimalarial drug hydroxychloroquine in the U.S. for COVID-19 despite sparse clinical data supporting the drug's efficacy in the indication....
BioCentury | Mar 19, 2020
Politics, Policy & Law

FDA urged to follow science, not hope, in quest for COVID-19 cures

Former FDA Commissioner Margaret Hamburg and FDA’s former Acting Chief Scientist Luciana Borio Thursday cautioned the agency to put science ahead of hope when responding to the COVID-19 pandemic. They spoke with BioCentury following public...
BioCentury | Mar 16, 2020
Product Development

Teva, Celltrion launch fourth U.S. Herceptin biosimilar at modest discount

Teva and Celltrion Monday launched Herzuma trastuzumab-pkrb, a biosimilar version of Genentech’s Herceptin trastuzumab, in the U.S. at a 10% discount to the original product. The launch price suggests that unlike generic drugs, the launch...
BioCentury | Mar 11, 2020
Product Development

Biocon, Mylan look ahead to U.S. launch of insulin glargine as last Lantus patent falls for Sanofi

A district court decision in favor of Biocon and Mylan sets the partners up to launch their version of insulin glargine in the U.S. midyear should the candidate get FDA approval in June. The partners...
BioCentury | Feb 6, 2020
Deals

Beyond Keytruda: How Merck envisions innovation and growth after a spinout

As Merck becomes the latest large pharma to split in two, separating its key growth drivers and innovative programs from its slower-growing businesses, the slimmed-down innovative company will rely on the fruits of recent and...
BioCentury | Feb 5, 2020
Product Development

Biogen investors look ahead to Alzheimer’s after Tecfidera IP win

The U.S. Patent Trial and Appeal Board removed a major overhang for Biogen investors on Wednesday after ruling to uphold the validity of a patent covering blockbuster MS therapy Tecfidera dimethyl fumarate. The news sent...
BC Extra | Jan 28, 2020
Company News

Bourla chooses BD over buybacks in 2020

CEO Albert Bourla outlined his vision for the new innovative business that will emerge from Pfizer after the spin-off of Upjohn, saying that the company would invest in business development and pipeline growth rather than...
BC Extra | Jan 28, 2020
Company News

Jan. 27 Company Quick Takes: Enhertu meets in pivotal gastric cancer study; plus Biocon-Mylan, CMS, Lilly-Boehringer, Ningbo-Genentech

Japan submission on horizon for AZ, Daiichi’s ADC  Daiichi Sankyo Co. Ltd. (Tokyo:4568) plans to seek approval of Enhertu for gastric cancer starting in Japan after the anti-HER2 antibody-drug conjugate met the primary and a...
Items per page:
1 - 10 of 619