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 | Jun 19, 2020
Product Development

June 18 Quick Takes: Approvals for Ultragenyx, Epizyme, Merck; plus Tecfidera tussle, Tecentriq in TNBC, Sarepta-Selecta, and Gelesis goes to China

A first from Ultragenyx in a rare disease  FDA approved Crysvita burosumab-twza from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat tumor-induced osteomalacia in patients age two and older. The anti-FGF23 mAb is the first to be...
BioCentury | Jun 12, 2020
Regulation

Approval of Biocon, Mylan insulin product could herald cheaper insulin in U.S.

After traveling a winding path that included patent disputes and complete response letters, Semglee insulin glargine from Biocon and Mylan has at last gained FDA’s approval to treat diabetes. Biocon Ltd. (NSE:BIOCON; BSE:532523) and Mylan...
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...
Items per page:
1 - 10 of 622
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 | Jun 19, 2020
Product Development

June 18 Quick Takes: Approvals for Ultragenyx, Epizyme, Merck; plus Tecfidera tussle, Tecentriq in TNBC, Sarepta-Selecta, and Gelesis goes to China

A first from Ultragenyx in a rare disease  FDA approved Crysvita burosumab-twza from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat tumor-induced osteomalacia in patients age two and older. The anti-FGF23 mAb is the first to be...
BioCentury | Jun 12, 2020
Regulation

Approval of Biocon, Mylan insulin product could herald cheaper insulin in U.S.

After traveling a winding path that included patent disputes and complete response letters, Semglee insulin glargine from Biocon and Mylan has at last gained FDA’s approval to treat diabetes. Biocon Ltd. (NSE:BIOCON; BSE:532523) and Mylan...
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...
Items per page:
1 - 10 of 622