BioCentury | Feb 22, 2020
Management Tracks

Everest names new CEO; plus Merck, Gilead, Turning Point, Adaptimmune, AskBio and more

Everest Medicines Ltd. hired Kerry Blanchard as CEO. Blanchard, who will also join the company’s board, succeeds interim CEO Sean Cao. Blanchard was an operating partner at Everest’s founding investor CBC Group and previously served...
BioCentury | Feb 22, 2020
Product Development

Esperion enters crowded LDL-lowering market with FDA approval

FDA’s approval of Nexletol marks Esperion’s transition to a commercial-stage company. Esperion Therapeutics Inc. (NASDAQ:ESPR) plans to launch Nexletol bempedoic acid on March 30. The drug, which is orally administered once-daily, is approved as an...
BioCentury | Feb 19, 2020
Regulation

Regulatory Roundup: Priority Review for Xpovio, Tecentriq in new indications; plus CRLs delay Keytruda dosing update

FDA granted Priority Review to supplemental applications for Karyopharm's Xpovio and Roche's Tecentriq, setting June deadlines for decisions that could expand each drug's label. The agency will consider granting accelerated approval to Xpovio selinexor to...
BioCentury | Feb 15, 2020
Product Development

The Phase III trials and pharma sales most likely to be disrupted by COVID-19

The coronavirus outbreak comes at a time when many major multinational pharmas are betting big on the China market for future growth. In an analysis of MNC revenues and dependence on trial sites in China,...
BioCentury | Feb 15, 2020
Regulation

Congo, three other countries license Merck’s Ebola vaccine

As biopharmas gear up to develop vaccines and therapies for COVID-19, four African countries at risk from the Ebola outbreak approved and licensed a vaccine from Merck & Co. Friday. The Democratic Republic of the...
BioCentury | Feb 14, 2020
Targets & Mechanisms

Entrepreneur watch: Iwasaki targets the lymphatic system to clear brain tumors

Rising serial entrepreneur Akiko Iwasaki aims to bring antitumor immunity to the brain by opening the brain’s lymphatics, a recently discovered system of vessels just starting to find translational uses. In 2015, a Nature paper...
BioCentury | Feb 14, 2020
Product Development

Feb. 13 Product Development Quick Takes: Priority Review for BMS, Seattle Genetics, Deciphera therapies; plus Roche, Ipsen, Merck, Eisai and Amgen-Pfizer

August decision dates for BMS, Seattle Genetics, Deciphera  A trio of cancer therapies have received Priority Review from FDA with August PDUFA dates. Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted a BLA for lisocabtagene maraleucel...
BioCentury | Feb 8, 2020
Emerging Company Profile

Serentrix: pain relief without side effects

Serentrix is looking to revive a well-known pain target that has been largely abandoned by drug developers after antagonists against it led to side effects. Early clinical testing by Serentrix LLC has shown that the...
BioCentury | Feb 8, 2020
Targets & Mechanisms

Astellas lays groundwork for oncolytic virus combination therapy

With its next-gen oncolytic virus, Astellas is reinforcing the promise of improved efficacy for versions that make cytokines stimulating T cells as well as innate immune cells. After more than two decades in development with...
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...
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BioCentury | Feb 22, 2020
Management Tracks

Everest names new CEO; plus Merck, Gilead, Turning Point, Adaptimmune, AskBio and more

Everest Medicines Ltd. hired Kerry Blanchard as CEO. Blanchard, who will also join the company’s board, succeeds interim CEO Sean Cao. Blanchard was an operating partner at Everest’s founding investor CBC Group and previously served...
BioCentury | Feb 22, 2020
Product Development

Esperion enters crowded LDL-lowering market with FDA approval

FDA’s approval of Nexletol marks Esperion’s transition to a commercial-stage company. Esperion Therapeutics Inc. (NASDAQ:ESPR) plans to launch Nexletol bempedoic acid on March 30. The drug, which is orally administered once-daily, is approved as an...
BioCentury | Feb 19, 2020
Regulation

Regulatory Roundup: Priority Review for Xpovio, Tecentriq in new indications; plus CRLs delay Keytruda dosing update

FDA granted Priority Review to supplemental applications for Karyopharm's Xpovio and Roche's Tecentriq, setting June deadlines for decisions that could expand each drug's label. The agency will consider granting accelerated approval to Xpovio selinexor to...
BioCentury | Feb 15, 2020
Product Development

The Phase III trials and pharma sales most likely to be disrupted by COVID-19

The coronavirus outbreak comes at a time when many major multinational pharmas are betting big on the China market for future growth. In an analysis of MNC revenues and dependence on trial sites in China,...
BioCentury | Feb 15, 2020
Regulation

Congo, three other countries license Merck’s Ebola vaccine

As biopharmas gear up to develop vaccines and therapies for COVID-19, four African countries at risk from the Ebola outbreak approved and licensed a vaccine from Merck & Co. Friday. The Democratic Republic of the...
BioCentury | Feb 14, 2020
Targets & Mechanisms

Entrepreneur watch: Iwasaki targets the lymphatic system to clear brain tumors

Rising serial entrepreneur Akiko Iwasaki aims to bring antitumor immunity to the brain by opening the brain’s lymphatics, a recently discovered system of vessels just starting to find translational uses. In 2015, a Nature paper...
BioCentury | Feb 14, 2020
Product Development

Feb. 13 Product Development Quick Takes: Priority Review for BMS, Seattle Genetics, Deciphera therapies; plus Roche, Ipsen, Merck, Eisai and Amgen-Pfizer

August decision dates for BMS, Seattle Genetics, Deciphera  A trio of cancer therapies have received Priority Review from FDA with August PDUFA dates. Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted a BLA for lisocabtagene maraleucel...
BioCentury | Feb 8, 2020
Emerging Company Profile

Serentrix: pain relief without side effects

Serentrix is looking to revive a well-known pain target that has been largely abandoned by drug developers after antagonists against it led to side effects. Early clinical testing by Serentrix LLC has shown that the...
BioCentury | Feb 8, 2020
Targets & Mechanisms

Astellas lays groundwork for oncolytic virus combination therapy

With its next-gen oncolytic virus, Astellas is reinforcing the promise of improved efficacy for versions that make cytokines stimulating T cells as well as innate immune cells. After more than two decades in development with...
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 10005