BioCentury | Feb 27, 2020
Product Development

Amgen’s plan for holding its competitive edge in two hot cancer spaces

Amgen has a first-mover advantage in two of the hottest areas of cancer R&D -- KRAS and bispecific antibodies -- and it’s using a combination of rapid clinical development and innovative trial designs to maintain...
BioCentury | Feb 22, 2020
Product Development

FDA approves Lundbeck's Vyepti, the first CGRP inhibitor for migraine delivered IV

FDA's approval of Vyepti eptinezumab-jjmr from Lundbeck is the first for an IV-delivered CGRP inhibitor for migraine prevention, but the therapy will face competition from established subcutaneous drugs in its class. Already on the market...
BioCentury | Feb 19, 2020
Finance

Feb. 19 Financial Quick Takes: bluebird's delayed BLA timeline, plus fundings for NeoTx, Scipher and EnClear

bluebird sheds value after pipeline update  Shares of bluebird bio Inc. (NASDAQ:BLUE) dipped $7.77 to $80.45 Wednesday, lopping off about $430 million of the company's market cap, after the company extended the BLA timeline for...
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 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 11, 2020
Product Development

Alzheimer’s prevention replays the same amyloid failures as the treatment setting

The Phase II/III DIAN-TU trial of Lilly’s solanezumab and Roche’s gantenerumab was always a long shot, given the previous late-stage failures of both agents in Alzheimer’s trials. Perhaps more surprising is that both compounds remain...
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
Management Tracks

BioMarin CFO steps down; plus Atara, Epirium, Abalos, CytomX and more

Dan Spiegelman stepped down as EVP and CFO at BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) to pursue other interests. SVP, Finance and Chief Accounting Officer Brian Mueller will serve as acting CFO as the rare diseases company...
BioCentury | Feb 5, 2020
Product Development

A look at MNCs with clinical trials that could be disrupted by the coronavirus outbreak

Almost all major biopharma MNCs are conducting clinical trials in China that could face disruptions as the outbreak of 2019-nCoV acute respiratory disease continues to unfold. An analysis of MNCs most active in the region...
Items per page:
1 - 10 of 6615
BioCentury | Feb 27, 2020
Product Development

Amgen’s plan for holding its competitive edge in two hot cancer spaces

Amgen has a first-mover advantage in two of the hottest areas of cancer R&D -- KRAS and bispecific antibodies -- and it’s using a combination of rapid clinical development and innovative trial designs to maintain...
BioCentury | Feb 22, 2020
Product Development

FDA approves Lundbeck's Vyepti, the first CGRP inhibitor for migraine delivered IV

FDA's approval of Vyepti eptinezumab-jjmr from Lundbeck is the first for an IV-delivered CGRP inhibitor for migraine prevention, but the therapy will face competition from established subcutaneous drugs in its class. Already on the market...
BioCentury | Feb 19, 2020
Finance

Feb. 19 Financial Quick Takes: bluebird's delayed BLA timeline, plus fundings for NeoTx, Scipher and EnClear

bluebird sheds value after pipeline update  Shares of bluebird bio Inc. (NASDAQ:BLUE) dipped $7.77 to $80.45 Wednesday, lopping off about $430 million of the company's market cap, after the company extended the BLA timeline for...
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 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 11, 2020
Product Development

Alzheimer’s prevention replays the same amyloid failures as the treatment setting

The Phase II/III DIAN-TU trial of Lilly’s solanezumab and Roche’s gantenerumab was always a long shot, given the previous late-stage failures of both agents in Alzheimer’s trials. Perhaps more surprising is that both compounds remain...
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
Management Tracks

BioMarin CFO steps down; plus Atara, Epirium, Abalos, CytomX and more

Dan Spiegelman stepped down as EVP and CFO at BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) to pursue other interests. SVP, Finance and Chief Accounting Officer Brian Mueller will serve as acting CFO as the rare diseases company...
BioCentury | Feb 5, 2020
Product Development

A look at MNCs with clinical trials that could be disrupted by the coronavirus outbreak

Almost all major biopharma MNCs are conducting clinical trials in China that could face disruptions as the outbreak of 2019-nCoV acute respiratory disease continues to unfold. An analysis of MNCs most active in the region...
Items per page:
1 - 10 of 6615