BioCentury | Feb 25, 2020
Product Development

Europe ramps up response to COVID-19 outbreak

With a call for proposals by the Innovative Medicines Initiative for COVID-19 development programs and a new vaccine development consortium led by a Denmark-based biotech, Europe is ramping up its response to the coronavirus outbreak....
BioCentury | Feb 18, 2020
Regulation

Regulatory Roundup: PharmaMar-Jazz, BioCryst products under FDA review; plus EU approvals of Vyndaqel, Beovu; and more

FDA is reviewing a pair of candidates to treat lung cancer and hereditary angioedema, while the European Commission has approved a new competitor for Eylea in wet AMD and expanded another drug's label to treat...
BioCentury | Feb 5, 2020
Regulation

EMA’s plan to integrate real-world data across Europe

One of EMA’s top priorities for incorporating real-world data earlier in the regulatory process is establishing DARWIN, a centralized system that would enable it to obtain harmonized data from healthcare systems across Europe. RWD is...
BioCentury | Feb 5, 2020
Regulation

Regulatory response: FDA authorizes emergency 2019-nCoV diagnostic, EMA activates emergency plan

FDA and EMA each unveiled measures Tuesday to combat the 2019-nCoV outbreak, with the U.S. agency issuing emergency use authorization for a diagnostic and its European counterpart activating its emerging health threats management plan. Both...
BioCentury | Feb 4, 2020
Product Development

Feb. 3 Product Development Quick Takes: European Commission’s €10M coronavirus program; plus Seqirus, Seattle Genetics, Merck, Lilly, NIAID

EC outlines €10M coronavirus program  The European Commission said it will use €10 million from its Horizon 2020 program to fund research into prevention and treatment of 2019-nCoV acute respiratory disease. The funding is expected...
BC Extra | Jan 22, 2020
Company News

Jan. 21 Company Quick Takes: First BCMA-targeted therapy gets Priority Review from FDA; plus Roche-Seattle Genetics, AZ-Merck, Chi-Med

Priority Review for GSK's anti-BCMA therapy in MM  GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said FDA granted Priority Review to a BLA for belantamab mafodotin to treat fourth-line relapsed or refractory multiple myeloma in patients who have...
BC Extra | Jan 16, 2020
Company News

Jan. 15 Company Quick Takes: Japan Tobacco gets rights to Dermavant therapy; plus Clovis, BMS, Recordati, BeiGene, Insilico-Pfizer, Novartis

Japan Tobacco gets Japanese rights to Dermavant’s dermatology therapy  Japan Tobacco Inc. (TOKYO:2914) licensed from Dermavant Sciences exclusive rights to develop and commercialize tapinarof in Japan for dermatology indications including psoriasis and atopic dermatitis. The...
BioCentury | Jan 1, 2020
Regulation

Fewer FDA approvals in 2019, but a basket of firsts

While the year held fewer approvals of new molecular entities than 2018, it was not short of major achievements. FDA greenlit several drugs with innovative modalities, against novel targets and for diseases that have long...
BC Extra | Dec 20, 2019
Company News

Regulatory roundup: Gilead, BMS seeking key approvals, plus news about AbbVie, Bavarian Nordic and more

A basket of regulatory news this week included submissions of closely watched products from Gilead and BMS, including the first-ever NDA for a candidate from Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG). Gilead Sciences Inc. (NASDAQ:GILD) is seeking...
BC Extra | Dec 14, 2019
Company News

Dec. 13 Company Quick Takes: Horizon, Intercept, Imfinzi, Evenity and Numab-3SBio

FDA panel backs Horizon's eye disease candidate  FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously Friday that the benefits of teprotumumab to treat active thyroid eye disease outweigh the potential risks. The mAb against...
Items per page:
1 - 10 of 2543
BioCentury | Feb 25, 2020
Product Development

Europe ramps up response to COVID-19 outbreak

With a call for proposals by the Innovative Medicines Initiative for COVID-19 development programs and a new vaccine development consortium led by a Denmark-based biotech, Europe is ramping up its response to the coronavirus outbreak....
BioCentury | Feb 18, 2020
Regulation

Regulatory Roundup: PharmaMar-Jazz, BioCryst products under FDA review; plus EU approvals of Vyndaqel, Beovu; and more

FDA is reviewing a pair of candidates to treat lung cancer and hereditary angioedema, while the European Commission has approved a new competitor for Eylea in wet AMD and expanded another drug's label to treat...
BioCentury | Feb 5, 2020
Regulation

EMA’s plan to integrate real-world data across Europe

One of EMA’s top priorities for incorporating real-world data earlier in the regulatory process is establishing DARWIN, a centralized system that would enable it to obtain harmonized data from healthcare systems across Europe. RWD is...
BioCentury | Feb 5, 2020
Regulation

Regulatory response: FDA authorizes emergency 2019-nCoV diagnostic, EMA activates emergency plan

FDA and EMA each unveiled measures Tuesday to combat the 2019-nCoV outbreak, with the U.S. agency issuing emergency use authorization for a diagnostic and its European counterpart activating its emerging health threats management plan. Both...
BioCentury | Feb 4, 2020
Product Development

Feb. 3 Product Development Quick Takes: European Commission’s €10M coronavirus program; plus Seqirus, Seattle Genetics, Merck, Lilly, NIAID

EC outlines €10M coronavirus program  The European Commission said it will use €10 million from its Horizon 2020 program to fund research into prevention and treatment of 2019-nCoV acute respiratory disease. The funding is expected...
BC Extra | Jan 22, 2020
Company News

Jan. 21 Company Quick Takes: First BCMA-targeted therapy gets Priority Review from FDA; plus Roche-Seattle Genetics, AZ-Merck, Chi-Med

Priority Review for GSK's anti-BCMA therapy in MM  GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said FDA granted Priority Review to a BLA for belantamab mafodotin to treat fourth-line relapsed or refractory multiple myeloma in patients who have...
BC Extra | Jan 16, 2020
Company News

Jan. 15 Company Quick Takes: Japan Tobacco gets rights to Dermavant therapy; plus Clovis, BMS, Recordati, BeiGene, Insilico-Pfizer, Novartis

Japan Tobacco gets Japanese rights to Dermavant’s dermatology therapy  Japan Tobacco Inc. (TOKYO:2914) licensed from Dermavant Sciences exclusive rights to develop and commercialize tapinarof in Japan for dermatology indications including psoriasis and atopic dermatitis. The...
BioCentury | Jan 1, 2020
Regulation

Fewer FDA approvals in 2019, but a basket of firsts

While the year held fewer approvals of new molecular entities than 2018, it was not short of major achievements. FDA greenlit several drugs with innovative modalities, against novel targets and for diseases that have long...
BC Extra | Dec 20, 2019
Company News

Regulatory roundup: Gilead, BMS seeking key approvals, plus news about AbbVie, Bavarian Nordic and more

A basket of regulatory news this week included submissions of closely watched products from Gilead and BMS, including the first-ever NDA for a candidate from Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG). Gilead Sciences Inc. (NASDAQ:GILD) is seeking...
BC Extra | Dec 14, 2019
Company News

Dec. 13 Company Quick Takes: Horizon, Intercept, Imfinzi, Evenity and Numab-3SBio

FDA panel backs Horizon's eye disease candidate  FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously Friday that the benefits of teprotumumab to treat active thyroid eye disease outweigh the potential risks. The mAb against...
Items per page:
1 - 10 of 2543