BC Extra | Jan 27, 2020
Company News

AZ regains brazikumab rights as AbbVie paves way for closure of $63B takeout of Allergan

AstraZeneca is regaining a late-stage immunology program from Allergan in a deal designed to clear the way for U.S. and EU regulators to approve AbbVie’s $63 billion takeover of Allergan. AstraZeneca plc (LSE:AZN; NYSE:AZN) told...
BC Extra | Jan 25, 2020
Company News

Pfizer seeking to dent market share with trio of discounted biosimilars

Pfizer is hoping that discounts of 22-24% from reference drugs’ wholesale acquisition costs (WACs) will help it gain market share for three new or soon-to-be launched biosimilars, each of which will compete with at least...
BC Extra | Jan 17, 2020
Tools & Techniques

EPO decision strengthens UC’s CRISPR patent position in Europe as Editas looks to Cas9 alternatives

A decision at the European Patent Office has confirmed that the CRISPR IP landscape is going to look much different in Europe than it does in the U.S., contributing to the growing complexity of global...
BC Extra | Jan 17, 2020
Financial News

Sofinnova Partners vet Tordjman launches Jeito with €200M first biotech fund

Paris-based Jeito Capital launched Monday with the €200 million ($223.1 million) close of its first fund, which the firm will invest in 15 therapeutics start-ups, primarily in Europe. Jeito founder and CEO Rafaèle Tordjman was...
BioCentury | Jan 11, 2020
Finance

Why buysiders say 2020 could be the year of the CNS

A pair of CNS approvals in the final days of 2019 has only added to the growing momentum buysiders were already tracking for 2020 in the once neglected disease area. Positive regulatory signals are converging...
BC Extra | Dec 30, 2019
Clinical News

Migraine readout completes December hat trick for surging Axsome

Axsome’s winning streak continued as its third auspicious clinical readout this month augurs a planned 2H20 NDA submission that could allow the company to carve out a niche for AXS-07 in acute migraine. Axsome Therapeutics...
BC Extra | Dec 24, 2019
Company News

Regulatory roundup: BioMarin poised to have first U.S., EU hemophilia gene therapy; plus Allergan, Eisai, FibroGen, ViiV and Vero

Monday's basket of regulatory news includes two landmark regulatory applications for BioMarin's hemophilia gene therapy in the U.S. and EU, and FDA approval of Allergan's migraine drug. BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) submitted a BLA to...
BioCentury | Dec 21, 2019
Product Development

China a priority for Novartis’ Narasimhan

Novartis CEO Vasant Narasimhan says capitalizing on the rise of China, by prioritizing drug launches in the country, will be a key pillar of the pharma’s strategy over the next few years. A second pillar...
BC Extra | Dec 9, 2019
Company News

Novartis downsizing internal efforts on CAR T in solid tumors

Novartis is pivoting away from internal development of CAR Ts in solid tumors, it said Thursday at its R&D day. The company is, however, pressing forward with the modality via partnerships, and plans to use...
BioCentury | Dec 7, 2019
Product Development

U.S. biosimilars glass--half full or half empty?

Ten years after the U.S. created a pathway for biosimilars--and four and a half years after the first FDA approval--a few manufacturers have demonstrated that they can overcome the technical, regulatory and commercial barriers to...
Items per page:
1 - 10 of 1302
BC Extra | Jan 27, 2020
Company News

AZ regains brazikumab rights as AbbVie paves way for closure of $63B takeout of Allergan

AstraZeneca is regaining a late-stage immunology program from Allergan in a deal designed to clear the way for U.S. and EU regulators to approve AbbVie’s $63 billion takeover of Allergan. AstraZeneca plc (LSE:AZN; NYSE:AZN) told...
BC Extra | Jan 25, 2020
Company News

Pfizer seeking to dent market share with trio of discounted biosimilars

Pfizer is hoping that discounts of 22-24% from reference drugs’ wholesale acquisition costs (WACs) will help it gain market share for three new or soon-to-be launched biosimilars, each of which will compete with at least...
BC Extra | Jan 17, 2020
Tools & Techniques

EPO decision strengthens UC’s CRISPR patent position in Europe as Editas looks to Cas9 alternatives

A decision at the European Patent Office has confirmed that the CRISPR IP landscape is going to look much different in Europe than it does in the U.S., contributing to the growing complexity of global...
BC Extra | Jan 17, 2020
Financial News

Sofinnova Partners vet Tordjman launches Jeito with €200M first biotech fund

Paris-based Jeito Capital launched Monday with the €200 million ($223.1 million) close of its first fund, which the firm will invest in 15 therapeutics start-ups, primarily in Europe. Jeito founder and CEO Rafaèle Tordjman was...
BioCentury | Jan 11, 2020
Finance

Why buysiders say 2020 could be the year of the CNS

A pair of CNS approvals in the final days of 2019 has only added to the growing momentum buysiders were already tracking for 2020 in the once neglected disease area. Positive regulatory signals are converging...
BC Extra | Dec 30, 2019
Clinical News

Migraine readout completes December hat trick for surging Axsome

Axsome’s winning streak continued as its third auspicious clinical readout this month augurs a planned 2H20 NDA submission that could allow the company to carve out a niche for AXS-07 in acute migraine. Axsome Therapeutics...
BC Extra | Dec 24, 2019
Company News

Regulatory roundup: BioMarin poised to have first U.S., EU hemophilia gene therapy; plus Allergan, Eisai, FibroGen, ViiV and Vero

Monday's basket of regulatory news includes two landmark regulatory applications for BioMarin's hemophilia gene therapy in the U.S. and EU, and FDA approval of Allergan's migraine drug. BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) submitted a BLA to...
BioCentury | Dec 21, 2019
Product Development

China a priority for Novartis’ Narasimhan

Novartis CEO Vasant Narasimhan says capitalizing on the rise of China, by prioritizing drug launches in the country, will be a key pillar of the pharma’s strategy over the next few years. A second pillar...
BC Extra | Dec 9, 2019
Company News

Novartis downsizing internal efforts on CAR T in solid tumors

Novartis is pivoting away from internal development of CAR Ts in solid tumors, it said Thursday at its R&D day. The company is, however, pressing forward with the modality via partnerships, and plans to use...
BioCentury | Dec 7, 2019
Product Development

U.S. biosimilars glass--half full or half empty?

Ten years after the U.S. created a pathway for biosimilars--and four and a half years after the first FDA approval--a few manufacturers have demonstrated that they can overcome the technical, regulatory and commercial barriers to...
Items per page:
1 - 10 of 1302