BC Extra | Nov 2, 2019
Company News

Management tracks: Genmab, Kintai, Aerie, Oasmia, Sangamo, Ovid, Checkmate, Third Pole, Actimed, IMV, Entasis, Rafael, Evaxion and Arvelle

David Eatwell will retire as CFO and EVP of Genmab A/S (CSE:GMAB; NASDAQ:GMAB) on Feb. 29. The cancer antibody therapy company will promote Anthony Pagano, SVP finance and corporate development, to CFO and EVP, effective...
BC Innovations | Oct 11, 2019
Targets & Mechanisms

CAR Ts can move well beyond cancer, but will need to go allogeneic first

Preclinical studies showing the utility of CAR T cells outside of cancer are ramping up, and developers have taken notice. But turning the modality into a general-purpose tool will require companies to break through safety...
BC Extra | Oct 8, 2019
Company News

After remedies to NDA, Intarcia’s diabetes implant under FDA review again

More than two years after well-funded Intarcia received a complete response letter from FDA, an NDA for the company’s implantable pump to treat Type II diabetes is back under the agency’s review. The new PDUFA...
BioCentury | Aug 31, 2019
Product Development

Privacy, transparency and consent

Patients need to control the use of their data. This calls for new policies on transparency and consent, and means establishing systems governing the ownership, collection and agency of those data. Data privacy is probably...
BC Extra | Aug 28, 2019
Politics & Policy

Aug. 28 P&P Quick Takes: Liver failure warning for HCV drugs; plus FDA guidances and more

Liver failure linked to HCV drugs  FDA said it has identified 63 incidences of worsening liver function, including cases of liver failure and death, in patients with liver impairment taking HCV drugs Mavyret glecaprevir/pibrentasvir from...
BC Extra | Aug 9, 2019
Company News

Aug. 8 Company Quick Takes: Amarin tumbles on Vascepa update; plus Alexandria, Cambrex, Kala and miRagen

FDA panel for Vascepa means likely delay  Amarin Corp. plc (NASDAQ:AMRN) said it expects FDA to extend the PDUFA date for Vascepa icosapent ethyl to late December from Sept. 28 after the agency scheduled an...
BioCentury | Jul 27, 2019
Product Development

How Gilead deal positions Galapagos to become Europe’s next big biotech

Galapagos’ pipeline partnership with Gilead sets the company up to become an independent leader of European biotech for years to come, and provides a template that other platform companies could follow. The July 14 deal...
BC Extra | Jul 27, 2019
Company News

Vitrakvi set to become EU’s first tissue-agnostic cancer drug

EMA's CHMP delivered its first positive recommendation for a tissue-agnostic cancer therapy to Vitrakvi in its monthly basket of positive opinions, which also included one for GW’s Epidyolex. CHMP backed approval of an MAA from...
BC Extra | Jul 19, 2019
Company News

July 18 Company Quick Takes: Mallinckrodt, Silence in RNAi deal; plus Pear, Blueprint and more

Mallinckrodt licenses RNAi candidate from Silence  Mallinckrodt plc (NYSE:MNK) obtained an exclusive, worldwide license to C3-targeted RNAi therapy SLN500 from Silence Therapeutics plc (LSE:SLN), plus options to license up to two additional complement-targeted preclinical candidates....
BC Extra | Jul 15, 2019
Company News

Galapagos maintains independence, adds R&D firepower with $5.1 billion megadeal with Gilead

A partnership with Gilead allows Galapagos to nearly double the size of its clinical pipeline, with the potential to add new technology platforms via BD, and ensures its independence into the next decade. Under the...
Items per page:
1 - 10 of 498
BC Extra | Nov 2, 2019
Company News

Management tracks: Genmab, Kintai, Aerie, Oasmia, Sangamo, Ovid, Checkmate, Third Pole, Actimed, IMV, Entasis, Rafael, Evaxion and Arvelle

David Eatwell will retire as CFO and EVP of Genmab A/S (CSE:GMAB; NASDAQ:GMAB) on Feb. 29. The cancer antibody therapy company will promote Anthony Pagano, SVP finance and corporate development, to CFO and EVP, effective...
BC Innovations | Oct 11, 2019
Targets & Mechanisms

CAR Ts can move well beyond cancer, but will need to go allogeneic first

Preclinical studies showing the utility of CAR T cells outside of cancer are ramping up, and developers have taken notice. But turning the modality into a general-purpose tool will require companies to break through safety...
BC Extra | Oct 8, 2019
Company News

After remedies to NDA, Intarcia’s diabetes implant under FDA review again

More than two years after well-funded Intarcia received a complete response letter from FDA, an NDA for the company’s implantable pump to treat Type II diabetes is back under the agency’s review. The new PDUFA...
BioCentury | Aug 31, 2019
Product Development

Privacy, transparency and consent

Patients need to control the use of their data. This calls for new policies on transparency and consent, and means establishing systems governing the ownership, collection and agency of those data. Data privacy is probably...
BC Extra | Aug 28, 2019
Politics & Policy

Aug. 28 P&P Quick Takes: Liver failure warning for HCV drugs; plus FDA guidances and more

Liver failure linked to HCV drugs  FDA said it has identified 63 incidences of worsening liver function, including cases of liver failure and death, in patients with liver impairment taking HCV drugs Mavyret glecaprevir/pibrentasvir from...
BC Extra | Aug 9, 2019
Company News

Aug. 8 Company Quick Takes: Amarin tumbles on Vascepa update; plus Alexandria, Cambrex, Kala and miRagen

FDA panel for Vascepa means likely delay  Amarin Corp. plc (NASDAQ:AMRN) said it expects FDA to extend the PDUFA date for Vascepa icosapent ethyl to late December from Sept. 28 after the agency scheduled an...
BioCentury | Jul 27, 2019
Product Development

How Gilead deal positions Galapagos to become Europe’s next big biotech

Galapagos’ pipeline partnership with Gilead sets the company up to become an independent leader of European biotech for years to come, and provides a template that other platform companies could follow. The July 14 deal...
BC Extra | Jul 27, 2019
Company News

Vitrakvi set to become EU’s first tissue-agnostic cancer drug

EMA's CHMP delivered its first positive recommendation for a tissue-agnostic cancer therapy to Vitrakvi in its monthly basket of positive opinions, which also included one for GW’s Epidyolex. CHMP backed approval of an MAA from...
BC Extra | Jul 19, 2019
Company News

July 18 Company Quick Takes: Mallinckrodt, Silence in RNAi deal; plus Pear, Blueprint and more

Mallinckrodt licenses RNAi candidate from Silence  Mallinckrodt plc (NYSE:MNK) obtained an exclusive, worldwide license to C3-targeted RNAi therapy SLN500 from Silence Therapeutics plc (LSE:SLN), plus options to license up to two additional complement-targeted preclinical candidates....
BC Extra | Jul 15, 2019
Company News

Galapagos maintains independence, adds R&D firepower with $5.1 billion megadeal with Gilead

A partnership with Gilead allows Galapagos to nearly double the size of its clinical pipeline, with the potential to add new technology platforms via BD, and ensures its independence into the next decade. Under the...
Items per page:
1 - 10 of 498