BC Extra | Jan 8, 2020
Company News

Management tracks: Fred Hutch taps BMS CSO Lynch; plus GSK, Rubius, Provention, Antengene, Revitope, Compugen, Wellington, Adamas, Arcturus and Turnstone

Fred Hutchinson Cancer Research Center hired Thomas Lynch as president and director, effective next month. Lynch was CSO of Bristol-Myers Squibb Co. (NYSE:BMY). He succeeds Gary Gilliland, who announced in September his plans to step...
BC Extra | Jan 7, 2020
Company News

Management tracks: New director for CMS’s CMMI, plus FibroGen, Turning Point, Akcea, Antengene, Biocon and more

CMS appointed Brad Smith as director of the Center for Medicare & Medicaid Innovation , through which HHS plans to implement the Trump administration’s proposed International Pricing Index model for Medicare Part B drugs. Smith, who...
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...
BC Extra | Nov 23, 2019
Company News

Nov. 22 Company Quick Takes: AZ’s Btk inhibitor gains expanded approval; plus WuXi Vaccines, SK Bio, ViiV, Horizon and Neon

Label expansion for AZ’s Calquence under Project ORBIS  FDA approved an sNDA for Calquence acalabrutinib from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat chronic lymphocytic leukemia and small lymphocytic leukemia under the agency’s Real-Time Oncology Review...
BC Extra | Nov 16, 2019
Company News

Nov. 15 Company Quick Takes: Qiagen continues climb after confirming takeout offers; plus Fetroja, selumetinib, PharmAbcine, semaglutide

Qiagen confirms acquisition interest  Qiagen N.V. (NYSE:QGEN; Xetra:QIA) said Friday it is reviewing its strategic alternatives after receiving several “non-binding indications of interest for the acquisition” of the diagnostics company. Since acquisition rumors emerged Wednesday,...
BC Extra | Oct 16, 2019
Company News

Shionogi antibiotic overcomes mortality concerns to win FDA panel’s support

Shionogi & Co. Ltd. (Tokyo:4507) said FDA’s Antimicrobial Drugs Advisory Committee on Wednesday recommended approving Fetroja cefiderocol to treat complicated urinary tract infections including pyelonephritis caused by Gram-negative bacteria in patients with limited or no...
BC Extra | Oct 14, 2019
Company News

Oct. 14 Company Quick Takes: Shionogi, Ultragenyx, BridgeBio-Eidos and MolMed

Imbalance in deaths likely focus of Shionogi advisory panel meeting  Briefing documents for an Oct. 16 meeting of FDA’s Antimicrobial Drugs Advisory Committee to discuss IV cefiderocol from Shionogi & Co. Ltd. (Tokyo:4507) to treat...
BioCentury | Aug 31, 2019
Product Development

Digital dollars: financing for digital health

The heyday of digital health may not yet even be on the horizon, but investments in the field are certainly starting to hit the radar in the areas most likely to impact patients first --...
BC Extra | Aug 19, 2019
Company News

Aug. 19 Company Quick Takes: PharmaMar gets bump on FDA timeline in SCLC; plus Shionogi, Vanda and Moderna

PharmaMar seeking accelerated approval of SCLC candidate PharmaMar S.A. (Madrid:PHM) climbed €0.46 (29%) to €2.06 after the company said that based on the results of dialogue with FDA, it will submit an NDA next quarter...
BC Extra | Jul 19, 2019
Company News

Management tracks: Iovance, ViiV, Hercules, Pappas and more

Cancer immunotherapy company Iovance Biotherapeutics Inc. (NASDAQ:IOVA) hired Friedrich Graf Finckenstein as CMO. He was global head of oncology translational medicine of the Pharma Research and Early Development (pRED) unit of Roche (SIX:ROG; OTCQX:RHHBY). ViiV...
Items per page:
1 - 10 of 837
BC Extra | Jan 8, 2020
Company News

Management tracks: Fred Hutch taps BMS CSO Lynch; plus GSK, Rubius, Provention, Antengene, Revitope, Compugen, Wellington, Adamas, Arcturus and Turnstone

Fred Hutchinson Cancer Research Center hired Thomas Lynch as president and director, effective next month. Lynch was CSO of Bristol-Myers Squibb Co. (NYSE:BMY). He succeeds Gary Gilliland, who announced in September his plans to step...
BC Extra | Jan 7, 2020
Company News

Management tracks: New director for CMS’s CMMI, plus FibroGen, Turning Point, Akcea, Antengene, Biocon and more

CMS appointed Brad Smith as director of the Center for Medicare & Medicaid Innovation , through which HHS plans to implement the Trump administration’s proposed International Pricing Index model for Medicare Part B drugs. Smith, who...
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...
BC Extra | Nov 23, 2019
Company News

Nov. 22 Company Quick Takes: AZ’s Btk inhibitor gains expanded approval; plus WuXi Vaccines, SK Bio, ViiV, Horizon and Neon

Label expansion for AZ’s Calquence under Project ORBIS  FDA approved an sNDA for Calquence acalabrutinib from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat chronic lymphocytic leukemia and small lymphocytic leukemia under the agency’s Real-Time Oncology Review...
BC Extra | Nov 16, 2019
Company News

Nov. 15 Company Quick Takes: Qiagen continues climb after confirming takeout offers; plus Fetroja, selumetinib, PharmAbcine, semaglutide

Qiagen confirms acquisition interest  Qiagen N.V. (NYSE:QGEN; Xetra:QIA) said Friday it is reviewing its strategic alternatives after receiving several “non-binding indications of interest for the acquisition” of the diagnostics company. Since acquisition rumors emerged Wednesday,...
BC Extra | Oct 16, 2019
Company News

Shionogi antibiotic overcomes mortality concerns to win FDA panel’s support

Shionogi & Co. Ltd. (Tokyo:4507) said FDA’s Antimicrobial Drugs Advisory Committee on Wednesday recommended approving Fetroja cefiderocol to treat complicated urinary tract infections including pyelonephritis caused by Gram-negative bacteria in patients with limited or no...
BC Extra | Oct 14, 2019
Company News

Oct. 14 Company Quick Takes: Shionogi, Ultragenyx, BridgeBio-Eidos and MolMed

Imbalance in deaths likely focus of Shionogi advisory panel meeting  Briefing documents for an Oct. 16 meeting of FDA’s Antimicrobial Drugs Advisory Committee to discuss IV cefiderocol from Shionogi & Co. Ltd. (Tokyo:4507) to treat...
BioCentury | Aug 31, 2019
Product Development

Digital dollars: financing for digital health

The heyday of digital health may not yet even be on the horizon, but investments in the field are certainly starting to hit the radar in the areas most likely to impact patients first --...
BC Extra | Aug 19, 2019
Company News

Aug. 19 Company Quick Takes: PharmaMar gets bump on FDA timeline in SCLC; plus Shionogi, Vanda and Moderna

PharmaMar seeking accelerated approval of SCLC candidate PharmaMar S.A. (Madrid:PHM) climbed €0.46 (29%) to €2.06 after the company said that based on the results of dialogue with FDA, it will submit an NDA next quarter...
BC Extra | Jul 19, 2019
Company News

Management tracks: Iovance, ViiV, Hercules, Pappas and more

Cancer immunotherapy company Iovance Biotherapeutics Inc. (NASDAQ:IOVA) hired Friedrich Graf Finckenstein as CMO. He was global head of oncology translational medicine of the Pharma Research and Early Development (pRED) unit of Roche (SIX:ROG; OTCQX:RHHBY). ViiV...
Items per page:
1 - 10 of 837