BioCentury | Mar 17, 2020
Product Development

March 16 Quick Takes: FDA raises efficacy questions for DBV allergy therapy; plus Novo, Provention, UCB, Pfizer-EMD Serono, Zai, AcelRx-Tetraphase, Medivir-Tan

DBV expects delay for peanut allergy product  DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) said the Aug. 5 PDUFA date for its peanut allergy therapy may be extended as FDA has raised questions on the long-term efficacy...
BioCentury | Mar 12, 2020
Finance

March 11 Quick Takes: PDL, Kala, InnoCare, LifeSci, BioSight, BillionToOne, SEC

PDL to dissolve by year-end  PDL BioPharma Inc. (NASDAQ:PDLI) said it will cease operations and seek to sell the company or monetize its assets. PDL acquires commercial-stage pharmaceutical assets and late clinical stage products. On...
BC Extra | Jan 7, 2020
Company News

Management tracks: Rhythm, Mirati, Aura, IFM, a16z, Cambrex, Alzheon and more

Rare metabolic disease company Rhythm Pharmaceuticals Inc. (NASDAQ:RYTM) said Keith Gottesdiener will step down as CEO, president and a board member after more than eight years. He will stay on through the company’s submission of...
BC Extra | Aug 27, 2019
Company News

Aug. 27 Company Quick Takes: GSK licenses Ionis HBV program; plus Adaptimmune-Noile, Purdue, Presage-BMS, Kyowa, Alexion, Viela, Kintai, OncoNano

GSK opts into Ionis' HBV program  Positive Phase II data prompted GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to exercise its option to license exclusive, worldwide rights to an antisense chronic HBV program from Ionis Pharmaceuticals Inc. (NASDAQ:IONS)....
BC Extra | Jun 28, 2019
Company News

Management tracks: Gottlieb joins Pfizer board; plus Adaptimmune, Xencor, Arcus and more

Pfizer Inc. (NYSE:PFE) appointed former FDA Commissioner Scott Gottlieb to its board. Gottlieb is joining the board's regulatory and compliance and science and technology committees. Since leaving the FDA in early April, Gottlieb returned to...
BC Extra | Jun 14, 2019
Clinical News

June 14 Clinical Quick Takes: Chi-Med, BeiGene, UCB, Global Blood and more

Chi-Med’s surufatinib meets in Phase III for extra-pancreatic neuroendocrine tumors  Hutchison China MediTech Ltd. (LSE:HCM; NASDAQ:HCM) said it is planning a pre-NDA meeting with China’s National Medical Products Administration (NMPA) after surufatinib (formerly sulfatinib) met...
BC Week In Review | Nov 9, 2018
Clinical News

FDA approves Empliciti plus pomalidomide and dexamethasone for MM

Bristol-Myers Squibb Co. (NYSE:BMY) said FDA approved an sBLA for Empliciti elotuzumab in combination with pomalidomide and dexamethasone to treat adults with multiple myeloma patients who have received at least two prior therapies, including lenalidomide...
BC Week In Review | Jul 13, 2018
Clinical News

BMS's Empliciti meets in Phase II for MM

Bristol-Myers Squibb Co. (NYSE:BMY) reported data from the Phase II ELOQUENT-3 trial in 117 patients with relapsed or refractory multiple myeloma showing that Empliciti elotuzumab plus pomalidomide and low-dose dexamethasone met the primary endpoint of...
BC Week In Review | Feb 9, 2018
Company News

Lee's announces several updates

Lee's Pharmaceutical Holdings Ltd. (HKSE:950) announced several pieces of news, including a deal with the Noden Pharma DAC subsidiary of PDL BioPharma Inc. (NASDAQ:PDLI). Noden granted Lee's exclusive rights in China, including Hong Kong and...
BC Extra | Oct 11, 2017
Company News

Management tracks: Aerpio, Scancell, TCR2

Ophthalmic company Aerpio Pharmaceuticals Inc. (OTCQB:ARPO) named Stephen Hoffman CEO, effective Dec. 1, 2017. He succeeds Aerpio founder Joseph Gardner, who will remain its president. Hoffman was a senior advisor at PDL BioPharma Inc. (NASDAQ:PDLI),...
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BioCentury | Mar 17, 2020
Product Development

March 16 Quick Takes: FDA raises efficacy questions for DBV allergy therapy; plus Novo, Provention, UCB, Pfizer-EMD Serono, Zai, AcelRx-Tetraphase, Medivir-Tan

DBV expects delay for peanut allergy product  DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) said the Aug. 5 PDUFA date for its peanut allergy therapy may be extended as FDA has raised questions on the long-term efficacy...
BioCentury | Mar 12, 2020
Finance

March 11 Quick Takes: PDL, Kala, InnoCare, LifeSci, BioSight, BillionToOne, SEC

PDL to dissolve by year-end  PDL BioPharma Inc. (NASDAQ:PDLI) said it will cease operations and seek to sell the company or monetize its assets. PDL acquires commercial-stage pharmaceutical assets and late clinical stage products. On...
BC Extra | Jan 7, 2020
Company News

Management tracks: Rhythm, Mirati, Aura, IFM, a16z, Cambrex, Alzheon and more

Rare metabolic disease company Rhythm Pharmaceuticals Inc. (NASDAQ:RYTM) said Keith Gottesdiener will step down as CEO, president and a board member after more than eight years. He will stay on through the company’s submission of...
BC Extra | Aug 27, 2019
Company News

Aug. 27 Company Quick Takes: GSK licenses Ionis HBV program; plus Adaptimmune-Noile, Purdue, Presage-BMS, Kyowa, Alexion, Viela, Kintai, OncoNano

GSK opts into Ionis' HBV program  Positive Phase II data prompted GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to exercise its option to license exclusive, worldwide rights to an antisense chronic HBV program from Ionis Pharmaceuticals Inc. (NASDAQ:IONS)....
BC Extra | Jun 28, 2019
Company News

Management tracks: Gottlieb joins Pfizer board; plus Adaptimmune, Xencor, Arcus and more

Pfizer Inc. (NYSE:PFE) appointed former FDA Commissioner Scott Gottlieb to its board. Gottlieb is joining the board's regulatory and compliance and science and technology committees. Since leaving the FDA in early April, Gottlieb returned to...
BC Extra | Jun 14, 2019
Clinical News

June 14 Clinical Quick Takes: Chi-Med, BeiGene, UCB, Global Blood and more

Chi-Med’s surufatinib meets in Phase III for extra-pancreatic neuroendocrine tumors  Hutchison China MediTech Ltd. (LSE:HCM; NASDAQ:HCM) said it is planning a pre-NDA meeting with China’s National Medical Products Administration (NMPA) after surufatinib (formerly sulfatinib) met...
BC Week In Review | Nov 9, 2018
Clinical News

FDA approves Empliciti plus pomalidomide and dexamethasone for MM

Bristol-Myers Squibb Co. (NYSE:BMY) said FDA approved an sBLA for Empliciti elotuzumab in combination with pomalidomide and dexamethasone to treat adults with multiple myeloma patients who have received at least two prior therapies, including lenalidomide...
BC Week In Review | Jul 13, 2018
Clinical News

BMS's Empliciti meets in Phase II for MM

Bristol-Myers Squibb Co. (NYSE:BMY) reported data from the Phase II ELOQUENT-3 trial in 117 patients with relapsed or refractory multiple myeloma showing that Empliciti elotuzumab plus pomalidomide and low-dose dexamethasone met the primary endpoint of...
BC Week In Review | Feb 9, 2018
Company News

Lee's announces several updates

Lee's Pharmaceutical Holdings Ltd. (HKSE:950) announced several pieces of news, including a deal with the Noden Pharma DAC subsidiary of PDL BioPharma Inc. (NASDAQ:PDLI). Noden granted Lee's exclusive rights in China, including Hong Kong and...
BC Extra | Oct 11, 2017
Company News

Management tracks: Aerpio, Scancell, TCR2

Ophthalmic company Aerpio Pharmaceuticals Inc. (OTCQB:ARPO) named Stephen Hoffman CEO, effective Dec. 1, 2017. He succeeds Aerpio founder Joseph Gardner, who will remain its president. Hoffman was a senior advisor at PDL BioPharma Inc. (NASDAQ:PDLI),...
Items per page:
1 - 10 of 958