19:24 , May 17, 2019 |  BioCentury  |  Product Development

Pushing China to the forefront: When a first-in-China regulatory strategy makes sense

As reforms in China shorten clinical and regulatory timelines for biotechs across the board, the country has a growing chance to become the first stop for regulatory approvals of first-in-class drugs. The decision to do...
21:36 , May 16, 2019 |  BC Extra  |  Clinical News

May 16 ASCO Quick Takes: Aduro ends MM trial; plus Puma, PharmaMar, Genocea, J&J

Abstracts were released late Wednesday ahead of the American Society of Clinical Oncology meeting starting May 31 in Chicago. See below for BioCentury's second round of Quick Takes on selected abstracts (see "May 15 ASCO...
00:06 , May 16, 2019 |  BC Extra  |  Clinical News

May 15 ASCO Quick Takes: After-hours pop for Iovance, MacroGenics; plus Takeda, Amgen, Forty Seven

Abstracts were released late Wednesday ahead of the American Society of Clinical Oncology meeting starting May 31 in Chicago. See below for BioCentury's first round of Quick Takes on selected abstracts. Iovance gains on 44%...
00:46 , May 11, 2019 |  BioCentury  |  Product Development

Now grown up, independent biotechs bulk up their platforms with more modalities

As the incoming class of independent biotechs look to build on their clinical and commercial successes, a handful are expanding beyond the technology that got them there, bringing in new modalities to complement their platforms...
21:54 , May 8, 2019 |  BC Extra  |  Clinical News

AZ, Daiichi planning global submissions for breast cancer ADC

After AstraZeneca paid Daiichi $1.35 billion up front to jointly develop and commercialize the Japanese pharma’s trastuzumab deruxtecan (DS-8201), the partners reported Wednesday that the antibody-drug conjugate met the primary endpoint in the pivotal Phase...
22:52 , May 3, 2019 |  BC Extra  |  Company News

May 3 Company Quick Takes: NHS England, Acacia, Insys, Novo, AZ

NHS strikes deal aimed at eliminating HCV in England  NHS England partnered with Gilead Sciences Inc. (NASDAQ:GILD), Merck & Co. Inc. (NYSE:MRK) and AbbVie Inc. (NYSE:ABBV) to identify and treat individuals who are unaware they...
21:34 , May 3, 2019 |  BC Week In Review  |  Clinical News

Keytruda monotherapy non-inferior to chemotherapy in first-line gastric cancer

Merck said April 25 that Keytruda pembrolizumab as monotherapy met the primary endpoint of non-inferiority to standard-of-care chemotherapy in improving overall survival (OS) in the Phase III KEYNOTE-062 trial as first-line treatment of gastric cancer....
19:05 , May 2, 2019 |  BC Innovations  |  Translation in Brief

Continuously capturing cancer cells

A wearable device that captures and isolates circulating tumor cells over the course of a few hours could offer better diagnostic accuracy than single-draw liquid biopsies that screen smaller amounts of blood. A University of...
22:52 , Apr 26, 2019 |  BC Extra  |  Company News

European regulatory roundup: CHMP opinions and a Portola approval

EMA's CHMP recommended a basket of approvals, including Dovato dolutegravir/lamivudine, Libtayo cemiplimab and two orphan therapies. Also Friday, the European Commission granted conditional approval to Ondexxya andexanet alfa from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) to reverse...
19:16 , Apr 26, 2019 |  BioCentury  |  Product Development

For patients’ sake, collaborate already

Cancer immunotherapy companies must stop squandering the most precious stakeholder, patients, and collaborate now on platform trials to test new combination regimens. A straightforward platform trial design that tests different combo partners with PD-1/PD-L1 agents...