19:15 , Feb 22, 2019 |  BC Week In Review  |  Clinical News

FDA issues handful of new PDUFA dates

With the government shutdown resolved, FDA has accepted a handful of applications for review during the beginning Feb. 18, according to company announcements. FDA granted Priority Review to two applications from Genentech Inc. for entrectinib...
22:39 , Feb 19, 2019 |  BC Extra  |  Company News

FDA issues handful of new PDUFA dates

With the government shutdown resolved, FDA has accepted a handful of applications for review, according to company announcements early this week. FDA granted Priority Review to two applications from Genentech Inc. for entrectinib and polatuzumab...
23:02 , Jan 18, 2019 |  BioCentury  |  Finance

Loxo's FOMO

Loxo Oncology Inc. (NASDAQ:LOXO) management held advanced licensing discussions with four potential partners during 2018 for its LOXO-292 program targeting RET, but the company instead chose an uncontested takeout offer from Eli Lilly and Co....
00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
01:32 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

FDA extends PDUFA for Keytruda monotherapy in first-line NSCLC

Merck & Co. Inc. (NYSE:MRK) said FDA has extended by three months the PDUFA date for an sBLA for Keytruda pembrolizumab as monotherapy for first-line treatment of locally advanced or metastatic non-small cell lung cancer...
23:02 , Dec 27, 2018 |  BC Extra  |  Company News

China’s NMPA approves Innovent’s PD-1 mAb Tyvyt for Hodgkin lymphoma

China's National Medical Products Administration approved anti-PD-1 mAb Tyvyt sintilimab (IBI308) from Innovent Biologics Inc. (HKSE:1801) to treat relapsed or refractory classical Hodgkin lymphoma. Tyvyt brings the country's slate of approved PD-1 inhibitors to at...
18:35 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

Imfinzi fails again in MYSTIC trial for first-line NSCLC

In another strike against tremelimumab, AstraZeneca plc (LSE:AZN; NYSE:AZN) said the anti-CTLA-4 mAb in combination with PD-L1 inhibitor Imfinzi durvalumab missed the co-primary endpoint of improving overall survival (OS) in the Phase III MYSTIC trial...
18:24 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

FDA approves Loxo's larotrectinib, second tissue-agnostic approval from agency

FDA granted accelerated approval to Vitrakvi larotrectinib from Loxo Oncology Inc. (NASDAQ:LOXO), making the drug the second tissue-agnostic cancer treatment approved by FDA. Vitrakvi is a small molecule inhibitor of neurotrophic tyrosine kinase receptor 1...
18:23 , Nov 30, 2018 |  BC Week In Review  |  Company News

NICE recommends Keytruda combo in first-line NSCLC

U.K.’s NICE recommended in draft guidance anti-PD-1 mAb Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) for use in combination with chemotherapy through the Cancer Drug Fund for untreated, metastatic non-squamous non-small cell lung cancer....