18:08 , Oct 12, 2018 |  BC Week In Review  |  Clinical News

Checkpoint's CK-101 leads to 75% ORR in NSCLC subgroup of Phase I/II

Checkpoint Therapeutics Inc. (NASDAQ:CKPT) said twice-daily 400 mg oral CK-101 (RX518) led to an objective response rate (ORR) of 75% in eight treatment-naïve patients with EGFR mutation-positive non-small cell lung cancer (NSCLC) in a dose-expansion...
00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
20:39 , Oct 5, 2018 |  BC Week In Review  |  Company News

U.K. judge upholds preferred prescribing of Avastin off label for wet AMD

A U.K. judge upheld in September a policy of prescribing Avastin bevacizumab as the preferred treatment option for wet age-related macular degeneration (AMD) over Eylea aflibercept and Lucentis ranibizumab. Avastin does not have marketing authorization...
20:14 , Oct 5, 2018 |  BC Week In Review  |  Financial News

New IPO filings include NGM, Arog, Gamida

Three biotechs filed late Sept. 28 to go public on NASDAQ, adding new companies to a 2018 class of IPOs that could surpass 2015's record for funds raised. The group includes NGM Biopharmaceuticals Inc. (South...
19:57 , Oct 5, 2018 |  BC Week In Review  |  Clinical News

Canbridge submits NDA in China for breast cancer drug Nerlynx

Canbridge Life Sciences Ltd. (Beijing, China) said China's National Medical Products Administration (NMPA) accepted an NDA for Nerlynx neratinib as an extended adjuvant treatment for adult patients with early stage HER2-positive breast cancer following adjuvant...
19:47 , Oct 5, 2018 |  BC Week In Review  |  Clinical News

FDA approves Pfizer's dacomitinib for first-line NSCLC

FDA approved Vizimpro dacomitinib from Pfizer Inc. (NYSE:PFE) as first-line treatment of EGFR-mutated metastatic non-small cell lung cancer. Pfizer spokesperson Jessica Smith told BioCentury the pharma will launch the drug in mid-October at a monthly...
16:19 , Oct 4, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Brain cancer Mouse studies suggest CAR T cells targeting ALCAM and HER2 could help treat brain cancer. The cells are generated by conjugating T cells expressing HER2-targeting CARs to a construct consisting of pentamers...
12:22 , Oct 1, 2018 |  BC Extra  |  Financial News

New IPO filings include NGM, Arog, Gamida

Three more biotechs filed late Friday to go public on NASDAQ, adding new companies to a 2018 class of IPOs that could surpass 2015's record for funds raised. The group includes NGM Biopharmaceuticals Inc. (South...
19:55 , Sep 28, 2018 |  BC Week In Review  |  Company News

China Medical gets Asian rights to Vaximm's immunotherapy portfolio

China Medical System Holdings Ltd. (HKSE:867) gained an exclusive license from Vaximm AG (Basel, Switzerland) to develop and commercialize Vaximm's oral cancer immunotherapy pipeline in China, Hong Kong, Macau, Taiwan and other Asian countries. The...
17:25 , Sep 28, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP on Sept. 21 recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta Therapeutics...