BioCentury | Jan 1, 2020
Regulation

Fewer FDA approvals in 2019, but a basket of firsts

While the year held fewer approvals of new molecular entities than 2018, it was not short of major achievements. FDA greenlit several drugs with innovative modalities, against novel targets and for diseases that have long...
BC Innovations | Oct 3, 2019
Targets & Mechanisms

Blocking the MAPK pathway for Trk inhibitor resistant cancers

Targeting the MAPK pathway could be a key to overcoming a new mechanism of tissue-agnostic therapy resistance identified by a Memorial Sloan Kettering Cancer Center team. FDA has approved two inhibitors of TrkA, TrkB and...
BC Extra | Sep 25, 2019
Company News

Sept. 24 Company Quick Takes: FDA approves smallpox vaccine; plus Epidyolex, Vitrakvi, Oral semaglutide, Takeda-Evotec, Guerbet-IBM Watson

FDA approves Bavarian Nordic’s smallpox/monkeypox vaccine  FDA approved Jynneos MVA-BN from Bavarian Nordic A/S (CSE:BAVA; Pink:BVNRY) to prevent smallpox and monkeypox, making the vaccine the only approved non-replicating smallpox vaccine in the U.S. and the...
BC Innovations | Sep 12, 2019
Distillery Therapeutics

ROS1 and pan-NTRK inhibitor for NSCLC resistant to Xalkori

DISEASE CATEGORY: Cancer INDICATION: Non-small cell lung cancer (NSCLC) A dual ROS1 and pan-NTRK inhibitor from Daiichi Sankyo Co. Ltd. could treat Xalkori crizotinib-resistant NSCLC, which has been linked to ROS1 mutations. In vitro high...
BC Extra | Sep 6, 2019
Financial News

Sept. 6 Financial Quick Takes: Turning Point, uniQure raise follow-ons; plus Autolus, Frequency, ADC

Turning Point, uniQure price follow-ons  Turning Point Therapeutics Inc. (NASDAQ:TPTX) and uniQure N.V. (NASDAQ:QURE) raised a total of nearly $428 million in follow-on offerings priced late Thursday. Days after a readout from the first part...
BC Extra | Aug 16, 2019
Company News

Genentech prices tissue-agnostic therapy at almost half the cost of Bayer's

After scoring FDA approval for its tissue-agnostic therapy Thursday, Genentech Inc. priced Rozlytrek entrectinib Friday at a wholesale acquisition cost of up to $17,050 per month, nearly half that of its only competitor. Rozlytrek is...
BC Extra | Aug 15, 2019
Company News

Genentech gains its first U.S. tissue-agnostic approval with Rozlytrek

Following a Japanese approval in June, Roche’s Genentech unit scored accelerated approval in the U.S. Thursday for its Rozlytrek entrectinib to treat NTRK fusion-positive solid tumors. FDA also approved the inhibitor of ROS1, TrkA, TrkB,...
BC Extra | Jul 27, 2019
Company News

Vitrakvi set to become EU’s first tissue-agnostic cancer drug

EMA's CHMP delivered its first positive recommendation for a tissue-agnostic cancer therapy to Vitrakvi in its monthly basket of positive opinions, which also included one for GW’s Epidyolex. CHMP backed approval of an MAA from...
BioCentury | Jul 13, 2019
Finance

How crossover, insider support and big money correlated with performance across 1H19 IPOs

The performance of 1H19 IPOs point toward a continuation of a dual-class system where biotechs backed by deep-pocketed VCs and crossover investors can tap the public market at will and generate stronger after-market performance than...
BC Innovations | Jun 28, 2019
Product Development

How Array stayed alive long enough to grow up

Array’s 21-year journey as an independent platform company, culminating in an $11.4 billion buyout, required shifting focus from research to development and back again. The acquisition sends a message that developing focused expertise and sticking...
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