BioCentury | Feb 13, 2020
Politics, Policy & Law

Catalyzing controversy: FDA emails challenge its claims that price plays no role in approvals

Over 200 pages of emails released as a result of litigation against FDA and HHS challenge FDA’s claims that it does not consider price when making approval decisions. The emails pull back the curtain on...
BioCentury | Jan 30, 2020
Distillery Therapeutics

HDAC3 identified as obesity target

DISEASE CATEGORY: Endocrine/metabolic INDICATION: Obesity Intestinal HDAC3 inhibition could treat obesity. In mice fed a normal diet, intestinal knockout of HDAC3 increased intestinal expression of lipid metabolism genes. In a mouse model of obesity induced...
BC Extra | Jan 29, 2020
Company News

Jan. 28 Company Quick Takes: Kite, Alkermes, Regeneron-Sanofi, Incyte, NantHealth-NantOmics, Sorrento, MicroCures, Paion-Mundipharma

Kite’s KTE-X19 under review in Europe   EMA has accepted an MAA for KTE-X19 from Kite, positioning the CAR T cell therapy from the Gilead Sciences Inc. (NASDAQ:GILD) unit to become the first CAR T...
BioCentury | Jan 25, 2020
Targets & Mechanisms

CAR T strategies for cracking the code in solid tumors

As drug developers try to crack the code for making CAR T cell therapies work in solid tumors, they aren’t sticking to the playbook that led to success with other modalities. BioCentury’s analysis of the...
BC Extra | Jan 22, 2020
Company News

Despite outreach to over 18 companies, Lilly was only biopharma to offer Dermira takeout

Dermira’s multiyear quest to find a partner for lebrikizumab found it knocking on the doors of over 18 biopharmas, but only Eli Lilly was interested in submitting a bid to acquire the autoimmune and dermatology...
BC Extra | Jan 14, 2020
Clinical News

Complete response to NK cell therapy prompts NantKwest to plan pivotal trials

NantKwest is planning registration trials for its off-the-shelf NK cell therapy in triple-negative breast cancer and pancreatic cancer after compassionate use of PD-L1.t-haNK led to a complete response in one patient. The data, reported at...
BioCentury | Jan 4, 2020

Politics aside, 2020 could be a good year for bringing back generalists

After largely being out of biotech stocks for four years, generalist investors have shown signs that they are ready to dip their toes again in 2020. The fourth quarter surge, and a spate of 2019...
BioCentury | Jan 4, 2020

All’s well that ends well

Biotech companies across all market cap tiers posted big gains in the fourth quarter of 2019, with median changes ranging from 7-18%. 4Q19 growth was enough to erase prior quarter losses, putting all tiers in...
BC Extra | Dec 26, 2019
Company News

Dec. 27 Company Quick Takes: Immunomedics, Qiagen, Eisai-Gilead, Melinta, Denovo-Rumpus

FDA again reviewing Immunomedics’ ADC  FDA has accepted a resubmitted BLA from Immunomedics Inc. (NASDAQ:IMMU) seeking accelerated approval of sacituzumab govitecan to treat third-line metastatic triple-negative breast cancer. The company had received a complete response...
BC Extra | Dec 24, 2019
Company News

Rival suitor could have pressed Synthorx takeout price even higher than winning $2.5B Sanofi bid

A new regulatory filing revealed that Synthorx received a sweeter offer than Sanofi’s $2.5 billion bid after the biotech had already agreed to the French pharma’s proposal. The biotech declined to backtrack on accepting Sanofi’s...
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