BioCentury | Jun 24, 2020
Regulation

Myovant eyes third NDA for relugolix after endometriosis readout

An NDA submission for an endometriosis therapy could come early next year from Myovant, whose shares gained $2.49 (14%) to $19.90 Tuesday after the company posted positive data for relugolix in a second Phase III...
BioCentury | Jun 2, 2020
Regulation

June 1 Quick Takes: CHMP recommendations, plus FDA action on AbbVie-Neurocrine, Shionogi, AZ, Lilly, Genentech

CHMP backs Ebola vaccine, targeted cancer therapies EMA’s CHMP recommended approval of a two-component Ebola vaccine -- Zabdeno and Mvabea -- from Johnson & Johnson (NYSE:JNJ) Friday. The agency also backed two targeted cancer therapies:...
BioCentury | Apr 23, 2020
Product Development

April 22 Quick Takes: Accelerated approval for Immunomedics’ Trodelvy; plus BioNTech-Pfizer, AskBio, Astellas, Merck KGaA, oNKo-Gilead, Myovant, Afyx and Sangam

Immunomedics’ Trodelvy approved for TNBC FDA granted accelerated approval to Trodelvy sacituzumab govitecan from Immunomedics Inc. (NASDAQ:IMMU) for adult metastatic triple-negative breast cancer patients in the third-line setting. Immunomedics said continued approval of the TROP2-targeting...
BioCentury | Jul 23, 2019
Clinical News

July 23 Clinical Quick Takes: Achillion plans U.S. IND; plus Chiasma, Myovant, Marinus and Merck

Achillion plans U.S. IND after latest readout for ACH-5228 Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) rose $1.19 (50%) to $3.57 since announcing early Monday that multiple ascending doses of its CFD inhibitor ACH-5228 led to 95% complement...
BioCentury | Jun 26, 2019
Company News

June 25 Company Quick Takes: Conatus restructuring; plus Almirall-Dermira, Acer, Glenmark and more

Conatus cuts headcount by 40% to extend runway Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) said it will lay off 40% of its staff and suspend development of caspase 1 inhibitor CTS-2090 in a bid to extend its...
BioCentury | Jan 5, 2019
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 year...
BioCentury | Oct 9, 2018
Politics & Policy

FDA pushes generic competition for transdermal complex drugs

FDA clarified how to develop generic versions of transdermal or topical complex drugs, releasing a series of guidances Tuesday as the agency continues its push for greater generics competition. Complex drugs, especially those with transdermal...
BioCentury | Oct 6, 2018
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...
BioCentury | Aug 23, 2018
Distillery Therapeutics

Neurology

INDICATION: Neurology Patient sample and rabbit studies suggest estradiol could help treat neurobehavioral disorders associated with defects in interneuron development resulting from preterm birth. In postmortem brain samples from preterm to full-term infants (20-40 gestational...
BioCentury | Jun 30, 2018
Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate...
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