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...
BC Extra | 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...
BC Extra | 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...
BC Extra | 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...
BC Innovations | 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...
BC Week In Review | Mar 16, 2018
Clinical News

AbbVie's elagolix meets in second Phase III for uterine fibroids

AbbVie Inc. (NYSE:ABBV) said elagolix (ABT-620) met the primary and all ranked secondary endpoints in the Phase III ELARIS UF-II (M12-817) trial, the second of two replicate Phase III trials of the non-peptide small molecule...
BC Extra | Mar 13, 2018
Clinical News

AbbVie's elagolix meets in second Phase III for uterine fibroids

AbbVie Inc. (NYSE:ABBV) said elagolix (ABT-620) met the primary and all ranked secondary endpoints in the Phase III ELARIS UF-II (M12-817) trial, the second of two replicate Phase III trials of the candidate to treat...
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