BC Extra | Sep 28, 2019
Company News

Management tracks: Bourla to succeed Read as Pfizer chair; plus Phathom, OnKure, Forma, Beam, Noven, Cerebral, Alpha Tau and InsightRX

Ian Read will retire as chairman of Pfizer Inc. (NYSE:PFE) on Dec. 31, with CEO Albert Bourla his successor. Read has been with the pharma since 1978, becoming CEO in 2010 and chairman in 2011....
BC Extra | Sep 26, 2019
Company News

Management tracks: Neurogene, HomoShear, Hookipa, Passage Bio, Artios, EMD Serono, Novartis, Illumina, Precision and CureDuchenne

Neurogene Inc . hired Christine Mikail as president. She is a co-founder of neurology specialty pharma Neumentum Inc. and biotech consulting firm Ferndale Advisors. Neurogene is developing disease-modifying gene therapies for two monogenic, pediatric disorders in...
BC Extra | Jul 11, 2019
Company News

Management tracks: President of Lilly BioMedicines steps down to lead Kite; plus Alnylam, GSK, and more

Christi Shaw, SVP and president of Lilly BioMedicines at Eli Lilly and Co. (NYSE:LLY), will step down at the end of August to serve as CEO of the Kite Pharma unit of Gilead Sciences Inc....
BC Week In Review | Jul 27, 2018
Clinical News

KemPharm's ADHD candidate meets in Phase III

KemPharm Inc. (NASDAQ:KMPH) said KP415 met the primary endpoint of improving classroom behaviors in the Phase III KP415.E01 trial to treat pediatric ADHD patients. The company reiterated plans to submit an NDA to FDA for...
BC Week In Review | Jul 13, 2018
Clinical News

FDA accepts resubmitted NDA for Ironshore's HLD200 for ADHD

The Ironshore Pharmaceuticals & Development Inc. subsidiary of Highland Therapeutics Inc. (Toronto, Ontario) said FDA accepted a resubmitted NDA for HLD200 to treat ADHD. The PDUFA date is Aug. 8. HLD200 is a modified-release formulation...
BC Week In Review | Feb 9, 2018
Clinical News

Hisamitsu's HP-3070 meets in Phase III for schizophrenia

Hisamitsu Pharmaceutical Co. Inc. (Tokyo:4530) reported data from a double-blind, U.S. Phase III trial in 617 patients with schizophrenia showing that HP-3070 met the primary endpoint of reducing Positive and Negative Syndrome Scale (PANSS) total...
BC Week In Review | Sep 1, 2017
Clinical News

Hisamitsu begins Ph III trial fo HP-3150 for cancer pain

Hisamitsu Pharmaceutical Co. Inc. (Tokyo:4530) began a double-blind, placebo-controlled, Japanese Phase III trial of HP-3150 to treat pain in cancer patients. The company plans to submit the product for regulatory approval in 2020. Last year,...
BC Week In Review | Jul 13, 2017
Clinical News

FDA approves Neos' Cotempla XR-ODT for ADHD

Last month, FDA approved an NDA from Neos Therapeutics Inc. (NASDAQ:NEOS) for Cotempla XR-ODT (methylphenidate XR-ODT) to treat ADHD in patients ages 6-17. The product is an extended-release oral disintegrating tablet formulation of methylphenidate using...
BC Week In Review | Dec 30, 2016
Clinical News

KP415: Preliminary Ph I KP415.101 data

Preliminary data from the open-label, crossover Phase I KP415.101 trial in 24 healthy volunteers showed that a single dose of 32 mg oral KP415 under fasted conditions was generally well tolerated with no serious adverse...
BC Week In Review | Dec 21, 2016
Clinical News

HP-3060 regulatory update

Hisamitsu said it submitted a regulatory application in Japan for HP-3060 to treat allergic rhinitis. The product is a systemic patch formulation of emedastine fumarate, a selective histamine H1 receptor (HRH1) antagonist, which uses Hisamitsu's...
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