BioCentury | Mar 3, 2020
Product Development

COVID-19 Update: India restricting API exports; blood tests coming to the U.S. soon

In response to the COVID-19 outbreak, “India has restricted the export of 26 active pharmaceutical ingredients which represents about 10% of their export capacity,” FDA Commissioner Stephen Hahn said Tuesday. Testifying to the Senate Health,...
BC Innovations | Jul 25, 2019
Distillery Therapeutics

Phenylisoxazole-quinoline-based DNA gyrase inhibitor for drug-resistant

DISEASE CATEGORY: Infectious disease INDICATION: Staphylococcus A phenylisoxazole-quinoline-based inhibitor of DNA gyrase could treat drug-resistant Staphylococcus aureus infections. In vitro , the compound inhibited S. aureus DNA gyrase supercoiling activity with an IC 50 of 85...
BioCentury | Jul 20, 2019
Emerging Company Profile

China Ophthalmology Focus eyes Asia market

Spun out from Lee’s in May and aiming for its first NDA submissions next year, China Ophthalmology Focus is already looking ahead to a Hong Kong IPO and an expansion into other Asian markets with...
BC Week In Review | Dec 21, 2015
Company News

GlaxoSmithKline, Almirall deal

GlaxoSmithKline granted Almirall rights to develop and commercialize Veltin Gel clindamycin/tretinoin worldwide and Altabax retapamulin in the U.S. in exchange for distribution rights to Toctino alitretinoin in Austria, the Czech Republic, Italy, the Netherlands, Poland,...
BC Week In Review | Dec 22, 2014
Clinical News

Onexton Gel clindamycin phosphate/benzoyl peroxide regulatory update

FDA approved Onexton Gel clindamycin phosphate/benzoyl peroxide from Valeant to treat acne vulgaris in patients ages =12 years. Valeant said it plans to launch the fixed combination of 1.2% clindamycin phosphate and 3.75% benzoyl peroxide...
BC Week In Review | Oct 6, 2014
Company News

Lumara Health, AMAG Pharmaceuticals deal

AMAG will acquire Lumara's maternal health business in a cash and stock deal. Lumara (formerly KV Pharmaceutical Co. ) will receive $600 million in cash and 3.2 million AMAG shares worth about $74.4 million based on...
BC Week In Review | Oct 6, 2014
Company News

Lumara Health, Perrigo deal

Perrigo will acquire Lumara's OTC women's healthcare business for $82 million in cash. Perrigo will gain Lumara's Clindesse clindamycin phosphate and Gynazole-1 butoconazole nitrate vaginal creams and Evamist estradiol transdermal spray. Perrigo said it plans...
BC Extra | Sep 30, 2014
Company News

AMAG gains on M&A deal to add Makena

AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) jumped $6.54 (28%) to $29.72 Monday on news it agreed to acquire the maternal health business of Lumara Health Inc. (Chesterfield, Mo.) -- once known as KV Pharmaceutical Co. -- for...
BioCentury | Aug 11, 2014
Strategy

Profusion of exclusions

Express Scripts Holding Co. 's 2015 formulary exclusions offer hope that companies can renegotiate once-excluded drugs back into coverage. But the pharmacy benefits manager appears to be expanding the number of drugs and drug classes...
BC Week In Review | May 12, 2014
Clinical News

Duac clindamycin/benzoyl peroxide regulatory update

GlaxoSmithKline submitted an application to Japan's Ministry of Health, Labor and Welfare (MHLW) for Duac clindamycin/benzoyl peroxide gel to treat acne. The company declined to comment on when it expects a decision in Japan. In...
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