02:18 , Feb 23, 2017 |  BC Week In Review  |  Clinical News

Naloxone Hydrochloride Nasal Spray regulatory update

FDA issued a complete response letter to an NDA from Amphastar for Naloxone Hydrochloride 2 mg/0.5 mL Nasal Spray for emergency treatment of known or suspected opioid overdose. According to Amphastar, the letter identified “issues...
23:41 , Feb 21, 2017 |  BC Extra  |  Company News

Amphastar falls on CRL for intranasal naloxone

Amphastar Pharmaceuticals Inc. (NASDAQ:AMPH) dropped $4.20 (23%) to $14.20 on Tuesday after it said it received a complete response letter from FDA for Naloxone Hydrochloride 2mg/0.5mL Nasal Spray, under review for the emergency treatment of...
08:00 , Dec 15, 2014 |  BioCentury  |  Strategy

Momenta moving on

Data announced in October represent the first fruits of Momenta Pharmaceuticals Inc. 's novel drug pipeline, which will play a larger role in the company's strategy going forward as it steps back from complex generics....
07:00 , Aug 18, 2014 |  BC Week In Review  |  Company News

MannKind, Sanofi deal

MannKind granted Sanofi exclusive, worldwide rights to develop and commercialize Afrezza to treat adults with Type I and II diabetes. MannKind will receive $150 million in cash up front and is eligible for up to...
07:00 , Aug 18, 2014 |  BioCentury  |  Strategy

Afrezza, partnered

Having signed on as the commercial partner for MannKind Corp. 's Afrezza inhaled insulin, Sanofi is clearly betting it can succeed where Exubera inhaled insulin from Pfizer Inc. and Nektar Therapeutics failed. To make the...
01:21 , Aug 12, 2014 |  BC Extra  |  Company News

MannKind licenses Afrezza to Sanofi

MannKind Corp. (NASDAQ:MNKD) granted Sanofi (Euronext:SAN; NYSE:SNY) exclusive, worldwide rights to develop and commercialize Afrezza inhaled insulin to treat adults with Type I and II diabetes. MannKind will receive $150 million in cash up front...
07:00 , Jul 14, 2014 |  BC Week In Review  |  Financial News

Amphastar Pharmaceuticals financial update

Amphastar Pharmaceuticals Inc. (NASDAQ:AMPH), Rancho Cucamonga, Calif.   Business: Generics   Date announced: 2014-06-30   Note: Amphastar raised $8.4 million through the sale of 1.2 million shares at $7 to cover the overallotment from its...
07:00 , Jul 14, 2014 |  BioCentury  |  Finance

3Q14 Financial Markets Preview: Discerning optimism

Investors and bankers are cautiously optimistic that the correction that began in late 1Q14 will provide a floor for a biotech recovery that should continue through the third quarter, with investors being more selective on...
07:00 , Jun 30, 2014 |  BC Week In Review  |  Financial News

Amphastar Pharmaceuticals completes IPO

Amphastar Pharmaceuticals Inc. (NASDAQ:AMPH), Rancho Cucamonga, Calif.   Business: Generics, Pharmaceuticals   Date completed: 2014-06-25   Type: IPO   Raised: $32.5 million   Shares: 4.6 million   Price: $7   Shares after offering: 43.4 million...
07:00 , Jun 30, 2014 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory milestones Basilea Pharmaceutica AG (SIX:BSLN) fell CHF9.10 to CHF104.90 last week after it said FDA confirmed additional Phase III data would be required to support U.S. approval of ceftobiprole to treat pneumonia. The company...