21:52 , May 1, 2019 |  BC Extra  |  Company News

May 1 Company Quick Takes: Heron, Nabriva, Allergan, GSK, Merck, Alnylam

Complete response letter for Heron’s non-opioid pain therapy  Heron Therapeutics Inc. (NASDAQ:HRTX) was off $3.93 (18%) to $17.75 on Wednesday after FDA issued a complete response letter for an NDA for HTX-011 to manage postoperative...
19:10 , Apr 12, 2019 |  BioCentury  |  Product Development

Changing models and minds to improve access to addiction treatment

A lack of acknowledgment by key stakeholders in the healthcare system that medications can treat opioid abuse, along with a fragmented reimbursement system, means that effective treatments aren’t getting to the majority of patients who...
21:56 , Apr 10, 2019 |  BC Extra  |  Company News

U.S. fraud charges pummel Indivior shares

Indivior fell 75.90p (72%) to 30.05p on Wednesday after the U.S. Department of Justice indicted the company for allegedly defrauding providers and payers to increase prescriptions of its opioid dependence drug Suboxone sublingual film. Wednesday's...
00:06 , Apr 6, 2019 |  BioCentury  |  Finance

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
00:04 , Apr 6, 2019 |  BioCentury  |  Finance

Everybody up

Biotech stocks were off to a strong start in 1Q19, with 71% of companies tracked by BioCentury seeing market cap growth in the quarter. Across all market cap bands, biotechs saw a median gain of...
13:29 , Apr 5, 2019 |  BioCentury  |  Product Development

Reaching addiction patients where they’re at

Coming at the opioid crisis from two different angles, NIH’s National Institute on Drug Abuse and Alkermes plc have concluded that ending the epidemic will mean developing ways of getting medication to patients who fall...
18:52 , Feb 22, 2019 |  BC Week In Review  |  Company News

Generic Suboxone products enter U.S. market

At least three companies have launched in the U.S. generic versions of opioid dependence drug Suboxone buprenorphine/naloxone sublingual film from Indivior plc (LSE:INDV). The generic Suboxone manufacturers include Alvogen Inc. (Pinebrook, N.J.), the Sandoz unit...
19:47 , Feb 15, 2019 |  BC Week In Review  |  Company News

Indivior divests Suboxone tablets to China’s Zhejiang Pukang

Indivior plc (LSE:INDV) will sell Chinese rights to its sublingual tablet formulation of Suboxone buprenorphine/naloxone to Zhejiang Pukang Biotechnology Co. Ltd. (Hangzhou, China) so that Indivior can focus on long-term growth of its extended release...
18:53 , Feb 7, 2019 |  BC Week In Review  |  Clinical News

FDA wants more data for Alkermes' depression therapy

Alkermes plc (NASDAQ:ALKS) said FDA issued a complete response letter for its NDA for ALKS 5461 as an adjunct treatment of major depressive disorder. The company said the agency is requesting additional clinical data showing...
20:28 , Feb 6, 2019 |  BC Extra  |  Company News

Management tracks: Astellas, Blueprint

Astellas Pharma Inc. (Tokyo:4503) said President of Pharmaceutical Technology Mitsunori Matsuda and President of Asia & Oceania Business Masatoshi Kuroda will resign, effective June 18. Hideki Shima will succeed Matsuda. Cancer and rare diseases company...