20:27 , Jul 3, 2019 |  BC Extra  |  Company News

July 3 Company Quick Takes: Dovato approved in Europe for HIV; plus Alexion, RedHill and Insys

EC approves Dovato for HIV The European Commission approved once-daily Dovato dolutegravir/lamivudine from ViiV Healthcare Ltd. (Brentford, U.K.) to treat HIV-1 infection in adults and adolescents above 12 years of age. Third approval for Ultomiris...
18:42 , Jun 3, 2019 |  BioCentury  |  Product Development

There are opportunities to eradicate opioid misuse: Investors and innovators should seize them

Eradicating opioid misuse and addiction will take an integrated, holistic approach involving prevention, treatment, and recovery. Crucially, it will also take the help of investors and innovators in biotechnology who understand the challenges and opportunities...
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...
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...
15:46 , Jan 17, 2019 |  BC Extra  |  Politics & Policy

FDA removes a barrier to OTC naloxone development

To make it easier for drug manufacturers to develop over-the-counter naloxone, FDA released Thursday two model consumer-friendly Drug Facts labels that companies can use to gain OTC approval. This is the first time FDA has...
01:39 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

FDA panel votes in favor of co-prescribing naloxone with opioids

A joint FDA advisory panel voted 12-11 that labeling language recommending co-prescription of naloxone for all or some patients prescribed opioids, or more targeted prescribing for patients otherwise at high risk for death from opioid...
19:27 , Dec 21, 2018 |  BC Week In Review  |  Company News

Orexo regains ex-U.S. rights to Zubsolv from Mundipharma

Orexo AB (SSE:ORX) will regain global, ex-U.S. rights to Zubsolv buprenorphine/naloxone from Mundipharma International Ltd. (Dublin, Ireland), effective April 13. Orexo, which holds U.S. rights to the drug, said the news follows a portfolio reorganization...