Camarus AB (STO:CAMX) and Braeburn Pharmaceuticals touted data yesterday from a Phase II trial of its long-acting buprenorphine depot. The 47-patient trial found that CAM2038 blocks the effects of opioids and suppresses withdrawal symptoms in adults with opioid use disorder. The in-patient trial included 5 3-day test sessions to evaluate the patients’ response to randomized […]
Pharmaceuticals
BioDelivery wins Health Canada approval for Belbuca pain relief product
BioDelivery Sciences International (NSDQ:BDSI) said today that Health Canada approved its buprenorphine hydrochloride buccal film, Belbuca, for the management of pain severe enough to necessitate daily, long-term opioid treatment and for which alternative management options are inadequate. The company said it plans to commercialize Belbuca in Canada through an unnamed partner and that the launch […]
Ocular Therapeutix founder & CEO Sawhney to step down | Personnel Moves – June 23, 2017
The president & CEO of Ocular Therapeutix (NSDQ:OCUL), Amarpreet Sawhney, is slated to step down from the company that he helped start in 2006. He will serve as the board’s executive chairman for 1 year, unless he decides to leave earlier. The company wrote in a regulatory filing that “his service will be automatically renewed for […]
Medtronic warns on button glitch with MiniMed 640G insulin pump
Medtronic (NYSE:MDT) issued a field safety notice in May, warning users that keypad buttons on its MiniMed 640G insulin pump may become temporarily stuck when the atmospheric pressure around the pump suddenly increases or decreases – like during air travel. If the keypad buttons are stuck, users may not be able to program a bolus or […]
Indivior touts late-stage trial for monthly buprenorphine depot
Indivior (LON:INDV) touted data today from its pivotal Phase III trial for RBP-6000, a once-monthly injectable buprenorphine depot for the treatment of adults with opioid use disorder. The 24-week study met its primary and key secondary endpoints for both dosage regimens, according to the company. “The clinical data from our Phase III study also showed […]
Mylan shareholders vote against executive pay package, but re-elect board
At the company’s annual meeting, Mylan (NSDQ:MYL) shareholders re-elected the drugmaker’s board despite a campaign spearheaded by major investors to do otherwise. The campaign hoped to encourage shareholders to vote down most of the board’s directors in response to Mylan’s drug pricing practices for its EpiPen device. The influential proxy advisory firm, ISS, also urged shareholders […]
FDA committee supports Nordisk’s cardiovascular risk claim for Victoza label
Novo Nordisk (NYSE:NVO) shares ticked up 1% earlier this week after an advisory committee for the FDA voted to recommend that the company’s cardiovascular risk reduction claim be added to its Victoza (liraglutide) label. The discussions among committee members involved data from the 9,300-patient Leader trial, which involved people with Type II diabetes at high risk […]
pSivida seeks European regulatory nod for Durasert
pSivida (NSDQ:PSDV) is looking to market its Durasert 3-year treatment for posterior segment uveitis in the European Union. Today, the Watertown, Mass.-based company submitted a marketing authorization application to the European Medicines Agency. Earlier this month, pSivida reported that its 2nd Phase III trial, which followed patients for 3 years, met its primary endpoint of […]
Another extended-release ADHD drug wins FDA nod
Days after Neos Therapeutics (NSDQ:NEOS) nabbed U.S. regulatory approval for its controlled-release formulation of methylphenidate, Shire (NSDQ:SHPG) said it won a nod from the FDA for its long-acting ADHD drug. The drug, Mydayis, is made up of the same active ingredient in Shire’s ADHD treatment Adderall XR – amphetamine – but it is designed to last up to […]
FDA working to lift barriers to generic drug competition
By: Scott Gottlieb, M.D. Too many patients are being priced out of the medicines they need. While FDA doesn’t have a direct role in drug pricing, we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines. Over the last […]