The FDA this week published a finalized guidance document for companies developing new buprenorphine depot products for the treatment of opioid use disorder. The agency is hoping to boost the development of modified-release buprenorphine products, like drug-eluting implants. In the document, the FDA detailed the studies needed to support approval for these products through the 505(b)(2) […]
Mylan wins race for generic Advair approval
FDA has approved the first generic of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug, this one by Mylan (NSDQ:MYL), six months after rejecting Mylan’s application. Canonsburg, PA-based Mylan’s shares jumped 7% to $30.82 at market close after yesterday’s late-afternoon announcement, and were trading at $30.96 mid-morning today. GSK’s stock dipped 2% to$38.70 on the news late yesterday, but had […]
FDA approves J&J’s Tremfya self-injection pen for psoriasis
FDA has approved Johnson & Johnson’s patient-controlled injector for Tremfya, a treatment for adults with moderate to severe plaque psoriasis. The self-injection approval may help Tremfya compete with AbbVie’s (NYSE:ABBV) Humira pen, which was previously approved for self-injection by psoriasis patients. Made by J&J subsidiary Janssen Pharmaceuticals (Horsham, Penn.), Tremfya is a biologic therapy that selectively […]
FDA issues revised draft guidances for blood glucose monitors
The FDA issued two revised draft guidances today relating to over-the-counter and prescription blood glucose monitors. The new documents, which are intended to update guidances issued in 2016, were based on feedback from stakeholders, who requested more clarification on design considerations and recommended standards, according to the U.S. regulatory agency. The guidances include recommendations for […]
FDA warns on pain drugs for implantable pumps
The FDA today warned doctors and patients about the serious complications that can occur when using the wrong painkillers with implantable drug pumps. Dosing errors, pump failure, and infection are just some of the potential problems that can crop up when using drugs that aren’t approved for use with particular devices, the regulatory agency said. […]
FDA proposes global harmonization of standards for generic drug developers
The FDA has proposed that the International Council on Harmonisation set global standards for generic drug developers, according to a report from FDA chief Dr. Scott Gottlieb. The U.S. regulatory agency argued that companies making generic drugs should be able to implement a single global drug development program and file for approval across multiple markets […]
Cook, AcuityBio ink deal for lung cancer drug technology
Cook Biotech will collaborate with drug-delivery maker AcuityBio on Acuity’s lead lung cancer product, the companies said today. Acuity’s ABC103 will use Cook Biotech’s proprietary extracellular matrix (ECM) technology. ABC103 is a platform technology designed for localized, sustained drug delivery to prevent post-surgical lung cancer recurrence. It combines approved/ cleared surgical staple-line buttress, drug-eluting polymers and […]
Kala Pharma wins FDA nod for twice-daily ocular corticosteroid
The FDA has approved Kala Pharmaceuticals’ (NASDAQ:KALA) Inveltys to treat post-operative inflammation and pain following ocular surgery. Inveltys is the first twice-daily (BID) ocular corticosteroid approved for this indication, according to the Waltham, Mass. company. While corticosteroids are used following ocular surgery to control inflammation and pain, physicians prescribe ocular steroids to achieve a rapid […]
FDA’s Gottlieb: Drug shortages are an ‘inevitable consequence of an imperfect system’
When doctors and nurses are faced with a shortage of medically necessary drugs, they are forced to make challenging decisions about how to ration whatever they have left. FDA commissioner Dr. Scott Gottlieb is looking to identify ways that the U.S. regulatory agency can help prevent and predict these shortages. In a statement this week, […]
FDA launches medical device innovation challenge to combat opioid crisis
The U.S. FDA today announced that it has launched an innovation challenge to encourage the development of medical devices to help reduce the country’s opioid abuse crisis. The hope is that the challenge will result in new medtech including digital health technologies and diagnostic tests to help detect, treat and prevent addiction, according to FDA. Go […]
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