An FDA advisory committee voted today in favor of Aerie Pharmaceuticals‘ (NSDQ:AERI) Rhopressa product candidate. The dermatologic and ophthalmic drugs advisory committee voted unanimously that clinical trials support the efficacy of Aerie’s netarsudil ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nine members of the committee voted to say […]
Drug-Device Combinations
Milestone Scientific names interim chief executive | Personnel Moves – Oct. 13, 2017
Milestone Scientific (NYSE:MLSS) said last week that chairman of the board Leslie Bernhard will take over as interim CEO after former president & CEO Daniel Goldberger resigned at the start of this month. The Livingston, N.J.-based company is conducting a formal search for a new CEO as the board of directors evaluates options for its CompuFlo […]
Tandem prices $16m public offering
Tandem Diabetes Care (NSDQ:TNDM) today priced an underwritten public offering of 4,630,000 shares of its common stock, Series A warrants and Series B warrants to buy 4,630,000 shares of common stock at $3.50 apiece. The San Diego, Calif.-based company said it expects to bring in $16.2 million in gross proceeds from the offering. Get the full story at […]
Nasdaq halts trading of Aerie stock as FDA reviews Rhopressa NDA
Aerie Pharmaceuticals (NSDQ:AERI) said today that Nasdaq has halted trading of the company’s common stock as an FDA committee convenes to review Aerie’s new drug application for its Rhopressa glaucoma and ocular hypertension drug. The Irvine, Calif.-based company submitted the NDA in February and the FDA is slated to finishing reviewing the application by Feb. 28, 2018. Get the full story […]
Allergan settles Restasis patent challenge after moving patents to Native American tribe
Allergan (NYSE:AGN) said yesterday that it inked a deal with InnoPharma to settle a patent challenge over Allergan’s dry eye drug, Restasis. InnoPharma is one of four companies challenging Allergan’s patents to its eye drop product. The group also includes Mylan (NSDQ:MYL), Teva Pharmaceuticals (NYSE:TEVA) and Akorn Inc. (NSDQ:AKRX) – all of which are challenging the Restasis patents in federal court. Get the full […]
Biologics & auto-injectors: How West Pharma designs for evolving trends in drug delivery
If you’ve ever received a flu shot or taken insulin, you’ve probably used a device designed by West Pharmaceutical Services (NYSE:WST), according to VP & GM of biologics Graham Reynolds. “Probably most people have come in contact with West and they wouldn’t even know it,” he told Drug Delivery Business News. Over the 40 years he’s been with […]
Boehringer Ingelheim, Anthem partner for largest real-world COPD trial
As part of a research collaboration launched in 2014, Boehringer Ingelheim and Anthem have partnered to study people with chronic obstructive pulmonary disease in real-world settings to assess how commonly-prescribed drugs may reduce the occurrence of COPD exacerbations. The team, which also includes Anthem’s outcomes research subsidiary HealthCore, plans to investigate whether adding an inhaled corticosteroid to […]
AcelRx shares tumble after FDA rejects Dsuvia painkiller
Shares in AcelRx Pharmaceuticals (NSDQ:ACRX) fell more than -50% this morning after the company announced that it received a complete response letter from the FDA for its Dsuvia sufentanil sublingual tablet. The FDA told the company that it can’t approve the new drug application in its present form, saying that AcelRx needs to collect additional data for […]
European task force: Docs should favor drug-eluting stents over bioresorbable scaffolds
Physicians should not use bioresorbable scaffolds in place of current-generation drug-eluting stents, according to a report from the European Society of Cardiology and European Association of Percutaneous Cardiovascular Inventions. The ECS/EAPCI report says that as long as concerns remain about the increased risk of myocardial infarction and scaffold thrombosis linked with bioresorbable scaffolds, physicians should […]
BioDelivery Sciences, Teva settle patent fight over opioid dependence treatment
BioDelivery Sciences (NSDQ:BDSI) said today that it inked a deal with Teva Pharmaceuticals (NYSE:TEVA) to settle claims that the generic form of BioDelivery Sciences’ Bunavail buccal film that Teva is trying to bring to market in the U.S. infringes upon several patents owned by the Raleigh, N.C.-based company. As part of the deal, which was reached in the […]
Here’s how the diabetes industry’s leaders think about patient-centered R&D
Designing devices centered around patients is a goal espoused by nearly all device companies nowadays, as they aim to make products that people want to use and can incorporate into their everyday lives. Underscoring those products is often years of research and some in the industry have begun to think about how a patient’s needs […]