Shares in Ocular Therapeutix (NSDQ:OCUL) fell last week after the company revealed that it received another letter from the FDA about issues spotted by the regulatory agency during a pre-approval inspection of a manufacturing plant. This isn’t the first time that the company has dealt with manufacturing issues. In July last year, the FDA denied approval for Ocular’s hydrogel […]
Regulatory/Compliance
New Canadian medical device incident reporting rules proposals
By Stewart Eisenhart, Emergo Group Canadian healthcare market regulator Health Canada is developing new requirements for certain hospitals to report serious medical device incidents and adverse drug reactions to better protect public health. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
Pacira halts DepoCyt production over manufacturing issue
Pacira Pharmaceuticals (NSDQ:PCRX) said late last month that it plans to stop producing its liposomal chemotherapeutic due to “persistent technical issues specific to the DepoCyt(e) manufacturing process.” In a regulatory note filed to the SEC, the N.J.-based company said it expects a charge of $5 million thanks to the discontinuation, including $500,000 related to employee lay-offs. […]
Endo pulls painkiller from the market following FDA request
Endo Pharmaceuticals (NSDQ:ENDP) said today that it will voluntarily pull its Opana ER painkiller from the market. The move comes just weeks after the FDA asked the company to pull the plug on its opioid, arguing that the benefits of the abuse-deterrent drug no longer outweigh the risks. To write off the remaining net book value […]
Oramed to dual-list on Tel Aviv exchange
Oramed Pharmaceuticals (NSDQ:ORMP) said today that it won approval from the Israel Securities Authority to dual-list its common stock on the Tel Aviv Stock Exchange. Stock in the Jerusalem-based company is slated to begin trading on the TASE on July 12 under the symbol ‘ORMP’. “We believe dual-listing on the TASE will provide many benefits […]
Antibody could be first new mechanism of action for HIV treatment in 10 years
Theratechnologies (TSE:TH) said today that the FDA granted priority review to the biologics license application for ibalizumab as a treatment for multi-drug resistant HIV-1. If the monoclonal antibody is approved, it will be the first antiretroviral treatment with a new mechanism of action to be introduced in a decade. It would also be the only […]
Ipsen wins approval for gastroenteropancreatic neuroendocrine tumor drug
Ipsen (EPA:IPN) said today that Teijin Pharma Ltd. won approval from the Japanese Ministry of Health, Labor and Welfare for Ipsen’s Somatuline as a therapy for gastroenteropancreatic neuroendocrine tumors. The subcutaneous drug was approved in Japan in 2012 for the treatment of acromegaly and pituitary gigantism. The latest approval was supported by Ipsen’s pivotal Phase III […]
SteadyMed seeks FDA nod for Trevyent drug-device combo
SteadyMed (NSDQ:STDY) said today that it submitted a new drug application to the FDA for its drug-device pulmonary arterial hypertension therapy. The San Ramon, Calif.-based company’s lead product candidate is a combination of treprostinil and the PatchPump prefilled, disposable infusion system. “The submission of our NDA for Trevyent is the latest in a series of significant […]
FDA user fee reauthorization advances without $1B fee increase
By Stewart Eisenhart, Emergo Group The US Senate’s version of a bill reauthorizing Food and Drug Administration user fees over the next several years diverges markedly from President Trump’s budget proposal to increase user fees by $1 billion in 2018 alone. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
Theraclion partner UVA wins FDA nod for combined HIFU, immunotherapy breast cancer trial
Theraclion said yesterday its academic development partner, the University of Virginia, won an FDA nod to launch a study of the combined use of echotherapy high intensity focused ultrasound and immunotherapy drug pembrolizumab for treating patients with breast cancer. The study will examine the combined treatment’s effect on fighting breast cancer tumor cells, the French […]