Vericel Corp (NSDQ:VCEL) shares soared 56% today after the Cambridge, Mass.-based company said the FDA approved its bioresorbable scaffold for cartilage repair. The product, Maci, is the 1st FDA-approved implant to use healthy cartilage tissue from a patient’s own knee to grow cells on the scaffold. “Different cartilage defects require different treatments, so therapy must be […]
Regulatory/Compliance
AcelRx seeks FDA nod for non-invasive sufentanil painkiller
AcelRx Pharmaceuticals (NSDQ:ACRX) said today that it submitted a new drug application to the FDA for its ARX-04 sublingual sufentanil tablet. The non-invasive compound has been studied as a treatment for patients experiencing moderate or severe acute pain and is administered in a medically supervised setting using a disposable, pre-filled, single-dose applicator. The Redwood City, Calif.-based […]
Pediapharm wins Health Canada nod for antibiotic, steroid combo ear drop
Pediapharm Inc. (CVE:PDP) said today that it won regulatory approval from Health Canada for its Otixal eye drop solution for the treatment of acute otitis media with tympanostomy tubes in pediatric patients. The Quebec-based company touts Otixal as the 1st antibiotic and steroid combination ear drop available in single, sterile unit-dose packaging. Otitis media, or […]
Flexion seeks FDA nod for osteoarthritis steroid injection
Flexion Therapeutics (NSDQ:FLXN) said today that it submitted a new drug application to the FDA for its extended-release steroid injection Zilretta. The Burlington, Mass.-based company won Fast Track status from the watchdog for its osteoarthritis injection last year. The new drug application is based on data from a pivotal phase III clinical trial evaluating Zilretta in […]
UK slaps Pfizer with record $107m fine over price hikes
The U.K.’s Competition & Markets Authority reportedly fined Pfizer (NYSE:PFE) and Flynn Pharma a record amount for the companies’ massive price hikes to their unbranded versions of anti-epilepsy drug Epanutin. The British anti-trust watchdog fined Pfizer and Flynn Pharma $107 million (£84.2 million) and $6.5 million (£5.2 million), respectively. New York City-based Pfizer used to market the phenytoin sodium anti-epilepsy […]
GSK, Innoviva seek EU nod for triple combo inhaled therapy
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said last week that they filed a regulatory submission with the European Medicines Agency for the once-daily, triple-combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for patients with chronic obstructive pulmonary disease. Last month, the companies submitted a new drug application for the inhaled therapy to the FDA for approval in the U.S. The triple combination therapy is […]
J&J’s Evarrest fibrin sealant patch wins expanded indication for hemostasis
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today that the FDA approved an expanded indication for its Evarrest fibrin sealant patch as an supplementary hemostat. With the expanded indication, the patch can be used with manual compression as an adjunct to hemostasis in adult surgery patients, when standard surgical techniques to control bleeding such as suture […]
Counterfeit prescription drug tracker raises $52m
TraceLink Inc. said yesterday that it raised $51.5 million in a Series C financing round, bringing its total raised to $77 million. The round was led by Goldman Sachs Growth Equity, joining FirstMark Capital, Volition Capital and F-Prime Capital. TraceLink developed a cloud-based global network of manufacturers, distributors, pharmacies and healthcare professionals. The firm’s system enables […]
Immunovaccine’s targeted ovarian cancer therapy wins orphan drug status in EU
Immunovaccine Inc. said today that the European Medicines Agency granted orphan drug designation for its immunotherapy candidate for ovarian cancer in the EU. Orphan drug designation is granted to medicines intended for disease with a prevalence no greater than 5 in 10,000 people. According to the Nova Scotia-based company, ovarian cancer affects 3 per 10,000 […]
FDA clears Allergan’s Xen gel stent for glaucoma
Allergan (NYSE:AGN) said today that it won FDA approval for its Xen gel stent and injector for glaucoma. The federal watchdog indicated the drug device for the management of refractory glaucoma, in cases where surgical treatment has failed or in patients with open angle glaucoma that is unresponsive to maximum tolerated medical therapy. The Dublin-based […]
