Brainstorm Cell Therapeutics (NSDQ:BCLI) said today that it’s preparing for a phase III trial of its NurOwn stem cell treatment, after meeting with the FDA about a biologic license application. The company is developing adult stem cell therapies derived from autologous bone marrow cells to treat neurodegenerative diseases, such as ALS. Hackensack, N.J.-based Brainstorm is planning […]
Food & Drug Administration (FDA)
Galderma wins FDA nod for dermal fillers
Galderma said today that it won FDA approval for 2 of its products to treat nasolabial folds, or “laugh lines”. The Fort Worth, Texas-based company’s Restylane Refyne and Restylane Defyne are made with XpresHAn technology to manufacture injectable gels with customized hyaluronic acid crosslinking in each product. The federal watchdog’s approval was based on 2 […]
FDA approves first bioresorbable scaffold with autologous cells for cartilage repair
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 […]
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 […]
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 […]
SRI wins $150m grant to develop HIV prevention products
SRI International said today that it landed a $150 million contract from the National Institutes of Health‘s National Institute of Allergy and Infectious Diseases and the Division of AIDS to support the development of HIV microbicides and other pre-exposure agents. According to the 7-year deal, the research institute will provide preclinical product development services for non-vaccine […]
Scilex touts data for novel lidocaine patch
Sorrento Therapeutics (NSDQ:SRNE) subsidiary Scilex Pharmaceuticals said today that its lidocaine patch, ZTlido, met primary and secondary endpoints in a pivotal study comparing the patch to Endo Pharmaceutical‘s Lidoderm patch. The data will be used to resubmit a new drug application to the FDA in mid-2017, the Malvern, Pa.-based company said. The clinical trial evaluated Scilex’s […]
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 […]
Pharma execs assess landscape under President Trump
Executives from U.S. drugmakers such as Regeneron Pharmaceuticals and Pfizer talked about the possible changes awaiting the industry under President-elect Donald Trump at the Forbes Healthcare Summit this week. After he was elected, pharmaceutical stocks surged as investors concluded the threat of action on drug pricing had lessened. Trump has said he wants to repeal […]
Nordisk touts Tresiba insulin injection data
Novo Nordisk (NYSE:NVO) said today that data from the Devote clinical trial indicated that its injected insulin, Tresiba, reduced the risk of severe hypoglycemia when compared to insulin glargine. The trial enrolled more than 7,500 type 2 diabetes patients at high risk of adverse cardiovascular events and treated them for 2 years with either Tresiba or insulin glargine […]
