Amphastar Pharmaceuticals (NSDQ:AMPH) said this week that the FDA denied its subsidiary’s new drug application for the latest version of its Primatene Mist epinephrine inhaler. The complete response letter from the federal watchdog told Amphastar’s subsidiary, Armstrong Pharmaceuticals, that the company needs to change the inhaler’s label and packaging. The FDA also recommended that the company […]
Food & Drug Administration (FDA)
Biogen, Ionis win FDA approval for first spinal muscular atrophy drug
Biogen (NSDQ:BIIB) said last week that it won FDA approval for its spinal muscular atrophy treatment, Spinraza. The drug is the 1st treatment approved in the U.S. for spinal muscular atrophy, a progressive and often fatal genetic disease that causes muscle weakness in infants and toddlers. The FDA previously granted Biogen’s application fast track designation […]
Another warning for CareFusion’s Alaris drug pump
The U.K.’s Medicines & Healthcare Products Regulatory Agency issued a warning today for Carefusion‘s Alaris syringe drug pumps. The UK watchdog said that Alaris pumps with broken springs in the plunger assembly could accidentally release a single dose of medication if the pump also uses non-recommended syringes. “This problem comes about through a combination of using […]
21st Century Cures Act adds Hatch-Waxman rule to drug-device combos
Section 3038 of the 21st Century Cures Act applies Hatch-Waxman rules to certain drug-device combination products, addressing the regulatory pathway for devices that incorporate already approved drugs. The Hatch-Waxman Act, named for Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), was approved in 1984. It was designed to make it easier for generic drugs to enter […]
Brainstorm’s NurOwn stem cell treatment for ALS readies for phase III
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 […]
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 […]
