Drugs
The Supreme Court may decide in June whether to hear Sandoz and/or Amgen’s petitions appealing a Federal Circuit Court of Appeals decision on interpretation of the “notice of commercial marketing” provision of the Biologics Price Competition and Innovation Act (BPCIA). A Big Molecule Watch blog post from Goodwin
Drugs
FDA Office of Chief Counsel (OCC) drugs counselor Julie Dohm has been named CDER senior science advisor for compounding. In this capacity, she will be the agency lead on compounding, developing and managing teams to implement legislation, perform inspections, prepare enforcement actions, develop policy, and conduct outreach to stakeholders. For
Drugs
FDA has extended its review of a Sarepta Therapeutics NDA for eteplirsen and its use in treating Duchenne muscular dystrophy. The submission has become a politically charged issue, with U.S. lawmakers weighing in and urging the agency to exercise its flexibilities when making a review decision. The agency notified
Drugs
Relypsa has submitted a supplemental NDA requesting label changes for Veltassa (patiromer) for oral suspension based on results of 12 Phase 1 drug-drug interaction studies in healthy volunteers. Veltassa was approved in 2015 for treating hyperkalemia. The drug-drug interaction program submitted as part of Veltassa’s original NDA
Drugs
FDA has granted Viamet Pharmaceuticals an orphan drug designation for VT-1598 for treating coccidioidomycosis (also known as Valley Fever). VT-1598 is a selective, orally available inhibitor of fungal CYP51 that the company says has demonstrated high potency in preclinical studies against Coccidioides species, the fungal pathogens responsible for
Drugs
A 5/4-7/15 FDA inspection at the BBT Biotech Gmbh drug manufacturing facility in Baesweiler, Germany, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API). A 5/16 Warning Letter says that specific deviations included: * failing to follow a documented, on-going stability testing
Drugs
FDA has approved a Janssen Pharmaceuticals NDA supplement for Invokamet, a fixed-dose combination therapy of Invokana (canagliflozin) and metformin hydrochloride, for treating first-line adults with Type 2 diabetes. With this approval, Invokamet may now be marketed for use in adults with Type 2 diabetes who are not already
Drugs
FDA has accepted for review an Allergan NDA for oxymetazoline HCl cream 1.0% for treating persistent facial erythema (redness) associated with rosacea in adults. The company expects a user fee target date in first half of 2017. Oxymetazoline is a sympathomimetic agonist that is selective for the a1A-adrenoceptor
Drugs
University of California-San Diego emeritus professor Daniel Kripke is suing FDA for not adequately regulating sleeping pills. Courthouse News Service reports that Kripke’s suit says that sleeping pills are among the more prescribed drugs in the country and “are the immediate cause of death of more than 10,
Drugs
A 5/4-11/15 FDA inspection at Tai Heng Industry, Shanghai, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to a 5/12 Warning Letter. Specific deviations observed included: * failing to adequately investigate out-of-specification results and implement appropriate corrective actions;
Drugs
Saying that drug manufacturers too often are ignoring informal FDA communications stating that the agency does not require submission of in vivo rabbit ocular and skin irritation tests (Draize), the Center for Responsible Science (CRS) is asking the agency to issue guidance “communicating broadly that FDA will accept in vitro
Drugs
A whistleblower who claimed that Pfizer induced false claims for its Lipitor because it marketed the drug as appropriate for patients whose risk factors and cholesterol levels are outside the National Cholesterol Education Program guidelines, has lost an appeal to the 2nd Circuit Court of Appeals. Dr. Jesse Polansky, who
Drugs
FDA has cleared an Avantis Medical Systems 510(k) for the Third Eye Panoramic device for use as a multi-use imaging product for colonoscopies. Previously cleared as a disposable device, the new clearance now allows the device to be marketed for use multiple times prior to disposal. Avantis Medical
Drugs
FDA reviewers have serious questions about a Sanofi NDA for its combination insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist for treating Type 2 diabetes. On 5/25, the agency’s Endocrinologic and Metabolic Drugs Advisory Committee will meet
Drugs
The Senate Committee on Homeland Security and Governmental Affairs has written FDA commissioner Robert Califf urging the agency to exercise its flexibilities when making a review decision this week on a Sarepta Therapeutics NDA for eteplirsen and its use in treating Duchenne muscular dystrophy. In April, the agency’s Peripheral
Drugs
FDA has awarded BioPharma Services a five-year, $20 million contract with CDER to conduct in vivo studies involving generic drug products in human subjects. The contract is intended to support CDER generic drug regulatory science issues, according to BioPharma. They will “proactively address scientific questions in developing generic approval
Drugs
The International Academy of Oral Medicine & Toxicology and the Fluoride Action Network have filed a petition urging FDA to take regulatory action to remove from the market all unapproved fluoride drugs, which are commonly known as fluoride supplements. Fluoride supplements are sodium fluoride-containing drops, tablets, and lozenges sold
Drugs
FDA has set an 8/5 joint meeting of its Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee to review an NDA resubmission from Pain Therapeutics for Remoxy (oxycodone) extended-release capsules in an abuse-deterrent formulation for treating pain. The agency has
Drugs
Acorda Therapeutics says it will discontinue developing Plumiaz (diazepam) Nasal Spray, an investigational therapy being studied for treating seizure clusters in people with epilepsy. Data from ongoing clinical trials do not demonstrate its bioequivalence to Valeant Pharmaceutical’s Diastat rectal gel, which is needed to file a 505(b)(2)
Drugs
FDA has granted orphan drug designation to Anavex Life Sciences’ Anavex 2-73 for treating Rett syndrome. The company describes the disease as a rare non-inherited genetic postnatal progressive neurodevelopmental disorder that occurs almost exclusively in girls and leads to severe impairments and is characterized by near constant repetitive
Drugs
ResQ Pharma, Inc. has submitted an Investigational New Drug application to FDA for LipidRescue Therapy (LRT) as a last resort in treating local anesthetic systematic toxicity. The company says LRT refers to administrating a lipid emulsion with the intent of reducing the life-threatening clinical manifestations of toxicity from excessive
Drugs
Attorney Kurt Karst (Hyman, Phelps & McNamara) says that while the GDUFA 2 reauthorization negotiations are likely to yield only small changes and refinements, one thing he would like to see included is a deadline for FDA to rule on a citizen petition asking the agency to designate a drug