Drugs
FDA and the generic drug manufacturing industry have reached agreement on an extension of the Generic Drug User Fee Amendments of 2012 (GDUFA), which expire in 2017. GDUFA 2 will run from FY 2017 through FY 2022. Generic Pharmaceuticals Association (GPhA) vice president for scientific and regulatory affairs David Gaugh
Drugs
FDA has granted Cynapsus Therapeutics a fast track designation for APL-130277, a product candidate for treating “off episodes” in patients with Parkinson’s disease. Off episodes are thought to occur when brain dopamine levels fall below a critical threshold to sustain relatively normal motor function, the company says. These
Drugs
Scientists in New York and London say there are steps researchers can take when a trial’s primary outcome fails to achieve statistical significance. Writing in the New England Journal of Medicine, they suggest that researchers ask a set of 12 questions to help them clarify whether the new treatment
Drugs
FDA has moved the drug safety labeling changes program from MedWatch in the Office of the Commissioner to the CDER Office of Communications in an effort to speed publication of labeling changes on the Internet. CDER director Janet Woodcock says that MedWatch posted safety labeling changes monthly. Now, she says,
Drugs
FDA has granted Perrigo tentative ANDA approval for a generic version of Gladerma’s Epiduo Gel (adapalene and benzoyl peroxide 0.1%/2.5%), indicated for treating acne vulgaris in patients 12 years of age and older. Annual sales for the brand product are about $379 million. According to FDA’
Drugs
FDA has accepted for review an Array BioPharma NDA for binimetinib for treating certain patients with melanoma. The agency has set a user fee review target date of 6/30/2017. The submission is based on data from the company’s Phase 3 NEMO (NRAS MELANOMA AND MEK INHIBITOR) trial
Drugs
GlaxoSmithKline says that while an FDA draft guidance on elemental impurities in drug products is a “well-written and informative document” that supports a risk-based approach to controlling elemental impurities, it is not up to date with respect to two U.S. Pharmacopeia (USP) chapters. “We assume that this
Drugs
An Alabama federal court has granted Sandoz’ motion to dismiss a suit against it alleging that it failed to warn sufficiently about risks in use of amiodarone (a generic form of Wyeth’s Cordarone), off-label promotion, negligence, and failure to provide a Medication Guide to a man who died
Drugs
A 7/11 FDA draft guidance would allow ANDA holders to update drug labels with new safety information if the reference-listed drug (RLD) has been withdrawn by the branded manufacturer. Attorney Bradley Davidsen (Epstein Becker Green) writes in an online analysis that the draft represents a limited compromise between
Drugs
In November, FDA has planned a two-day public hearing to obtain input on off-label communication by drug and medical device companies. An FDA notice says the agency is “engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical
Drugs
FDA says that regulations generally prevent it from disclosing the existence of an IND or discussing much of the information in an IND file before the product is licensed. Thus, it says, it can’t respond substantively to a Rosalind Advisors 1/16 citizen petition asking that it place the
Drugs
FDA says it is requiring class-wide changes to drug labeling to inform healthcare providers and patients about the serious risks associated with combined use of certain opioids and benzodiazepines. An agency statement says that a Boxed Warning will be required, along with Medication Guides, for nearly 400 prescription opioid
Drugs
FDA inspections at China’s Xinxiang Pharmaceutical Co. (9/14-16/15) and Xinxiang Tuoxin Biochemical Co. (9/15-18/15) found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs), according to an 8/19 Warning Letter. Specific deviations cited in the letter include: * failing
Biologics
A 3/23-5/4 FDA inspection at Amniotic Therapies, Farmers Branch, TX, found multiple violations in the firm’s receiving of amniotic tissue recovered from cesarean births and processing the amnion, a structural tissue, from donors for allogenic use. The firm also produces AlphaGEMS, AlphaGEMS Micro and AlphaGEMS Nano
Drugs
An improved FDA combination product review and approval system could help speed needed products to market, like generic copies of Mylan’s EpiPen that has drawn a lot of attention lately due to allegedly unwarranted price increases, Pharmaceutical Research and Manufacturers of America (PhRMA) argues in a new blog post.
Drugs
The California Supreme Court has ruled 4-3 that its state courts have jurisdiction over eight Bristol-Myers Squibb (BMS) product liability lawsuits involving the company’s blood thinner Plavix even though the plaintiffs are not residents of the state. “Although BMS’s business contacts in California are insufficient to
Drugs
Harvard Medical School researchers say that over the past two decades, fewer investigational cardiovascular drugs have entered clinical trials across all stages of development. Writing in JACC Basic to Translational Science, the researchers say, however, that recently more therapies have targeted novel biological pathways and have been sponsored by small
Drugs
The U.S. Pharmacopeial Convention says that an FDA draft guidance on elemental impurities in drug products “provides clarity and assistance to human drug product manufacturers regarding the control of elemental impurities consistent with implementation of International Council for Harmonization guidance for industry … and pursuant to the USP requirements for
Drugs
FDA has published a final rule that requires drug/biologic makers to electronically submit, unless waived in certain circumstances, their registration and listing information. The 2006-proposed rule featured a requirement that FDA, not registrants, develop national drug codes (NDCs) for assignment to listed drugs, and a requirement that the
Drugs
House Energy and Commerce Committee leaders have written FDA asking for details on what the agency can do to expedite generic copies of Mylan’s EpiPen Auto-Injector (epinephrine injection) amid growing criticism of cost increases related to the product. The letter asks FDA to provide details on how many
Drugs
FDA has posted a draft guidance on Bioequivalence Recommendations for Risperidone that outlines recommended bioequivalence testing for ANDA sponsors seeking approval for a generic copy of Jannsen’s antipsychotic Risperdal. The document recommends an in vitro drug release study and an in vivo two-period, crossover steady-state study. The
Drugs
Faced with mounting criticism over its costly EpiPen Auto-Injector (epinephrine injection), Mylan now says it will launch an authorized generic of the product that will be discounted 50% of the branded product’s list price. “The authorized generic will be identical to the branded product, including device functionality and