Drugs
A 12/1-12/9/16 FDA inspection at Tubilux Pharma, Rome, Italy, found significant violations of current good manufacturing practice for finished pharmaceuticals. A 7/6 Warning Letter says specific violations included: * failing to use equipment in the manufacture, processing, packing, or holding of drug products that is of
Drugs
CBER says that GlaxoSmithKline is recalling one lot of Menveo [meningococcal (Groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine] solution for intramuscular injection 5 doses (10 vials) per package) as a precautionary measure since the associated batch was subject to a mechanical intervention executed during the
Drugs
FDA has approved Gilead’s Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to treat adults with chronic hepatitis C virus genotypes 1-6 without cirrhosis or with mild cirrhosis. An agency news release says Vosevi is a fixed-dose, combination tablet containing two previously approved drugs (sofosbuvir and velpatasvir) and a new drug
Drugs
FDA has accepted an Otonomy supplemental NDA seeking approval of Otiprior (ciprofloxacin otic suspension) as a treatment for acute otitis externa (swimmer’s ear). The agency has set a user fee review action target date of 3/2/2018. Otiprio is a fluoroquinolone antibacterial currently indicated for treating pediatric patients
Drugs
Attorney Michael Blume (Venable) says that even though the Supreme Court declined to hear the appeal of Quality Egg owners Jack and Peter DeCoster from their three-month sentence after pleading guilty to misdemeanor violations of the Federal Food, Drug, and Cosmetic Act (FFDCA), the Justice Department briefs submitted in
Drugs
FDA has issued Amgen a Complete Response Letter on its BLA for the Evenity (romosozumab) as a treatment for postmenopausal women with osteoporosis. The initial submission included data from the pivotal Phase 3 placebo-controlled FRAME study of postmenopausal women with osteoporosis. “With the availability of data from the Phase
Drugs
FDA has approved a Puma Biotechnology NDA for Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. FDA says Nerlynx is the first therapy approved to be taken after an initial treatment to further lower the risk of the cancer coming back. It is indicated
Drugs
FDA has accepted for priority review a Spark Therapeutics BLA for Luxturna (voretigene neparvovec), a investigational gene therapy for treating patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease. The agency has set a 1/12/2018 user fee review target date. The submission is based
Drugs
FDA has proposed new research to be conducted on prescription drug promotional messages that are embedded in character space-limited online prescription drug communications. An agency notice says that certain online communication efforts (e.g., Twitter, sponsored link promotion and microblog messaging) has led to questions about how to use
Drugs
FDA has posted a “REMS Platform Standards Initiative: Needs Assessment” document that is intended to help standardize risk evaluation and mitigation strategies (REMS) with elements to assure safe use, and better integrate them into the growing electronic healthcare system. The initiative is intended to support data standards development to facilitate
Drugs
FDA has told Repros Therapeutics that its clinical development program for Proellex, an oral delivery mechanism for telapristone acetate for treating uterine fibroids, will remain on partial clinical hold based upon its review of existing liver function safety data. The agency has also indicated that the company will be required
Drugs
FDA has revised an internal policy on “Communicating Drug Approval Information” that demands quicker online posting, from three days to two days, for the approved labeling for recently approved drugs. The policy also lays out the posting schedule for approved risk evaluation and mitigation strategy documents, a summary review and
Drugs
Responding to a National Academies of Sciences, Engineering, and Medicine report on the nation’s opioid epidemic, FDA commissioner Scott Gottlieb highlighted steps the agency is taking as part of his commitment to reduce the scope of the epidemic. In a statement, Gottlieb says that reducing the epidemic is his
Drugs
Mallinckrodt has filed a citizen petition asking FDA to assure that follow-on drug products citing its Inomax (nitric oxide) 800 ppm for inhalation as the reference listed drug include features necessary for the safe and effective administration of inhaled nitric oxide. Two previous petitions seeking similar actions were earlier
Drugs
FDA’s Oncologic Drugs Advisory Committee has voted 17-0 to support approval of an Amgen BLA for a biosimilar version of Roche’s Avastin (bevacizumab) and its use in six non-exclusivity-protected indications. In a separate 16-0 vote, the panel backed approval for a Mylan BLA for
Drugs
FDA has approved a Janssen Biotech BLA for Tremfya (guselkumab) for treating adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya works by selectively blocking IL-23, a cytokine that plays a key role in plaque psoriasis. Approval follows an expedited regulatory review
Drugs
FDA has approved an Amgen supplemental BLA for Blincyto (blinatumomab) to include overall survival data from the Phase 3 TOWER study. The approval converts Blincyto’s accelerated approval to a full approval. The sBLA approval also included data from the Phase 2 ALCANTARA study supporting the treatment of patients with
Drugs
FDA has granted Sangamo Therapeutics a fast track designation for SB-318 and SB-913, two clinical stage in vivo genome editing product candidates for treating Mucopolysaccharidosis Type I (MPS I) and MPS II, respectively. MPS I and MPS II are caused by mutations in the genes encoding alpha-L-
Drugs
FDA’s Oncologic Drugs Advisory Committee has voted 10-0 to support approval of a Novartis BLA for CTL019 (tisagenlecleucel-T), a chimeric antigen receptor T-cell (CAR-T) for treating pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. CAR-T therapies are different
Drugs
Although FDA encourages development of abuse-deterrent formulations (ADF) for opioid drugs, lack of a consistent regulatory policy may hinder innovation in the area, according to a roundtable of pharmaceutical experts convened by the Tufts Center for the Study of Drug Development. The experts’ assessment of the clinical development, regulatory,
Drugs
FDA has accepted for review a Pfizer supplemental NDA for Xeljanz (tofacitinib citrate) for treating adult patients with moderately to severely active ulcerative colitis (UC). Tofacitinib citrate is a Janus kinase inhibitor currently approved for treating adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work
Drugs
FDA has cleared a TechLab 510(k) for the Tri-Combo Parasite Screen test for detecting Giardia, Cryptosporidium, and Entamoeba histolytica, the three most common intestinal protozoan parasites. The enzyme immunoassay simultaneously detects the parasites in human fecal specimens, according to the company. It is indicated as an aid in