Drugs
Consumer advocacy group Public Citizen is urging Congress to reject three “right to try” bills (S 204, HR 878 and HR 1020) because they would “put countless patients at risk by dramatically undermining the FDA’s role in ensuring that medical products are safe and effective before they become widely
Drugs
Former FDA commissioner Mark McClellan has weighed in on President Trump’s address to Congress last week where he criticized the agency’s approval process (see story) as “slow and burdensome.” In an interview with NPR reporter Audie Cornish, McClellan noted that the approval process takes only eight and a
Drugs
Sen. Chuck Grassley (R-IA) has expanded his inquiry into potential misuses of FDA’s orphan drug program in the wake of the agency’s recent approval of Marathon Pharmaceuticals’ orphan drug Emflaza (deflazacort) tablets and oral suspension to treat patients age five and older with Duchenne muscular dystrophy (see
FDA Policy/General
Federal Register Notice: FDA has determined that GlaxoSmithKline’s allergy drug Flonase (fluticasone propionate) nasal spray, 0.05 mg, was not withdrawn from sale for safety or effectiveness reasons. This determination means the agency will not begin procedures to withdraw ANDA approvals that reference the brand drug product. To view
FDA Policy/General
Federal Register Notice: FDA has announced a 5/4 public meeting and an opportunity for public comment on Patient-Focused Drug Development for autism. The meeting is part of FDA’s performance commitments agreed to under the Prescription Drug User Fee Act (PDUFA V). It is intended to allow FDA
FDA Policy/General
Federal Register Notice: FDA has awarded Biogen a priority review voucher (PRV) for gaining approval of rare disease drug Spinraza (nusinersen), indicated for treating spinal muscular atrophy in pediatric and adult patients. The PRV was awarded under a provision that encourages development of new drugs and biologics for rare pediatric
FDA Policy/General
FDA Global Regulatory Operations and Policy deputy commissioner Howard Sklamberg has left the agency effective 3/3 “to pursue new opportunities.” Sklamberg had reportedly informed former commissioner Robert Califf last September that he planned to leave the agency early this year. Global Regulatory Policy associate commissioner Dara Corrigan will serve
FDA Policy/General
Panel to Review OTC Meds for Upset Stomach/Hangovers Federal Register Notice: FDA has announced a 4/4 joint meeting of the Nonprescription Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss safety issues associated with over-the-counter analgesic combination products used
Devices
A 2.3% medical device tax in the Affordable Care Act (ACA), which was suspended for tax years 2016 and 2017, cost the U.S. economy 28,000 jobs, according to a new AdvaMed-backed report entitled “Employment Effects of the Medical Device Tax.” Absent a repeal of the ACA
Drugs
FDA has granted aTyr Pharma an orphan drug designation for Resolaris for treating limb girdle muscular dystrophy (LGMD) patients. The company is developing Resolaris as a potential first-in-class intravenous protein therapeutic for treating rare myopathies with an immune component. It says Resolaris is derived from a naturally occurring
Drugs
FDA has granted EnGeneIC an orphan drug designation for its epidermal growth factor receptor-targeted, doxorubicin-loaded EDV nanocells for treating glioblastoma multiforme. The clinical stage biopharmaceutical company says it is focused on developing its proprietary bacterially-derived EDV nanocells as a powerful nanoparticle drug, siRNA, or miRNA delivery platform
FDA Policy/General
Federal Register Notice: FDA has announced a 4/4 joint meeting of the Nonprescription Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss safety issues associated with over-the-counter analgesic combination products used for upset stomach (i.e., heartburn, nausea, fullness, belching,
Drugs
FDA has awarded Biogen a priority review voucher (PRV)for gaining approval of rare disease drug Spinraza (nusinersen), indicated for treating spinal muscular atrophy in pediatric and adult patients. FDA has approved Biogen’s Spinraza (nusinersen) for treating children and adults with spinal muscular atrophy. Spinraza, the first drug indicated
Drugs
FDA has approved a Serenity Pharmaceuticals NDA for Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Approval was based on data from two 12-week trials in
Drugs
FDA has approved a Lupin Ltd. ANDA for a generic copy of Braintree Laboratories’ Suprep Bowel prep kit. Drugs contained in the kit includes sodium sulfate, potassium sulfate, and magnesium sulfate oral solution, 17.5 g/3.13 g/1.6 g, respectively per six ounces. Suprep Bowel Prep Kit
FDA Policy/General
When President Trump told Congress 2/28 his first budget request will seek a 10% increase in defense programs and a 10% cut in non-defense discretionary programs, he put FDA at risk, says Alliance for a Stronger FDA deputy executive director Steven Grossman in his latest weekly analysis and
Drugs
FDA has approved Merck, Sharp & Dohme’s Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite-induced nasal inflammation with or without eye inflammation in people aged 18 to 65 years. “Odactra exposes patients to house dust mite allergens, gradually training
Drugs
A Delaware federal judge has dismissed a Genentech suit filed against Amgen under the Biologics Price Competition and Innovation Act (BPCIA). The suit involves Amgen’s application for a biosimilar version of Genentech’s blockbuster cancer drug Avastin. FDA accepted that application for review 1/4. Under the BPCIA, once
Drugs
Drug companies often use the citizen petition process as a strategy to delay generic competition, according to a study from the University of California Institute for Innovation Law reported in the New England Journal of Medicine. The authors reviewed 12 years of FDA citizen petition data and found that drug
Devices
FDA has cleared a Neocis Inc. 510(k) for Yomi, a robotic guidance system for dental implant procedures. The computerized navigational system is intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery, according to the company. It provides software
Drugs
Juno Therapeutics says it is ceasing development of its CAR-T cell product candidate JCAR015, indicated for relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL) due to a greater than expected incidence of severe neurotoxicity and five deaths from cerebral edema were observed last year. The product
Drugs
The Government Accountability Office (GAO) says that FDA should clarify the role of its draft guidances issued under the Generating Antibiotic Incentives Now (GAIN) provisions of the 2012 FDA Safety and Innovation Act. In its report on implementation of GAIN, GAO also says the agency should develop guidance on the