Drugs
FDA has approved Adamas Pharmaceuticals’ Gocovri (amantadine) extended-release capsules for treating dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The company says Gocovri is the only medicine approved by FDA for this indication. It previously had been granted orphan drug
Drugs
US Bioservices Corp. will pay $13.4 million to settle claims that the company violated the anti-kickback law and the False Claims Act by participating in a kickback scheme with Novartis involving its iron-lowering drug Exjade (desfirasirox). According to a Justice Department news release, US Bioservices was promised
Drugs
A team of FDA researchers says that it can be difficult to interpret post-marketing surveillance studies on the effectiveness of opioid abuse deterrent properties because the underlying sampling mechanisms can bias the results in unpredictable ways. Writing online in Pharmacoepidemial Drug Safety, the researchers say that using comparators has
Drugs
Genmab and Janssen are planning to meet with FDA and other global regulators following positive Phase 3 data being reported from the ALCYONE study of daratumumab in combination with bortezomib, melphalan and prednisone (VMP) in front line multiple myeloma. The data met the primary endpoint at a pre-planned interim
Drugs
FDA has given Titan Pharmaceuticals a green light to begin a clinical trial involving its ropinirole implant for treating the signs and symptoms of Parkinson’s disease. The implant, developed utilizing Titan’s ProNeura technology, is designed for the long-term, continuous delivery of ropinirole HCL for the treatment of
Drugs
FDA has accepted for priority review a Vertex Pharmaceuticals NDA for tezacaftor/ivacaftor combination use in people with cystic fibrosis ages 12 and older who have two copies of the F508del mutation or one F508del mutation and one residual function mutation that is responsive to tezacaftor/ivacaftor. The submission is
Drugs
FDA has granted Epygenix Therapeutics an Orphan Drug Designation for EPX-300 for treating patients with Dravet Syndrome, a lifelong form of epilepsy that begins in the first year of life with frequent or prolonged seizures. “The effectiveness of EPX-300 was discovered using a proprietary phenotype-based zebrafish drug
Drugs
FDA has granted Perrigo final approval for its over-the-counter (OTC) equivalent of AstraZeneca’s Nexium 24-hour (esomeprazole magnesium) capsules, indicated for treating frequent heartburn (occurs two or more days a week). Perrigo says it has also reached a settlement in patent litigation with AstraZeneca allowing for the
Drugs
The European Medicines Agency (EMA) says that a new confidentiality commitment among it, FDA, and the European Union (EU) will allow FDA to share non-public and commercially confidential information, including trade secret information relating to medicine inspections, with EU regulators. “This confidentiality commitment is a milestone in the ongoing
Drugs
Eli Lilly CEO David Ricks told an 8/22 earnings call that he expects President Donald Trump to sign an executive order on drug prices before the end of this year. CNBC reports that Ricks expressed hope that Trump’s order would include ideas the drug industry has proposed, such
Drugs
Centurion Labs has recalled one lot of Ninjacof (Lot# 200N1601) and one lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet and distributed by Centurion Labs to the retail level due to potential contamination with Burkholderia cepacia. “Use of a product that may contain B. cepacia, could result in infections
Drugs
Ultragenyx says its aceneuramic acid extended release (Ace-ER) drug did not achieve its primary endpoint in a Phase 3 clinical trial in patients with GNE myopathy. The company says it is terminating its development program based on the Phase 3 results. The primary endpoint called for the therapy to
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Bicooya Cosmetics Ltd. Zhejiang, China (8/11): FDA inspected the firm’s drug manufacturing facility in May and cited it for significant GMP violations with finished pharmaceuticals. For example,
Drugs
ChromaDex, which says it is the only supplier of nicotinaminde riboside chloride (Niagen) that has been recognized by FDA as generally safe (GRAS), is asking the agency to investigate and take appropriate remedial action against Elysium Health over its Basis dietary supplement. The ChromaDex petition says that in the past,
Drugs
Pfizer is asking FDA to issue a product-specific bioequivalence (BE) guidance applicable to any ANDA for a generic version of its Estring (estradiol vaginal ring), and to require any ANDA applicant to establish bioequivalence for its generic Estring product based on the conditions set forth in such a guidance.
Drugs
FDA says it approved 8/21 changes to labeling for Guilead’s Odefsey (emtricitabine/rilpivirine/tenofovir/alafenamide HIV-1 treatment. The changes add data from 48-week trials in which subjects switched to Odefsey from tenofovir disoproxil fumarate-based regimens such as Gilead’s Complera or Bristol-Myers Squibb’s
Drugs
FDA has told Cardiome Pharma that a data package proposed by the company would not be sufficient to support a resubmission of its NDA for Brinavess (vernakalant hydrochloride, IV), an antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation. “In our most recent communication with the FDA, we
Drugs
With President Donald Trump signing the FDA Reauthorization Act 8/18, FDA says it will revise an earlier draft guidance on pre-submission of facility information as part of an expedited review of qualifying priority ANDAs. The reauthorization law includes provisions providing for the expedited review of qualifying priority ANDAs
Drugs
AdvaMed says the current 2003 FDA guidance on using electronic records and signatures in medical product clinical investigations is outdated and uses enforcement discretion. In its comment on a new draft guidance, the trade association says it supports the risk-based approach to validation and audit trails outlined in the
Drugs
President Trump has signed the FDA Reauthorization Act of 2017 that renews the agency’s user fee programs for another five years. Enacting the measure into law removes the threat of having to send reduction-in-force (RIF) notices to staff who are funded by user fees. In late July,
Drugs
FDA says it is carefully evaluating prescription opioid medications approved to treat cough in children, and it has planned a 9/11 Pediatric Advisory Committe meeting to discuss the topic and receive panel recommendations. “There are few more common decisions that parents and providers are asked to make than the
Drugs
A July inspection at outsourcing drug manufacturer Leesar, Inc. (Fort Myers, FL) found that the firm’s aseptic processing areas were deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. According to a just-posted Form 483, procedures designed to prevent microbiological contamination