Drugs
Aimmune Therapeutics mistakingly paid a $2.5 million user fee with a BLA submission for AR101, an investigational biologic oral immunotherapy for treating peanut allergy that was submitted just before the partial government shutdown. Under the agency’s shutdown guidelines, such a submission could have been accepted for review because
Drugs
FDA medical reviewers are raising safety issues associated with Sanofi’s sotagliflozin that will be considered by the agency’s Endocrinologic and Metabolic Drugs Advisory Committee 1/17. A briefing document released in advance of the meeting says Sanofi is seeking approval for the drug as an adjunct to insulin
Drugs
FDA has accepted for review two Pfizer NDAs for tafamidis for treating transthyretin amyloid cardiomyopathy (ATTR-CM). The submission are based on two formulations of tafamidis — meglumine salt and free acid. The company says the tafamidis meglumine form (20 mg capsule) has been granted a priority review with a user
Drugs
A joint meeting of the FDA Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee has voted 19 to 2 that based on its benefit-to-risk profile there is a patient population with gout that exists for Takeda’s Uloric (febuxostat) for its current indication as
Drugs
FDA commissioner Scott Gottlieb says the agency is monitoring whether branded biologic companies are taking any steps to undermine the fledgling biosimilar product market. “FDA continues to be concerned about branded companies creating confusion about the safety and effectiveness of biosimilars and we’ll take action if we determine a
Drugs
An FDA Bone, Reproductive and Urologic Drugs Advisory Committee 1/16 will discuss an Amgen BLA for romosozumab, indicated for treating osteoporosis in postmenopausal women at high risk of fracture, and a cardiovascular safety issue that arose during the submission’s earlier review that led to a complete response letter.
Drugs
FDA has granted BeiGene a breakthrough therapy designation for its investigational Bruton’s tyrosine kinase inhibitor, zanubrutinib, for treating adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. MCL is typically an aggressive form of non-Hodgkin lymphoma that arises from B-cells originating
Drugs
FDA principal associate commissioner for legislative affairs John Martin is departing to lead the government affairs unit at CRISPR Therapeutics, a leading gene editing company focused on developing gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. Martin joined FDA in 2017 and directed the negotiation to
Drugs
The U.S. Ninth Circuit Court of Appeals has affirmed a district court decision siding with dietary supplement maker NBTY over structure/function claims on its vitamin E supplements claiming to “support cardiovascular health” and to “promote immune function,” “immune health,” “heart health,” and “circulatory health.” In Dachauer vs. NBTY,
Drugs
An unidentified California man with glioblastoma, the same deadly form of brain cancer that claimed the life of Sen. John McCain (R-AZ) last year, is the first patient to receive an experimental therapy under the so-called “Right-to-Try” law that was signed into law in 5/2018
Drugs
A new study on drug development costs has found that clinical costs per approved orphan drug were half that of a non-orphan drugs. Appearing in the 1/10 issue of the Orphanet Journal of Rare Diseases, the study examined the differences in trial characteristics and clinical development costs with
Drugs
FDA commissioner Scott Gottlieb says he is “worried that there are deliberate or unintentional efforts by branded companies to create confusion” about the safety and effectiveness of unbranded biologic drugs. In an interview with the Washington Post, Gottlieb says such messages “can potentially undermine consumer confidence in biosimilars in ways
Drugs
Sun Pharmaceutical Industries has recalled three lots of vecuronium bromide for injection, 10 mg (lyophilized powder), and one lot of the 20 mg size because they have been found to contain particulate matter identified as glass. The drug is used as an adjunct to general anesthesia, to facilitate endotracheal intubation
Drugs
FDA has accepted for review a Clinuvel Pharmaceuticals 505(b)(2) NDA for Scenesse (afamelanotide) 16mg for preventing phototoxicity and anaphylactoid reactions in adult patients with erythropoietic protoporphyria whose skin is exposed to light. Scenesse was granted orphan drug designation by FDA in 2008, and it was approved for use
Drugs
Former Insys Therapeutics CEO Michael Babich has pleaded guilty in Massachusetts federal court for his role in a nationwide scheme to bribe physicians to unnecessarily prescribe a fentanyl-based pain medication and defraud healthcare insurers. Late last year, formr company vice president Alec Burlakoff also pleaded guilty in the scheme
Drugs
A 4/9-5/16/18 FDA inspection at the Akorn drug manufacturing facility in Decatur, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 1/4 Warning Letter, announced by the company this week, says specific violations were: * failing to follow appropriate written
Drugs
Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) have reintroduced their Preserve Access to Affordable Generics and Biosimilars Act to crack down on anti-competitive pay-for-delay drug deals in which branded companies pay their generic competitors not to compete as part of a patent settlement. The
Drugs
Sen. Bernie Sanders (I-VT) and Rep. Ro Khanna (D-CA) will introduce the Prescription Drug Price Relief Act of 2019 to require the HHS secretary to license generic and biosimilar competition on patented prescription products when they are deemed excessively priced or cost more than the median in Canada,
Drugs
Members of the FDA Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will discuss 1/11 a sNDA for Takeda’s Uloric (febuxostat) in light of results of an FDA-mandated postmarketing safety trial (CARES) evaluating the drug’s cardiovascular safety. An agency briefing document released in
Drugs
Hyman, Phelps & McNamara has released its annual report highlighting leading cases and settlements from 2018 affecting FDA- and DEA-regulated industries. The report provides a concise summary of the relevant facts and key takeaways of each case and also has a list of “hot-button” cases being monitored this
Drugs
The Consumer Healthcare Products Association (CHPA) says it applauds introduction and passage of H.R. 269, which includes the Over-the-Counter Monograph Safety, Innovation, and Reform Act. The bipartisan measure was approved in the House on a 401-17 vote. CHPA says this is the third time the House
Drugs
FDA commissioner Scott Gottlieb says the agency is launching a new five-year strategy that envisions a more robust Sentinel System that operates as a transformative national resource. Sentinel is a national electronic system for monitoring the safety of FDA-approved drugs and other medical products. Writing with CDER Office