Drugs
FDA has granted Menlo Therapeutics a breakthrough therapy designation for serlopitant for treating pruritus associated with prurigo nodularis (PN). The designation is based on data from a Phase 2 clinical trial in pruritus associated with PN, according to the company. In the 127-patient trial, serlopitant met its primary and
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
Devices
FDA has approved an Abbott PMA for the Amplatzer Piccolo Occluder, a tiny medical device that can be implanted in the smallest babies (weighing as little as two pounds) to treat patent ductus arteriosus, or PDA. The device, which is smaller than a pea, is intended for premature infants and
FDA Policy/General
Concerned that the partial government shutdown affecting FDA will have lingering effects over the course of the year impacting medical product reviews/approvals and its oversight of the food supply, a group of 34 Senate Democrats have sent a letter to commissioner Scott Gottlieb requesting information on the potential damage
FDA Policy/General
DEVICES FDA has cleared a Delta Med 510(k) for the DeltaVen Closed System Catheter. The peripheral intravenous device has a needle, extension tubing, and an option for a needleless connecter to the catheter. It will be available in a variety of sizes and configurations, including the only 26 gauge
FDA Policy/General
As thousands of FDA employees missed their normal paychecks 1/11, FDA commissioner Scott Gottlieb posted a special note of gratitude for their dedication to their public health mission. “I deeply regret these hardships,” he said on his Twitter feed. “And I admire very much their continued dedication to our
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,
Devices
FDA has cleared an RFPi Inc. 510(k) for its iCertainty open surgery blood flow and perfusion imaging medical device, which is intended to show real-time blood flow and perfusion in vascular structures and critical tissues during surgeries. The company says iCertainty does not require injections, dyes, radiation, direct
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
Devices
During the current government shutdown, FDA says it is continuing to conduct device post-market surveillance. In a series of Twitter posts, FDA commissioner Scott Gottlieb sought to reassure constituents, saying that “while it’s not business as usual at the agency, we are continuing to prioritize our device safety
Devices
The 11th Circuit Court of Appeals has affirmed the sentence approved by a Florida federal court jury for a former Ethicon employee accused of stealing and reselling prescription medical devices on the grey market. The jury had sentenced Kerri Kaley, who formerly supervised sales representatives for Ethicon, to 36 months
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