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
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) says that while its goal is to provide comments on draft promotional materials within 45 days of the voluntary submission of the materials by sponsors, some recent draft materials “have raised complex issues that required additional review, resulting in review times that
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
Devices
SightGlass Vision, a medical device company developing spectacle lenses to slow the progression of nearsightedness or myopia in children, has been given an FDA green light to begin a pivotal clinical trial called CYPRESS. The study will evaluate the safety and efficacy of the company’s novel lenses compared to
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