Biologics
FDA has accepted a Dynavax Technologies submission that addresses an 11/2016 Complete Response Letter (CRL) for its BLA for Heplisav-B [hepatitis Bb vaccine, recombinant (adjuvanted)], a vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older. The agency has set a user
Devices
A Pennsylvania federal court last year allowed a strict-liability medical device manufacturing defect claim to proceed, based on a misconstruction of prior decisions and the state’s product liability law generally, according to a Washington Legal Foundation Counsel’s Advisory by attorney Michelle Yeary (Dechert). She writes that the
Drugs
FDA and the European Union have finalized a mutual recognition agreement allowing each party to rely on good manufacturing practice inspections of drug manufacturing facilities conducted by the other party within its own borders. The agreement comes at the end of three years of cooperative efforts between FDA and EU
Drugs
Wockhardt says its Morton Grove Pharmaceuticals unit received an FDA Warning Letter that indicated that its current portfolio can remain on the market but new approvals will be withheld until issues are resolved. In an online report, India’s Money Control Web site says Wockhardt has already been struggling with
Drugs
Gilead is asking FDA for five-year new chemical entity (NCE) exclusivity for its Stribild (cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate) and for that exclusivity to be applied to all subsequently approved drug products (Tybost and Vitekta) that contain any of the new active moieties (elvitegravir and cobicistat) approved in
Drugs
The second iteration of the Generic Drug User Fee Act (GDUFA), which begins 10/1 once approved by Congress and signed into law, would aim to improve first-cycle review approvals, CDER director Janet Woodcock told a House Energy and Commerce health subcommittee hearing 3/2. Currently, first-cycle generic
FDA Policy/General
Melayna Lokosky, a self-described corporate fraud expert and market analyst, who won a whistleblower case against Johnson & Johnson’s Acclarent unit, says that venture capitalists have no place running FDA. Writing in an online MedCity News opinion piece, Lokosky says that her experience is that “venture capitalists can
Devices
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says FDA may finally give medical device manufacturers relief on reporting requirements for Class 1 and 2 devices that Congress called for 10 years ago. Writing in his firm’s FDA Law Blog, Shapiro says that the FDA Amendments Act of 2007 directed
Drugs
Three Mayer-Brown attorneys say that a recent FDA draft guidance on the standards for demonstrating interchangeability of biosimilar products “is a significant step forward in FDA’s progress toward full implementation of the regulations required by the Biologics Price Competition and Innovation Act (BPCIA).” Writing in a Legal Update,
Drugs
President Trump took aim at speeding up FDA’s approval process during his 2/28 address to Congress. Noting that it was Rare Disease day, Trump illustrated the need for getting therapies to patients sooner by profiling rare disease survivor Megan Crowley, who was sitting in the Capitol gallery. “Megan
Devices
FDA has approved a CeloNova BioSciences PMA for its first-in-class Cobra PzF NanoCoated Coronary Stent System, indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries with reference vessel diameter of
Drugs
Rep. Gus Bilirakis (R-FL) has introduced H.R. 1223, the Orphan Product Extensions Now Accelerating Cures and Treatments Act (OPEN Act) that he says will help open the door to potentially hundreds of new treatments for rare diseases. In commenting on his bill on the House floor, Bilirakis said,
Drugs
A Duane Morris client alert says that FDA will receive comments until 3/14 on a draft guidance that uses a question-and-answer format to discuss generic drug 180-day marketing exclusivity. The alert says the guidance consolidates court decisions and application-specific decisions FDA has taken in citizen
Devices
In a letter to healthcare providers, CDRH says it is aware of marketing materials and recently published literature that imply a new intended use for some neurovascular guide catheters for neurovascular thrombosis removal in patients with acute ischemic stroke. The letter says that FDA has not cleared neurovascular guide catheters
Drugs
FDA has approved a Lexicon Pharmaceuticals NDA for Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for treating adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled. Carcinoid syndrome occurs in less than 10% of patients with carcinoid tumors, usually after the tumor has
Drugs
FDA has accepted for priority review a Celgene NDA for enasidenib (AG-221/CC-90007) for treating patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation. The agency has set a user fee review target date of 8/30. The company says enasidenib
FDA Policy/General
Federal Register final rule technical amendment: FDA has amended the identification of manual gastroenterology-urology surgical instruments and accessories to reflect that the device does not include specialized surgical instrumentation for use with urogynecologic surgical mesh specifically intended for use as an aid in the insertion, placement, fixation, or anchoring
FDA Policy/General
Federal Register Notice: FDA has withdrawn approval of a new animal drug application and an abbreviated new animal drug application at the sponsors’ requests because the products are no longer manufactured or marketed. Products withdrawn are Baxter Healthcare Aerrane (isoflurane USP) and Hospira’s Ceftiofur (ceftiofur sodium) for injection. To
Drugs
FDA has approved an AstraZeneca NDA for once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for treating type-2 diabetes. The combination drug is indicated as an adjunct to diet and exercise to improve glycemic (blood sugar level) control in adults with type-2 diabetes who have inadequate control with
Drugs
A 5/10-6/8/16 FDA inspection at Pfizer’s Hospira drug manufacturing facility in McPherson, KS, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/14 Warning Letter from the agency’s Kansas City District Office. Specific violations included: * failing
Drugs
A 5/16-5/19/16 FDA inspection at Chongqing Pharma Research Institute, Chongqing, China, found significant deviations from current good manufacturing practice regulations for active pharmaceutical ingredients, according to a 2/14 Warning Letter. Specific deviations included failing to maintain complete data derived from all laboratory tests conducted to
Drugs
FDA has accepted for priority review a Teva Pharmaceutical Industries NDA for SD-809 (deutetrabenazine) for treating tardive dyskinesia. The submission is based on results from two Phase 3 studies, ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia) and AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia). The agency