Drugs
FDA has granted Genentech a breakthrough therapy designation for Venclexta (venetoclax) in combination with azacitidine for treating adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS). The designation was granted based on interim results from the Phase Ib M15-531 study investigating Venclexta plus azacitidine
Drugs
Covis Pharma is asking FDA to take several administrative actions on a Eugia Pharma NDA for a generic version of Makena Autoinjector. A 7/19 petition asks that the agency (1) review the basis for submission of the ANDA; (2) determine that the ANDA should have been filed as a
Drugs
FDA says Pfizer has expanded its recall of Chantix (varenicline) to 12 lots to the consumer level due to the presence of N-nitroso-varenicline above the company’s acceptable limit for this impurity. The company initially recalled nine lots of the drug 7/2. An agency update also says
Drugs
To attempt to stave off government drug price regulation, the Business Group on Health’s Pharmaceutical Supply Chain Leadership Forum (PSCLF) is calling on stakeholders to reform the drug supply chain based on principles and recommendations released following a two-year PSCLF study. “In an environment of high and rising
Drugs
FDA has announced a class-wide labeling change for cholesterol-lowering statin drugs to remove its strongest warning against their use in pregnant patients. “We have conducted a comprehensive review of all available data and are requesting that statin manufacturers make this change to the prescribing information as part of
Drugs
FDA has denied a 2/12/20 petition submitted by an Ohio State University College of Medicine emeritus professor asking the agency to revoke its approval of tolvaptan (Osaka’s Jynarque) for treating autosomal dominant polycystic kidney disease. The petition says FDA approval should be revoked because the drug is
Drugs
Ortho Regenerative Technologies says it has provided all chemistry, manufacturing, and control (CMC)-related data and characterization information requested by FDA as part of the agency’s clinical hold on the IND application for Ortho-R, a drug/biologic combination product candidate used as an adjunct to improve the success
Drugs
FDA has approved Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for active immunization for preventing invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. Approval was based
Drugs
FDA has accepted for review an Aquestive Therapeutics NDA resubmission for Libervant (diazepam) Buccal Film for managing seizure clusters. The agency has set a 12/23 user fee review action target date. After receiving a complete response letter 9/2020, Aquestive received feedback from FDA outlining a path to resubmit
Drugs
FDA has approved a new use for Astellas Pharma’s Prograf (tacrolimus), based on real-world evidence (an observational study), for use in combination with other immunosuppressant drugs to prevent organ rejection in adult and pediatric patients receiving lung transplantation. The drug was originally approved for preventing organ rejection in
Drugs
FDA is pushing for a “major paradigm shift” to move the clinical development community from “systemic exclusion to the inclusion” of pregnant and breastfeeding women in clinical studies. Writing in an online FDA Voices post, officials say it is time to give this patient population needed data about the safety
Drugs
Ardelyx says it received a letter from FDA saying that as part of its ongoing review of the company’s NDA for tenapanor, it found deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The submission is seeking an indication for controlling serum phosphorus in
Drugs
FDA’s Cardiovascular and Renal Drugs Advisory Committee 7/15 overwhelmingly voted against recommending approval for a FibroGen NDA for roxadustat, indicated for treating anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis. Committee members agreed with an FDA briefing document citing risks of
Drugs
FDA has approved a Kadmon Pharmaceuticals NDA for Rezurock (belumosudil), a kinase inhibitor for treating adult and pediatric patients 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy. Approval was based on data from KD025-213 (NCT03640481), a
Drugs
FDA has placed the Jubilant Pharmova dosage formulation facility at Roorkee, India, under an import alert following a March inspection. The company says the facility received an OAI (official action indicated) designation in 12/2018 and a Warning Letter in 3/2019. It says FDA exempted from the import alert
Drugs
A 6/2021 FDA draft guidance clarifies the enhanced system requirements listed in the Drug Supply Chain Security Act (DSCSA) and gives recommendations on the system attributes necessary for enabling the secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation as
Drugs
BIO says an FDA Covid-19 emergency guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the Covid-19 Public Health Emergency, provides clarity on inspection activities during the Covid-19 pandemic and is an important step in discussions on modernizing inspectional activities. The association’s 7/
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says a professional animated banner for Amgen’s Neulasta (pegfilgrastim) injection for subcutaneous use makes false or misleading claims and representations about the drug’s benefits and thus misbrands it. A 7/7 Notice of Violation says the FDA Bad Ad Program
Drugs
FDA has denied a 5/9/13 Janssen petition asking that the agency apply specific bioequivalence parameters to any ANDA submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FFDCA) or NDA submitted under section 505(b)(2) that references the company’s Invega Sustenna (paliperidone
Drugs
FDA has lifted a partial clinical hold against Ryvu Therapeutics and its Phase 1b dose escalation clinical trial of RVU120 (also known as SEL120) in patients with relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. The hold was issued after Ryvu reported a patient death that might have
Drugs
A 7/8 petition submitted by an unidentified party is asking FDA to refuse to approve the NDA for United Therapeutics’ Tyvaso DPI, a dry powder inhalation formulation of treprostinil in the absence of additional clinical data demonstrating that it is safe for use in patients with certain chronic lung
Drugs
In a somewhat contentious interview with Stat News, FDA acting commissioner Janet Woodcock defended the agency’s decision to approve Biogen’s controversial Alzheimer’s treatment Aduhelm (aducanumab) but said: “It’s possible that the process could have been handled in a way that would have decreased the amount of