Biologics
Pfizer and BioNTech 9/20 announced results from a Phase 2/3 trial showing a “favorable safety profile and robust neutralizing antibody responses” for a lower-dose Covid-19 vaccine for children five to 11 years of age. The antibody responses in children were comparable to those recorded in a
Drugs
FDA has issued Verrica Pharmaceuticals a complete response letter regarding its NDA for VP-102 for treating molluscum contagiosum. Previously, the agency extended by three months (until 9/23) to allow additional time to review information submitted by the company in response to comments about its human factors study. The
FDA Policy/General
Q & A Guide on Biosimilar Development 9/17/2021 Federal Register notice: FDA has made available a final guidance entitled Questions and Answers on Biosimilar Development and the BPCI Act. The document is intended to inform prospective applicants about the development of proposed biosimilars and proposed interchangeable biosimilars. It
FDA Policy/General
Baxter International has acquired two hemostat and sealant products from Mallinckrodt — Recothrom Thrombin topical (recombinant) and Preveleak Surgical Sealant that is used in vascular reconstruction. Under the transaction, Baxter paid an upfront payment of $153 million and agreed to potential contingent payments in the future. H. Lundbeck has agreed to
FDA Policy/General
DEVICES FDA has granted a Roche de novo request to allow the marketing of its Anti-Müllerian (AMH) assay, which the company calls the first approved fully automated AMH test available in the U.S. to help women who are planning to become pregnant or struggling with infertility. The blood
Devices
FDA has approved a Neovasc IDE for the company to begin the COSIRA-II IDE clinical trial later this year for its Reducer device and its use in treating certain patients with refractory angina pectoris. The company says the trial is designed to address issues raised during a 10/2020
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee 9/17 voted unanimously (18 to 0) to recommend Pfizer-BioNTech’s Comirnaty Covid-19 booster vaccine, under an emergency use authorization, in individuals 65 years of age and older and those at high risk of severe covid-19 (e.g.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Questions and Answers on Biosimilar Development and the BPCI Act. The document is intended to inform prospective applicants about the development of proposed biosimilars and proposed interchangeable biosimilars. It also describes FDA’s interpretation of certain statutory requirements added
Drugs
Pfizer is expanding its Chantix (varenicline) recall to include all lots of 0.5 mg and 1 mg tablets because of the potential presence of unacceptable N-nitroso-varenicline levels. “To lessen the impact to patients from a drug shortage due to this ongoing recall, FDA will not object to
Drugs
An FDA safety alert warns healthcare professionals and patients not to use compounded products from Prescription Labs, doing business as Greenpark Compounding Pharmacy (Houston, TX), due to lack of sterility assurance. Using non-sterile products may result in serious and potentially life-threatening infections or death, the alert says. FDA
Drugs
The U.S. District Court for the Middle District of Florida has entered a consent decree against Premier Pharmacy Labs that prohibits it from producing or distributing any drugs until the company completes corrective actions and comes into FDA compliance. Under the consent decree, Premier Pharmacy may not resume compounding
Drugs
FDA has placed a clinical hold against Protagonist Therapeutics and its clinical studies for rusfertide. Affected trials for the injectable hepcidin mimetic include a Phase 2 proof-of-concept clinical trial for polycythemia vera (PV), a Phase 2 study in PV subjects with high hematocrit levels, and a Phase 2
Drugs
Modifications to the risk evaluation and mitigation strategy (REMS) for the antipsychotic drug clozapine approved by FDA 7/20 will take effect 11/15. An agency online FAQ document says the changes are intended to ensure that the drug’s benefits outweigh the risk of severe neutropenia. “The clozapine REMS
Biologics
Moderna says data from studies conducted with Kaiser Permanente and the Centers for Disease Control demonstrate that the company’s mRNA-1273 Covid-19 vaccine is “highly effective against circulating variants of concern.” A company statement also says a new analysis of the incidence of breakthrough Covid-19 cases among
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance for industry entitled Draft Guidance for Ferric Oxyhydroxide. The document provides product-specific recommendations on the design of bioequivalence studies to support ANDAs for ferric oxyhydroxide oral tablets and intravenous injectable products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Biosimilars User Fee Program” (OMB Control Number 0910-0718). For efficiency purposes, the agency is consolidating a related information collection on current user fee commitment goals as set forth in the document “BsUFA Reauthorization Performance Goals and
Drugs
AbbVie has submitted a supplemental BLA for Rinvoq (upadacitinib) (15 mg and 30 mg (maintenance dose) and 45 mg (induction dose)) for treating adults with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
Drugs
FDA has approved Takeda’s Exkivity (mobocertinib) to treat adults with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) Exon20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The company says Exkivity
Drugs
FDA says it has incorporated International Council for Harmonization Q2B Validation of Analytical Procedures: Methodology with the parent document Q2A Text on Validation of Analytical Procedures and retitled the combined document Q2(R1) Validation of Analytical Procedures: Text and Methodology. The consolidated guidance consists of the previously published FDA guidances,
FDA Policy/General
FDA has released a Bad Ad Quiz so people can test their knowledge about prescription drug promotion and the agency’s Bad Ad Program. The agency says the program helps to ensure that information from prescription drug promotions that healthcare providers may use to inform their assessment of a drug’
Drugs
FDA has cleared a Biomea Fusion IND to begin a Phase 1 trial of BMF-219, a selective irreversible menin inhibitor, in adults with relapsed or refractory acute leukemia, including those with an MLL/KM2TA gene rearrangement or an NPM1 mutation. The company says BMF-219 is a synthetic compound
Devices
FDA has cleared a Gynesonics 510(k) for the Sonata System 2.2 for treating fibroids. The company says the new device features a 20% reduction in the smallest ablation size setting, which increases the ability to treat fibroids in tighter anatomical locations. The device also has new software that