Drugs
FDA has approved Seagen’s Adcetris (brentuximab vedotin) for treating pediatric patients two years and older with previously untreated high risk classical Hodgkin lymphoma (cHL). The drug is intended for use in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. The approval is based on data from a Phase 3
Drugs
FDA has issued a refusal to file letter to BrainStorm Cell Therapeutics for its BLA for NurOwn to treat ALS (amyotrophic lateral sclerosis). The company says FDA said it could request a Type A meeting with the agency to discuss the content of the letter. Company officials said they plan
Drugs
FDA’s Pulmonary-Allergy Drugs Advisory Committee has voted 16 to 1 to support approval of an AstraZeneca NDA for PT027 (albuterol/budesonide) for treating asthma in those aged 18 years and older, but it did not support (16 to 1 vote against) the product’s use in children and
Drugs
FDA has issued an emergency use authorization (EUA) to Swedish Orphan Biovitrum for its Kineret (anakinra) injection to treat Covid-19 in hospitalized adults with pneumonia requiring supplemental oxygen who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator
Drugs
FDA has released the form FDA-483 issued following a 10/3-10/14 inspection at the Lupin drug substance and drug product manufacturing facility in Pune, Maharashtra, India. The specific observations were: * aseptic monitoring for fill line, filling and cleaning machine, is not adequate; * failing to make an adequate
Drugs
FDA has released the form FDA-483 with nine observations from a 7/11-8/5 inspection at ImprimisRx NJ, a Ledgewood, NJ, producer of sterile and non-sterile drug products. The inspection observations were: * the ISO 5 classified aseptic processing areas had visibly dirty equipment or surface; * personnel did
Drugs
Washington Legal Foundation (WLF) says the DC Circuit federal court should reject an FDA claim of privilege in denying a Freedom of Information Act request. The case involves Vanda Pharmaceuticals’ suit seeking to compel the agency to produce drug review records associated with the company’s sNDA for Hetlioz (tasimelteon)
Drugs
FDA’s Pulmonary-Allergy Drugs Advisory Committee 11/9 voted 8 to 5 to recommend against an emergency use authorization for Veru’s investigational prostate cancer drug VERU-111 (sabizabulin) and its use as a treatment for hospitalized adults with moderate to severe Covid-19 who are at high risk
Drugs
An FDA 10/18-10/22/21 inspection at the NatureLab Corp. dietary supplement manufacturing facility in Carrollton, TX, found serious violations of the Federal Food, Drug, and Cosmetic Act and FDA regulations. A just-released 7/12 Warning Letter says the inspection found serious violations of FDA’s current
Drugs
A 3/28-4/6 FDA inspection at Abraxis Bioscience, Phoenix, AZ, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/31 Warning Letter says the specific violation was: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of
Drugs
FDA has published a guidance, Sameness Evaluations in an ANDA — Active Ingredients, to assist applicants in preparing an ANDA by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic product and its reference-listed drug. The document says FDA will refuse to approve an ANDA if
Drugs
In advance of an 11/9 meeting of the FDA Pulmonary-Allergy Drugs Advisory Committee, FDA medical reviewers are raising several “uncertainties” about a Veru request for an emergency use authorization for its investigational prostate cancer drug VERU-111 (sabizabulin) as a treatment for hospitalized adults with moderate to severe
Drugs
CDER’s Office of New Drugs (OND) has denied an Omeros appeal of a complete response letter (CRL) on its BLA for narsoplimab as a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy. In the CRL, according to the company, FDA said it had difficulty in estimating the drug’
Drugs
The Combination Products Coalition (CPC) says its members have recently experienced FDA requesting that combination product manufacturers demonstrate how they have “validated” device user interface specifications in the intended user population. A CPC statement says its member companies are not aware of any agency guidance or recognized consensus standards that
Drugs
FDA may be raising the bar for sponsors seeking accelerated approval by requesting that they be “well underway with their Phase 3 confirmatory trial and ideally fully enrolled.” At least, that is the requirement the agency laid out for ADC Therapeutics during a meeting to discuss a potential accelerated approval
Drugs
FDA has approved Regeneron Pharmaceuticals’ PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations. “Patients must either have metastatic or locally advanced tumors that
Drugs
FDA Office of Combination Products director Thinh Nguyen says seven priority guidances are in the clearance process and should be published in the first quarter of 2023. Speaking at the Combination Products Summit 2022, Nguyen said the guidances address: * human factors for combination products (final guidance); * essential performance requirement: established
Drugs
GSK says a Phase 3 trial involving its accelerated-approved Blenrep (belantamab mafodotin) in patients with relapsed or refractory multiple myeloma (RRMM) did not meet its primary endpoint of progression-free survival (PFS). The therapy was earlier granted accelerated approval in 2020 as a monotherapy for treating adult patients with
Drugs
FDA has placed a clinical hold on a Verve Therapeutics IND for its VERVE-101 in patients with heterozygous familial hypercholesterolemia (HeFH). The IND was submitted last month and the company is awaiting an agency official letter within 30 days to provide more information about the hold. VERVE-101 is
Drugs
Verrica Pharmaceuticals is planning an NDA resubmission in the first quarter next year for VP-102 to treat molluscum contagiosum, described by the Centers for Disease Control as an infection caused by the molluscum contagiosum virus. The result of the infection is usually a benign, mild skin disease characterized by
Drugs
FDA has posted a final guidance entitled “M10 Bioanalytical Method Validation and Study Sample Analysis.” The International Council for Harmonization document is intended to provide recommendations for validating bioanalytical methods for chemical and biological drug quantification and their application in the analysis of study samples. “Adherence to the principles presented
Drugs
FDA has updated the Health Care Provider Fact Sheet for Eli Lilly’s Covid-19 antibody therapy bebtelovimab to highlight expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2. The revised information indicates that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.