Drugs
A new Government Accountability Office (GAO) report on FDA’s priority review voucher (PRV) program shows that after a decade of experience, the vouchers have had little or no effecet on drug development. However, GAO says that the seven drug sponsors GAO interviewed said PRVs were a factor in drug
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FDA and FTC are pledging to crack down on anti-competitive practices, such as making false or misleading statements comparing biological reference products and biosimilars, which may be slowing the uptake of biosimilar products. “The agencies intend to take appropriate steps to address companies making false or misleading communications about
Drugs
GW Pharmaceuticals has submitted a supplemental NDA for Epidiolex (cannabidiol) oral solution for an expanded use to include seizures associated with Tuberous Sclerosis Complex (TSC), a rare genetic condition. Epidiolex is currently approved in the U.S. to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome. The submission
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A DC federal judge has sided with FDA in a Vanda Pharmaceuticals lawsuit that sought to remove a partial clinical hold the agency was alleged to have “illegally imposed prohibiting Vanda from studying a promising new drug in humans for more than 12 weeks without conducting unnecessary and unethical animal
Drugs
DePuy Ireland has announced plans to acquire Neuravi Ltd., a privately held Irish company foicusing on neurovascular therapies and improving clinical outcomes for acute ischemic stroke patients. The transaction will give DePuy access to the EmboTrap Revascularization Platform. The device is engineered to restore blood flow to the brain by
Drugs
FDA has approved Aimmune Therapeutics’ Palforzia [peanut (Arachis hypogaea) allergen powder-dnfp] for treating allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. An FDA release says Palforzia may be administered in individuals aged four through 17 years, and that patients must continue to avoid peanuts in
Drugs
FDA is requesting that all bacitracin for injection manufacturers voluntarily withdraw their product from the market because the benefits no longer outweigh safety concerns. Bacitracin for injection is currently approved for treating infants with pneumonia and empyema (a collection of pus in the space between the membranes lining the lungs)
Drugs
FDA has approved a Teva Pharmaceuticals autoinjector device for its Ajovy (fremanezumab-vfrm) injection for preventing migraine in adults. Previously, the calcitonin gene-related peptide antagonist was approved for administration in a pre-filled syringe. Teva says that hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with
Drugs
FDA has granted Aprea Therapeutics a breakthrough therapy designation for APR-246 in combination with azacitidine for treating myelodysplastic syndromes (MDS) with a susceptible TP53 mutation. MDS is a hematopoietic stem cell malignancy where bone marrow fails to produce healthy blood cells, the company says. About 30-40% of MDS
Drugs
Public Citizen has filed suit against FDA in DC federal court to obtain the scientific reviews used 4/2019 to grant accelerated approval for Janssen Pharmaceutical’s Balversa (erdafitinib), a treatment for certain adult patients with locally advanced or metastatic bladder cancer (see approval story). The group filed a Freedom
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AstraZeneca says it welcomes an FDA proposal for a novel excipient review program as it could “significantly de-risk the introduction of novel excipients into formulations for new marketed products and hence improve patient access to potentially life-enhancing medicines, as well as to encourage the use of a wider
Drugs
FDA has granted a priority review to an Eli Lilly NDA for selpercatinib and its use for treating patients with advanced RET fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer. The agency has set a user fee review action target
Drugs
Johnson & Johnson says it is mobilizing resources at its Janssen unit to launch a multi-pronged response to the coronavirus outbreak. It says it has initiated efforts to develop a vaccine candidate against coronavirus and to broadly collaborate with others to screen a library of antiviral therapies. “Identifying compounds
Drugs
FDA has issued a guidance, Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims, to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. With few exceptions, the document says, current labeling for antihypertensive drugs includes only the information that the drugs are
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The U.S. Pharmacopeia says it agrees with FDA’s position in a draft guidance on clinical immunogenicity considerations for biosimilar and interchangeable insulin products that a comparative clinical immunogenicity study generally will not be necessary to support a demonstration of biosimilarity or interchangeability. The comment letter says the agency
Drugs
CDER says it plans to publish 80 new and revised draft guidances in 14 categories during the 2020 calendar year. A notice lists the categories, with the number of guidances, as Biostatistics (3), Clinical/Antimicrobial (1), Clinical/Medical (10), Clinical Pharmacology (11), Drug Safety (8), Electronic Submissions (3), Generics (20)
Drugs
FDA says CDER has revised the Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements, to efficiently allocate limited resources to areas where priority review is most likely to meaningfully increase generic drug access and ensure fairness to applicants. An agency
Drugs
FDA has denied a Public Citizen 6/11/15 petition asking the agency to revise the Indications and Usage, Carcinogenesis, Mutagenesis, and Pregnancy sections of the labeling for Vanda’s Hetlioz (tasimelteon) capsules. The petition also asked that once the labeling is changed, FDA require distribution of a Medication Guide,
Drugs
A survey of China-based active pharmaceutical ingredient (API) makers and worldwide users indicates that API suppliers may experience some disruptions during the first quarter due to the coronavirus outbreak and related distribution troubles and travel restrictions. According to a 1/28 In-Pharma Technologist report, a “number of pharmaceutical
Drugs
Genus Lifesciences, which was awarded new chemical entity exclusivity (NCEE) by FDA for its Goprelto (cocaine hydrochloride), indicated for the induction of local anesthesia of the mucous membranes in certain diagnostic procedures and surgeries, is asking the DC federal court to declare FDA’s approval of Lannett’s Numbrino, a
Drugs
FDA says that a Wave Miami Web site and Facebook page for its Lipro Dietary Capsule are promoting an unapproved new drug that also is misbranded. A 1/13 Warning Letter says the agency confirmed through laboratory analysis that the Lipro Dietary Capsule contains undeclared tadalafil (branded Cialis), used to
Drugs
FDA says it is launching an interactive database offering “a wealth of critical information” about antiretrovirals (ARVs) eligible for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR) program. The agency says the list of ARVs eligible for purchase in the PEPFAR program has been publicly available on