Drugs
Three Hogan Lovells attorneys say it is not clear that recent changes announced by FDA and the Centers for Medicare and Medicaid Services to permit some drug importation will result in any additional importation of drugs, let alone meet the expressed goal of materially reducing the cost of prescription drugs.
Drugs
The National Institutes of Health has paused the ACTIV-3 trial of the Lilly LYCoV555 Covid-19 antibody drug due to an undisclosed safety issue. Endpoints News reports online that the halt comes one week after Lilly said it had applied to FDA for an emergency use authorization (EUA) for
Drugs
FDA says its review of the Haloderm, Inc., Web site indicated the firm takes orders for products that are unapproved new drugs the company is marketing directly to consumers. A 10/6 Warning Letter says the company’s products “are concerning from a public health perspective because they are labeled
Drugs
A study by researchers from Harvard Medical School and other academic institutions in the U.S. and abroad says that there is a widening gap between regulatory approval and the clinical and public health priorities of health systems, payers, and patients after approval of drugs. Writing in an open-source
Drugs
Pfizer and the German Breast Group (GBC) say the Phase 3 PENELOPE-B trial studying Ibrance (palbociclib) did not meet the primary endpoint of improved invasive disease-free survival in women with hormone receptor-positive, human epidermal growth factor-negative early breast cancer who have residual invasive disease after completing
Drugs
FDA’s Psychopharmacologic Drugs Advisory Committee and its Drug Safety and Risk Management Advisory Committee have voted to support approval of an Alkermes NDA for ALKS 3831 (olanzapine/samidorphan), an oral atypical antipsychotic drug candidate for treating adults with schizophrenia and for treating adults with bipolar 1 disorder. The committees
Drugs
A March FDA inspection of Colchester, VT-based Edge Pharma produced a just-released 17-page Form FDA 483 that cites numerous GMP deficiencies. For example, agency investigators said the firm failed to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to
Drugs
FDA has issued Avenue Therapeutics a complete response letter due to safety concerns on its NDA for intravenous tramadol, indicated for treating patients in acute pain who require an opioid. The FDA letter told the company that while its Phase 3 clinical trials demonstrated statistically significant outcomes for all of
Drugs
FDA has approved Alexion Pharmaceuticals’ Ultomiris (ravulizumab-cwvz) 100 mg/mL, a new dosing formulation for treating adults with paroxysmal nocturnal hemoglobinuria (PNH) and for atypical hemolytic uremic syndrome (HUS) to inhibit complement-mediated thrombotic microangiopathy for adult and pediatric patients. The new formulation was designed to reduce average annual
Drugs
FDA has accepted for review a Foresee Pharmaceuticals 505(b)(2) NDA for Camcevi 42mg, a ready-to-use six-month depot formulation of leuprolide mesylate, indicated for treating advanced prostate carcinoma patients. The agency has set a user fee review action target date of 5/27/2021. The submission
Drugs
FDA has issued a revised Manual of Policies and Procedures (MAPP) on ANDA Suitability Petitions to clarify certain issues and include minor updates to the process and organization. The MAPP establishes the policies and procedures for CDER’s Office of Generic Drugs to respond to suitability petitions submitted to it
Drugs
Intercept Pharmaceuticals says FDA has told the company that it is evaluating a “newly identified safety signal regarding liver disorder for Ocaliva which the FDA classified as a potential risk.” The signal was noticed in May during the agency's routine safety surveillance, Intercept says in a financial report.
Drugs
FDA has sent Griffo Botanicals (Petaluma, CA) a Warning Letter after reviewing the company’s Web site and social media sites and determining that its herbal tincture products are unapproved new drugs because they are being marketed to mitigate, prevent, treat, diagnose, or cure Covid-19. The agency letter took
Drugs
An online post from Govzilla, data intelligence consultants, gives tips for regulated companies on how to talk with FDA officials and how to listen when FDA officials talk to them. The post is based on information presented at a 9/2019 Regulatory Affairs Professionals Society meeting by former FDA team
Drugs
FDA has granted X4 Pharmaceuticals a Fast Track Designation for mavorixafor for treating adult patients with WHIM (Warts, Hypogammaglobulinemia Infections and Myelokathexis) syndrome, an inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. The company describes mavorixafor as a small molecule antagonist of chemokine receptor CXCR4,
Drugs
FDA has awarded six new clinical trial research grants to principal investigators from academia and industry worth $16 million over the next four years. The grants, awarded through the Orphan Products Grants Program, enhance the development of medical products for patients with rare diseases, an agency announcement says. The agency
Drugs
FDA has granted Y-mAbs Therapeutics an orphan drug designation and rare pediatric disease designation for its antibody nivatrotamab and its use in treating neuroblastoma. The humanized bispecific anti-GD2 antibody is currently in Phase 1 clinical development in collaboration with Memorial Sloan Kettering Cancer Center in patients with relapsed/
Drugs
Regeneron says it has submitted to FDA an emergency use authorization (EUA) for its experimental antibody cocktail that president Trump has taken for his coronavirus infection and already the president is applying political pressure on FDA to act fast and calling the therapy a cure. Regeneron’s filing comes on
Drugs
Lilly says it has asked FDA for an emergency use authorization (EUA) for its bamlanivimab neutralizing IgG1 monoclonal antibody as monotherapy in higher-risk patients who have recently been diagnosed with mild-to-moderate Covid-19. The company says it expects to submit an EUA request for combination therapy with
Drugs
FDA has published a draft guidance, Premenopausal Women with Breast Cancer: Developing Drugs for Treatment, with recommendations to sponsors developing drugs or biologic products regulated by CDER and CBER for treating breast cancer. The document specifically includes recommendations on the inclusion of premenopausal women in breast cancer trials. The issues
Drugs
A 9/30 University of Kentucky petition asks FDA to recall one lot of acetazolamide manufactured by Mylan in India and one lot manufactured by Hikma in Portugal, due to insufficient active ingredient and/or increased impurities. A university news release says the Drug Quality Study at the UK HealthCare
Drugs
FDA has denied a 10/8/19 Public Citizen petition asking the agency to (1) withdraw approval of all medications containing hydroxyprogesterone caproate (HPC), approved and marketed as Amag Pharmaceuticals’ Makena and generics, and (2) place HPC on the list of drug products that have been withdrawn or removed from