Drugs
An FDA reinspection at a troubled Eli Lilly drug manufacturing plant in Branchburg, NJ has found additional GMP problems that could pose a hurdle for a promising Covid-19 drug that will be made there, according to a report from Reuters. Last week, Lilly said it has asked FDA for
Drugs
Bayer has submitted a supplemental NDA seeking to extend the duration of use for its intrauterine device (IUD) Mirena (levonorgestrel-releasing intrauterine system) 52 mg. In August, the agency approved Mirena for up to six years of pregnancy prevention. The new submission will seek to extend the indication another year
Drugs
FDA has sent Warning Letters to five companies manufacturing dietary supplements containing cesium chloride. An agency statement says that cesium chloride is a new dietary ingredient that has not previously been present in the food supply in a non-chemically altered form. Firms are required to provide specific safety-related
FDA Policy/General
Taking advantage of a supportive audience at the Reagan Udall Foundation 10/13 annual meeting, FDA commissioner Stephen Hahn again reiterated the agency’s science-based decisions and avoidance of political pressure. “Of course, our work on Covid-19 and non-Covid issues comes with unprecedented public scrutiny,” Hahn said.
Drugs
FDA has accepted for review a Biohaven Pharmaceutical Holding supplemental NDA for Nurtec ODT (rimegepant) for preventing migraines. The drug was launched in March for the acute treatment of migraine, and Biohaven says it is the first and only CGRP receptor antagonist available in an orally disintegrating tablet for rapid
Drugs
FDA has placed a clinical hold on a Voyager Therapeutics planned clinical trial for VY-HTT01 for treating Huntington’s disease. The company submitted an IND last month and the FDA hold was placed pending the resolution of certain chemistry, manufacturing and controls matters. Voyager says it expects to receive
Devices
Researchers from Yale University and the University of California San Francisco say that FDA could ensure that better evidence is generated to guide clinical decision-making by requiring that medical devices cleared through the de novo pathway meet prespecified effectiveness endpoints for clearance. They also say that postmarket studies should
Devices
FDA has cleared an ImmersiveTouch 510(k) for its ImmersiveView Surgical Plan digital surgery platform that is intended to assist surgeons in planning cases with patient-specific 3D models. “This technology will not only help the surgeon prepare, predict and plan for any potential complication but will also improve patient
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
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Haloderm, Carlsbad, CA (10/6) FDA recently reviewed the firm’s Web site and determined that it takes orders for products that are unapproved new drugs. The letter says
Devices
FDA has granted miR Scientific a Breakthrough Device Designation for its miR Sentinel PCC4 Assay, a prostate test that offers a new method to analyze small non-coding RNAs derived from a urine specimen from age-eligible men. The company says the test uses a “statistical classification algorithm” to score
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
Biologics
Johnson & Johnson says it has temporarily paused all dosing in its Janssen Covid-19 vaccine candidate clinical trials due to an “unexplained illness” in a study participant. The illness is being reviewed and evaluated by the Phase 3 ENSEMBLE trial’s independent data safety monitoring board and the company’
Biologics
FDA says its review of the Web site and YouTube channel maintained by Optimal Health Stem Cell and Wellness Institute, Appleton, WI, indicates that the firm markets cellular products derived from human umbilical cord, adipose tissue, and amniotic membrane. A 10/1 Notice of Violation says that to lawfully market
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
Devices
FDA has granted CartiHeal a breakthrough device designation for the Agili-C implant and its use in treating cartilage lesions in arthritic and non-arthritic joints. CartiHeal is currently conducting a pivotal clinical study to evaluate the implant’s superiority over the current surgical standard of care – microfracture and debridement.
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
FDA Policy/General
Federal Register notice: FDA has announced an 11/16 virtual public meeting entitled “Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.” The meeting is intended to obtain early input from the public on a potential
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