Drugs
FDA has approved AbbVie’s JAK inhibitor Rinvoq (upadacitinib; 15 mg, once daily) for treating adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. Approval is based on data from two pivotal Phase 3 trials, SELECT-PsA
Drugs
FDA has approved a new indication for Bristol-Myers Squibb’s Orencia (abatacept) to be used in combination with certain immunosuppressants to prevent acute graft versus host disease. An agency announcement says the disease occurs when donor bone marrow or stem cells attack the graft recipient. Orencia may be used
Drugs
FDA has approved a Pfizer supplemental NDA for its JAK inhibitor Xeljanz /Xeljanz XR (tofacitinib) for treating adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. Approval is based on data from a Phase 3 study that showed
Drugs
A 5/25-6/3 FDA inspection at Sanitor Corp., Stanton, CA, found significant violations of current good manufacturing practice (CGMP) regulations and other violations in the firm’s work manufacturing drug products to bleach or lighten the skin that FDA says are unapproved new drugs. An 11/29 Warning
Drugs
A California federal judge has suspended the state’s law banning drug industry “pay for delay” deals, saying the first-in-the-nation law intended to increase the flow of generic drugs likely violates out-of-state commerce protections. The judge sided with a group of generic drug manufacturers in
Drugs
Pfizer says new data on its Covid-19 oral antiviral drug Paxlovid (nirmatrelvir tablets and ritonavir tablets) show the drug significantly reduced the risk of hospitalization or death for any cause by 89% compared to placebo in non-hospitalized, high-risk adult patients with Covid and treated within three days
Drugs
FDA has published an immediately effective guidance, Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the Covid-19 Public Health Emergency, communicating its temporary policy for certain REMS (risk evaluation and mitigation strategies) requirements for tocilizumab (Genentech’s Actemra) due to the shortage related to the Covid-
Drugs
A just released U.S. House Oversight and Reform Committee staff report has found that drug companies have “raised prices relentlessly for decades while manipulating the patent system and other laws to delay competition from lower-priced generics.” The report, which examined 12 drugs from 10 companies, said they targeted
Drugs
FDA has placed clinical holds on Merck INDs for the oral and implant formulations of islatravir (MK-8591) for HIV-1 pre-exposure prophylaxis (PrEP); the injectable formulation of islatravir for HIV-1 treatment and prophylaxis; and the oral doravirine/islatravir (DOR/ISL) forulation for HIV-1 once-daily treatment.
Drugs
FDA has published a draft guidance entitled Cover Letter Attachments for Controlled Correspondences and ANDA Submissions. The document discusses optional attachments that can be used when preparing cover letters that accompany controlled correspondence to CDER’s Office of Generic Drugs, as well as original ANDAs, amendments to ANDAs, and supplements
Drugs
FDA has posted an International Council for Harmonization guidance entitled Q3C(R8) Impurities: Guidance for Residual Solvents. The document provides recommendations for permitted daily exposures for three residual solvents: (1) 2-methyltetrahydrofuran, (2) cyclopentyl methyl ether, and (3) tert-butyl alcohol. It is intended to recommend acceptable amounts for these
Drugs
FDA has published a draft guidance, Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment, to assist sponsors in developing drugs or biological products for treating chronic rhinosinusitis with nasal polyps. The document has the agency’s current recommendations for trial population, design, effectiveness, statistical analysis, and safety for drugs
Drugs
FDA has published a guidance, Development of Anti-Infective Drug Products for the Pediatric Population, with general recommendations on the development of antibacterial, antifungal, and antiparasitic products for the pediatric population. The document says the agency encourages sponsors to discuss their initial pediatric study plans for anti-infective products with
Drugs
FDA has published a draft guidance, Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products, as part of its mandate under the 21st Century Cures Act. The document discusses the applicability of the agency’s IND regulations
Drugs
FDA has published a guidance, CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports, with recommendations to holders of BLAs for specified biological products regarding the types of changes to an approved BLA to be documented in an annual report. The document says it describes
Drugs
The CDER Office of Strategic Planning has issued a Manual of Policies and Procedures establishing remote access best practices for conducting effective Web-based meetings including training sessions, workshops, division meetings, and town halls across the Center. The MAPP outlines procedures and responsibilities of all meeting participants to ensure Center
Drugs
FDA has lifted a clinical hold against an Aprea Therapeutics clinical trial evaluating the combination of its lead compound, eprenetapopt, with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies. The action gives the company the green light to proceed with its future clinical study of eprenetapopt in non-Hodgkin&
Drugs
FDA says its review of a Web site maintained by Synaptent, Chicago, IL, indicated that the company markets 17 dietary supplements that are legally considered to be unapproved new drugs. A just-released 11/09 Warning Letter lists some of the claims made for the supplements that establish that they
Drugs
FDA has released the FDA-483 issued following a 10/10-10/29 inspection at the Dr. Reddy’s sterile drug manufacturing facility in Duvvada, Andhra Pradesh, India. The eight inspection observations were: * the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed;
Drugs
Pfizer CEO Albert Bourla told CNBC 12/8 that the company will submit full data on its Paxlovid oral anti-viral Covid pill to FDA within a few days. He said Pfizer hopes for an agency decision on the company’s November emergency use authorization request this month. Bourla said
Drugs
FDA says it has released an updated version of the Clinical Outcome Assessment (COA) Compendium to encourage the development and implementation of patient-focused clinical outcome assessments in clinical trials to support drug approvals and labeling claims. The agency says the compendium is a communications tool that organizes and summarizes
Drugs
A Cleveland Clinic study says sildenafil (Viatris’ Viagra for treating erectile dysfunction and Revatio for treating pulmonary hypertension) is a promising drug candidate to help prevent and treat Alzheimer’s disease. Findings published by the Cleveland Clinic’s Genomic Medicine Institute in Nature Aging said researchers used computational methodology to