Drugs
For the second time in three days, an accelerated approval application has been withdrawn due to disagreements with FDA over confirmatory/post marketing study commitments. On 1/28, Regeneron Pharmaceuticals and Sanofi withdrew their supplemental BLA for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical
Drugs
A Congressional Budget Office (CBO) report on trends in nationwide spending on prescription drugs for 1980-2018 finds that since the mid-2000s, per capita spending on prescription drugs has fallen as a percentage of total spending on healthcare services and supplies. The slower growth in spending is associated with
Drugs
FDA has just released an Establishment Inspection Report (EIR) from a 9/5/2019-9/13/2019 inspection at Emergent BioSolutions Canada, Winnipeg, Manitoba, and an FDA-483 with one inspection observation from that inspection. The company is a contract manufacturer of sterile human drugs. The one observation on the
Drugs
FDA has just released a 9/16/2021 Notice of Violation issued to Hopkinton Drug, a Hopkinton, MA, sterile drug producer, following an 8/25-11/2/20 inspection that identified deficiencies in the company’s practices for producing drug products that put patients at risk. The letter says the
Drugs
FDA says that in FY 2020, the percentage of regulatory actions for OAI (official action indicated) drug manufacturing facilities completed within six months of inspection closing dropped to 63% from 74% in FY 2019. In both fiscal years, the performance measure for issuing a final facility classification letter within 90
Biologics
FDA would have many responsibilities in the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act) released 1/25 by Sens. Patty Murray (D-WA) and Richard Burr (R-NC), the chair and ranking member of the Senate HELP Committee. Murray and Burr
Drugs
FDA has published a guidance, Good ANDA Submission Practices, to assist applicants preparing to submit ANDAs to the agency. The document highlights common recurring deficiencies that may lead to a delay in approving an ANDA. It also makes recommendations to applicants on how to avoid the deficiencies to minimize the
Drugs
Incyte says that after discussions with FDA, it has made a business decision to withdraw its NDA for parsaclisib to treat patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma. The company says its decision followed discussions with FDA about confirmatory studies needed to support
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) is urging the Judicial Conference Committee on Evidence Rules to adopt a proposed amendment to Federal Rule of Evidence 702 that governs courts’ role as gatekeepers deciding whether to allow expert testimony. The PhRMA 1/25 comment letter says its members are interested
Drugs
The CDER Office of Generic Drugs has issued a Manual of Policies and Procedures, Issuance of Information Requests and/or Discipline Review Letters for Abbreviated New Drug Applications, describing how the Office of Generic Drugs and Office of Pharmaceutical Quality will issue such requests and letters under GDUFA 2 commitments.
Drugs
FDA has placed a partial clinical hold on Gilead Sciences’ studies evaluating the combination of magrolimab plus azacitidine (Celgene’s Vidaza) due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions between study arms. “While no clear trend in the adverse reactions or new safety signal has
Drugs
An FDA 8/2-8/12/21 inspection at the Aurobindo Pharmaceutical drug manufacturing facility in Doultabad, Telangana, India, found significant deviations from Current Good Manufacturing Practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 1/12 Warning Letter says the specific deviations were: * failing to evaluate the potential effect
Drugs
Federal Register notice: FDA is announcing a 3/3 Vaccines and Related Biological Products Advisory Committee meeting at which panel members are scheduled to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2022–2023 influenza season. To view the
Drugs
FDA has told Soleno Therapeutics that an additional clinical trial is necessary before the company submits an NDA for once-daily DCCR (diazoxide choline) extended-release tablets for treating Prader-Willi Syndrome (PWS). Soleno says that recent meeting minutes from a 12/21/2021 Type C meeting with CDER’s
Drugs
Pfizer and BioNTech have begun a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults aged 18 through 55 years. The 1,400-patient study, which will have three cohorts examining different regimens of their current Covid-19 vaccine or an
Drugs
An FDA 6/23-7/1/21 inspection at the Health Plus drug manufacturing facility in Chino, CA, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. A just-released 12/29/21 Warning Letter says specific violations were: * failing to ensure that returned drugs meet
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it commends FDA for releasing a draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products, that gives key principles on the reliability and use of relevant data from
Drugs
FDA has issued Merck a complete response letter on its NDA for gefapixant, an orally administered selective P2X3 receptor antagonist for treating refractory chronic cough or unexplained chronic cough in adults. Without providing specific information on the rejection, the company said FDA requested additional information related to “measurement of efficacy.
Drugs
FDA has placed a clinical hold on a Viking Therapeutics Phase 1b clinical trial of VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD). The agency has requested an additional preclinical study prior to continuing the study, according to the company. “The request is not due to any findings from
Drugs
The Southern District of Florida federal court has sentenced former clinical study coordinator Duniel Tejeda to 30 months in prison for his participation in a conspiracy to falsify clinical drug trial data. The court also ordered Tejeda to pay $2.1 million in restitution. According to a Justice Department release,
Drugs
The RWE Alliance has suggested that FDA increase communications with external stakeholders about concrete real-world evidence (RWE) use cases. In comments submitted on an FDA draft guidance entitled Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products,
Drugs
Due to effectiveness concerns in treating the Covid-19 omicron variant, FDA has revised Eli Lilly’s emergency use authorization for bamlanivimab and etesevimab and Regeneron’s emergency use authorization for Regen-Cov (casirivimab and imdevimab). Both authorizations have now been limited for use only when the patient is likely