Drugs
Novartis has recalled one lot of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/ml due to crystal formation observed in some bottles, which could affect dosing. The drug is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The affected lot number
Drugs
U.S. Senators Joe Manchin (D-WV) and Mike Braun (R-IN) have reintroduced their bipartisan FDA Review of Efficacy EERW Double-Blinds (FREED) of Opioids Act, which would require an advisory committee to review the “controversial enriched enrollment randomized withdrawal (EERW) methodology used to approve new opioids and ensure
Drugs
House Energy and Commerce Committee chair Cathy McMorris Rodgers (R-WA) and Health Subcommittee chair Brett Guthrie (R-KY) have announced a 9/14 legislative hearing titled “Legislative Proposals to Prevent and Respond to Generic Drug Shortages.” The lawmakers are concerned about cancer patients who are facing growing drug shortages
Drugs
FDA has posted a guidance entitled “Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products.” The document says that IRB review of an expanded access (compassionate use) submission for an individual patient should focus on the key factors needed to assess the
Drugs
Roche’s Genentech will not be getting FDA approval this month for a subcutaneous formulation of its lung cancer drug Tecentriq (atezolizumab) after the agency requested that the company update the chemistry, manufacturing and controls (CMC) information in the supplemental BLA submission. The approval delay was revealed in a financial
Drugs
Danco Laboratories, which distributes the abortifacent drug Mifeprex (mifepristone), petitioned 9/8 the U.S. Supreme Court asking it to review last month’s decision (see earlier story) by the Fifth Circuit Court of Appeals that would restrict how the drug is used by, and distributed to, patients. The company’
Drugs
Reps. Dan Crenshaw (R-TX), Robert Latta (R-OH), and Debbie Dingell (D-MI) say FDA should not permit simultaneous marketing of the same prescription and over-the-counter (OTC) drug product involved in an Rx-to-OTC switch. In a 9/6 letter to CDER director Patrizia Cavazzoni, the
Drugs
FDA has published a draft guidance entitled “Endogenous Cushing’s Syndrome: Developing Drugs for Treatment.” The document provides recommendations on clinical trial designs for drugs and biologics intended for treating Cushing’s syndrome in those where surgery is not an option or has not been curative. The agency says the
Drugs
Janssen Pharmaceutical has stopped, due to futility, its Phase 3 MACiTEPH study evaluating macitentan 75 mg in patients with chronic thromboembolic pulmonary hypertension. The decision to stop follows a recommendation by the study’s independent data monitoring committee after a pre-planned interim analysis. “Additionally, the pivotal Phase 3 UNISUS
Drugs
CymaBay Therapeutics says it will seek FDA approval for seladelpar after reporting positive data from its pivotal Phase 3 RESPONSE study that evaluated the drug for treating adult patients with primary biliary cholangitis (PBC). In the study, 61.7% of patients on seladelpar 10 mg (n=128) met the primary
Drugs
FDA has published a guidance, Application of Human Factors Engineering Principles for Combination Products: Questions and Answers, with questions and answers on applying human factor engineering (HFE) principles to developing combination products. The document finalizes a 2/2016 draft and clarifies how the unique aspects of a combination product influence
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it applauds efforts by the International Council for Harmonization (ICH) and FDA to facilitate harmonized scientific and regulatory considerations for Good Clinical Practice (GCP). Responding to FDA’s publication of the ICH E6(R3) draft guideline, PhRMA says it supports the revision
Drugs
FDA’s Oncology Center of Excellence and Flatiron Health have renewed a five-year collaboration to jointly develop and implement specific research projects to advance real-world data (RWD) use and explore strengths and limitations with using real-world evidence (RWE) for regulatory purposes. “The partnership will specifically evaluate RWD
Drugs
The FDA Office of New Drugs will hold an 11/13-11/14 meeting on “Positron Emission Tomography: Product Quality Regulatory Submissions, Facility Inspections, and Benefit-Risk Considerations.” An online notice says the purpose of the session is to provide a forum for the exchange of information and perspectives on
Drugs
Janssen says its Rybrevant (amivantamab-vmjw) met the MARIPOSA-2 dual primary endpoints, showing statistically significant and clinically meaningful improvement in progression-free survival plus chemotherapy with and without lazertinib (Janssen’s Leclaza) versus chemotherapy alone in patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer
Drugs
FDA has issued AstraZeneca’s Alexion unit a complete response letter (CRL) on a supplemental BLA for long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz). The suupplent sought expanded use in treating adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 antibody positive (Ab+). The company
Drugs
FDA has approved Boston Scientific’s latest generation of its Watchman FLX Pro Left Atrial Appendage Closure (LAAC) device, indicated for reducing stroke risk in patients with non-valvular atrial fibrillation who need an alternative to oral anticoagulation therapy. The new device features a polymer coating, visualization markers, and a
Drugs
A 2/13-2/28 FDA inspection at the Lex, Inc., drug manufacturing facility in Medley, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/17 Warning Letter says the violations were: * failure of the quality control unit to exercise its responsibility to
Drugs
FDA says a review of records submitted by Green Pharmaceutical Co., registered with the agency as a manufacturer of over-the-counter drugs in Jincheon, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/23 Warning Letter says the specific violations were:
Drugs
FDA has published a guidance, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs, to identify the standards necessary to facilitate the adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain. The document also clarifies the trading partners, products,
Drugs
A group of five doctors and eight organizations have submitted a citizen petition to FDA calling for urgent action on the off-label use of GnRH agonists, a class of drugs also known as puberty blockers. “We are concerned by the dramatic increase in the off-label use of puberty
Drugs
Six Epstein Becker Green attorneys say an 8/15 FDA final guidance on informed consent for clinical investigations updates the agency’s 7/2014 draft guidance and supersedes a 9/1998 guide to informed consent. The attorneys say the final guidance: * summarizes the informed consent process; * outlines and discusses FDA’