Drugs
Last week’s accelerated approval of Replimune’s Tudriqev (vusolimogene oderparepvec-wtpg) came despite significant concerns about the reliability of efficacy results from the company’s Phase 1/2 IGNYTE trial. The genetically modified oncolytic viral therapy’s approval covers its use in combination with Bristol Myers Squibb's
Drugs
FDA has issued a warning letter to a Telangana, India, sterile drug manufacturing facility operated by Aurobindo Pharma subsidiary Eugia Pharma Specialities, following a February inspection (see earlier story) that identified deficiencies involving aseptic manufacturing, process validation, visual inspection and investigations of complaints involving glass particles. The agency subsequently classified
Drugs
FDA has granted Bristol-Myers Squibb accelerated approval for Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. Approval was based on data from EXCALIBER-
Drugs
ADC Therapeutics says that at a recent meeting with FDA, agency officials indicated that they have “substantial concerns regarding the benefit/risk or verification of clinical benefit” in the LOTIS-5 trial of the company’s Zynlonta (loncastuximab tesirine) to treat diffuse large B-cell lymphoma (DLBCL). In an online
Drugs
FDA has released the Form FDA-483 with three observations from a 2/19-2/27 inspection at the Reliance Life Sciences Private Limited drug manufacturing facility in Navi Mumbai, Maharashtra, India. The observations were: * failure of laboratory records to include complete data derived from all tests, examinations, and assay
Drugs
FDA has released proposed recommendations for the eighth reauthorization of the Prescription Drug User Fee Act (PDUFA VIII), outlining changes to drug review, manufacturing oversight, regulatory science programs and the structure of industry fees for fiscal years 2028 through 2032. The proposed PDUFA VIII commitment letter follows negotiations with the
Drugs
FDA has issued a draft guidance proposing a risk-based framework for evaluating the container-closure systems used to package human drugs and biologics. The draft, “Container Closure Systems for Human Drugs and Biological Products,” covers packaging systems for drugs, biologics and combination products and addresses the quality assessment and
Drugs
New real-world reports of edema and other serious heart and respiratory problems among people with Prader-Willi syndrome (PWS) taking Neurocrine’s Vykat XR have prompted PWS patient groups to issue recommendations for closer monitoring of some patients, according to the Foundation for Prader-Willi Research. FDA is “evaluating
Drugs
In a 64-page petition, Children’s Health Defense calls on FDA to withdraw over-the-counter approval for Infants’ Tylenol and other products containing acetaminophen approved for use with children under age two. The petition also asks the agency to require a Boxed Warning and other safety information concerning
Drugs
FDA should strengthen advisory committee deliberations by appointing more temporary voting members, according to Center for Medicine in the Public Interest president Peter Pitts and vice president Robert Goldberg. Writing in a Real Clear Health opinion column, Pitts and Goldberg say the agency already has the authority to appoint temporary
Drugs
While U.S. biotech companies focused on treating rare and serious diseases overwhelmingly prefer to conduct first-in-human (FIH) clinical trials in the U.S., historical obstacles posed by FDA are prompting the companies to seek development overseas. That’s a key finding from a survey of 37 U.
Drugs
After a 28-year career at FDA, CDER associate Center director for strategic initiatives Theresa Mullin has retired. During her tenure, she also served as assistant commissioner for planning, and director of CDER’s Office of Strategic Programs. In her most recent role, Mullin oversaw areas of strategic interest to
Drugs
FDA has issued updated guidance outlining procedures for formal meetings between the agency and sponsors or applicants developing or seeking approval for drugs and biological products. The document, “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products,” describes standardized procedures for requesting, preparing, scheduling, conducting and documenting
Drugs
A central feature of FDA’s new expedited IND pilot program will be a rolling pre-IND submission process. Under the current system, sponsors generally prepare for one formal pre-IND meeting and must decide when they have sufficient information to engage FDA on their development program. Under the pilot,
Drugs
Eli Lilly has filed six new lawsuits against U.S. entities it alleges are selling illegal, unapproved retatrutide products, escalating the drugmaker’s efforts to shut down what it describes as a growing black market for the investigational medicine. The company says it has also referred more than 200 individuals
Drugs
The Department of Justice says it has reached a deferred prosecution agreement (DPA) with Veloxis Pharmaceuticals under which the company will pay $46 million to resolve criminal and civil allegations that it paid kickbacks to induce prescriptions and purchases of Envarsus XR (envarsus), its kidney transplant immunosuppressive drug. A department
Drugs
Aquestive Therapeutics says topline results from new human factors and pharmacokinetic studies of its Anophylm (dibutebinephrine) support its plan to resubmit an NDA for the drug to FDA in the third quarter of this year. A company statement says the tests were conducted in response to an FDA January complete
Drugs
FDA has released the Form FDA-483 issued following a 9/9-9/13/2024 inspection at the MSN Life Sciences Private Limited Unit II active pharmaceutical ingredient (API) manufacturing facility in Chandampet, Telangana, India. The three inspection observations were: * failure to thoroughly investigate critical deviations and/or the failure(
Drugs
Resilient Pharmaceuticals reportedly has resubmitted an NDA for its midomafetamine (MDMA) capsules for a proposed indication of treating post-traumatic stress disorder (PTSD). Resilient (formerly the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) and Lykos Therapeutics) resubmitted the application following a 2024 Complete Response Letter (see story), which recommended additional
Drugs
FDA has accepted for priority review a Belite Bio NDA for tinlarebant for treating Stargardt Disease Type 1 (STGD1). The agency has set a user fee review action target date of 2/12/2027. The submission was based on data from the Phase 3 DRAGON trial, which demonstrated a statistically
Drugs
An 8/4 petition submitted by a Matthew Arp (no affiliation or organization listed) asks FDA to create a continuation access pathway, not unrestricted shelf access, for adults with a prior albuterol sulfate inhalation aerosol prescription or clinician-diagnosed airway disease. The petition says the nonprescription product would remain subject
Drugs
President Trump has signed an executive order directing the federal government to develop what the White House calls "Gold Standard Childhood Vaccine Recommendations," reducing the number of diseases for which routine childhood immunization is recommended and giving parents more flexibility in vaccination decisions. The order calls for routine