Biologics
DBV Technologies has submitted a BLA for the VIASKIN Peanut Patch in children with a peanut allergy aged 4 through 7 years. The company says it requested a priority review for the submission. The patch uses epicutaneous immunotherapy, which the company describes as an innovative, non-oral, non-injection approach
Drugs
A 1/28-2/5 FDA inspection at the Curia New York drug manufacturing facility in Rensselaer, NY, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A just-released 9/18 Warning Letter says the specific deviations were: * failure to have laboratory control
Drugs
FDA has issued Warning Letters to Neogen Corp. and Sciarra Aeromed Inc. after an investigation linked fungal contamination in a veterinary wound-care product to serious infections in nearly 100 horses and at least 20 deaths. An agency notice says Neogen Vet HYCOAT, a hyaluronate sodium solution labeled as sterile,
Biologics
Daiichi Sankyo and Merck have withdrawn a BLA seeking accelerated approval for ifinatamab deruxtecan (I-DXd) for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The action was based on input from FDA indicating that “data supporting
Drugs
Drugs
FDA is maintaining a clinical hold preventing enrollment of new U.S. patients in Newron Pharmaceuticals’ Phase 3 ENIGMA-TRS 2 study of evenamide for treatment-resistant schizophrenia. Newron says it expects written communication from the agency providing additional information on the decision and identifying any further protocol changes that
Drugs
FDA is making approval of generic GLP-1 drugs a priority as it seeks to increase competition and reduce the cost of the increasingly widely used medicines, CDER director Michael Davis told a recent FDA meeting, according to a report by the Regulatory Affairs Professionals Society (RAPS). Speaking at a
Drugs
Chugai Pharmaceutical is preparing to revive emugrobart’s (GYM329) development for spinal muscular atrophy (SMA) just six months after Roche abandoned the program, citing new consideration of long-term clinical signals and modifications to a potential Phase 3 trial design. The reversal comes as Roche decided to discontinue a separate
Devices
The National Institutes of Health has awarded $19.4 million for a five-year international research project aimed at developing a blood test that could determine whether Alzheimer’s disease has progressed far along to explain a patient’s cognitive symptoms and help predict future disease progression. The project, led
Devices
EBR Systems says FDA issued a Form 483 with two observations following an inspection of the company’s new manufacturing facility in Santa Clara, CA. The inspection is related to the agency’s review of a PMA supplement seeking to add the site as a manufacturing facility for its WiSE
FDA Policy/General
FDA’s Office of Global Policy and Strategy principal advisor Ravi Bharwani has been promoted to OGPS deputy director. Since 2021, he served as principal policy advisor in OGPS’ immediate office (IO) leading stakeholder or counterpart engagements and coordination, advising the associate commissioner on complex issues, and managing IO functions,
FDA Policy/General
FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’
FDA Policy/General
FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few
Devices
FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued
Drugs
FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing
Biologics
FDA has accepted for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) in combination with enfortumab vedotin (EV) for treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy. The agency set a user fee review action target date for upcoming
Drugs
FDA says it has directed Takeda to add a Boxed Warning to the labeling for its Adzynma, a recombinant ADAMTS13 enzyme replacement therapy approved for congenital thrombotic thrombocytopenic purpura (cTTP). An agency online notice says Adzynma has been associated with the development of neutralizing antibodies that can prevent the drug
FDA Policy/General
FDA commissioner nominee Heidi Overton pledged to accelerate drug development, strengthen regulatory oversight and preserve the agency's scientific independence during her Senate confirmation hearing Thursday, while facing pointed questions from lawmakers about vaccine safety, medication abortion, tobacco regulation and political interference in FDA decisions. Overton, a White House
Drugs
FDA has approved Eli Lilly’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for controlling high blood sugar in adults with Type 2 diabetes when used along with diet and exercise. Onswik is designed to deliver steady basal insulin levels over a full seven days, the
Devices
FDA has published a draft guidance, Robotically-Assisted Surgical Devices—Premarket Submissions, with recommendations for premarket submissions for certain robotically-assisted surgical devices (RASDs). The document applies to RASDs except pre-operative planning systems and stereotaxic systems. It also does not address RASDs intended to assist in performing surgical tasks
Drugs
FDA Policy/General
On the eve of FDA commissioner-nominee Heidi Overton’s Senate confirmation hearing, Former FDA head Scott Gottlieb appeared on CNBC to offer his ringing endorsement of President Trump’s pick to lead the agency. Gottlieb cited as being positive her White House experience, relationships with administration officials, and her