Drugs
FDA has approved Bristol Myers Squibb’s combination of Opdivo (nivolumab) with Yervoy (ipilimumab) for treating adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The agency says it also converted the
Drugs
Physician Douglas R. Smith is asking FDA to severely curtail the use of the indications of opioid addiction and opioid use disorder. His just-released 2/18 petition says the agency should curtail the indications for treatment and for manufacturing. It is the second opioid-related petition Smith has submitted.
Drugs
FDA has accepted for review a Teva Pharmaceuticals supplemental BLA for Ajovy (fremanezumab-vfrm) to expand the indication to include preventing episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kg or more. The application is based on positive results from the Phase 3 SPACE
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A Senate HELP Committee hearing tentatively planned for 4/10 has been postponed because the focus of interest, HHS secretary Robert F. Kennedy Jr., reportedly could not appear this week. Sens. Bill Cassidy (R-LA) and Bernie Sanders (I-VT), chairman and ranking member of the Senate HELP Committee respectively,
Drugs
Draeger has recalled (Class 1) its Flex 220 ID breathing circuit due to the risk of cracks forming in the breathing circuit hose. The device is intended for “conveying breathing gases between an anesthesia machine or ventilator and an adult patient,” according to a recall notice. Notification letters were sent
Drugs
FDA has granted Ideaya Biosciences a breakthrough therapy designation for darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor for neoadjuvant use in adult patients with primary uveal melanoma (UM) for whom enucleation has been recommended. The designation was based on interim clinical data from an ongoing Phase
Drugs
FDA has issued a complete response letter to Aldeyra Therapeutics for its NDA for reproxalap to treat the signs and symptoms of dry eye disease. A company statement says the CRL indicated that while no safety or manufacturing issues were identified, the NDA “failed to demonstrate efficacy in adequate and
Drugs
FDA has granted orphan drug designation for Sanofi’s rilzabrutinib for two rare diseases — warm autoimmune hemolytic anemia and IgG4-related disease. A company statement says there is a significant unmet need for the two diseases which do not have any approved medicine. Rilzabrutinib is described as an investigational, novel,
Drugs
Researchers at NYU Langone Health say the effectiveness of poly-ADP-ribose polymerase (PARP) inhibitors in any cancer cell depends on how well the BRAC2 cancer gene works in the cell. The Langone researchers’ study (subscription or purchase required) published in the journal Nature builds on the fact that as
Drugs
BeiGene says it is discontinuing development of BGB-A1217 (ociperlimab), an anti-TIGIT antibody, as a potential treatment for lung cancer. The decision was based on an independent data monitoring committee recommendation to terminate the company’s ongoing Phase 3 AdvanTIG-302 trial (NCT04746924) based on its findings as part
Drugs
FDA’s accelerated approval program is under renewed scrutiny after a recent JAMA study highlighted concerns about cancer drugs that remain available despite failing to show clinical benefit in confirmatory trials. The program allows drug companies to bring medications for serious conditions to market based on preliminary or biomarker evidence.
Drugs
FDA has granted Biogen a fast-track designation for BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau in treating Alzheimer’s disease. The company says BIIB080 is the first tau-targeting ASO to enter clinical development for Alzheimer’s, and it is currently being evaluated in the Phase 2
Drugs
Roche says the Phase 3 MUSETTE trial evaluating whether a higher dose of the approved Ocrevus IV 600 mg would provide additional benefit to people living with relapsing multiple sclerosis failed to meet its primary endpoint. A company statement says the trial results support Ocrevus IV 600 mg as the
Drugs
Edgewise Therapeutics says its EDG-7500 demonstrated rapid and clinically meaningful reductions in left ventricular outflow tract gradients in the Phase 2 CIRRUS-HCM four-week trial in hypertrophic cardiomyopathy. A company statement says four-week treatment with EDG-7500 demonstrated substantial improvements in measures of feel and function, reductions
Drugs
HHS began laying off FDA employees 4/1, with many receiving email notifications in the early morning hours or being denied entrance at security checkpoints at the agency’s White Oak, MD campus. The terminations are part of the plans HHS announced last week (see earlier story) that estimated FDA
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FDA has accepted for priority review an Apellis Pharmaceuticals supplemental NDA for Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are severe and rare kidney diseases. The agency has set a user fee review action target date of 7/28. “Empaveli demonstrated clinically
Drugs
Axsome Therapeutics says that in the PARADIGM Phase 3 proof-of-concept trial of solriamfetol to treat major depressive disorder with and without excessive daytime sleepiness, the drug failed to meet its primary endpoint in the overall patient population. A company statement says solriamfetol did not demonstrate a statistically significant
Drugs
Compass Therapeutics is announcing statistically significant top-line data on the primary efficacy endpoint from its COMPANION-002 trial, an ongoing Phase 2/3 randomized study of tovecimig in combination with paclitaxel in patients with advanced biliary tract cancer. The trial evaluated tovecimig in 168 patients with unresectable advanced, metastatic
Drugs
FDA has released the form FDA-483 issued following a 2/13-3/6 inspection at SKNV, a Pompano Beach, FL, outsourcing facility. The three inspection observations were: * failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed; * failure to provide adequate containment, segregation,
Drugs
Vanda Pharmaceuticals has filed an NDA for Bysanti (milsaperidone) for treating acute Bipolar I disorder and schizophrenia. The new chemical entity is believed to work by interacting with a host of neurotransmitter receptors in the brain, including the alpha-adrenergic receptor, serotonin receptors and dopamine receptors, according to the company.
Drugs
FDA has approved AstraZeneca’s Imfinzi (durvalumab) for treating adults with muscle invasive bladder cancer (MIBC). The approval covers Imfinzi’s combination use with gemcitabine and cisplatin as a neoadjuvant therapy, followed by durvalumab as an adjuvant monotherapy after radical cystectomy. The approval is based on the results of the
Drugs
Merck says data from its Phase 3 ZENITH trial showed that Winrevair (sotatercept-csrk) significantly reduces the risk of major morbidity and mortality events in adults with pulmonary arterial hypertension. The findings prompted an independent data monitoring committee to recommend early termination of the trial due to overwhelming efficacy, according