Drugs
The U.S. Supreme Court has declined to hear a series of pharmaceutical industry challenges to the federal government’s Medicare drug price negotiation program, preserving a key element of the Inflation Reduction Act and handing a setback to major drugmakers seeking to block the initiative. The justices, without comment,
Drugs
FDA has granted Bayer a priority review for its supplemental NDA for Hyrnuo (sevabertinib) as a first-line treatment for patients with HER2-mutant non-small cell lung cancer. The filing seeks approval for sevabertinib in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose
Drugs
Regeneron Pharmaceuticals says its Phase 3 trial evaluating the experimental immunotherapy combination of fianlimab and cemiplimab in advanced melanoma failed to meet its primary endpoint of statistically significant improvement in progression-free survival compared with pembrolizumab (Merck’s Keytruda) monotherapy. The study tested two dose levels of the LAG-3
Drugs
Merck is reporting that its Phase 3 TroFuse-005 trial evaluating the investigational antibody-drug conjugate sacituzumab tirumotecan (Sac-TMT) met its primary endpoints of overall survival and progression-free survival in certain patients with advanced or recurrent endometrial cancer. The company says sac-TMT became the first TROP2-directed
Drugs
An FDA guidance issued last year is reshaping how pharmaceutical and medical device companies can communicate scientific information about off-label uses of approved products, while also creating new compliance challenges for industry, according to a legal analysis by Suzanne Levy Friedman (Honigman partner) posted in Life Science Leader. The
Drugs
FDA has approved AstraZeneca’s Baxfendy (baxdrostat), making it the first aldosterone synthase inhibitor in the U.S. for adults with hypertension whose blood pressure remains uncontrolled despite treatment with other medicines. The approval marks the first new mechanism for treating hypertension in roughly two decades and targets patients whose
Drugs
Aardvark Therapeutics said it plans to unblind key clinical trial data on its experimental metabolic drug ARD-101 after FDA imposed a full clinical hold on the program, affecting both its pivotal Phase 3 HERO study and an open-label extension trial. The hold reportedly followed reports of “reversible cardiac
Drugs
The U.S. Supreme Court on Thursday temporarily preserved nationwide access to the abortion pill mifepristone by mail, blocking a lower court ruling that would have reinstated in-person dispensing requirements while litigation continues. In a 7-2 decision, the court granted emergency requests from manufacturers Danco Laboratories and GenBioPro
Drugs
CDER acting director Tracey Beth Hoeg is expected to leave the agency just days after the resignation of former FDA commissioner Marty Makary, according to three people familiar with internal planning, Reuters reported Friday. Hoeg, an epidemiologist and sports physician who drew criticism during the Covid-19 pandemic for questioning
Drugs
FDA’s recent rejection of an experimental melanoma treatment has become a flashpoint in broader criticism of former FDA commissioner Marty Makary and the agency’s increasingly unpredictable regulatory climate under the Trump administration, according to a report published Friday by KFF Health News. FDA last month declined to approve
Drugs
FDA has approved Genentech’s Tecentriq (atezolizumab) and a subcutaneous formulation of the drug for the adjuvant treatment of certain patients with muscle-invasive bladder cancer who test positive for circulating tumor DNA after surgery. The approval covers adults with muscle-invasive bladder cancer who have undergone cystectomy and are
Drugs
FDA says Sun Pharma is recalling one batch of 675 vials of DOXOrubicin hydrochloride liposome injection 50mg/25mL with an expiration date of 5/2027. An agency notice says the batch was recalled on 5/13 due to the detection of glass particles in some vials during production. A Sun
Drugs
CDER has published a Manual of Policies and Procedures (MAPP) on Assessing Impurity Acceptance Criteria as Part of Specifications for NDAs, ANDAs, and BLAs Based on Clinical Relevance. “While the ICH guidance for industry Q3A(R2) Impurities in New Drug Substances (June 2008) and the ICH guidance for industry Q3B(
Drugs
The sudden resignation of FDA commissioner Marty Makary capped one of the shortest and most turbulent FDA tenures in recent memory, with media reports over the past two days painting a portrait of an agency consumed by political warfare, regulatory uncertainty and internal upheaval. Makary formally stepped down Tuesday after
Drugs
AstraZeneca says perioperative treatment with Imfinzi (durvalumab) combined with neoadjuvant enfortumab vedotin (EV) (Astellas/Pfizer's Padcev) significantly improved event-free survival and overall survival in patients with muscle-invasive bladder cancer who were ineligible for or declined cisplatin chemotherapy, according to interim Phase 3 VOLGA trial results released
Drugs
Americans for Scientific Integrity is petitioning FDA to amend the labeling requirements for over-the-counter acetaminophen-containing drug products to include warnings about their potential effects on fertility and reproductive development. The petition says the advocacy group “does not assert a causal relationship has been definitively established between acetaminophen
Drugs
FDA has released a draft guidance outlining recommendations for drugmakers developing local anesthetic products designed to provide prolonged postoperative pain relief, as the agency seeks to support alternatives to opioid-based pain management. The draft guidance, titled “Development of Local Anesthetic Drug Products With Prolonged Duration of Effect,” focuses on
Drugs
Three Morgan Lewis attorneys say the FDA 3/11 launch of its new Adverse Event Monitoring System (AEMS) “marks an important evolution in safety data transparency and accessibility, offering single-platform advanced analytics and real-time information for drugs, biologics, cosmetics, and vaccines, with medical device data to be added
Drugs
FDA has published draft guidances addressing the development of non-opioid analgesics and considerations for a benefit/risk assessment framework for opioid analgesics. The guidance on developing non-opioid analgesics for chronic pain addresses two FDA priorities — (1) fostering the development of novel analgesic products and (2) decreasing opioid analgesic
Drugs
FDA has issued a draft guidance detailing how the agency will evaluate the benefits and risks of new opioid analgesic drugs, emphasizing that approval decisions will consider not only patient outcomes but also broader public health effects such as misuse, abuse, overdose, and opioid use disorder. The draft guidance, “Opioid
Drugs
An FDA review of websites maintained by Navah Pharma/Bigdam Inc, based in Netanya, Israel (Navah) and Atlanta, GA (Bigdam), determined that the firms are selling unapproved new drugs through several online websites. A 5/4 Warning Letter says the Websites are selling RSV Hypertonic Saline 3% and Hypertonic Saline
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned that an FDA draft guidance on responding to form FDA-483 observations at the end of a drug CGMP inspection “could be interpreted to go beyond the topic … and to suggest new substantive CGMP expectations.” The comment letter asks