Drugs
FDA has approved Bayer’s Lynkuet (elinzanetant) to treat moderate to severe vasomotor symptoms, or hot flashes, associated with menopause, marking the first U.S. approval for a therapy that targets both neurokinin 1 (NK1) and neurokinin 3 (NK3) receptors. Approval was based on data from Bayer’s Phase 3
Drugs
FDA has issued Sydnexis a complete response letter for SYD-101, a low-dose atropine eye-drop candidate intended to slow disease progression in children with pediatric progressive myopia. The agency concluded that the data submitted do not support the drug’s effectiveness in treating myopia in children, despite acknowledging
Drugs
FDA has granted Partner Therapeutics a breakthrough therapy designation for zenocutuzumab-zbco and its use for treating cholangiocarcinoma defined by NRG1 gene fusions. The designation covers adults with advanced unresectable or metastatic NRG1+ cholangiocarcinoma, the company says, and is based on data from the Phase 2 eNRGy trial. The company
Drugs
FDA has granted Heidelberg Pharma a fast track designation for HDP-101 (pamlectabart tismanitin), the company’s lead amanitin-based antibody drug conjugates candidate. The designation was based on data from the ongoing Phase 1-2a study that is evaluating the drug’s safety and antitumor activity in patients with
Drugs
Ventyx Biosciences is reporting positive Phase 2 data for its oral NLRP3 inhibitor VTX3232 in patients with obesity and cardiovascular risk factors. The 175-participant study examined VTX3232 versus placebo, alone or in combination with semaglutide (Novo Nordisk's Ozempic and Wegovy), and evaluated safety and tolerability as the
Drugs
FDA has approved a GSK BLA for Blenrep (belantamab mafodotin-blmf) in combination with bortezomib (Velcade) and dexamethasone for treating adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent. The BLA
Drugs
FDA has published a guidance, Expanded Access to Investigational Drugs for Treatment Use, providing information in a question-and-answer format for industry, researchers, doctors, institutional review boards, and patients about the implementation of the agency’s 10/13/2009 regulations on expanded access to investigational drugs for treatment use
Drugs
Tango Therapeutics says new data from its ongoing Phase 1-2 study of vopimetostat (TNG462) showed early signs of efficacy across multiple methylthioadenosine phosphorylase (MTAP)-deleted cancers, including pancreatic and lung tumors, paving the way for a pivotal trial next year. Such cancers are described as malignancies characterized by the
Drugs
The investigative newsroom ProPublica says FDA is keeping vital information about issues in generic drug foreign manufacturing from doctors, pharmacists, and patients who could use the information to make more informed decisions. One of the report’s concerns is that for decades, the agency has redacted the names of generic
Drugs
The CDER Office of New Drugs has published a Manual of Policies and Procedures (MAPP) with the policies, responsibilities, and procedures for CDER staff to follow when determining whether there is a basis to refuse to file (RTF) an NDA, sNDA, BLA, or sBLA submitted to the Center. The document
Drugs
To increase transparency and reduce the prevalence of drug regulatory filing deficiencies, FDA has made public the filing checklists CDER uses to determine if a submitted application is complete and reviewable. An agency statement notes that filing deficiencies consume resources and delay promising treatments. “Drug applications should not be derailed
Biologics
FDA has accepted for priority review an Astellas supplemental BLA for Padcev (enfortumab vedotin-ejfv) in combination with Merck’s Keytruda (pembrolizumab) for treating cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC). The submission seeks approval for the regimen as both a neoadjuvant treatment before surgery and an adjuvant
Drugs
DA has granted a fast track designation to Myosin Therapeutics and its investigational drug MT-125 for treating glioblastoma (GBM), one of the most aggressive and treatment-resistant brain cancers. “This fast track designation validates our conviction that MT-125 has the potential to offer an entirely novel treatment approach
Drugs
Alector’s efforts to advance a therapy for a rare genetic form of frontotemporal dementia (FTD) to market has ended in disappointment. The company reports that latozinemab (AL001) failed to meet its primary endpoint in a Phase 3 study, prompting the biotech to wind down the development program. The INFRONT-
Drugs
FDA says its review of records submitted by over-the-counter drug product manufacturer Foshan Yiying Hygiene Products Co., in Lishui Town, Guangdong, China, in response to an agency request, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/10 Warning Letter says the
Devices
A 7/10-7/11 FDA inspection at Dongguan Rainbow Tech Electronic & Plastic Products Co., Ltd., in Guangdong Sheng, China, found Quality System Regulation violations in the firm’s manufacturing of Class 2 manual emergency ventilators. A 10/7 Warning Letter says the specific violations were: * failure to establish
Drugs
The Senate Special Committee on Aging has released a report, “Protecting Seniors’ Access to Essential Medications: Securing the Foreign Generic Pharmaceutical Supply Chain,” focused on what it calls America’s dangerous overreliance on foreign-made generic drugs, which are largely imported from China and India. A committee statement (includes a
Drugs
FDA commissioner Marty Makary recently addressed the agency’s significant shift in enforcement policy directed at direct-to-consumer (DTC) pharmaceutical advertising. During a wide-ranging FDA podcast 10/16, Makary criticized certain drug ads for relying on distracting visuals such as “singing and dancing … marching in some fake town”
Drugs
After receiving several Warning Letters from FDA. Nephron Pharmaceuticals in Columbia, SC, still does not have the needed systems in place to ensure its products are made in a sterile environment. In a news story posted on Yahoo! News, The State, a newspaper in Columbia, says Nephron’s most recent
Biologics
Moderna’s bid to bring the first vaccine for congenital cytomegalovirus (CMV) to market has ended in disappointment. The company says its investigational CMV vaccine, mRNA-1647, failed to meet the primary endpoint in a large Phase 3 trial, prompting the company to discontinue development for use in preventing congenital
Drugs
FDA has published the third of a planned four-guidance series on patient-focused drug development. The latest document, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, covers approaches to selecting, developing, modifying, and evaluating clinical outcome assessments (COAs) to measure outcomes of importance
Drugs
FDA has posted hiring data showing steep declines in staffing at its two key centers, CDER and CBER, responsible for drug and biologics regulation. The figures come amid a sweeping reorganization earlier this year at HHS and mounting concerns that the agency may be losing capacity to keep up with