Drugs
CBER director Peter Marks says the agency will decide in June what the fall Covid-19 vaccine composition should look like, adding that firms need to focus on broadening the protection of their annual booster vaccines to help public uptake of future annual shots. Speaking at the World Vaccine Congress
Drugs
Phathom Pharmaceuticals says it will resubmit by the end of June an NDA for vonoprazan for treating erosive esophagitis, and a post-approval supplement for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin). In February, FDA sent two complete response letters related to the submissions that
Drugs
FDA has accepted for review two Pfizer Supplemental NDAs for Braftovi (encorafenib) and Mektovi (binimetinib) and their use in patients with metastatic non-small cell lung cancer with a BRAF V600E mutation, as detected by an FDA-approved test. The agency has set a user fee review action target date
Drugs
A JAMA research letter says 54% of the 177 accelerated approval-related confirmatory studies conducted between 2012 and 2021 were late in meeting their FDA completion deadlines. “Trials for nononcologic indications (93% [15 of 16]) were more likely to be late than those for oncologic indications (46% [39 of 84]
Drugs
FDA has approved an Astellas Pharma BLA for Padcev (enfortumab vedotin-ejfv) for use with Merck’s Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. Approval was based on data from the EV-103/KEYNOTE-869 study. The confirmed
Drugs
FDA has cleared a BC3 Technologies 510(k) for its SEAL Hemostatic Wound Spray, described as an aerosolized chitosan for rapidly addressing serious arterial bleeding. “When sprayed on a bleeding wound, SEAL quickly forms a strong barrier that helps stop bleeding within seconds and without pain,” the company says. “SEAL
Drugs
FDA says it is requiring opioid analgesic manufacturers to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional disposal option for patients. “Expanding impactful opioid disposal options, such as mail-back envelopes and in-home disposal, for patients to safely and securely dispose of
Drugs
CBER’s Office of Compliance and Biologics Quality has issued an untitled letter to Minneapolis Regenerative Medicine, objecting to claims and statements made on the firm’s Web site and marketing materials. The letter says the cellular product is marketed for treating various diseases or conditions, such as osteoarthritis and
Drugs
FDA has told Ascendis Pharma that deficiencies identified in the company’s NDA for TransCon PTH (palopegteriparatide), indicated for treating hypoparathyroidism, prevents the agency from holding further discussions about labeling and post-marketing requirements/commitments. While not disclosing any specifics, an agency letter said that its position does not currently
Drugs
A recent inspection of Global Pharma Healthcare in Tamilnadu, India has led to a just-posted 14-page FDA Form-483 that cites significant GMP deficiencies. For example, the form says the company’s procedures for preventing microbiological contamination were inadequate because they did not include validation of the sterilization
Drugs
Senators Tina Smith (D-MN) and Mike Braun (R-IN) have reintroduced bipartisan legislation that would prevent pharmaceutical company actions to block generic drug competition through a practice called “parking.” The senators say that parking occurs when a brand company agrees not to sue the first company that submits an
Drugs
Hutchmed Ltd. has completed a rolling NDA submission for fruquintinib, wgich it describes as a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3 for treating refractory metastatic colorectal cancer (CRC). The submission is based on data from the global Phase 3 multi-regional clinical trial FRESCO-
Drugs
FDA has released a final guidance entitled “Identification of Medicinal Products — Implementation and Use” that is intended to support the development and implementation of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards for substances, terminologies, and other information for use throughout the global medicinal product development
Drugs
A U.S. government amicus brief has FDA supporting the generic drug industry in a closely watched Supreme Court appeal of a lower court’s ruling in a so-called “skinny label” case brought by GlaxoSmithKline (GSK) against Teva over a generic form of GSK’s heart drug Coreg (carvedilol)
Drugs
FDA has published a guidance, Research Involving Children as Subjects and Not Otherwise Approvable by an IRB: Process for Referrals to FDA and OHRP, to assist institutional review boards (IRBs), institutions, investigators, and sponsors in understanding the processes used for review of research involving children as subjects that is not
Drugs
FDA has converted from accelerated to full approval Merck’s Keytruda (pembrolizumab) to treat certain adult and pediatric patients with advanced microsatellite instability-high or mismatch repair deficient solid tumors. The full approval is for treating adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair
Drugs
FDA has lifted its partial clinical hold against Vigil Neuroscience and doses greater than 20 mg/kg for VGL101 in clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). The investigational drug is currently being studied in IGNITE, a Phase 2 proof-of-concept
Drugs
A 6/23/22-7/8/22 FDA inspection of two pediatric clinical trials conducted by Dr. Robert Hayashi at the Washington University School of Medicine in St. Louis, MO, found objectionable conditions that indicated Hayashi did not adhere to the applicable legal requirements and regulations governing the conduct of
Drugs
FDA and the Lupus Research Alliance have launched the Lupus Accelerating Breakthrough Consortium (Lupus ABC) focused on addressing challenges affecting lupus clinical trial success. An agency announcement says Lupus ABC “will convene people living with lupus, medical societies, industry, academic clinical researchers and scientists, FDA, and other federal agencies to
Drugs
FDA has approved Emergent BioSolutions’ Narcan 4 mg naloxone hydrochloride nasal spray, the first nonprescription over-the-counter product for reversing the effects of opioid overdose. “In accordance with a process to change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug
Drugs
Attorneys Joshua Oyster and Rebecca Williams (Ropes & Gray) say recent FDA actions “potentially signal a broader shift in FDA’s approach to accelerated approval drugs.” Writing in an online post, they note the agency plans to hold workshops this year to discuss the role of surrogate efficacy endpoints, their
Drugs
The DC federal court has granted final judgment to Vanda Pharmaceuticals in its Freedom of Information Act (FOIA) fight with FDA to obtain agency records created during the review of Vanda’s sNDA for Hetlioz (tasimelteon) to treat jet lag disorder. In the suit, Vanda complained that FDA had denied