Drugs
A 5/5-5/9 FDA inspection at the World Perfumes drug manufacturing facility in Opa-Locka, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 10/29 Warning Letter says the specific violations were: * failure to conduct at least one test
Drugs
As FDA works to streamline biosimilar approvals, the U.S. Patent and Trademark Office is creating new barriers that will slow the process of bringing the drugs to market. That’s the conclusion of a CBS News report republished by KFF Health. The report says drug industry officials reacted positively
Drugs
The U.S.-China Economic and Security Review Commission, which was created by Congress in 2000, says it is difficult to tell how entrenched China is in manufacturing drugs used in the U.S. because FDA “doesn’t collect data on where the basic building blocks of medicines are made.
Devices
FDA has denied a citizen petition requesting that it warn patients about whether surgical mesh implanted off-label during cosmetic mastopexy procedures may interfere with breast cancer detection using mammography or ultrasound. In an 11/14 denial letter, FDA said it has found no evidence of a safety signal linking
Drugs
A 3/16-4/6 FDA inspection at the DermaRite Industries drug manufacturing facility in North Bergen, NJ, found multiple violations in the firm’s production of over-the-counter drugs, including significant violations of current good manufacturing practice (CGMP) regulations. A just-released 13-page 10/27 Warning Letter
Drugs
FDA and generic drug manufacturers kicked off formal negotiations on the next cycle of the Generic Drug User Fee Amendments (GDUFA IV) during a recent meeting at the agency’s White Oak campus, which saw both parties offer several operating proposals. Negotiations began by establishing ground rules intended to keep
Drugs
Former CDER chemistry, manufacturing and controls (CMC) reviewer Fabiola Cervantes-Gomez has joined Hyman, Phelps & McNamara’s CMC regulatory expert team. According to the law firm, Cervantes-Gomez spent more than eight years at CDER, where she reviewed biotechnology products ranging from monoclonal antibodies and antibody-drug conjugates to
Drugs
Advocacy group Public Citizen is urging FDA to add new, class-wide pregnancy warnings to the labels of commonly prescribed serotonin reuptake inhibitor antidepressants, citing risks to newborns exposed in utero. In an 11/15 petition,the watchdog group asks the agency to strengthen safety information for both selective serotonin
FDA Policy/General
FDA has determined that a direct-to-consumer television advertisement for AstraZeneca’s Farxiga (dapagliflozin) tablets is misleading and misbrands the drug. In a just-posted untitled letter, CDER Office of Prescription Drug Promotion (OPDP) takes issue with the ad, titled “Farxiga DTC TV: 45 – Places You Want to Be
Drugs
Hims & Hers Health has appointed former FDA Global Regulatory Operations and Policy deputy commissioner Deb Autor as its first chief policy officer, tasking her with leading the company’s global public policy, regulatory, and government affairs efforts. Autor has been a member of Hims & Hers’ Board of Directors
Drugs
A new analysis has found that more than 380 clinical trials supported by the NIH lost funding this year — affecting about 1 in 30 active trials and impacting more than 74,000 participants, according to a study published 11/17 in JAMA Internal Medicine. The research letter found that: * Out
FDA Policy/General
Health and Human Services secretary Robert F. Kennedy Jr. has privately discussed plans to scale back the operational role of FDA commissioner Marty Makary, including the possibility of appointing another official to run day-to-day operations while leaving Makary as a more ceremonial figure — a move that administration officials
Biologics
Zymeworks says its HER2-targeted bispecific antibody Ziihera (zanidatamab-hrii) significantly improved outcomes for patients with HER2-positive gastroesophageal adenocarcinoma (GEA) in a large Phase 3 study. Topline results from the HERIZON-GEA-01 trial showed that Ziihera combined with chemotherapy, with or without the PD-1 inhibitor Tevimbra (tislelizumab)
Drugs
FDA has cited significant lapses in aseptic manufacturing practices at Sanofi’s sterile drug-product facility in Anagni, Italy, following a 5/2023 inspection that resulted in a just-posted Form 483 detailing multiple contamination risks. Inspectors visiting the site reported that procedures intended to prevent microbiological contamination were not
Drugs
Bristol Myers Squibb (BMS) and Johnson & Johnson have stopped their Phase 3 Librexia ACS trial of the investigational anticoagulant milvexian after an independent monitoring committee concluded the study was unlikely to meet its primary endpoint. The decision followed a planned interim analysis by the monitoring committee, which found the
FDA Policy/General
FDA commissioner Marty Makary and CBER director Vinay Prasad offered an unusually candid preview of upcoming agency reforms during an FDA Direct podcast focused on the appointment of longtime oncology regulator Rick Pazdur as CDER’s new director (see earlier story). The two officials described Pazdur — formerly head of the
FDA Policy/General
An Axios report examines growing criticism of recent FDA actions that are fueling uncertainty among drug developers and weakening public confidence in the agency. The article notes that top Trump-era health officials entered office arguing that the FDA lacked transparency, was overly influenced by industry, and failed to follow
Drugs
The ACLU has filed a lawsuit seeking to force FDA to release documents related to its ongoing safety review of mifepristone, accusing the agency of withholding information requested under a Freedom of Information Act filing submitted in August. The FOIA request seeks details on the scope of the agency’s
Drugs
FDA says it is approving new labeling submitted by Sarepta Therapeutics’ for its gene therapy Elevidys (delandistrogene moxeparvovec-rokl) that includes the addition of a Boxed Warning describing the risk of serious liver injury and acute liver failure, including fatal outcomes based on such reports in non-ambulatory patients treated
Drugs
FDA has granted Parabilis Medicines a fast track designation for FOG-001, a first-in-class inhibitor targeting the β-catenin:TCF interaction, for treating desmoid tumors. The action is based on the company’s early clinical data showing signs of meaningful antitumor activity. In an ongoing Phase 1-2
Drugs
FDA has released a final guidance entitled “Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.” The document describes how the agency intends to evaluate a request for a waiver, concerning a pH adjuster, of the regulatory requirement that a drug
Drugs
Gilead Sciences says its investigational single-tablet regimen combining bictegravir and lenacapavir met its primary endpoint in a pivotal Phase 3 trial, marking a potential advance for people with HIV who rely on complex, multi-pill treatments. The open-label ARTISTRY-1 study tested the once-daily tablet, which combines