Drugs
Pharmaceutical Research and Manufacturers of America says FDA should revise its draft guidance on implementing the safety labeling changes (SLCs) provision included in the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act to promote an efficient and rational regulatory process, and based on
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Sens. Chris Coons (D-DE) and Ted Budd (R-NC) have introduced the Biomanufacturing Excellence Act that they say would promote U.S. leadership in biotechnology and strengthen domestic biopharmaceutical manufacturing. A statement (includes links to the bill text and a one-page summary) from Coons says the legislation would
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FDA has launched a new pilot program aimed at reducing delays and confusion that often follow formal meetings between the agency and drug developers. Announced 11/19 by FDA commissioner Marty Makary, the initiative creates a streamlined process for companies to get rapid clarification on specific points in their official
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CNBC TV-18, India’s leading business television station, says Cyberabad cyber crime police have arrested two individuals who were accused of running an extortion and cyber-intimidation racket targeting Hetero Drugs. The station says a Hetero senior employee reported receiving emails demanding a $250 million ransom. Police said the
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FDA has approved Genmab’s Epkinly (epcoritamab-bysp) for combination with lenalidomide and rituximab in adults with relapsed or refractory follicular lymphoma (FL), expanding treatment options for one of the most common indolent B-cell lymphomas. The agency action also converted the drug’s 2024 accelerated approval for third-line
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A 6/25-7/12 FDA Bioresearch Monitoring Program inspection at Verdure Sciences in Noblesville, IN, found that the company failed to submit an IND as the sponsor of a clinical investigation of its investigational drug Maplifa. An 11/10 Warning Letter says the company indicated it did not believe
Drugs
FDA has approved an Arrowhead Pharmaceuticals NDA for Redemplo (plozasiran) for reducing dangerously high triglyceride levels in adults with familial chylomicronemia syndrome (FCS), a rare genetic disorder that can trigger life-threatening pancreatitis. Redemplo is approved as an adjunct to a very low-fat diet for adults with FCS, a
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Roche says its investigational selective estrogen receptor degrader (SERD) giredestrant significantly improved invasive disease-free survival in people with early-stage, ER-positive/HER2-negative breast cancer, marking the first time an oral SERD has shown superiority to standard endocrine therapy in the adjuvant setting. The Phase 3 lidERA trial
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
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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.
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
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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
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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
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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
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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
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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
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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
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