Drugs
New FDA research on direct-to-consumer (DTC) television ads found that study subjects have trouble differentiating progression-free survival and overall response rate from overall survival. The agency says research has suggested that disclosures can help consumers stop conflating overall survival with other endpoints. Such disclosures specifically state that
Drugs
FDA has granted Genmab an accelerated approval for its BLA for Epkinly (epcoritamab-bysp) injection for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B‑cell lymphoma after two or more lines of systemic therapy. DLBCLs are the most common type of
Drugs
Vanda Pharmaceuticals is asking FDA to revoke its approval of an MSN Pharmaceuticals ANDA for generic Hetlioz (tasimelteon) capsules and order a recall of any product that has been distributed under the ANDA. The Vanda petition says MSN failed to satisfy bioequivalence requirements in its ANDA. Hetlioz is indicated for
Drugs
FDA has released the form FDA-483 issued following an 11/8-12/2/22 inspection at the Nephron Pharmaceuticals warehouse in Murray, KY. The four inspection observations were: * failing to have a quality control unit; * failing to examine visually at least once a year reserve samples from representative sample
Drugs
FDA has approved AbbVie’s Rinvoq (upadacitinib) for treating adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. Previously, Rinvoq was approved as a treatment for rheumatoid arthritis, active psoriatic arthritis and active ankylosing
Drugs
FDA has cleared an Abbott 510(k) for its Assert-IQ insertable cardiac monitor (ICM) for diagnosing and long-term monitoring of people experiencing irregular heartbeats (arrhythmias). ICMs are small devices with sensors inserted just under the chest’s skin to provide constant, real-time monitoring of a person’s
Drugs
The Give Kids a Chance Act, legislation that would provide children greater access to cancer trials and therapies, has been reintroduced by Reps. Anna Eshoo (D-CA) and Michael McCaul (R-TX). It has 12 bipartisan cosponsors. A statement (includes a link to the bill text) from Eshoo says the
Drugs
House Energy and Commerce Committee ranking member Frank Pallone (D-NJ) says the committee’s minority staff is working with FDA and the White House to address the shortage of the cancer drugs carboplatin and cisplatin and implement long-term solutions to prevent the shortages from occurring in the future.
Drugs
FDA has published 46 new or revised product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDA approvals. A notice says the latest batch includes 25 new and 21 revised PSGs; 34 PSGs for products with no approved ANDAs (including 19 complex products); 13
Drugs
FDA has published two draft guidances that when finalized will provide recommendations to support the approval of pediatric drugs, biological products, and vaccines under the Pediatric Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children Act (BPCA). The two documents revise and replace a previous draft guidance. The
Drugs
FDA has modified a partial clinical hold on an Avidity Biosciences study involving AOC 1001, allowing Avidity to double the number of participants in the MARINA Open-Label Extension (MARINA-OLE) study receiving 4 mg/kg of the drug. “The FDA is also allowing new participant enrollment for AOC 1001
Drugs
ICU Medical has recalled the replacement batteries in its in Plum A+ & Plum A+3 Infusion Systems due to a manufacturing defect by a battery supplier. Affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier than
Drugs
FDA is asking the Gastrointestinal Drugs Advisory Committee to weigh the benefits and risks of Intercept Pharmaceuticals’ obeticholic acid (OCA) to treat pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH). In a briefing document released in advance of the committee’s 5/19 meeting, agency medical reviewers say there
Drugs
Bipartisan legislation to use penalties paid by drug, cosmetic, supplement, and medical device companies to increase childhood cancer research has been introduced by Sens. Tim Kaine (D-VA), Jerry Moran (R-KS), and Mark Warner (D-VA). A version of the bill has also been introduced in the House by
Drugs
The American Economic Liberties Project and the Initiative for Medicines, Access, and Knowledge (I-MAK) say the “illegal and anticompetitive tactics used by the pharmaceutical industry to perpetuate monopolies — in the form of government-backed patents over brand drugs — and block competition from more affordable generic drugs” cost final payers
Drugs
UCB is asking FDA to reject an Apotex ANDA for fenfluramine hydrochloride oral solution that cites UCB’s Fintepla as the reference-listed drug. The UCB 5/15 petition says that to ensure that generic fenfluramine products are appropriately labeled for the life-threatening pediatric disease Dravet Syndrome (DS), the
Drugs
FDA has accepted for priority review a Takeda BLA for TAK-755, an enzyme replacement therapy for treating congenital thrombotic thrombocytopenic purpura, an ADAMTS13 deficiency disorder. The ultra-rare clotting disorder is caused by a deficiency in ADAMTS13 protease, the company says, adding that the mortality rate, if left untreated,
Drugs
Prothena says it has appointed former CDER Office of Neuroscience director Billy Dunn to its board of directors. The company is a self-described “late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise.” Dunn was a top figure in FDA’s controversial
Drugs
An 11/1-11/7/22 FDA inspection at the Pharmedica USA drug manufacturing facility in Phoenix, AZ, determined that drug products manufactured there are adulterated in that they have been prepared, packed, or held under insanitary conditions. As a result, the company said it would shut down all manufacturing
Drugs
FDA has just released the form FDA-483 issued following a 4/18-4/26 inspection at the Ipca Laboratories drug manufacturing facility in Haveli, India. The three inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to
Drugs
The Accelerating Medicines Partnership Bespoke Gene Therapy Consortium, a public-private partnership between FDA, the National Institutes of Health, biopharmaceutical and life science companies, and nonprofit and other organizations to help speed the development and delivery of customized or “bespoke” gene therapies that could treat the millions of people affected
Drugs
Alliance for Pharmacy Compounding CEO Scott Brunner says Congress should include in any legislation addressing drug shortages provisions that “will equip state-licensed pharmacy compounders to provide urgent-use medications to hospitals and for in-clinic administration, within tight regulatory guardrails, when those drugs are demonstrably in shortage and unavailable