Drugs
FDA has issued a safety clarification about its 9/12 Non-prescription Drug Advisory Committee deliberation and 16 to 0 vote (see story) that current scientific data do not support the effectiveness of the over-the-counter monograph dosage of orally administered phenylephrine (10mg) as a nasal decongestant. In the
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Zydus Pharmaceuticals submitted a 9/14 petition asking FDA to take certain actions concerning Indocin (indomethacin) suppositories, 50 mg, and its generic equivalent. The petition says the International Conference on Harmonization (ICH) standards and established drug product impurity acceptance criteria should be followed by ANDA sponsors and applicants, given the
Drugs
FDA and Rocket Pharmaceuticals have reached an agreement on a pivotal Phase 2 trial of the company’s RP-A501 to treat Danon Disease. Rocket CEO Gaurav Shah says the investigational gene therapy infusion “has the potential to restore normal cardiac function and provide a lifetime of benefit to patients
Drugs
Eiger Pharmaceuticals says it is discontinuing the Phase 3 LIMT-2 study of peginterferon lambda in patients with chronic hepatitis delta based on a recommendation from the trial data safety monitoring board. The board recommended on 9/7 that the trial be discontinued due to observations of four patients with
Drugs
The Supreme Court is likely to decide at the beginning of its term in 10/2023 whether to hear Shire’s appeal from an 11th Circuit Court of Appeals decision in a case involving state failure-to-warn law and the Highlights section of a drug’s labeling. That’s
Drugs
A 9/12 White House statement discusses steps taken by FDA to address cancer drug supply issues and prevent impacts to patients. The statement identifies these FDA actions: * for generic carboplatin and cisplatin, the agency worked closely with cancer drug manufacturers to help identify opportunities to increase manufacturing capacity and
Drugs
FDA has accepted for priority review a Madrigal Pharmaceuticals NDA for resmetirom and its use in treating adult patients with nonalcoholic steatohepatitis (NASH). The agency has set a 3/14/2024 user fee review action date. The company is seeking accelerated approval. Resmetirom is described as a once daily, oral,
Drugs
Commenting on an FDA draft guidance on determining “good cause” for noncompliance with postmarketing requirements, Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned that the proposed standard for “good cause” is unduly inflexible. The trade association recommends that the draft be revised “to account for a totality
Drugs
Bipartisan legislation was introduced 9/13 in the Senate and House to close a patent-listing loophole that drug manufacturers use to extend their exclusivity periods. “Because of incomplete coordination between the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO), drug manufacturers are currently
Drugs
FDA’s Cardiovascular and Renal Drugs Advisory Committee 9/13 voted 9 to 3 that the benefits of Alnylam Pharmaceuticals’ patisiran (Onpattro) outweigh its risks for treating cardiomyopathy induced by transthyretin amyloidosis (ATTR). Panel members who voted favorably for the drug agreed that while the benefit was small, any safety
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FDA medical reviewers are questioning the efficacy of Alnylam Pharmaceuticals’ patisiran (Onpattro) in treating a larger pool of patients as sought in an sNDA. The filing will be considered on 9/13 by the FDA Cardiovascular and Renal Products Advisory Committee. In a briefing paper released in advance of the
Drugs
FDA has published the FY 2022 annual report on the extent to which GDUFA science and research-funded projects support the development of generic drug products, the generation of evidence needed to support efficient review and timely approval of ANDAs, and the evaluation of generic drug equivalence. The report contains
Drugs
A 3/7-3/16 FDA inspection at the Safecor Health drug manufacturing facility in Woburn, MA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/5 Warning Letter says specific violations were: * failing to adequately inspect the packaging and labeling facilities immediately before
Drugs
A 3/27-4/3 FDA inspection at the Similasan AG drug manufacturing facility in Jonen, Switzerland, determined that the firm is marketing several unapproved new ophthalmic drugs. A 9/11 Warning Letter identifies significant violations of current good manufacturing practice (CGMP) regulations in the production of the unapproved drugs.
Drugs
FDA has issued Warning Letters to eight companies for illegally manufacturing or marketing unapproved ophthalmic products. An agency online notice (includes links to the eight Warning Letters) says the companies’ unapproved drugs are marketed to treat conjunctivitis, cataracts, glaucoma, and other ophthalmic conditions. Some of the letters also identify CGMP
Drugs
In its response to an Oncopeptides AB written appeal challenging CDER’s proposal to withdraw Pepaxto (melphalan flufenamide) from the market, CDER says the required study to confirm the drug’s accelerated approval did not meet the prespecified primary endpoint. “The sponsor’s assertion that the primary endpoint demonstrated statistically
Drugs
A new white paper by the Duke Margolis Center for Health Policy recommends that the federal government and Congress “take urgent action to establish a new coordinating effort, the Prevent Drug Shortages Initiative, with requisite authorities and funding to lead a cross-cutting effort to improve drug supply chain reliability,
Drugs
FDA’s Nonprescription Drugs Advisory Committee 9/12 voted 16 to 0 that current scientific data do not support the effectiveness of the over-the-counter monograph dosage of orally administered phenylephrine (10mg) as a nasal decongestant. Phenylephrine is the active ingredient found in a number of common OTC cold
Drugs
A Florida federal court jury has convicted two defendants in a scheme involving the falsification and fabrication of clinical trial data. The jury on 9/5 convicted Miguel Angel Montalvo Villa and Ivette Maria Portela Martinez, both of Miami, on one count each of conspiracy to commit wire fraud and
Drugs
The Department of Justice has petitioned the U.S. Supreme Court asking it to reverse last month’s decision (see earlier story) by the Fifth Circuit Court of Appeals that would restrict how the abortifacient drug Mifeprex (mifepristone) is used by, and distributed to, patients. The government’s petition was
Drugs
AstraZeneca says data from its FLAURA2 Phase 3 trial showed that Tagrisso (osimertinib) plus chemotherapy extended median progression-free survival by nearly nine months compared to Tagrisso alone for patients with locally advanced (Stage 3B-3C) or metastatic (Stage 4) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung
Drugs
FDA and Duke-Margolis Center for Health Policy are holding a 9/18-19 two-day public workshop to discuss pregnancy safety studies. The workshop is one of FDA’s continuing efforts to enhance postapproval pregnancy safety studies, “capitalizing on the increased availability of population-based healthcare data and advances