Drugs
FDA appears to be backing the approval of Novo Nordisk’s Glucagon-like peptide-1 (GLP-1) diabetes drug semaglutide as it heads for an advisory committee review 10/18. In a briefing document released in advance of the meeting, agency reviewers said the indication of semaglutide as an adjunct
Drugs
FDA has accepted for review a Bristol-Myers Squibb supplemental BLA for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection. The submission is based on data from the ongoing Phase 3 CheckMate-238 study, which evaluated Opdivo in patients
Drugs
A push by states to relax off-label communications between the pharmaceutical marketers and physicians and insurers may force FDA’s hand at curbing such restrictions nationally. That is the premise behind a recent Pew Charitable Trust Stateline report reprinted in the Washington Post and entitled “Pressure mounts to lift
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Draft Guide on Whether to Submit ANDA or 505(b)(2) Application Federal Register notice: FDA makes available a draft guidance on “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” 10/13/2017 Panel to Meet on Barricaid Anular Closure Device Federal Register notice: FDA announces
Drugs
FDA has posted a draft guidance on “Post-Complete Response Letter (CRL) Meetings Between FDA and ANDA Applicants Under GDUFA.” The document provides recommendations to industry about such meetings to clarify deficiencies identified in a CRL. It provides procedures to promote well-managed post-CRL meetings and to ensure that
Drugs
FDA has accepted a Prometic BLA for Ryplazim (plasminogen), indicated for treating plasminogen deficiency. The agency has set a user fee review action target date of 4/14/2018. If approved, Prometic’s plasminogen replacement therapy will be eligible for a rare pediatric disease priority review voucher. The submission is
Drugs
To prevent drug shortages caused by the hurricanes that hit Puerto Rico last month, FDA has been expediting reviews and approvals of different dosage forms and generic versions of products as alternate sources of critical products coming from the island. In an update on current efforts, commissioner Scott Gottlieb illustrated
Drugs
FDA medical reviewers say that Aerie Pharmaceuticals’ Rhopressa (netarsudil ophthalmic solution 0.02%) is effective for its proposed indication of reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. A briefing document released in advance of a 10/13 meeting of the FDA Dermatologic and Ophthalmic
Drugs
To meet a statutory time deadline, FDA has denied a 5/15 AstraZeneca petition asking for specific agency action involving the company’s Falsodex (fulvestrant) intramuscular (IM) injection without commenting on whether it will ultimately take the requested actions. The AstraZeneca petition cited a Teva 505(b)(2) NDA referencing
Drugs
A PriceWaterhouseCoopers Health Research Institute (HRI) report says the drug industry is facing a growing threat from safety data on drugs being produced. “FDA has fostered unprecedented transparency on drug safety data,” the report says, “forcing companies to manage novel challenges from parties already busy mining those data: regulators, the
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FDA has issued a draft guidance, Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017, to explain the new PDUFA 6 user fee structure and the types of fees for which entities are responsible. The document describes the types of user fees authorized by PDUFA 6, the
Drugs
FDA has issued a draft guidance, Determining Whether to Submit an ANDA or a 505(b)(2) Application, to assist applicants to determine which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FFDCA) is appropriate for the submission of a marketing application to FDA.
Drugs
Merck says it will not seek FDA regulatory approval for anacetrapib, an investigational cholesteryl ester transfer protein (CETP) inhibitor for lowering cholesterol. The company says its decision follows a thorough review of anacetrapib’s clinical profile, including discussions with external experts, concluding that the “clinical profile for anacetrapib does not
Drugs
FDA has issued a draft guidance, Requests for Reconsideration at the Division Level Under GDUFA, with recommendations for industry on the procedures for resolving scientific and/or regulatory issues or matters between FDA and ANDA applicants at the division level or original signatory authority. The document does not describe the
Drugs
FDA says that to address critical drug shortages in the aftermath of Hurricane Maria, Baxter Healthcare Corp. is coordinating with the agency to increase the availability of products from the company’s manufacturing facility in Ireland. An FDA notice lists the four IV products the company is temporarily importing and
Drugs
FDA has issued a draft guidance, Format and Content of a REMS Document, with updated recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product, including biological products. The document provides recommendations to applicants on drafting proposed REMS documents and
Drugs
Janssen Biotech has submitted an NDA for apalutamide, an investigational, next-generation oral androgen receptor inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC). Currently, no FDA approved treatments exist for these men. The company says apalutamide works by inhibiting the action of testosterone in prostate cancer cells
Drugs
The Biotechnology Innovation Organization (BIO) says that FDA could minimize ambiguity when it finalizes a draft guidance, “Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports,” by giving examples of situations where annual reportable listed changes in the guidance may be better
Drugs
FDA has awarded contracts to two companies to help the agency better determine how to collect more scientifically valid data in postmarketing studies of opioid abuse deterrence in real-world evidence. An online conversation with CDER Office of Surveillance and Epidemiology associate director for public health initiatives Judy Staffa indicates
Drugs
FDA has published a draft guidance on “Respiratory Syncytial Virus (RSV) Infection: Developing Antiviral Drugs for Prophylaxis and Treatment” that addresses the agency’s current thinking about the overall development program and clinical trial designs for such products. It focuses primarily on the development of drugs with antiviral mechanism for
Drugs
Novo Nordisk is asking FDA not to approve any ANDA referencing any of the company’s liraglutide-containing drugs as the reference-listed drug. The company’s 10/2 petition also asks that the agency: * not approve any 505(b)(2) NDA that references any of the company’s liraglutide-
Drugs
Pfizer says there may be conflicts between an FDA draft guidance on chemistry, manufacturing, and controls postapproval manufacturing changes for specified biological products to be documented in annual reports, and other guidance documents. In its comment letter on the draft, the company says it is difficult to determine which guidance