Drugs
FDA has issued Alvotech a complete response letter on its BLA for AVT02, a high-concentration biosimilar candidate referencing AbbVie’s Humira (adalimumab). The letter cites manufacturing deficiencies that were documented during a 3/17 reinspection of the company’s Reykjavik, Iceland facility. An earlier complete response letter was issued
Drugs
Solgenix says FDA is requiring an additional study to resolve a refuse-to-file letter it received in February for its HyBryte (synthetic hypericin) NDA for treating early stage cutaneous T-cell lymphoma. At a just-completed Type A meeting the agency revealed that it is requiring positive results from
Drugs
FDA has released a 13-page Form FDA-483 addressed to Lupin LTD. that cites significant GMP deficiencies from a 03/21-29 inspection of the firm’s Pithampur, India manufacturing facility. According to the inspection document, the company’s investigations of a batch failure did not extend to other
Drugs
The Justice Department says it will seek “emergency relief” from the U.S. Supreme Court after the Fifth Circuit Court of Appeals ruled late 4/12 that while the abortion drug mifepristone can remain on the market it cannot be mailed and thus limits access for women. “The Justice Department
Drugs
A 4/14 joint meeting of the FDA Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee will consider a sNDA from Otsuka Pharmaceutical and Lundbeck for their Rexulti (brexpriprazole) to treat agitation in patients with Alzheimer’s dementia. An FDA briefing paper distributed in
Drugs
The Texas House has approved legislation to create a program that would allow certain drugs to be imported from Canada. The bill must still be debated and voted on by the state Senate. CBS News reports the legislation would require the state to work with Canadian suppliers to select drugs
Drugs
Responding to a government amicus brief supporting the generic drug industry and asking the Supreme Court to hear an appeal of the so-called “skinny label” case brought by GlaxoSmithKline against Teva over labeling for a generic form of GSK’s heart drug Coreg (carvedilol), GSK says the government doesn’
Drugs
FDA has published a draft guidance, Over-the-Counter Monograph Order Requests (OMORs): Format and Content, to assist requestors in preparing OMORs for submission to the agency. The document provides FDA’s recommendations on the format and content of the information that requestors should provide in an OMOR and identifies
Drugs
FDA has published a draft guidance, Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs, with recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical drug delivery system (TDS). The document says its recommendations relate to studies submitted in support of
Drugs
The National Cancer Institute (NCI) says it has helped to launch a Phase 3 trial of a two-drug combination to treat patients with advanced non-small cell lung cancer (NCSLC). An NCI announcement says the Pragmatica-Lung Study is part of a broader effort by FDA and the National
Drugs
A 10/18-11/17/22 FDA inspection at the Omega Packaging Corp. drug manufacturing facility in Totowa, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/20 Warning Letter says specific violations were: * failing to test samples of each component for identity
Drugs
Vanda Pharmaceuticals says FDA should revoke its approval of a Teva ANDA for a generic form of Vanda’s Hetlioz (tasimelteon 20 mg capsules), indicated to treat non-24-hour sleep/wake disorder, and order the product recalled because it fails to satisfy the bioequivalence requirement. A Vanda 4/10
Drugs
FDA has published a draft guidance, Assessing the Irritation and Sensitization Potential of Generic Transdermal and Topical Delivery Systems for ANDAs, with recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a proposed drug transdermal or topical delivery
Drugs
An antiabortion group leading the legal fight against the abortion drug mifepristone (Mifeprex) told the Fifth Circuit Court of Appeals 4/11 that the court does not have jurisdiction to review the lower court’s order because that was an administrative stay and not a preliminary injunction, but the Department
Drugs
FDA has cleared an Avation Medical 510(k) for Vivally, which the company describes as a non-invasive, bladder control therapy device and mobile application for treating patients with urinary urgency and urge urinary incontinence caused by overactive bladder syndrome. The “closed loop” neuromodulation system “objectively confirms activation of the
Drugs
FDA has released a draft guidance entitled “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers” that contains recommendations on monitoring studies involving drugs, biologics and medical devices. It provides input on planning a monitoring approach, developing the monitoring plans content, and communicating monitoring results. The document
Drugs
FDA has placed a partial clinical hold on a Molecular Templates (MTEM) Phase 1 study of MT-0169 based on previously disclosed cardiac adverse events noted in two patients dosed at 50 mcg/kg that prompted a dose reduction from 50 mcg/kg to 5 mcg/kg last year, according
Drugs
Five stakeholders are making suggestions they say will improve the Biosimilar Regulatory Research Pilot Program Roadmap issued as part of the third biosimilars user fee (BsUFA 3) reauthorization. Sandoz says it is a “strong supporter” of the regulatory research on biosimilars outlined in BsUFA 3. It expresses an “overarching concern”
Drugs
An FDA review of records submitted by Champaklal Maganlal Homeo Pharmacy Private Limited, a manufacturer of over-the-counter and homeopathic drug products in Ahmedabad, Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/10 Warning Letter says the specific violation was
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says that while it supports the general development of the International Council for Harmonization M13A draft guidance on bioequivalence for immediate-release solid oral dosage forms, it sees several opportunities to improve the draft. The PhRMA comment letter suggests ways to clarify the
Drugs
The FDA Guidance Snapshot Pilot Program, a joint effort of the CDER Office of Translational Sciences (OTS) and the CDER Office of Communications (OCOMM), will soon expand with the issuance of its first two snapshots and podcasts for patients. The program is explained in an online post featuring interviews with
Drugs
[Analysis by Jim Dickinson] He “does not second-guess FDA’s decision-making lightly,” writes mifepristone (Mifeprex) trial pro-life judge Matthew J. Kacsmaryk, a Trump appointee, in his 67-page condemnation of the abortion drug – but he relishes doing so. The historic order, the heaviest-ever to hit the