Drugs
FDA reviewers say data contained in a Valeant Pharmaceuticals BLA for Siliq (brodalumab) injection for treating adults with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy showed that the therapy was superior to placebo in reducing psoriasis severity after 12 weeks of treatment. The
Drugs
FDA has posted the commitment letter (performance goals and procedures) from industry negotiations to reauthorize the Prescription Drug User Fee Act for fiscal years 2018 through 2022. The letter outlines the agency intention to enhance regulatory science and expedite drug development. “To ensure that new and innovative products are developed
Drugs
The House Energy & Commerce Committee has voted out a bill that would establish a new priority review program that would award a voucher to sponsors that develop a “material threat medical countermeasure” product. The voucher would entitle the holder to a priority review for a future NDA submission. The
Drugs
The Government Accountability Office (GAO) says that to help address drug shortages, FDA prioritized review of 383 drug applications and supplements between calendar years 2010 and 2015. Most were for generic sterile injectable drugs. “FDA’s approval of some of these submissions occurred before the shortage was resolved,” a new
Drugs
The latest Tufts Center for the Study of Drug Development Impact Report reviews the burgeoning regenerative medicine (RM) market worldwide and the differing regulatory approaches taken in the U.S., Europe, and Japan. The report (subscription required) says that FDA does not plan to establish a separate regulatory pathway for
Drugs
FDA has issued a draft guidance, Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product, as a “how-to” supplement to an earlier final guidance that defined in vitro companion diagnostic (IVD) devices and set an expectation that companion diagnostics and corresponding therapeutic products should
Drugs
FDA has told Santhera Pharmaceuticals that its planned clinical trial for Raxone (idebenone) in Duchenne muscular dystrophy (DMD) patients will not support an accelerated approval pathway, but it will support, if the results are positive, a traditional NDA approval route. The company had proposed an accelerated approval pathway using its
Drugs
CDER director Janet Woodcock, celebrating 30 years with FDA, says that in the next 30 years the pace of change will accelerate and there will be a splintering of diseases into molecular subtypes. Interviewed for an agency Director’s Corner podcast, Woodcock predicts that placing diseases in molecular subtypes will
Drugs
The DC federal court has granted FDA summary judgment in a case brought by Boehringer Ingelheim involving a dispute over the agency’s interpretation of the legal reference to the date that a drug application is initially submitted for an approved drug product. The company brought suit to resolve the
Drugs
Virtus Pharmaceuticals is asking that FDA start proceedings to remove two NDAs for potassium chloride oral solution from Lehigh Valley Technologies because the company inappropriately avoided paying $2.2 million in user fees. The petition also asks that the matter be investigated in accordance with the agency’s application integrity
Drugs
As FDA prepares to make approval decisions on a slew of ANDAs for generic copies of AstraZeneca’s blockbuster cholesterol-lowering Crestor (rosuvastatin calcium), the DC federal court has ordered that it be provided 24 hours notice before any decision is rendered on any ANDA or a related citizen petition
Drugs
FDA has placed two Chinese and two Indian companies on import alert that bans their products from being shipped into the U.S. because they failed to submit self-identifying information or pay facility fees required under the Generic Drug User Fee Act. This is the first time the agency
Drugs
FDA has posted a draft guidance on “Bacterial Vaginosis: Developing Drugs for Treatment” that should assist sponsors in their overall clinical development program and clinical trial designs to support drugs for such indications. It focuses only on developing antibacterial drugs for treating symptomatic bacterial vaginosis (BV). “There are epidemiological associations
Drugs
FDA says that its analyses so far on the use of Alere’s faulty blood testing devices (INRatio and INRatio 2 PT/INR) appear to have had “minimal” impact on a clinical trial involving Johnson & Johnson’s blood thinner Xarelto. “Our analyses so far indicate that effects on strokes
Drugs
FDA researchers say that a survey they conducted shows an increasing trend in the evaluation of transporter-mediated drug-drug interactions (DDIs) either during drug development or post-approval. Writing in The Journal of Clinical Pharmacology, the researchers say that their observation may be a reflection of recent interest in
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Imarc Research says in an online post that the release of FDA and European Medicines Agency guidances on incorporating risk management strategies in the clinical research industry, sets an expectation for implementation of quality principles and risk-based decision-making. “It is the responsibility of the industry to incorporate these
Drugs
FDA has denied three separate petitions asking it to take specific actions relating to labeling for biosimilar products and has said it will consider the petitions’ requests as part of comments received on a draft guidance on the topic. The agency says that given the subject matter overlap between the
Drugs
The full Appeals Court for the Federal Circuit has rejected application of the on-sale bar to contract manufacturers, paving the way for specialty companies to use outside vendors to manufacture their inventions. (An on-sale bar provides that an invention cannot be patented if it was for sale more
Drugs
FDA’s Arthritis Drugs Advisory Committee has voted 20 to 0 to support approval for a Sandoz BLA (GP2015) for a biosimilar copy of Amgen’s Enbrel (etanercept). The panel recommended approval for the therapy to treat all five of Enbrel’s indications — rheumatoid arthritis, plaque psoriasis, psoriatic psoriasis, ankylosing
Drugs
In a positive sign for Juno Therapeutics and other developers of promising CAR-T cell product candidates, FDA has removed a clinical hold on Juno’s Phase 2 clinical trial of JCAR015 (ROCKET trial) in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia. The agency placed the
Drugs
FDA has approved a Shire NDA for Xiidra (lifitegrast ophthalmic solution) for treating dry eye disease signs and symptoms. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) antagonist, according to an agency release. Approval was based on data from
Drugs
Senate HELP Committee chairman Lamar Alexander (R-TN) says that Senate should finish its work on the 21st Century Cures legislation in September. “Rarely do we have such an opportunity,” Alexander says in a statement. “It includes support for the president’s precision medicine initiative and the vice president’s