Drugs
FDA’s alleged foot dragging in recommending updated Covid-19 vaccines last month and in approving the release of new Monkeypox vaccines illustrates the need to reform the agency, according to a 7/18 Forbes article by Pacific Research Institute president Sally Pipes in which she takes issue with what
Drugs
FDA has approved a Pfizer supplemental NDA for Xalkori (crizotinib) for adult and pediatric patients with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT). Approval was based on data from two single-arm, open-label trials that included 14 pediatric patients from trial ADVL0912 (NCT00939770)
Drugs
The Vermont federal court has permanently enjoined a Colchester, VT, compounding pharmacy from distributing drugs unless they are manufactured in compliance with FDA regulations. A federal government complaint alleges that Edge Pharm Inc., and its owners, Marc Chatoff and Kurt Radke, violated agency regulations by manufacturing and distributing adulterated and
Drugs
FDA has approved a Provepharm NDA for Bludigo (indigotindisulfonate sodium), a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults who’ve undergone urological and gynecological open, robotic or endoscopic surgical procedures. The company says iatrogenic damage of
Drugs
Pfizer’s Hospira unit is recalling one lot of propofol injectable emulsion (containing benzyl alcohol) due to a visible particulate observed in a single vial during annual examination of retained samples. An FDA notice says patients receiving the affected product are at risk of experiencing life-threatening adverse clinical effects
Drugs
FDA has published a guidance, Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format, with recommendations for developing the content and format of a patient instructions for use (IFU) document for human prescription drugs and biological products, as well as drug-led or biologic-
Drugs
Summit Therapeutics says it will consider at least one additional clinical trial (XXX SINGULAR XXX) of its ridinilazole, an investigational treatment for C. Diff infection, as discussed at a recent Type C meeting with FDA officials. The company says the meeting focused on data from the Ri-CoDiFy Phase 3
Drugs
Teva is asking the Supreme Court to hear its appeal of a U.S. Court of Appeals for the Federal Circuit decision in a case involving a so-called “skinny label” for a generic form of the heart drug Coreg (carvedilol). The Teva filing says the question it wants the
Drugs
Citing its inability to conduct inspections in China due to Covid-19 travel restrictions, FDA has deferred action on a BeiGene BLA for tislelizumab as a second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma. The company says it was informed that FDA is delaying action
Drugs
Washington Legal Foundation (WLF) says the California First District Court of Appeal should review and then overturn a trial court ruling that advances a “radical new theory for manufacturers of non-defective prescription drugs.” A WLF news release says plaintiffs in the case alleged injury from Gilead Science’s HIV/
Drugs
In a joint blog post, FDA commissioner Robert Califf and U.S. Patent and Trademark Office (USPTO) director Kathi Vidal discuss initiatives their two agencies are undertaking to execute the Biden administration’s agenda to lower drug prices and promote competition. “These initiatives will strengthen our relationship and expand the
Drugs
Citrus Pharmaceuticals says that as a result of a pre-BLA meeting with FDA, it plans to submit a BLA later this year for I/ONTAK (denileukin diftitox) to treat patients with persistent or recurrent cutaneous T-cell lymphoma. The company says I/ONTAK is a purified and more bioactive
Drugs
FDA has lifted the clinical hold placed on the Greenwich LifeSciences Flamingo-01 Phase 3 clinical trial of the company’s GLSI-100 as a treatment for some invasive breast cancers. Greenwich says FDA placed the hold due to concerns over manufacturing and the pharmacy process. The statement says discussions
Drugs
Catalyst Pharmaceuticals says it has settled ongoing patent infringement litigation with Jacobus Pharmaceutical Co. and PantherRx Rare. Catalyst had asserted that Jacobus and PantherRx induced infringement by third parties of Firdapse (amifampridine)-related patent rights in their marketing and distribution of Ruzurgi (amiframpridine). Catalyst says that as part of the
Drugs
FDA says its review of a Web site operated by Elite Supplement Center and Elite Training Facility, Wayne, NJ, determined that the company is taking orders for five products marketed as selective androgen receptor modulators (SARMs). A 7/6 Warning Letter says the SARMs products are unapproved new drugs that
Drugs
Mylan has recalled one batch of insulin glargine (insulin glargine-yfgn) injection in 3mL prefilled pens that are packaged in cartons of five pens. A company statement posted by FDA says the recalled product is not the branded Semglee pen but the unbranded insulin glargine-yfgn pens. The batch being
Drugs
FDA has published two draft guidances covering portions of the Drug Supply Chain Security Act (DSCSA). The first guidance, DSCSA Standard for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs, identifies the standards necessary to facilitate the adoption of secure, interoperable, electronic data exchange among
Drugs
FDA has sent Warning Letters to five distributors of kratom products, saying that claims made for the products on Web sites and social media establish them as unapproved new drugs that are being illegally delivered into interstate commerce. The 6/30 letters went to Kratom Exchange, Herbsens Botanicals, Klarity Kratom,
Drugs
FDA has told Vertex Pharmaceuticals it can proceed with studies for its diabetes stem cell therapy that was placed on a clinical hold in May. The company says the agency had expressed concerns about a lack of information ahead of the dose-escalation portion of the study. Known as VX-
Drugs
FDA has declined to issue an emergency use authorization (EUA) for NRx Pharmaceuticals’ Zyesami (aviptadil) for a sub-group of patients that received remdesivir in addition to Zyesami and continued to progress. The company said the denial was not unexpected given that the agency had recently denied a breakthrough therapy
Drugs
The FDA Peripheral and Central Nervous System Drugs Advisory Committee will meet on 9/7 to again discuss an Amylyx application for its AMX0035 (sodium phenylbutyrate and taurursodiol) ALS drug that was rejected 6-4 by the committee earlier this year. At that time the committee said Amylyx did not
Drugs
Wellcome Genome researchers in the UK say that for 33 of the 50 (66%) FDA-approved new drugs in 2021, the genes coding for their primary assigned targets, or for proteins that are known to physically interact with the targets, have been previously associated in some way with the indication