Drugs
FDA has issued Warning Letters to two companies it says are illegally marketing products labeled as dietary supplements that contain tianeptine, a chemical compound that companies illegally claim treats opioid use disorder, pain and anxiety, and other claims the agency says are unproven and unlawful. “These actions follow reports to
Drugs
FDA and Duke-Margolis Health Policy Center have planned an 11/27 public meeting to seek stakeholder input on long-term solutions to address the drug shortage problem and identifying potential ways to implement the solutions. The meeting, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions, is
Drugs
FDA has approved an expanded label for Novartis’ Promacta (eltrombopag) to include first-line treatment for adults and pediatric patients two years and older with severe aplastic anemia (SAA) in combination with standard immunosuppressive therapy (IST). The oral thrombopoietin receptor agonist is currently approved for SAA for patients who have
Drugs
FDA is alerting health care professionals and patients not to use drug products produced and distributed by Pharm D Solutions (Houston, TX) due to lack of sterility assurance. FDA says it sent the firm a Warning Letter 12/2016, and a recent follow-up inspection in August cited insanitary conditions,
Drugs
FDA has issued Aquestive Therapeutics a complete response letter (CRL) on its 505 (B)(2) NDA tadalafil oral film, a PDE5 inhibitor currently marketed (Eli Lilly’s Cialis) in tablet form for treating erectile dysfunction and benign prostatic hyperplasia, and for treating pulmonary arterial hypertension (Lilly’s Adcirca). The letter
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FDA is seeking input on how it can promote the development of digital technologies that would guide safe and effective prescription drug use to help patients improve their health. “As part of this process, we’re seeking input from the public on new steps to modernize our approach to overseeing
Drugs
AstraZeneca and MedImmune say results from their Phase 3 MYSTIC trial involving Imfinzi (durvalumab) did not meet primary endpoints of improving overall survival compared to standard-of-care (SoC) platinum-based chemotherapy in previously-untreated patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). The randomized, open-label,
Drugs
In less than two weeks after submitting a supplemental BLA, FDA approved a Seattle Genetics submission for Adcetris (brentuximab vedotin) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (see earlier story). The agency says it reviewed the sBLA under its Real-Time
Drugs
Pharmaceutical Manufacturing Research Services (PMRS) has petitioned FDA asking it to not approve any opioid product seeking an indication or any other labeling that suggests it is appropriate for chronic use. Specifically, the petition cited SpecGx’s MNK-812 (oxycodone), with relies on Roxicodone as the reference listed drug (see
Drugs
FDA is seeking to eliminate the use of dogs in clinical research by animal drug developers. The agency says it will propose a study that, once completed, could help establish a non-animal based model that will “potentially replace much of the need to use dogs in future trials with
Drugs
The American Medical Association (AMA) 2018 interim meeting has adopted a report saying that letting Americans import prescription drugs in person from licensed Canadian brick-and-mortar pharmacies could improve cost-sharing levels and address a major barrier to medication adherence. An AMA statement says Canadians spend about half the
Drugs
FDA has granted Seattle Genetics a breakthrough therapy designation for Adcetris (brentuximab vedotin) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with CHP (cyclophosphamide, doxorubicin, and prednisone). The designation
Drugs
Agreeing with points made in a Pfizer 8/22 citizen petition, Novartis says FDA needs to do more to promote biosimilars and counter a communication campaign that it says is spreading false information about the products. The company’s comment letter acknowledges steps FDA and HHS have taken to increase
Drugs
FDA Office of Communications associate director for research and risk communications Paula Rausch says the agency is identifying and analyzing online and social medical conversations as part of a broad, systematic approach to monitoring drug use and abuse trends in society. In a CDER Conversation, Rausch says the data gathered
Drugs
A joint meeting of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee has voted 10 to 7 to recommend approval of Mallinckrodt subsidiary SpecGx’s investigative abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets for managing pain severe enough
Drugs
PharmaCyte Biotech says it has completed an FDA-required formal report on safety studies using a pig model that were undertaken before getting the agency to sign off on the first clinical trial in humans using its cellulose-based capsules that contain live genetically altered cells which activate the anticancer
Drugs
FDA has released the FDA-483 issued following a 10/22-10/30 inspection at Dr. Reddy’s Laboratories, Visakhapatnam, Andhra Pradesh, India. The inspection observations were: * failing to have written procedures for production and process controls to assure that drug products have the identity, strength, quality, and purity they
Drugs
Seven samples of dietary supplements intended to improve memory were tested by a qualified laboratory and did not contain their stated ingredients in the stated quantity, according to a report from the Government Accountability Office (GAO) to two Democratic senators. The report says the senators asked GAO to examine the
Drugs
FDA has approved Stallergenes Greer’s Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract) for treating patients aged five to nine years with grass pollen-induced allergic rhinitis. Previously, the sublingual tablet was approved for treating patients aged 10 to 65 years. In
Drugs
Eli Lilly has submitted an NDA for lasmiditan for the acute treatment of migraine with or without aura in adults. The company describes the centrally-penetrant, selective serotonin 5-HT1F agonist as “structurally and mechanistically distinct from other approved migraine therapies and lacks vasoconstrictive activity.” The NDA includes data from
Drugs
A California Court of Appeals has reversed a lower court ruling that cases claiming that manufacturers of incretin-based drugs failed to warn consumers that the drugs increase the risk of developing pancreatic cancer were preempted. The lower court had agreed with the manufacturers (Amylin Pharmaceuticals for its Byetta, Lilly
Drugs
Four Harvard Medical School researchers say the hope that rising drug prices could be addressed in part by biosimilars has not been realized for a number of reasons. In an online article for the American Society for Clinical Pharmacology and Therapeutics, the researchers say there are steps the federal government