Drugs
Is the pharmaceutical industry secretly plotting the demise of president Trump and supporting the current impeachment inquiry in the House of Representatives? That is what Trump suggested to supporters (see White House transcript) at an event in the Villages development in central Florida 10/3. Without citing any evidence, Trump
Drugs
FDA has approved AstraZeneca’s self-administration version of Fasenra (benralizumab) Pen in a pre-filled, single-use auto-injector as an add-on maintenance treatment for severe eosinophilic asthma. The approval is based on data from the Phase 3 GRECO trial and the Phase I AMES trial. “The safety
Drugs
FDA has granted Janssen Pharmaceutical a breakthrough therapy designation for niraparib, an orally-administered poly ADP-ribose polymerase inhibitor, for treating patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer who have received prior taxane chemotherapy and androgen receptor-targeted therapy. The designation is based on data from
Drugs
Public Citizen says the Trump administration “has been unable to enact a single meaningful reform to bring down drug prices. That happens when you hire pharma execs to regulate pharma execs. Now the president is turning to the Council of Economic Advisers (CEA) to invent the drug pricing victory he
Drugs
The Koch-supported Taxpayers Protection Alliance has issued a report, Reforming the FDA: Saving Money, Saving Lives, calling on the agency to “pursue a series of reforms that, if enacted, would save consumers millions of dollars and millions of lives. Across all divisions of the agency, a more permissive approach
Drugs
FDA says a “Bioanalytical Methods Template” technical specifications guidance is available for industry to use. An agency notice says the guidance provides ready-to-use templates that sponsors can use to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation. Templates in the guidance
Drugs
FDA has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for use in at-risk adults and adolescents weighing at least 35kg for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex.
Drugs
Nippon Shinyaku says it has completed submission of a rolling NDA for its viltolarsen that is under development to treat Duchenne muscular dystrophy amenable to exon 53 skipping. The company says the drug is expected to generate functional dystrophin proteins and be effective for Duchenne muscular dystrophy amenable to dystrophin
Drugs
FDA has denied three requests included in a 5/6 citizen petition submitted on behalf of Zydus Pharmaceuticals relating to its Mephyton (phytonadione) vitamin K1 tablets. The company had asked that the agency: * require that manufacturers of generic phytonadione tablets establish sameness with the reference-listed-drug (RLD) Mephyton by
Drugs
FDA has granted Verastem an orphan drug designation for Copiktra (duvelisib) for use in treating T-Cell lymphoma. The therapy is currently approved in the U.S. for treating chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies have failed, and accelerated approval in follicular lymphoma after
Drugs
FDA says it has opened a new Web page — FY 2018 GDUFA Science and Research Outcomes — to provide greater transparency into “the important work the agency engages in to advance the science of generic drugs and provide generic drug developers, applicants, and FDA reviewers essential tools and information to help
Drugs
FDA says it is continuing to test ranitidine products (see earlier story) from multiple manufacturers and is assessing the potential impact on patients who have been taking the product that has been found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA). In addition, the agency has asked ranitidine manufacturers
Drugs
FDA has published a guidance, Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment, to help sponsors develop and conduct nonclinical studies during development of investigational enzyme replacement therapy (ERT) products. Specifically, the document describes the agency’s current thinking about the substance and scope of nonclinical information needed to support start
Drugs
GlaxoSmithKline and Innoviva have submitted a supplemental NDA seeking an additional indication for once-daily use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for treating asthma in adults. Trelegy Ellipta was originally approved 9/2017 for treating patients with chronic obstructive pulmonary disease (COPD). The submission is based on data
Drugs
Johnson & Johnson has agreed to pay $20.4 million to resolve claims by two Ohio counties relating to the company’s role in promoting opioid use. Reuters reports that J&J will pay $10 million to Cuyahoga and Summit counties, reimburse $5 million of their legal and other
Drugs
The National Institutes of Health (NIH) has awarded $29 million to fund five additional hubs to speed the translation of biomedical discoveries into commercially viable diagnostics, devices, therapeutics, and tools to improve patient care and enhance health. The newly selected Research Evaluation and Commercialization Hubs expand a national network of
Drugs
FDA has accepted for priority review a Merck NDA for Dificid (fidaxomicin) for oral suspension, and a supplemental NDA for a new indication for Dificid tablets and oral suspension for treating Clostridium (also known as Clostridioides) difficile infections in children aged six months or older. The macrolide antibacterial is currently
Drugs
FDA has approved a Puma Biotechnology labeling supplement for Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer. The label now includes safety information that is based on interim results from Puma’s Phase 2 CONTROL trial, a study evaluating dose escalation in reducing neratinib-
Drugs
A 3/25-3/29 FDA inspection at Dermameal Co., Gunpo-si Gyeonggi-do, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/12 Warning Letter says specific violations were: * failing to establish an adequate quality control unit with the responsibility and
Drugs
FDA has awarded a contract that may reach $220 million over the next five years to Harvard Pilgrim Health Care Institute to lead the Sentinel Operations Center and develop a new Sentinel Innovation Center. Harvard Pilgrim says the contract builds on its 10 years of experience developing and operating the
Drugs
Endo says it is voluntarily withdrawing its 10/2017 suit against FDA challenging the agency’s interim policy authorizing bulk compounding of drugs that relied on enforcement discretion to allow bulk compounding of vasopressin, the active ingredient in Vasostrict, manufactured by Endo’s Par Sterile Products subsidiary. Endo says the
Drugs
An 11/26-12/4/18 FDA inspection at Lupin Limited Unit 1, Madhya Pradesh, India, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients. A 9/10 Warning Letter says the agency has found similar CGMP violations