Drugs
FDA has approved a subcutaneous formulation of Genentech’s Actemra (tocilizumab) for treating active polyarticular juvenile idiopathic arthritis in patients two years of age and older. FDA in 2013 approved an intravenous formulation of Actemra for patients two years of age and older for the same indication. Actemra can be
Drugs
President Trump’s just-released blueprint for lowering prescription drug prices orders FDA to require drug companies advertising their drugs to include pricing information in the advertisements. HHS secretary Alex Azar, who joined the president in a 5/11 Rose Garden announcement, had this to say: “Think about all the
Drugs
FDA has expanded the approval of Novartis’ Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. Gilenya was first approved by the FDA in 2010 to treat adults with relapsing MS. Approval was based on clinical trial data from 214 patients aged
Drugs
FDA has posted a draft guidance on “Pediatric HIV Infection: Drug Development for Treatment” that provides general recommendations on developing drug products for such infections. The document is intended to help sponsors understand when it is appropriate to initiate pediatric formulation development and to begin pediatric studies to evaluate antiretroviral
Drugs
FDA has issued a guidance, Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act, to answer questions from outsourcing facilities and other stakeholders about the meaning of the term “outsourcing facility.” The document says questions have been received about whether multiple suites used for compounding human
Drugs
FDA and Oncolytics Biotech have reached agreement on a special protocol assessment for the protocol design, clinical endpoints, and statistical analysis approach for the company’s Phase 3 study evaluating Reolysin (pelarorep) for treating metastatic breast cancer. FDA granted Reolysin fast-track designation 5/2017 for treating metastatic breast cancer.
Drugs
FDA has filed two federal court complaints seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval due to significant GMP deviations. The actions were filed against U.S. Stem Cell Clinic (Sunrise, FL) and California Stem Cell Treatment Center (locations in Rancho
Drugs
FDA has denied a Mylan 12/5/17 petition asking that the agency not approve any ANDA for a generic version of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) that relies on multiple-batch pharmacokinetic bioequivalence study design unless, after conducting an appropriately rigorous review, the agency concludes that
Drugs
FDA has granted Sellas Life Sciences Group an orphan drug designation for its novel drug candidate, galinpepimut-S (GPS), for treating multiple myeloma. GPS is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in several tumor types, according to the
Drugs
FDA is asking drug developers to submit product applications (INDs, NDAs, BLAs, and ANDAs) with SNOMED CT nomenclature to state what disease or diseases the drug is indicated for. SNOMED CT is a nomenclature for the hundreds of thousands of clinical terms that characterize patient care that has been used
Drugs
FDA has approved an Astellas Pharma supplemental NDA that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for treating overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. In the U.S., Myrbetriq (mirabegron) and VESIcare (solifenacin succinate) are individually
Drugs
Orphan drugs take on average 2.3 years longer to go from patent to launch than other drugs, according to an analysis by the Tufts Center for the Study of Drug Development reported in the May/June issue of its Impact Report (subscription or purchase required). The center studied all
Drugs
FDA has published a question-and-answer document, S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling Questions and Answers, with points to consider before incorporating the microsampling method in toxicokinetic studies. The document relates to the S3A guidance implemented by
Drugs
FDA has issued a draft guidance to assist sponsors in the clinical development of drugs to treat uncomplicated urinary tract infections (uUTI). The document specifically addresses the agency’s current thinking on the overall development program and clinical trial designs for drugs to serve as a focus for continued discussions
Drugs
Congress and state legislatures may be where new efforts are made to ease FDA restrictions on off-label promotion of drugs, according to an open-source PLOS Medicine report by Harvard Medical School’s Michael Sinha and Arnold Kesselheim. They cite the 2012 case U.S. v. Caronia in which
Drugs
CDER director Janet Woodcock says that when a drug candidate qualifies for breakthrough therapy designation, sponsors can get greater input from FDA staff so that development can move along as efficiently as possible. Speaking on a CDER Director’s Corner podcast, Woodcock emphasized that the designation does not signal a
Drugs
FDA commissioner Scott Gottlieb says the agency is seeking input from the patient community on how best to strike a balance between restricting loperamide availability to deter its abuse to produce an opioid high and the legitimate need for the drug for patients suffering from chronic diarrhea associated with inflammatory
Drugs
Pacira Pharmaceuticals is petitioning FDA not to approve any ANDA for a fixed-dose combination of bupivacaine and meloxicam unless the application “includes sufficient evidence from adequate and well-controlled studies, including those that use a factorial design, demonstrating the safety and effectiveness of the combination product. In particular, FDA
Drugs
FDA has issued a draft guidance, Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act, with agency recommendations for how trading partners and stakeholders should request a waiver, exception, or exemption from requirements that drug distribution supply chain trading partners must
Drugs
Attorney Victor Schwartz (Shook, Hardy & Bacon) says the Supreme Judicial Court of Massachusetts has clouded the question of innovator drug company liability in cases alleging injury caused by a generic drug company’s version of their product. Writing in a Washington Legal Foundation Legal Opinion Letter, Schwartz says the
Drugs
FDA has provided a target date of 8/19 for its response to a Rockwell Medical submission seeking approval of a new contract manufacturer for its approved generic drug Calcitriol vitamin D injection indicated for treating secondary hyperparathyroidism in dialysis patients. The agency indicated that the submission is getting an
Drugs
FDA has approved a Relypsa supplemental NDA for Veltassa (patiromer) for oral suspension in treating hyperkalemia. The label update is based on results from the Phase 4 TOURMALINE study, which showed no statistically significant difference between the groups taking Veltassa with or without food in achieving serum potassium levels within