Drugs
FDA has granted priority review to Eli Lilly for a BLA for olaratumab to be used in combination with doxorubicin, for the potential treatment of advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery. Olaratumab is a human IgG1 monoclonal antibody, according to the company,
Drugs
FDA has granted fast track status to Axsome Therapeutics for AXS-02 for treating knee osteoarthritis pain associated with bone marrow lesions. There is currently no product approved specifically for this indication, according to the company. AXS-02 is a potent osteoclast inhibitor being developed as an oral, targeted, non-
Drugs
Angiochem says FDA has scheduled a 6/16 end-of-Phase 2 meeting to discuss clinical study results for the company’s ANG1005 for treating Leptomeningeal Carcinomatosis in patients with breast cancer and brain metastases. The company says the parties will determine the adequacy of current studies, and the safety
Drugs
Attorneys Frederick Ball and Carolyn Alenci (Duane Morris) say that a recent FDA draft guidance on data integrity and subsequent Warning Letter to Sri Krishna Pharmaceuticals indicate that “FDA is anticipating long-term measures to be part of a corrective action plan that includes enhancing procedures, systems, and ‘human resources.
Drugs
The HHS Office of Inspector General (OIG) finalized 4/18 a guidance explaining how it will base its decision to exclude drug or medical device companies or their personnel from federal healthcare programs due to False Claims Act suits or investigations. The guidance says a decision to exclude is based
Drugs
A study by the Centers for Disease Control and Pew Charitable Trusts that involved researchers across the country says that only about 70% of antibiotic prescriptions in the U.S. in 2010-2011 were appropriate, supporting the need for establishing a goal for outpatient antibiotic stewardship. The story was published
Drugs
Reps. Gerry Connolly (D-VA) and Morgan Griffith (R-VA) have introduced the Curb Opioid Misuse by Advancing Technology (COMBAT) act that they say would encourage drug manufacturers to engage in studies demonstrating abuse-deterrent effectiveness and to increase diversity in abuse-deterrent technologies by providing for extended periods of
Drugs
Responding to a Depomed 1/29 citizen petition, FDA says that it must deny the petition at this time because it cannot interpret contradictory information on a patent use code for the company’s Nucynta ER (tapentadol). The petition asked the agency to stay final approval of any ANDA referencing
Drugs
FDA is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with using the antipsychotic drug aripiprazole (Otsuka’s Abilify and Abilify Maintena, Alkermes’ Aristada, and generics). An agency drug safety communication says that the uncontrollable urges were reported to have stopped
Drugs
A 2/10-12/15 FDA inspection at Apotheca Supply, a Decatur, AL, pharmaceutical manufacturing (repackaging and relabeling) facility found significant deviations from current good manufacturing practice for the manufacture of active pharmaceutical ingredients, according to a just-released Warning Letter from the agency’s New Orleans District Office. Specific
Drugs
FDA has posted a draft guidance on “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral (DAA) Drugs for Treatment” that offers recommendations on the overall development program and clinical trial designs to support such drugs. The document is intended to serve as a focus for continued discussions among the
Drugs
FDA has released a draft guidance on “Special Protocol Assessment (SPA)” that provides procedures and general policies adopted by CDER/CBER for such an assessment. The process allows a sponsor to request a meeting with the agency to reach agreement on the design and size of certain clinical trials, clinical
Drugs
FDA has approved an Eisai NDA for Fycompa (perampanel) oral suspension as adjunctive therapy for treating partial-onset seizures with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. The oral suspension formulation is a bioequivalent, interchangeable alternative
Drugs
FDA has recently begun issuing many more “Easily Correctable Deficiency (ECD)” and “Information Request (IR)” letters to generic drug makers over ANDAs that have been submitted to CDER, according to a new generic drug dashboard report. The agency says this is a positive move because the increase in these categories
Drugs
FDA has approved a brand name change for H. Lundbeck’s antidepressant Brintellix (vortioxetine) to help decrease prescribing and dispensing errors resulting from name confusion with AstraZeneca’s anti-blood clotting medication Brilinta (ticagrelor). The new brand name of the drug will be Trintellix, and it is expected to be
Drugs
Novo Nordisk says it will file in the fourth quarter an NDA for its diabetes drug semaglutide based on positive data from its sixth and last global Phase 3a trial, SUSTAIN6. The new glucagon-like peptide-1 (GLP-1) analog, which is intended to be administered subcutaneously once weekly, achieved
Drugs
FDA has approved an Acadia Pharmaceuticals NDA for Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease. “Hallucinations or delusions can occur in as many as 50% of patients with Parkinson’s disease at some time
Drugs
FDA has approved a Watson Pharmaceuticals ANDA for a generic copy of AstraZeneca’s cholesterol-lowering Crestor (rosuvastatin calcium) tablets. This is the first generic version of the blockbuster drug, and it is approved for the following uses: in combination with diet for treating high triglycerides in adults;in combination
Drugs
In a move to curb lower federal courts from hearing Racketeer Influenced and Corrupt Organizations Act (RICO) cases against pharmaceutical manufacturers for alleged inaccuracies in their marketing concerning the safety and efficacy of their prescription drugs, the Washington Legal Foundation (WLF) has filed a brief with the U.S. Supreme
Drugs
FDA has approved a Tract Therapeutics proposed Phase 2 trial to investigate the efficacy and safety of its novel therapy for kidney transplant recipients, which uses a patient’s own cells that are expanded in a laboratory and infused back into the patient after an organ transplant in order to
Drugs
FDA has approved a Teva Pharmaceutical Industries supplemental NDA for ProAir RespiClick (albuterol sulfate) Inhalation Powder for treating or preventing bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for preventing exercise-induced bronchospasm. The product was originally approved in 2015 for patients 12
Drugs
A Florida federal judge has entered a consent decree against Paul W. Franck of Ocala, FL that prohibits his drug compounding operations from making sterile drug products until they comply with GMPs. According to the decree, Franck manufactured and distributed drug products that were adulterated and misbranded. “Mr. Franck risked