Drugs
FDA has selected Booz Allen Hamilton for one of two spots on a competitive $300 million seven-year blanket purchase agreement to support implementation of a CDER transformational informatics platform to enable the Center to bring drugs to market with greater speed and efficiency. The company says its team of
Drugs
FDA has accepted for review a Pain Therapeutics NDA resubmission for Remoxy ER (oxycodone capsules), indicated for treating severe pain. The agency has set a user fee review action target date of 8/7. The drug has a long history at FDA, having been rejected on three previous submissions. The
Drugs
FDA has extended the PDUFA review target date for Allergan’s ulipristal acetate to 8/2018 to allow time for a full file review. The company says ulipristal is an investigational drug for treating abnormal uterine bleeding in women with uterine fibroids. It is described as a progesterone receptor modulator
Drugs
FDA has confirmed the capability of four additional European Union (EU) countries to conduct good manufacturing practice (GMP) drug inspections under the mutual recognition agreement between FDA and the EU. The addition of Czech Republic, Greece, Hungary, and Romania brings to 12 the list of EU member states whose results
Drugs
Mylan and Revance Therapeutics have entered into a collaboration to develop a proposed biosimilar to Botox (onabotulinumtoxinA). The collaboration includes a $25 million upfront payment to Revance, with contingent milestone payments upon achievement of additional clinical, regulatory and sales targets. Botox is indicated for treating bladder conditions, migraine headaches, muscle
Drugs
A new FDA safety alert warns health care professionals and patients not to use compounded drug products made by Cantrell Drug Co. (Little Rock, AR) due to quality issues. An agency notice says the alert covers opioid products and other drugs intended for sterile injection. “The agency is concerned about
Drugs
FDA has issued a draft guidance, Standardization of Data and Documentation Practices for Product Tracing, elaborating standards for the interoperable exchange of transaction information, transaction history, and transaction statements required by the Drug Supply Chain Security Act to facilitate tracing products through the pharmaceutical distribution supply chain by requiring trading
Drugs
FDA has accepted a Shire BLA for calaspargase pegol (Cal-PEG; SHP663), indicated as a component of a multi-agent chemotherapeutic regimen for treating patients with acute lymphoblastic leukemia. The agency has set a user fee review action target date of 12/22. The mechanism of action is thought to
Drugs
FDA has approved a Scilex Pharmaceuticals NDA for ZTlido (lidocaine topical system) 1.8%, indicated for relieving pain associated with post-herpetic neuralgia (post-shingles pain). The anhydrous topical system is based on a novel technology that is designed to achieve superior adhesion and drug delivery efficiency, according to the
Drugs
FDA has posted an International Council for Harmonization guidance on “E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1)” that provides a unified standard for regulatory agencies to allow the mutual acceptance of clinical data. The document amends earlier guidance to encourage implementation of improved and more efficient
Drugs
FDA has issued Celgene a refusal-to-file letter on an NDA for ozanimod for treating patients with relapsing forms of multiple sclerosis. In the letter, the agency said its preliminary review determined that the nonclinical and clinical pharmacology sections in the submission were insufficient to permit a complete review,
Drugs
Attorney Kurt Karst (Hyman, Phelps & McNamara) says FDA granted 476 orphan drug designation requests in 2017 and approved 77 orphan drugs. He says requests for designation and approvals both “skyrocketed” last year, “obliterating” the previous records of 49 approvals in 2014 and 355 requests in 2015. “The increase in
Drugs
The former president of Cumberland Distribution, Inc., a Houston, Texas-based drug company, was convicted by a Tennessee federal court jury of conspiracy, 15 counts of mail fraud, and one count of making false statements to FDA in connection with a 32-month, $50 million drug diversion scheme. An FDA
Drugs
The FDA Office of Pharmaceutical Quality (OPQ) 2017 annual report outlines challenges faced by the organization last year and the key quality initiatives it undertook. OPQ director Michael Kopcha says the challenges included new commitments in conjunction with reauthorization of human drug user fee programs and the devastation caused by
Drugs
The Justice Department (DoJ) says it will file a “Statement of Interest” in a multi-district action regarding hundreds of lawsuits against opioid manufacturers and distributors. Plaintiffs in the suits include numerous cities, municipalities, and medical institutions that have borne the costs of the prescription opioid crisis. They contend the
Drugs
A 9/11-9/15/17 FDA inspection at Alchymars ICM SM Private Limited, Chennai, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to a 2/16 Warning Letter. Specific deviations cited in the letter were: * failing to have laboratory control records
Drugs
A 4/10-4/14/17 FDA inspection at Shanghai Weierya Daily Chemicals Factory, Shanghai, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/7 Warning Letter. Specific violations cited in the letter were: * failing to have for each batch of
Drugs
Akorn says it and Fresenius are using outside consultants to investigate alleged breaches of FDA data integrity requirements relating to product development at Akorn. “To date the company’s investigation has not found any facts that would result in a material impact on Akorn’s operations and the company does
Drugs
FDA has accepted for review a Tetraphase Pharmaceuticals NDA for eravacycline for treating complicated intra-abdominal infections. The user fee review action target date was set for 8/28. The submission includes data from the IGNITE1 and IGNITE 4 Phase 3 clinical trials and showed that twice-daily eravacycline was
Drugs
Synergy Pharmaceuticals is petitioning FDA to require changes to the approved package insert for Forest Laboratories’ Linzess (linaclotide) to ensure that it contains adequate information for its use because it “misrepresents or obfuscates the incidence of adverse events in its clinical trials in several respects.” The petition says a Forest
Drugs
FDA commissioner Scott Gottlieb says the agency is taking new steps to support and expedite development of rare disease products. Writing in an FDA Voice blog post to mark 2/28 as the 11th Rare Disease Day, Gottlieb identifies the actions as: * a new pilot for more efficient orphan designation
Drugs
FDA has approved Eli Lilly’s Verzenio (abemaciclib) in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for treating postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. This is the third indication for Verzenio within five months;