Drugs
In a Washington Legal Foundation webinar, attorneys John Boese and Douglas Baruch (Fried Frank) outlined the contents of two Justice Department internal memos dealing with False Claims Act cases and their impact on whistleblowers and federal prosecutors. Boese said that a 1/10 memo by Michael Granston states the department’
Drugs
Commenting on an International Council on Harmonization draft guidance on statistical principles for clinical trials addendum on estimands and statistical analysis in clinical trials, Pharmaceutical Research and Manufacturers of America (PhRMA) says that additional clarity is needed in several areas to help reduce clinical trial complexity and increase clarity in
Drugs
Actelion Pharmaceuticals has filed a supplemental NDA to expand the indication for Opsumit (macitentan) to include treating adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) to improve exercise capacity and pulmonary vascular resistance (PVR). The submission is based on data from the MERIT-1 trial, which showed significant improvements in
Drugs
FDA is reminding drug sponsors that although the compliance date for submitting Type 3 master drug files in electronic common technical document (eTCD) format has been extended one year to 5/5/19, other eCTD deadlines remain unchanged and drug master files other than Type 3 and commercial INDs are
Drugs
The CDER Ombudsman 2017 annual report shows a 28% decrease in the number of stakeholder contacts from 289 in 2016 to 207 in 2017. “Based upon percentage decreases from 2016 to 2017,” the report says, “the two demographic categories with the most significant drops were the number of whistleblowers, which
Drugs
The American Association for Cancer Research says it has four recommendations in response to the FDA 3/15 public meeting on the structure and function of the Oncology Center of Excellence (OCE). The comment letter says (1) OCE should have clear, final signoff authority for all product reviews associated with
Drugs
UCB BioPharma says it appears that an International Conference for Harmonization draft guidance on statistical principles for clinical trials addendum on estimands and sensitivity analysis in clinical trials “still does not give real guidance on which estimands (specifically, handling strategies for intercurrent events) are to be used. The company’s
Drugs
CDER deputy director for regulatory programs Douglas Throckmorton says that Controlled Substances Staff (CSS) acting director Dominc Chiapperino has been promoted to be the director. In a note to staff, Throckmorton says CSS oversees and provides consultation throughout FDA regarding drugs of abuse, which includes assessing drugs for abuse potential
Drugs
FDA has issued a list of Medication Guides, showing six that are new and 30 that have been updated since 3/2017. New guides were issued for Kempharm’s Apadaz, Merck’s Ilumya, Bracco Diagnostics’ Multihance, Intercept Pharmaceuticals’ Ocaliva, Synergy Pharmaceuticals’ Trulance, and rtis’ Zortress. Guides were updated for AstraZeneca’
Drugs
CDER has issued a Manual of Policies and Procedures outlining the policies of the Office of Pharmaceutical Quality (OPQ) for granting or denying a request for an expedited review for NDA and BLA prior approval supplements that (1) involve chemistry, manufacturing, and controls changes and (2) are managed by OPQ.
Drugs
Members of the FDA Arthritis Advisory Committee and Drug Safety and Risk Management Committee voted 15-5-1 that the post-marketing PRECISION study demonstrates that Pfizer’s Celebrex (celecoxib) has comparable cardiovascular safety with naproxen (Aleve) and ibuprofen (Motrin). If FDA accepts the recommendation, the study results will be
Drugs
FDA commissioner Scott Gottlieb says the agency has launched its INFORMED (Information Exchange and Data Transformation) internal data science incubator that will initially focus on the conduct of regulatory science research in areas related to health technology and advanced analytics related to cancer. Speaking 4/26 at the Academy Health
Drugs
CDER Office of Testing and Research senior staff fellow Xiaoming Xu says there has been a steady increase in the number of approved drug products containing nanomaterials, including INDs, NDAs, and ANDAs. “More than 60 applications have been approved since the early 1970s and interest continues to rise,” Xu writes
Drugs
A 4/26-5/2/17 FDA inspection at Phase 4 Pharmaceutical, Aventura, FL, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A 4/18 Warning Letter says specific violations were: * failing to establish a quality control unit with the responsibility and authority to approve or
Drugs
FDA has issued a guidance, Clinical Trial Imaging Endpoint Process Standards, to assist sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biologic products. The document focuses on imaging acquisition, display, archiving, and interpretation process standards that the agency says
Drugs
FDA has approved a MannKind supplemental NDA for Afrezza (insulin human) inhalation powder to remove a required Risk Evaluation and Mitigation Strategy (REMS) communication plan. The drug was approved in 2014 and included the REMS related to a Boxed Warning advising that acute bronchospasm had been observed in patients with
Drugs
AbbVie has submitted a BLA for risankizumab, an investigational interleukin-23 inhibitor being evaluated for treating patients with moderate to severe plaque psoriasis. The submission is based on data from the global risankizumab Phase 3 psoriasis program evaluating more than 2,000 patients with moderate to severe chronic plaque psoriasis
Drugs
FDA has released the FDA-483 issued following a 2/5-2/15 inspection at Suven Life Sciences Limited, Telangana, India. The inspection observations were: * appropriate controls are not exercised over computer or related systems to assure that changes in master production and control records or other records are instituted
Drugs
FDA has granted Omeros Corp. a breakthrough therapy designation for OMS721 for treating patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (TMA), specifically those patients who have persistent TMA despite modification of immunosuppressive therapy. This is the second breakthrough therapy drug designation for OMS721, which last year
Drugs
FDA says that the drug lamotrigine (GlaxoSmithKline’s Lamictal), indicated for seizures and bipolar disorder, can cause a rare but very serious reaction known as hemophagocytic lymphohistiocytosis (HLH) that excessively activates the body’s infection-fighting immune system. An agency drug safety notice says the reaction can cause severe inflammation
Drugs
Washington Legal Foundation (WLF) is asking the Supreme Court to hear Alcon’s appeal of a 3rd Circuit Court of Appeals decision granting standing to sue to consumers who claim they paid too much for eye drops because of the size of the tip of the bottle containing the drops.
Drugs
Bloomberg News says that sources close to an almost four-year criminal investigation into alleged price-fixing by generic drug makers have indicated that at least two companies are likely to be indicted within coming months, in addition to several executives. The sources also said that another company could agree