Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes an FDA draft guidance on refusal to file NDA and BLA submissions to CDER will help manufacturers prepare complete applications that are ready for filing, reducing burdens on industry and the agency both. But it also says that some aspects
Drugs
FDA has approved a Janssen Pharmaceutical NDA for Erleada (apalutamide) for treating patients with prostate cancer that has not spread, but that continues to grow despite treatment with hormone therapy (castration-resistant). An agency release says that this is the first approved treatment for non-metastatic, castration-resistant prostate cancer.
Drugs
Merck says it is ending its APECS Phase 3 study evaluating verubecesat, an investigational small molecule inhibitor of the beta-site amyloid precursor protein cleaving enzyme, in people with prodromal Alzheimer’s disease. The company says its decision to end the study follows an external data monitoring committee evaluation that
Drugs
The National Institute of Allergy and Infectious Diseases says it is sponsoring a clinical trial to determine whether low blood levels of the protein procalcitonin (PCT) can reliably indicate whether a person’s lower respiratory tract infection will improve with antibiotic treatment. The agency says that healthcare providers often prescribe
Drugs
A 1/12-1/20/17 FDA inspection at the Bayer Pharma AG drug manufacturing facility in Leverkusen, Germany, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a just-released 11/14/17 Warning Letter. Specific violations cited in the letter were: * failing to
Drugs
GE Healthcare says it recognizes and appreciates FDA efforts to bring clarity and the appropriate level of regulatory oversight to clinical and patient decision support software, but is concerned that some language in a draft guidance “raises some questions and uncertainty regarding scope and extent of the proposed level of
Drugs
Three stakeholders say FDA could improve its draft guidance on a collaborative approach for drug development to be used in pediatric rare diseases that uses Gaucher disease as a model. The National Organization for Rare Diseases (NORD) says that much of the draft guidance is very specific to Gaucher disease
Drugs
Sen. Claire McCaskill (D-MO), ranking Democrat on the Senate Homeland Security and Government Affairs Committee, has released a report alleging the opioid manufacturers have made millions of dollars in payments to advocacy organizations and affiliated individuals that have advocated for broad use of opioids in pain management. “The pharmaceutical
Drugs
Public Citizen has supplemented its 11/15/17 petition asking FDA to require removal from the market of all medications containing olmesartan medoxomil, an angiotensin II receptor blocker (ARB), due to risk of sprue-like enteropathy. The 2/1 supplement cites a large cohort study published in Alimentary Pharmacology and
Drugs
A 9/18-9/22/17 FDA inspection at Cosmecca Korea, Chungcheongbuk-do, Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/2 Warning Letter. Specific violations cited in the letter were: * failing to have, for each batch of drug product,
Drugs
FDA has approved a Vertex Pharmaceuticals NDA for Symdeko (tezacaftor/ivacaftor) for treating the underlying cause of cystic fibrosis in patients aged 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene or who have at least one mutation that is
Drugs
FDA has released a guidance on Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment that is intended to assist sponsors with pathological diagnosis and staging, risk stratification, and trial design, including assessment of appropriate clinical endpoints. These issues were discussed at an FDA/American
Drugs
A Washington Legal Foundation brief has urged U.S. Court of Appeals for the Seventh Circuit to reject a “novel theory of liability” that would hold pharmaceutical manufacturers liable for injuries caused by drugs they did not manufacture. In Dolin v. GlaxoSmithKline, Wendy Dolin alleges that her husband’s 2010
Drugs
CDER has launched a new External Stakeholder Meeting Request system for requesting meetings with Center officials on drug development and drug safety matters. “Meetings with patient advocacy groups, health care professionals, and other non-industry stakeholders are invaluable to our work,” the agency says. “They provide a mechanism for communicating
Drugs
FDA has extended by three months the user fee review of Salix Pharmaceuticals’ NDA for Plenvu (NER1006). The new review target date is 5/13, and it gives agency reviewers more time to review additional data that were recently provided at FDA’s request. Plenvu is an investigational, novel, low-
Drugs
FDA has granted Xeris Pharmaceuticals an orphan drug designation for its ready-to-use, liquid-stable glucagon for treating hyperinsulinemic hypoglycemia, a condition in which blood glucose levels become low due to excessive insulin secretion. The designation was granted, in part, on the basis that mini-doses of glucagon may
Drugs
A new report on cutting drug prices from the White House’s Council of Economic Advisers has recommended innovation cost reductions through FDA reforms, among other suggestions. Because it takes 10 years and $2.6 billion to develop a drug and reach approval, reforms that significantly reduce the fixed costs
Drugs
FDA says it and the Nuclear Regulatory Commission (NRC) have taken steps to ensure a stable and secure supply of Technetium-99m (Tc-99m), the most widely used radioisotope in medical imaging. An FDA news release says the agency approved NorthStar Medical Radioisotope’s RadioGenix System, a unique system for
Drugs
FDA has issued 57 new and updated product-specific guidances intended to help the generic drug industry identify the most appropriate methodology for generating evidence needed to support approval of generic drug applications. The online document says generic drug applicants should consider that their product is expected to be pharmaceutically
Drugs
Five days after FDA denied without comment United Therapeutics’ fourth Tyvaso (treprostinil) inhalation solution ANDA petition, the company has submitted a fifth petition, that it says is substantively the same as the previous four. In each petition, the company asks that FDA not approve any ANDA for a treprostinil inhalation
Drugs
FDA has issued Sandoz a complete response letter, denying approval for its proposed generic copy of GlaxoSmithKline’s Advair Diskus (fluticasone propionate/salmeterol). The product is indicated for treating asthma in patients aged four years and older, in addition to providing maintenance treatment of airflow obstruction and reducing exacerbations in
Drugs
FDA has approved a Novartis supplemental BLA for Cosentyx (secukinumab) to update its label to include moderate-to-severe scalp psoriasis. Expanded approval was based on data from a Phase 3 trial in scalp psoriasis patients where Cosentyx demonstrated superior efficacy compared to placebo, the company says. The human interleukin-