Drugs
FDA has approved Bayer and Loxo Oncology’s Vitrakvi (larotrectinib) for treating adult and pediatric cancers in patients who have a specific genetic feature (biomarker). The accelerated approval drug is indicated for treating patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known
Drugs
FDA says it is reducing the minimum measles antibody potency specification for immune globulin (IG) products in response to declining titers of measles antibodies in plasma donors. In a letter to licensed IG manufacturers, the agency says that declining levels of measles antibodies in plasma are caused by a decrease
Drugs
A Goldwater Institute investigative report, “Studied to Death: FDA Overcaution Brings Deadly Consequences,” says the result of an FDA fear that regulators might miss something and be subject to congressional and media criticism is “more preventable deaths and more diseases that go untreated because of a regulatory system that emphasizes
Drugs
Pfizer says an FDA draft guidance is less clear and helpful than a previous guidance on the same topic. In addition, the comment letter says, there are assumptions and general comments throughout the guidance that likely will be rendered incorrect by case-by-case science and program understanding. “Thus,” it
Drugs
A 3/19-4/12 FDA inspection at the Mylan drug manufacturing facility in Morgantown, WV, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 11/9 Warning Letter identifies the violations as: * failing to clean, maintain, and, as appropriate for the nature of the
Drugs
FDA has placed a clinical hold on a Zafgen clinical trial of ZGN-1061, the company’s second-generation, investigational MetAP2 inhibitor currently in development for treating Type 2 diabetes. The agency cited the possibility of cardiovascular (CV) safety risk based on the company’s prior compound and outlined multiple
Drugs
FDA has issued a Form FDA-483 after an August inspection of a Cantrell Drug Co. outsourcing facility in Little Rock, AR. According to the FDA-483, buildings used in manufacturing, processing, packing, or holding of drug products did not have the suitable construction to facilitate cleaning, maintenance, and proper
Drugs
FDA has approved Genentech’s ACTPen 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra (tocilizumab) as an additional formulation for adult patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs, and
Drugs
FDA has accepted for review a Biohaven Pharmaceutical Holding Co. 505(b)(2) NDA for BHV-0223, an investigational sublingual form of riluzole for treating patients with amyotrophic lateral sclerosis (ALS). Biohaven previously announced that the agency granted orphan drug designation for BHV-0223 in ALS. The company says BHV-
Drugs
FDA has approved Pfizer’s Daurismo (glasdegib) tablets for use in combination with low-dose cytarabine to treat newly-diagnosed acute myeloid leukemia (AML) in adults age 75 or older or who have other chronic health conditions or diseases that may preclude use of intensive chemotherapy. An agency news release
Drugs
Mylan says a comprehensive restructuring and remediation plan is underway at its Morgantown, WV, drug manufacturing facility. Reference to the plan was included in the company’s comment on an FDA 11/9 Warning Letter that was based on observations at the plant in April. “The issues raised in the
Drugs
Bristol-Myers Squibb is finding fault with FDA for issuing a draft guidance on product identifiers under the Drug Supply Chain Security Act (DSCSA) close to the end of the enforcement discretion period. The company says that “manufacturers have been preparing for a number of years to comply with the
Drugs
FDA has accepted for priority review a Daiichi Sankyo NDA for quizartinib for treating adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). The agency set a user fee review action target date of 5/25/2019. The NDA is based on results from the Phase 3 QuANTUM-
Drugs
FDA says Mylan Pharmaceuticals has recalled 15 lots of valsartan-containing products due to the presence of N-Nitrosodiethylamine (NDEA). The agency notice says that not all Mylan valsartan-containing products distributed in the U.S. are being recalled. The company is only recalling lots that tested positive for NDEA
Drugs
FDA has granted OBI Pharma an Orphan Drug Designation for OBI-888 for treating pancreatic cancer. OBI-888 is a first-in-class monoclonal antibody cancer immunotherapy targeting Globo H, a glycolipid antigen. A Phase 1 study is underway at the University of Texas M.D. Anderson Cancer Center in
Drugs
FDA has approved an Elite Pharmaceuticals ANDA for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. The combination medication and is used to help relieve moderate to moderately severe pain. U.S. annual sales are about
Drugs
A 2/12-3/1 FDA inspection at Surmasis Pharmaceutical, Des Moines, IA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 11/6 Warning Letter says specific violations were: * failure of the firm’s quality control unit to review and approve all drug product
Drugs
A new FDA drug safety alert is warning that when Novartis’ multiple sclerosis (MS) drug Gilenya (fingolimod) is stopped, the disease can become much worse than before therapy started. “This MS worsening is rare but can result in permanent disability,“ the agency says. In response, FDA has ordered a new
Drugs
Sen. Bernie Sanders (I-VT) and Rep. Ro Khanna (D-CA) say they will introduce at the start of the next Congress their Prescription Drug Price Relief Act to “significantly reduce prescription drug prices for Americans.” In a media statement (contains links to text and summaries of the Senate and
Drugs
FDA has approved an Elite Pharmaceuticals ANDA for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. The combination medication and is used to help relieve moderate to moderately severe pain. U.S. annual sales are about
Drugs
FDA has posted online questions and answers about impurities found in certain generic angiotensin II receptor blocker products. Beginning in June, the agency says, it found that some generic versions of the prescription drug valsartan contained unexpected impurities that posed a safety concern. The document says the impurities, N-Nitrosodimethylamine
Drugs
FDA has approved Novimmune’s Gamifant (emapalumab) for treating pediatric and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional therapy. HLH is a condition in which the body’s immune cells do not work properly, according to an FDA release.