Drugs
FDA has accepted for review a Radius Health NDA for abaloparatide-SC, indicated for treating postmenopausal women with osteoporosis. The submission is supported by data from an 18-month Phase 3 trial called ACTIVE, which evaluated 2,463 postmenopausal women with osteoporosis. It also includes data from the first six
Drugs
Republican leaders of the House Energy and Commerce Committee say they understand that FDA’s failure to publicly clarify its thinking on communication of truthful and non-misleading information on off-label uses of drugs and medical devices may be due to a disagreement between FDA and HHS leadership. In
Drugs
The U.S. Chamber Institute for Legal Reform says that although it is too soon to measure the full impact of the 9/2015 Justice Department policy memorandum directing attorneys to focus enforcement efforts on holding individuals accountable for corporate malfeasance (memo from deputy attorney general Sally Yates), “it is
Drugs
FDA has determined that Amarin Pharmaceuticals’ Vascepa (icosapent ethyl) capsules are now eligible for five-year, new chemical entity marketing exclusivity under the Hatch-Waxman Amendments. The exclusivity period will run until 7/2017, and the statutory 30-month stay triggered by patent litigation following a generic application submission would
Drugs
A 5/21-29/15 FDA inspection at Corden Pharma Latina, Sermoneta, Italy, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients. A 5/20 Warning Letter says that specific violations and deviations included: * failing to have
Drugs
FDA says that Megafine Pharma, Mumbai, India, was placed on a 10/14/15 import alert due to findings from a 5/11-15/15 inspection showing significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API). A 5/19 Warning Letter says that specific violations included: * failing
Drugs
FDA has granted Intercept Pharmaceuticals accelerated approval for Ocaliva (obeticholic acid) for treating primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA. The condition causes the small bile ducts in the
Drugs
FDA has approved a Boehringer Ingelheim and Eli Lilly NDA for Jentadueto XR (linagliptin and metformin hydrochloride extended-release) tablets for treating Type 2 diabetes in adults. Linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, works by increasing hormones that stimulate the pancreas to produce more insulin and the liver
Drugs
FDA has issued AstraZeneca a complete response letter (CRL) for its NDA for ZS-9 (sodium zirconium cyclosilicate), indicated for treating hyperkalemia (high potassium level in the blood serum). The letter identifies observations cited during a pre-approval manufacturing inspection, acknowledging recently-submitted data which it has yet to review,
Drugs
FDA has approved a Blue Earth Diagnostics NDA for Axumin, a radioactive diagnostic agent for injection, indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment. Approval was based on data from two studies. “The
Drugs
FDA has cleared a Cynosure 510(k) to market a new laser delivery system for its PicoSure aesthetic picosecond laser for removing the full color spectrum of tattoo inks. “The new 1064 nm wavelength is designed for removal of black and other dark tattoo inks,” Cynosure says. The laser is
Drugs
FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted 15 to 1 to recommend approval for a St. Jude Medical PMA for its Amplatzer Patent Foramen Ovale (PFO) Occluder System. The device is indicated for percutaneous, transcatheter closure of a PFO to prevent recurrent ischemic
Drugs
Symbiomix says it had a successful pre-NDA meeting with FDA and has reached agreement with the agency on all aspects for an NDA filing in the fourth quarter of 2016 for its SYM-1219 (secnidazole) for treating bacterial vaginosis. The drug is described as a next-generation, 5-nitroimidazole
Drugs
Researchers at the Massachusetts Institute of Technology are seeking FDA approval for a drug manufacturing plant that is the size of a home refrigerator and can produce 1,000 pills in 24 hours, faster than it takes to produce some batches in a conventional drug manufacturing facility. Kaiser Health News
Drugs
FDA has approved a CSL Behring BLA for Afstyla [antihemophilic factor (recombinant), single chain], a factor VIII single-chain therapy for adults and children with hemophilia A. The company says it is the first and only single-chain product for hemophilia A that is specifically designed for long-lasting protection
Drugs
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has voted 12 to 2 to recommend approval for a Sanofi NDA for iGlarLixi (insulin glargine and lixisenatide) injection and lixisenatide injection as monotherapy, indicated for improving glycemic control in adults with Type 2 diabetes mellitus. Several panel members expressed concern with
Drugs
American College of Rheumatology president Joan Van Feldt and Arthritis Association president Ann Palmer say that FDA should be allowed to do its job and implement transparency measures in biosimilar drug naming and labeling. “It is a common-sense decision that upholds the agency’s responsibility to protect the public
Drugs
FDA has approved a Titan Pharmaceuticals Inc. and Braeburn Pharmaceuticals NDA for Probuphine (buprenorphine), an implant for maintenance treatment of opioid dependence. The product is designed to provide a “constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of
Drugs
FDA says it is requiring safety labeling changes for methadone and buprenorphine products when used by pregnant women for medication-assisted treatment (MAT) of opioid use disorder. The changes are intended to ensure that doctors have complete information on the products’ benefits and risks. An agency notice says that while
Drugs
A shortage of Pfizer’s Bicillin L-A (penicillin G benzathine), the recommended treatment for patients with syphilis and the only treatment available for pregnant women who are infected with or exposed to syphilis, is creating problems according to a National Public Radio report. The company has told consumers that
Drugs
Members of the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 on 5/24 to support the safety and efficacy of Novo Nordisk’s Xultophy (insulin degludec and liraglutide injection) for the proposed indication of adjunct to diet and exercise to improve glycemic control in treating adults with
Drugs
The Supreme Court may decide in June whether to hear Sandoz and/or Amgen’s petitions appealing a Federal Circuit Court of Appeals decision on interpretation of the “notice of commercial marketing” provision of the Biologics Price Competition and Innovation Act (BPCIA). A Big Molecule Watch blog post from Goodwin