Regulatory News

The FDA has issued the first warning letters to e-cigarette companies for illegal claims on their websites, according to an article published in JAMA.
Vertex's investigational drug Orkambi (lumacaftor/ivacaftor) could potentially treat 8,500 Americans with cystic fibrosis aged 12 and older with two copies of the F508del mutation.
Swiss drugmaker Novartis said European health regulators have approved its ALK inhibitor Zykadia (ceritinib) for advanced lung cancer.
The US FDA has approved the antibiotic moxifloxacin (Avelox) to treat septicemic and pneumonic plague.
B&B Medical Technologies has received ISO 13485 Certification and Health Canada Medical Device Licenses to sell the B&B Bubbler and HOPE Nebulizer into the Canadian market.
The FDA has released enhanced recommendations on the production and disinfection of reusable medical devices, according to a press release.
A Medscape news report indicates that the US House of Representatives voted overwhelmingly to repeal Medicare's sustainable growth rate (SGR) formula for physician reimbursement.
The FDA has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.
FDA approves expanded use of Kalydeco for CF
The US FDA has expanded the approved use of Kalydeco for children aged two to five years with cystic fibrosis who have one of 10 mutations in their CFTR gene.
3B Medical Inc has filed a legal action in the United States District Court for the Middle District of Florida alleging antitrust violations by ResMed, according to a 3B news release.
The US Drug Enforcement Agency has issued a nationwide alert about the dangers of the narcotic fentanyl, which is often used in anesthesia to prevent pain after surgery or other procedures.
Thanks to a federal rule change, schools could start billing Medicaid for health services such as asthma screenings, vaccinations, and care for chronic diseases provided to some low-income students.
Actavis has launched its generic version of AstraZeneca’s Pulmicort Respules after a US District Court judge in New Jersey denied AstraZeneca’s request for a permanent injunction and invalidated its patent.
New York Governor Andrew M. Cuomo’s administration will ban hydraulic fracturing (or "fracking") in New York State due to concerns over health risks, according to a Dec 17 report in the New York Times
Drive Medical has successfully obtained ISO 13485:2003 certification, according to a news announcement from Harvey Diamond, board chairman and CEO of Drive Medical.
The Hamilton-T1 transport ventilator is now approved in the EU with a neonatal option, according to the company.
Arnuity Ellipta (fluticasone furoate inhalation powder) is a once-daily ICS for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older.
A White House department reportedly edited language in the FDA's proposed rules for tobacco products that may weaken and limit the agency's ability to regulate e-cigarettes and cigars, according to published documents cited by a Reuters news article.
Halyard Health
Kimberly-Clark Corp has filed a Form 10 Registration Statement with the SEC to spin-off its Kimberly-Clark Health Care business and rebrand it Halyard Health Inc, which would be based in Alpharetta, Ga.
Flight Medical Innovations Ltd has received FDA 510(k) clearance for its Flight 60 ventilator integrated O2 mixer version, and three advanced ventilation modes, according to a company announcement.