Updated to include the Senate Judiciary Committee’s response. Mylan (NDSQ:MYL) declined to testify at a U.S. Senate committee regarding its $465 million pending settlement to deal with charges that it underpaid government healthcare programs when it misclassified its EpiPen injector as a generic. The Canonsburg, Pa.-based company penned a letter to the Senate Judiciary Committee […]
Pharmaceuticals
Novo Nordisk, Sanofi win FDA nods for diabetes drugs
Both Novo Nordisk (NYSE:NVO) and Sanofi (NYSE:SNY) said yesterday that they won FDA approval for pre-filled pens with drug combinations indicated for adults with Type II diabetes. Paris-based Sanofi’s Soliqua 100/33 is an injectable medicine composed of 2 diabetes drugs – insulin glargine and lixisenatide. The drug is approved for adults with Type II diabetes not controlled with less than […]
GSK files for FDA approval of inhaled triple-combo therapy for COPD
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that GSK filed a regulatory submission with the FDA for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for patients with chronic obstructive pulmonary disease. The triple-combo therapy includes 3 drugs: fluticasone furoate, an inhaled corticosteroid; umeclidinium, a long-acting muscarinic antagonist; vilanterol, a long-acting beta2-adrenergic agonist. The medicines […]
Intarcia seeks FDA nod for 1st drug to use Medici drug delivery system
Intarcia Therapeutics said today that it submitted a New Drug Application to the FDA for its injection-free ITCA 650 candidate, the 1st drug to use Intarcia’s Medici drug delivery system to treat Type II diabetes. The ITCA 650 enables subcutaneous delivery of exenatide using a match-sized osmotic pump placed under the skin in an in-office procedure. With […]
Restoring blood vessels to tumor cells aids delivery of chemotherapy
Researchers from the Flanders Institute for Biotechnology in Belgium say they have found a way to repair dysfunctional blood vessels which allow cancer cells to escape from the blood stream and reach other organs, and which play a vital role in cancer metastasis. In a study published in Cancer Cell, researchers describe how they manipulated the blood […]
Mallinckrodt touts data for Ofirmev injected acetaminophen
Mallinckrodt Pharmaceuticals (NYSE:MNK) today released results from a clinical pharmacokinetic study evaluating the effect of IV morphine on the absorption of oral acetaminophen, touting the effectiveness of its Ofirmev IV administered acetaminophen over orally administered acetaminophen in adjunct to IV morphine. The results were presented at this year’s Pain Medicine Meeting of the American Society of […]
Report finds pressure from Congress does not budge drug prices
Committees in Congress have issued more than a dozen subpoenas to drug-makers for alleged price-hiking in the last 2 years, with members of the House and Senate collecting hundreds of thousands of documents on pricing strategies and marketing tactics. They’ve put pharmaceutical execs through more than 16 hours of public testimony. But an Associated Press review shows that pressure from Washington […]
DBV, BioNet-Asia study needle-free pertussis booster vaccination
DBV Technologies (NSDQ:DBVT) and BioNet-Asia said today that the independent Data & Safety Monitoring Board positively reviewed DBV’s needle-free vaccine patch technology, Viaskin, and that enrollment in a Phase I trial for booster immunization against pertussis will continue into the 2nd dosing cohort. The Viaskin pertussis booster vaccination program will test the ability of DBV’s needle-free vaccine […]
New drug capsule delivers medicine for weeks after swallowing
Researchers from Massachusetts Institute of Technology, spurred by a challenge from Bill Gates, developed a star-shaped drug capsule that can gradually release medication and stay in the stomach for to 2 weeks after being swallowed. The study, published yesterday in Science Translational Medicine, described the team’s work using the capsule to deliver an anti-parasitic drug, invermectin, which […]
Cumberland Pharma acquires U.S. rights to Nordic’s injectable methotrexate
Cumberland Pharmaceuticals (NSDQ:CPIX) said today that it acquired exclusive U.S. rights to Nordic Group‘s injectable methotrexate product line to treat rheumatoid arthritis, juvenile idiopathic arthritis, severe psoriatic arthritis, and severe disabling psoriasis. Nordic Group has registered the product line for patient use in European countries, so Cumberland will register and commercialize the products in the U.S. […]
