The FDA said today that it awarded premarket approval to Thermo Fisher Scientific‘s (NYSE:TMO) next-gen sequencing-based test that can simultaneously screen tumor samples for biomarkers associated with 3 approved therapies for non-small cell lung cancer. The company’s Oncomine Dx Target Test evaluates 23 genes associated with non-small cell lung cancer. The tests results could help […]
Respiratory
Novartiz unit Sandoz seeks FDA nod for generic Advair Diskus
Novartis (NYSE:NVS) unit Sandoz said today that the FDA has accepted the abbreviated new drug application for its generic version of Advair Diskus. The fluticasone propionate/salmeterol device is designed to treat asthma in patients ages 4 and older, as well as provide maintenance treatment of airflow obstruction and reduce exacerbations in patients with chronic obstructive […]
Adapt Pharma touts usability data for Narcan nasal spray
Adapt Pharma touted data today from 2 human factors studies that evaluated the usability of its Narcan nasal spray by adolescents and people with low literacy. The Dublin-based company’s product is a ready-to-use, needle-free device that delivers a single dose of naloxone in a nasal spray to someone experiencing an opioid overdose and does not require […]
Pulmatrix inks licensing deal for novel inhaled kinase inhibitors
Pulmatrix (NSDQ:PULM) said today that it inked an exclusive, worldwide license agreement with Janssen Biotech subsidiary RespiVert. According to the deal, Pulmatrix will have access to the company’s portfolio of novel kinase inhibitors. The agreement covers respiratory and oncology indications for the drug candidates and Pulmatrix said it plans to take over the portfolio’s global […]
InCarda touts inhaled flecainide as paroxysmal atrial fibrillation therapy
InCarda Therapeutics touted top-line data today from a Phase I study of its InRhythm inhaled flecainide as a treatment of symptomatic acute episodes of paroxysmal atrial fibrillation. InRhythm delivers flecainide via inhalation to get the drug to the heart through the lungs. Flecainide is already approved as an oral anti-arrhythmic drug for patients with PAF. […]
Inhaled Parkinson’s treatment improves motor function in Phase III
Shares in Acorda Therapeutics (NSDQ:ACOR) jumped this morning after the company reported that its inhaled Parkinson’s drug significantly improved motor function in a Phase III trial. The investigational drug is being studied as a therapy for people with Parkinson’s disease experiencing “off” periods, or a re-emergence of symptoms. The Phase III Span-Pd trial enrolled 339 patients with […]
MannKind inks deal to bring inhaled insulin to Brazil
MannKind Corp. (NSDQ:MNKD) said today that the company inked a supply and distribution deal with Biomm for the commercialization of its inhaled insulin, Afrezza, in Brazil. According to the agreement, Biomm will prepare and file the necessary applications for regulatory approval. MannKind will be responsible for manufacturing and supplying Afrezza and Biomm is slated to […]
Mylan board faces pressure from pension funds
Investors, including the New York City and State pension funds and the California State Teacher’s Retirement System, are urging shareholders to vote against Mylan (NSDQ:MYL) chairman Robert Coury and 5 other board members at the company’s upcoming annual meeting. Coury was compensated with more than $97 million last year and some investors aren’t happy about it. […]
Medtronic launches opioid-induced respiratory depression study
Medtronic (NYSE:MDT) said today that it’s starting a large study on the effect of pulse oximetry and capnography in opioid-induced respiratory depression, using its Capnostream device. The 1,650-patient Prodigy study aims to create a tool to score the risk of OIRD in patients being treated with opioids for pain, using Capnostream’s continuous pulse oximetry and capnography monitoring […]
FDA deals setback to Sunovion for inhaled COPD therapy
The FDA issued a complete response letter to Sunovion Pharmaceuticals in regards to the new drug application for its eFlow chronic obstructive pulmonary disease drug-device combo. The investigational eFlow closed-system nebulizer delivers a long-acting muscarinic antagonist bronchodilator, glycopyrrolate, to reduce airflow obstruction in COPD patients. The company said it plans to work with the FDA to determine […]