Bayer (ETR:BAYN) said yesterday that the FDA approved a supplemental biologics license application for the BetaConnect Navigator and myBetaApp – software for its electronic BetaConnect auto-injector. The company’s BetaConnect auto-injector administers Betaseron for patients with relapsing-remitting multiple sclerosis. The newly-approved software allows patients to connect their device with the myBetaApp on their mobile device or computer […]
Drug-Device Combinations
Nanoparticles: An industry buzzword meets reality
Young startups backed by nanoparticle tech face a world hurdles before reaching the clinic. It’s been decades since the first innovations with nanotechnology – and experts are asking, “Where are all the drugs?” It’s been more than 20 years since the FDA approved the first nanoparticle drug, Doxil. At the time, nanoparticles were heralded as a […]
Lamellar Biomedical launches dry-eye trial
Lamellar Biomedical said today that the 1st patients were enrolled in its trial evaluating Lamelleye for the treatment of moderate to severe dry-eye disease. Lamelleye uses the Scotland-based company’s Lamellasome technology to mimic the actions of serous lamellar bodies and regulate interfaces between tissues and external environments. The trial is slated to compare Lamelleye to […]
Mallinckrodt faces probe over price hikes for injectable pain-killer
Sen. Claire McCaskill (D-Mo.) penned a letter to Mallinckrodt Pharmaceuticals (NYSE:MNK) last week, probing for details about the company’s pricing strategies for its injectable pain-killer, Ofirmev. Mallinckrodt acquired Ofirmev in 2014, when it bought Cadence Pharmaceuticals in a $1.4 billion deal. In May of that year, Mallinckrodt hiked the pain-killer’s list price from $14.75 per vial to […]
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 […]
Senseonics prices $41m underwritten offering for Eversense CGM
Senseonics (NYSE:SENS) said today that it priced an underwritten offering of 29 million shares of common stock at $1.41 apiece to a group of institutional investors. Roche (PINK:RHHBY) agreed to purchase 21 million shares and New Enterprise Associates agreed to purchase 7 million shares in the offering, according to the Germantown, Md.-based company. Senseonics said […]
Colorectal cancer patients treated with SIR-spheres more likely to be candidates for resection
Treatment with Sirtex Medical‘s (ASX:SRX) Y-90 resin microspheres and chemotherapy was associated with a statistically significant gain in potentially curative liver resectability, according to data published earlier this week. The results come 1 week after the Australian company reported that its radioactive microspheres had no effect in improving survival in patients with colorectal cancer in its […]
Study: Radiation may boost immunotherapy in mesothelioma treatment
Doctors in Pennsylvania reported this week that combining immunotherapy drugs with radiotherapy could help to more efficiently treat malignant pleural mesothelioma. The analysis from the University of Pennsylvania looked at studies that combined immunotherapy drugs like Merck‘s (NYSE:MRK) Keytruda with radiation therapy. The team concluded that radiotherapy may boost the cancer-killing effects of immunotherapies. Malignant pleural […]
Artificial pancreas: These companies are racing to make one
Medical device companies are close to achieving the holy grail of diabetes treatment: a combined glucose sensor, control algorithm and insulin infusion device that effectively acts as an “artificial pancreas.” We explain more in the newest video from editors at Drug Delivery Business’s sister publication Medical Design & Outsourcing. (And for a deeper dive, check out […]
Ultrasound-drug combo treats pulmonary embolism in less time with fewer drugs
When venous clots break off and travel through a patient’s circulatory system, they can become trapped in the lung and block blood flow. This strains the heart’s ability to pump blood through the lungs and can ultimately lead to heart failure. Traditionally, patients with pulmonary embolisms are treated overnight with systemic infusions of tissue plasminogen […]