Delcath Systems (NSDQ:DCTH) said today that it inked a commercial supply deal with Tillomed Laboratories in Europe. According to the deal, Tillomed Labs is slated to provide Delcath with melphalan – the drug used in Delcath’s hepatic Chemosat delivery system. In Europe, the drug-device combo is approved to treat liver cancer. “We are particularly pleased to […]
Pharmaceuticals
Sen. McCaskill: Teva is “stonewalling” Senate investigation into opioid crisis
Sen. Claire McCaskill (D-Mo.) said that Teva Pharmaceuticals (NYSE:TEVA) is “stonewalling” a Senate probe into the the role that opioid manufacturers have in the nation’s opioid crisis. In the senator’s initial inquiries with the generic drugmaker, McCaskill requested an array of documents detailing arrangements between Teva and its customers, as well as internal reviews of pharmacies […]
Clearside Biomedical floats $75m public offering
Clearside Biomedical (NSDQ:CLSD) plans to offer $75 million in shares of its common stock in an underwritten public offering. The Alpharetta, Ga.-based company is slated to use the funds to prepare and submit an application to the FDA for its suprachoroidal eye drug as a treatment for patients with macular edema associated with non-infectious uveitis. Clearside […]
Adamis Pharma’s EpiPen alternative succeeds in human factors study
Adamis Pharmaceuticals (NSDQ:ADMP) has positioned its emergency allergy treatment as a cheaper alternative to Mylan‘s (NSDQ:MYL) EpiPen device. The company has also set out to prove that its epinephrine injector is easy to use, even by people using an auto-injector for the first time. Data from a human factors study conducted by Adamis were presented this week […]
FDA updates Opdivo label to include four-week dosing option
The FDA approved a label update for Bristol-Myers Squibb (NYSE:BMY) Opvido cancer drug, giving patients the option to receive 480-mg infused every four weeks instead of 240-mg every two weeks. The PD-1 inhibitor was also cleared for shorter, 30-minute infusions across its approved indications, according to the biopharmaceutical company. “From the introduction of our first immuno-oncology […]
Smiths Medical inks distro deal for infusion therapy products
Smiths Medical plans to distribute its CADD infusion systems to non-hospital-based providers through a preferred partnership with Medical Specialties Distributors, the company reported today. As part of its new distribution model, Smiths will also make its infusion pumps and sets available to providers outside of the hospital setting through InfuSystem (NYSE:INFU) and Integrated Medical Systems. The […]
Clearside Biomedical enrolls first patient in Ph3 macular edema trial
Clearside Biomedical (NSDQ:CLSD) has enrolled the first patient in a Phase III trial evaluating its eye drug combined with an intravitreally-administered anti-VEGF agent as a treatment for macular edema associated with retinal vein occlusion. The company’s drug, CLS-TA, is a proprietary suspension of triamcinolone acetonide designed to be administered in the space located between the choroid […]
NIH: Asthma flare-ups not prevented by temporary increases to inhaled steroid dose
Temporarily increasing the amount of inhaled steroids that young children take when their asthma symptoms worsen does not prevent severe flare-ups, according to a new study from the National Institutes of Health. The findings buck traditional medical practice involving kids with mild-to-moderate asthma. Asthma flare-ups are common among children with asthma and most doctors recommend […]
NanOlogy looks to transform chemotherapy with localized delivery platform
Paclitaxel revolutionized cancer treatment when it was first used as a chemotherapeutic in the 1990s. But although the product is a powerful cancer killer, patients taking systemic doses of paclitaxel have to endure side effects such as peripheral neuropathy and hair loss. Marc Iacobucci and his team at NanOlogy believe they could replace the need […]
Clearside Biomedical shares soar after eye drug succeeds in Ph3 trial
Clearside Biomedical (NSDQ:CLSD) shares soared more than 50% in pre-market activity today after the company reported that its suprachoroidal eye drug succeeded in a pivotal Phase III trial of patients with macular edema associated with non-infectious uveitis. The company’s drug, CLS-TA, is a proprietary suspension of a corticosteroid, triamcinolone acetonide, designed to be administered to the […]