A committee for the European Union’s pharmaceutical regulatory agency backed changes to the dosing schedule for Bristol-Myers Squibb‘s (NYSE:BMY) Opdivo cancer drug, the company touted today. The Committee for Medicinal Products for Human Use recommended that the European Commission approve a dosing schedule of 480-mg infused over 60 minutes every four weeks as an option […]
Oncology
GlycoMimetics prices $119m public offering
GlycoMimetics (NSDQ:GLYC) priced an underwritten public offering of 7,000,000 shares of common stock at $17.00 apiece today, reporting that it expects to bring in $119 million from the offering. The Rockville, Md.-based company plans to offer underwriters a 30-day option to buy an additional 1,050,000 shares of common stock at the same price. GlycoMimetics will use […]
Equashield gears up for first orders of compounding robot designed for hazardous drugs
Equashield received the first purchase orders for its Equashield Pro closed-system compounding robot, the company said earlier this month, and plans to start installing the systems in the second quarter of this year. The company’s robotic system is designed to compound patient-specific chemotherapy doses and prepare other hazardous drugs quickly, using an optimized process to […]
Q Biomed seeks FDA nod for new manufacturing facility
Q Biomed (OTC:QBIO) and Bio-Nucleonics, the company licensing Q Biomed’s strontium chloride injection, have asked the FDA to approval a new manufacturing facility for the drug. Strontium-89 is a non-opioid injectable designed to relieve pain in patients with metastatic bone disease. The drug is given in a single injection and takes two weeks to reach its […]
Inovio Pharmaceuticals logs Q4 earnings, sales beat
Inovio Pharmaceuticals (NSDQ:INO) topped sales and earnings estimates on Wall Street yesterday with its fourth quarter and full year results. The Plymouth Meeting, Pa.-based company posted a net loss of -$21.5 million on sales of $8.8 million for the 3 months ended Dec. 31, for bottom-line growth of 17.9% on sales growth of 3.5% compared with […]
U.S., German antitrust authorities clear Varian’s $1.3B Sirtex buyout
U.S. antitrust authorities and the German Federal Cartel Office cleared Varian Medical‘s (NYSE:VAR) $1.3B proposed buyout of Sirtex Medical (ASX:SRX), Varian reported today. The companies first announced that they inked a deal for Varian to acquire all of Sirtex’s outstanding shares in January this year. The transaction is slated to close in late May. Sirtex shareholders […]
Delcath inks supply deal with Tillomed Laboratories in Europe
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 […]
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 […]
EMA committee backs Amgen’s on-body injector for Neulasta
Amgen (NSDQ:AMGN) said today that a committee for the European Medicines Agency has recommended that the regulatory body approve a label variation for its Neulasta product to include the Onpro on-body injector delivery device. Neulasta’s Onpro kit includes a pre-filled syringe paired with a single-use on-body injector. The lightweight device is given to the patient on the […]
Novocure misses Q4 EPS by a penny, tops sales estimates
Shares in Novocure (NSDQ:NVCR) rose slightly today in premarket activity after the medical device maker met sales expectations, but missed earnings estimates on Wall Street with its fourth quarter and full-year financial results. The St. Helier, N.J.-based company reeled in losses this quarter, posting -$10.9 million on sales of $53.7 million for the 3 months ended […]