Steadymed Ltd., of San Ramon, Calif., said its shareholders voted to approve the acquisition by United Therapeutics Corp., of Silver Spring, Md. Shareholders also approved the nonbinding advisory proposal regarding executive compensation related to the acquisition. Read More
Delcath Systems Inc., of New York, said it has filed a registration statement with the SEC for the sale of up to 28.57 million shares at a subscription price of $1.75 per share. After its record date of Aug. 3, the company expects to distribute, at no charge, a non-transferable subscription right to purchase 500 shares of its common stock to holders of record for each share of common stock held on the record date, and to holders of its warrants to purchase common stock. Read More
Incyte Corp., of Wilmington, Del., reported for the quarter ended June 30, 2018, GAAP net product revenues of JAK inhibitor Jakafi (ruxolitinib) were $346 million as compared to $276 million for the same period in 2017. For the six month period, product revenues of Jakafi were $659 million as compared to $527 million for the same period in 2017. Read More
Arrhythmogenic right ventricular cardiomyopathy (ARVC) affects one in 5,000 people worldwide and has been a perennial puzzle for clinicians as to its cause and treatment. Now a cardiologist with the research team that has won Canada's prestigious Governor General's Innovation Award for identifying the gene responsible for the condition is looking to California for assistance in repairing it. Read More
Progenics Pharmaceuticals Inc.'s newly approved Azedra (iobenguane I 131) arrives on the market with a nod for ultra-orphan neuroendocrine tumors, a hefty price tag and a label the New York-based firm hopes will lay the foundation for its broader radiopharmaceutical efforts. Read More
While the cost of just about everything else seems to be going up, biosimilar sponsors are in for a bit of a break next year when it comes to FDA user fees. Read More
Guadecitabine (SGI-110), the prize in Otsuka Pharmaceutical Co. Ltd.'s 2013 pick-up of Astex Pharmaceuticals Inc. for $886 million in cash, failed its first pivotal test. Read More
To the layperson, dry eye disease (DED), technically xerophthalmia, often is dismissed as an innocuous nuisance that can be treated with over-the-counter eye drops. But Anat Galor, an ophthalmologist in Miami and clinical expert with the American Academy of Ophthalmology (AAO), said the disease name "is a little bit of a misnomer" for a chronic indication that encompasses a variety of symptoms and can have serious consequences for patients. The multifactorial disease of the tears and ocular surface can result not only in burning and aching but also in visual disturbances and tear film instability that have the potential to damage the ocular surface. Read More
DUBLIN – Shares in Active Biotech AB dropped 37 percent Tuesday on news that its lead drug laquinimod, which is licensed to Teva Pharmaceuticals Industries Ltd., missed the primary endpoint of a phase II trial in Huntington's disease. Read More