OSE Pharma SA, of Paris, said it initiated in the U.S. its phase III trial, Atalante 1, evaluating Tedopi, an off-the-shelf immunotherapy, for advanced non-small-cell lung cancer (NSCLC). The study, which is comparing Tedopi to standard chemotherapies in positive HLA-A2 patients with stage IIIb or IV NSCLC, started in Europe in early 2016. The trial will include a total of 500 patients and results are expected in 2018. Read More
Capstone Therapeutics Corp., of Tempe, Ariz., and Lipimetix Development Inc., Capstone's 60 percent-owned joint venture (JV), said its lenders informed the companies they would not exercise their option to extend the exclusive due diligence period through March 31, by loaning Capstone a second $1 million, under the terms of the previously reported securities purchase agreement. Read More
Alexion Pharmaceuticals Inc., of New Haven, Conn., reported 2015 revenues of $2.604 billion, representing 21 percent growth over 2014 revenues of $2.146 billion, excluding the impact of $88 million in 2014 for reimbursement of shipments in prior years. Read More
Kempharm Inc., of Coralville, Iowa, priced $75 million aggregate principal amount of 5.5 percent senior convertible notes due 2021 in a private placement to qualified institutional buyers, granting the initial purchasers of the notes a 30-day option to purchase up to an additional $11.25 million more to cover overallotments. The sale of the notes is expected to close next Tuesday. Cowen and Co. is acting as lead book-running manager, RBC Capital Markets is book-running manager and Canaccord Genuity and Oppenheimer and Co. are serving as co-managers. Read More
HONG KONG – Yet another prominent Chinese biopharma company may be going private, saying goodbye to a U.S. stock market that is much less welcoming that it once was. Read More
Removing senescent cells from middle-aged mice by pushing them into apoptosis lengthened the life span of the animals by 25 to 35 percent, researchers from the Mayo Clinic have reported. Read More
Delays in putting out much-needed guidance earned the FDA a C+ Thursday in its implementation of the biosimilar path, but the Centers for Medicare & Medicaid Services (CMS) got a D- for not even trying. Read More
OXFORD, U.K. – The increasing level of funding dedicated to the commercialization of university research is indicative of progress, but the U.K. is not quite there in terms of translating knowledge that is the fruit of publicly funded research into real benefits. Read More
With a possible fix for compliance and side-effect issues in Alzheimer's disease (AD), Corium International Inc. drew attention from Wall Street by way of positive top-line phase I data that disclosed pharmacokinetics (PK) of its Corplex once-weekly transdermal patch delivering the acetylcholinesterase inhibitor donepezil, sold as oral, daily Aricept by Pfizer Inc. Read More
Robert Califf, whose nomination as FDA commissioner has been held up over the agency's response to the nation's opioid abuse epidemic, joined other FDA leaders Thursday in committing to an action plan to reassess the regulator's approach to the potent painkillers. Read More
