Tesaro Inc., of Waltham, Mass., said it submitted an IND for TSR-033, a monoclonal antibody targeting LAG-3. A phase I trial is set to begin in the middle of this year. Read More
Atlantic Healthcare plc, of Cambridge, U.K., started the rolling submission of its NDA with the FDA and filed its nonclinical package for alicaforsen to treat pouchitis, a form of inflammatory bowel disease. Read More
LONDON – The EMA is now planning for a post-Brexit future in which the U.K. national regulator – currently responsible for handling one-third of drug approval reviews in Europe – will have no involvement in the EMA’s work after March 30, 2019. Read More
Hope springs eternal in Alzheimer’s disease (AD), and Neurotrope Inc. sought to keep that aspiration alive when reporting top-line data from its phase II study of bryostatin-1 in patients with moderate to severe AD. Read More
Takeda Pharmaceutical Co. Ltd. subsidiary Ariad Pharmaceuticals Inc. won accelerated approval from the FDA for Alunbrig (brigatinib). The approval covers the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) who have progressed on or are intolerant to Pfizer Inc.’s Xalkori (crizotinib). Read More
Astrazeneca plc won FDA accelerated approval for durvalumab, its breakthrough-designated PD-L1 inhibitor, for treating locally advanced or metastatic urothelial carcinoma, a market in which it will face Roche Holding AG’s Tecentriq (atezolizumab), approved in May 2016. Read More
The findings of a Chinese study showing that some health care workers exposed to high doses of the TB pathogen Mycobacterium tuberculosis (Mtb) made protective antibodies against future infection, despite having had no previous latent TB infection, may have important implications for rational development of new therapeutic and protective vaccines. Read More
Ongoing market access barriers for U.S. pharma and medical device companies landed India, Canada and Colombia on the U.S. Trade Representative’s annual “Special 301” watch list again. Read More
Biopharmx Corp., of Menlo Park, Calif., closed a registered direct offering following its entry into securities purchase agreements with certain existing institutional investors for the purchase and sale of about 6.4 million shares of common stock at a price of 78 cents per share with 50 percent warrant coverage (representing warrants to purchase up to about 3.2 million shares of common stock). Read More
Aeterna Zentaris Inc.’s conference call with investors on the phase III failure of Zoptrex (zoptarelin doxorubicin) in endometrial cancer ended quickly and the company put off until its first-quarter earnings report next Tuesday details about what the blowup means for the company’s future. Read More
