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Home » Newsletters » BioWorld

BioWorld

May 2, 2017

View Archived Issues

In the clinic

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

Other news to note

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

Spending bill ignores the president’s calls for NIH, FDA cuts

True to their word, U.S. lawmakers are pushing forward with plans to give the NIH its second consecutive $2 billion funding bump. Read More

Against industry wishes, post-Brexit EMA to leave U.K. out in the cold

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

Neurotrope shares swoon on weak signal in Alzheimer’s phase II

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

Ariad wins accelerated approval for second-line NSCLC drug brigatinib

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 joins I-O party, gets FDA nod in bladder cancer

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

Antibody study may change TB vaccine design

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

U.S. trade rep names the usual suspects; PhRMA adds Australia

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

Financings

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

Holy Macrilen: No Zoptrex but hope springs Aeterna for FDA-bound AGHD test

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

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