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Home » Newsletters » BioWorld

BioWorld

May 3, 2018

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Clinical data for May 2, 2018

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Earnings

United Therapeutics Corp., of Silver Springs, Md., reported revenue of $389 million in the first quarter. Sales of top-selling pulmonary arterial hypertension (PAH) drug Remodulin (treprostinil injected) were $126.8 million while fellow PAH drugs, Tyvaso (treprostinil inhaled) and Adcirca (tadalafil), registered sales of $94.6 million and $97.6 million, respectively.  Read More

Other news to note

Evotec AG, of Hamburg, Germany, said it expanded its CRISPR service offering with the addition of a license from ERS Genomics Ltd., of Dublin. Evotec gains access to the leading technology for gene editing by way of the license.  Read More

Financings

Onconova Therapeutics Inc., of Newtown, Pa., closed its previously announced offering of about 67.6 million shares of its common stock for 42.5 cents per share. The offering included warrants to purchase about 8.8 million 8.8 million shares of common stock and 220,588.225 shares of series B convertible preferred stock.  Read More

Thinking on a global scale, Emergex Vaccines using lessons from Ebola outbreak

LONDON – The lessons of the Ebola epidemic have come together with a series of scientific advances, and expertise acquired over a lifetime in biotech, to inspire a novel vaccine technology that is designed to provide genus-wide protection against viral infections. Read More

Refuge closes $25M series B with China twist

Refuge Biotechnologies Inc., a company developing chimeric antigen receptor (CAR) T-cell therapies designed to enable multitargeted cancer treatment, has raised a $25 million series B round. The new funds will support advancement of multiple CRISPR-leveraging candidates, including the company's lead, the preclinical CAR RB-1916 for diffuse large B-cell lymphoma. Read More

Deaths divert Wall Street attention in Esperion's BA phase III; endpoint winner

Despite Wall Street's harsh reaction to Esperion Inc.'s second, successful phase III trial with bempedoic acid (BA) in dropping low-density lipoprotein cholesterol (LDL-C), analysts found the data salutary in the big picture and supportive of approval. "All in all, there are some positives here and it's good enough to cross the bar in our view, but also [there are] some issues [that] the bears will try to harp on vs. 'expectations,' which is what is impacting the stock," wrote Jefferies' Michael Yee in a report. Read More

Plazomicin gets split decision on LPAD path to first approval

As the tenor of presentations by officials from Achaogen Inc. and the FDA at Wednesday's Antimicrobial Drugs Advisory Committee (AMDAC) meeting seemed to suggest, the new drug application (NDA) for plazomicin received a ringing 15-0 endorsement in passing the safety and efficacy bar to treat complicated urinary tract infections (cUTIs) caused by multidrug-resistant pathogens, including Escherichia coli, Klebsiella pneumoniae, Proteus spp and Enterobacter cloacae. However, with 11 opposed and four in favor (one committee member left early and did not vote on either question), the aminoglycoside antibacterial candidate drew a strong thumb's down for the treatment of bloodstream infections (BSIs) caused by K. pneumoniae and E. coli. Read More

BRIC road still paved with regulatory hurdles and trade barriers

When the 21st century dawned, the global marketing map for U.S. drug and device companies looking to expand came with one simple direction: Follow the BRIC road. Read More

Regulatory actions for May 2, 2018

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