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Home » Newsletters » BioWorld

BioWorld

May 24, 2017

View Archived Issues

In the clinic

Prometic Life Sciences Inc., of Laval, Quebec, presented data at the American Thoracic Society International Conference in Washington, including results from a phase II study showing that lung function in 25 idiopathic pulmonary fibrosis patients receiving either PBI-4050 alone or PBI-4050 in combination with Ofev (nintedanib, Boehringer Ingelheim GmbH) remained stable as measured by the difference between the forced vital capacity (FVC) at baseline and following 12 weeks of treatment. Read More

Other news to note

Vaxil Bio Ltd., of Toronto, hired Barcelona-based BCN Peptides SA to manufacture a new batch of its lead candidate, Immucin (VXL-100), intended for use in the company's upcoming trials, including multiple myeloma and/or solid tumor indications. Read More

Financings

G1 Therapeutics Inc., of Research Triangle Park, N.C., said it closed its IPO of 7.78 million shares of common stock at $15 per share, including 781,564 shares sold following the partial exercise of the underwriters' option to purchase additional shares. Read More

Regulatory front

Although several members of Congress, both Republicans and Democrats, have expressed support for Francis Collins remaining as head of the NIH, not all U.S. lawmakers agree. Read More

2018 budget proposal would fund reviews entirely with user fees

In a move that took no one by surprise, the Trump administration has released a budget proposal for fiscal 2018 that calls for nearly $6 billion in cuts to the NIH budget, but the proposal also calls on industry to pay for all premarket review costs with user fees, which would require a $1.3 billion increase in total FDA user fees. Read More

Sanofi, Regeneron win approval for sarilumab in rheumatoid arthritis

Following an initial rejection over manufacturing issues, FDA approval for the rheumatoid arthritis (RA) therapy sarilumab arrived late Monday. Read More

First flesh-eating bug drug passes futility analysis in pivotal ph III

Encouraged but still cautious, Dan Teleman, CEO of Atox Bio Ltd., was careful not to raise expectations about the eventual outcome of the ongoing phase III ACCUTE (AB-103 Clinical Composite endpoint StUdy in necrotizing soft Tissue InfEctions), which is evaluating reltecimod (previously AB-103) in patients with necrotizing soft tissue infections (NSTIs), or so-called "flesh-eating" bacteria. Read More

Hospira's Retacrit next biosimilar on tap for FDA

The U.S. biosimilar pipeline continues to trickle, with Hospira Inc.'s epoetin follow-on the next one on tap. Read More

Bioverativ paying up to $825M for rare blood disorder specialist True North

Biogen Inc. spin-off Bioverativ Inc. will pay $400 million up front plus assumed cash to acquire True North Therapeutics Inc., a privately held Ipierian Inc. spinout with an early stage FDA breakthrough-designated candidate for the rare blood disorder cold agglutinin disease (CAD). Read More

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