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Home » Newsletters » BioWorld

BioWorld

March 28, 2019

View Archived Issues

Secondary offering in MS: Novartis' Mayzent cleared with cross-spectrum label

Trial designer and steering committee member Bruce Cree told BioWorld that the FDA made "a very wise decision" in assigning the broad label to Novartis AG's oral sphingosine 1-phosphate (S1P) receptor modulator Mayzent (siponimod) in multiple sclerosis (MS), "covering the continuum from clinically isolated syndrome all the way into active secondary progressive MS [SPMS]." Read More

Drug price reforms advance in U.S. House despite debate on 'nuclear' provisions

When the marketplace doesn't work anymore, Congress and government have to step in. This is one of those times, Rep. Frank Pallone (D-N.J.) said Wednesday as the House Energy and Commerce Subcommittee on Health began to mark up six bills aimed at increasing competition in the prescription drug market and lowering prices. Read More

Expert pitches controversial approach to tackle drug-resistant infections: government control

LONDON – The author of an influential U.K. government review on tackling drug-resistant infections globally has decried the vapid response of the pharma industry and suggested there should be moves to form a public utility-like company to buy up relevant assets and fill the gap. Read More

Big 'diff' separating drugs from FMT; FDA expected to offer guidance clarity

With further FDA guidance yet to come on how fecal microbiota transplants (FMTs) to treat Clostridium difficile (C. diff) infections will be regulated, investors continue to weigh the odds of drugs vs. the controversial but popular therapy. Read More

Lilly deepens commitment to immunology with Immunext deal

Eli Lilly and Co.'s new partnering deal with privately-held Immunext Inc. to research and globally license an antibody to treat certain autoimmune diseases is another sign that Lilly is deepening its commitment to the immunology space. Read More

New target surfaces for KRAS-driven cancers

By investigating the "surfaceome," the group of proteins that move to the cell surface in response to KRAS signaling, researchers have identified a protein, Syndecan-1, that is critical for KRAS-driven cancer cells to obtain nutrients from the environment. Read More

Transformation and translation: Evotec's Lanthaler urges biopharma to rethink its model

VIENNA – After nearly three days of partnering meetings and sessions touting the latest therapeutic advances such as cell and gene therapy and the microbiome, along with presentations depicting the unprecedented level of capital flowing into the sector, it would be easy to think the biopharma industry had reached optimal capacity. But as the BIO Europe Spring meeting came to a close Wednesday, Evotec AG CEO and Austria native Werner Lanthaler suggested that progress and innovation "aren't happening as fast as they should." Read More

Appointments and advancements

Synspira Inc., of Framingham, Mass., appointed Robert Gallotto president and CEO and to its board. Read More

Other news to note

Destiny Pharma plc, of Brighton, U.K., selected the Surrey, U.K.-based contract research organization Medpharm Ltd. as its partner to develop new topical formulations of the company's XF platform compounds, potential new treatments for dermal and ocular infections. Destiny said one product of the platform, XF-73 nasal gel, for the prevention of post-surgical infections, will begin phase IIb testing in 2019. Read More

Financings

Myokardia Inc., of South San Francisco, priced an underwritten public offering of 4.93 million shares of its common stock at $51 per share, the proceeds from which it will use to fund trials, preclinical programs, R&D and corporate needs, it said. Oppenheimer & Co. acted as the sole book-running manager. Myokardia shares (NASDAQ:MYOK) fell by $1.10 cents, or 2.1 percent, to $51 on Wednesday. Read More

Clinical data for March 27, 2019

Read More

Regulatory actions for March 27, 201

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