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Home » Newsletters » BioWorld

BioWorld

Oct. 31, 2016

View Archived Issues

Attorneys counsel at-ready stance on cyber-attacks

The rising tide of digital attacks touching politics, finance and retail also poses significant threats for the pharmaceutical and medical device industries. During a Thursday webinar, attorneys at King & Spalding LLP counseled that internal identification of "crown jewel" trade secrets, rigorous protection plans and an at-ready stance for incident response to thefts should form the core of corporate game plans. Read More

Financings

Promethera Biosciences SA, of Mont-Saint-Guibert, Belgium, raised €10 million (US$11 million) in a series C extension that included major existing shareholders Vesalius Biocapital, SRIW, Fund+, MGI Global Fund (Mitsui & Co.), Boehringer Ingelheim Venture Fund and SMS Investments. Read More

Other news to note

Acucela Inc., of Seattle, said the agreement regarding its proposed triangular merger was adopted by shareholders. Upon completion of the merger, Kubota Pharmaceutical Holdings Co. Ltd. will become a publicly listed Japanese holding company. Read More

In the clinic

Helocyte Inc., of New York, and the City of Hope research and cancer treatment center, said data from the phase I trial of Helocyte's Triplex vaccine were published online in Blood. Read More

Bench Press: BioWorld looks at translational medicine

Heat-shock proteins (Hsps) are typically intracellular chaperone proteins that help other proteins fold. But researchers at the National Human Genome Research Institute have discovered an extracellular role for Hsp60 in wound healing. Read More

India's TB drug R&D in need of more funding, innovation

NEW DELHI – While India's tuberculosis (TB) drug industry is generally geared to meet the country's enormous TB burden, which is mainly due to poor patient compliance and multidrug resistance, it is hampered by limited access to high-risk funding and hurdles in regulatory approval. Read More

Experts call on Brazil's Anvisa to improve clinical trial processes

SAO PAULO, Brazil – Brazilian regulators should move quickly to improve the processes involved in clinical trials in the country, said industry stakeholders gathered for the annual BIO Latin America conference. Read More

Butantan pledges pentavalent Zika vaccine by end 2017, early 2018

SAO PAULO, Brazil – Brazil's Butantan Institute is moving forward with the development of a Zika vaccine, which could be ready for the market by the end of next year or early 2018. Read More

Astellas laudin' claudin: $1.4B Ganymed buy after ASCO sees phase II 'Xtandi' and deliver

It was hardly rocket science that Jupiter moon-named Ganymed Pharmaceuticals AG's claudin 18.2-targeting antibody would draw big pharma's top cancer players to the table. And Astellas Pharma Inc.'s potential $1.4 billion takeover, with €422 million (US$461.3 million) up front plus another €860 million if progress milestones are met, gets not only the IMAB362 antibody but also Claudetect 18.2. Read More

Not gonna 'make' it: CRL re Regeneron's sarilumab lands on brink of PDUFA

Just ahead of the PDUFA date assigned to sarilumab, an end-of-the-week "oof" moment came for Regeneron Pharmaceuticals Inc. and Sanofi SA in the form of a complete response letter Friday regarding the BLA for their interleukin-6 antibody to treat adults with moderate to severe rheumatoid arthritis. Read More

Study suggests orphan drug legislation might be too successful

LONDON – A study by U.K. academics shows that orphan drug legislation designed to incentivize investment in treatments for rare diseases is generating products so profitable that investment in broader indications is being stifled. Read More

Q3 earnings reports weigh on Abbvie and Amgen, keep Biomarin and Seagen steady

Worries over slowing global sales of Abbvie Inc.'s largest product, Humira (adalimumab), and fears about the outlook for Amgen Inc.'s Enbrel (etanercept) dimmed the shine on shares of both companies by Friday's close, shaving 6.3 percent from Abbvie shares (NYSE:ABBV) and pushing Amgen shares (NASDAQ:AMGN) shares down 9.6 percent. Read More

New approach reverses liver scarring in NASH

Fatty liver is an exception to the rule that early intervention is best. Nonalcoholic fatty liver disease (NAFLD) is now the leading cause of liver failure. Read More

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