Industry news

24 April 2017

Epic Sciences Announces Completion of $40 Million Series D Financing

Epic Sciences (Epic) announced today that the company has completed a $40 million Series D financing led by Hermed Capital. Altos Capital Partners, Domain Associates, Genomic Health, Pagoda Investment, Reach Tone Limited, RMI Partners, Sabby Capital and VI Ventures also participated in the financing. Epic is developing a portfolio of blood-based tests that predict drug response in cancer and recently partnered with Genomic Health to commercialize the OncotypeDx® AR-V7 Nucleus Detect™ test to leverage Genomic Health's world-class commercial channel and enterprise systems.

EU crushes U.K. hopes of retaining EMA after Brexit

Nick Paul Taylor / FierceBiotech

The European Commission has again sought to extinguish the United Kingdom’s lingering hopes of keeping the European Medicines Agency (EMA) in London after Brexit. Lead Brexiteer David Davis became the latest politician to claim London could retain the regulator earlier this week, only for a spokesperson for the commission to rubbish the idea.

20 April 2017

Clearside Biomedical, Inc. Announces Completion of Patient Enrollment in Phase 1/2 Open Label Clinical Trial of CLS-TA in Diabetic Macular Edema

Clearside Biomedical, Inc.  (Nasdaq:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, today announced completion of enrollment of an exploratory clinical trial (the “HULK” trial) of CLS-TA for suprachoroidal administration, its proprietary suspension formulation of the corticosteroid triamcinolone acetonide, with or without intravitreal Eylea® (aflibercept), for the treatment of diabetic macular edema (“DME”).

The New England Journal of Medicine compared FDA and EMA

GMP News

The New England Journal of Medicine compared review times for new therapeutic agents that were approved by the The Food and Drug Administration (FDA) or The European Medicines Agency (EMA) between 2011 and 2015.

New tuberculosis drug with proven efficacy tested in Russia

Marchmont Innovation News

Infectex, a Russian biomed company, has completed clinical trials for its SQ109 candidate “unparalleled elsewhere in the world,” as the developers say, the Skolkovo Foundation website  reported . Infectex claims this is the first new proven drug for tuberculosis in the global market in four decades. 

China to tighten rules against faking clinical trial data, criminal charges possible

Angus Liu / Fierce Pharma

Forged clinical trial data have hurt China’s reputation, and the country’s administrative and judicial branches are proposing new actions against such activities in a seemingly synchronized move, and criminal charges are on the table.

Can 2017's top launches hit blockbuster goals? Roche, AstraZeneca, Novo sure hope so

Tracy Staton / Fierce Pharma

When it comes to drug launches, who doesn’t love to gaze into a crystal ball? Here at FiercePharmaMarketing, we featured some of those numbers in a special report this February.

U.K. starts handing out £4.7B boost to science funding

Nick Paul Taylor / FierceBiotech

The United Kingdom has unveiled bioscience research investments facilitated by the government’s commitment to provide £4.7 billion ($5.9 billion) more in R&D funding over the next five years. Officials at the Biotechnology and Biological Sciences Research Council (BBSRC) have awarded cash to projects tackling topics including the role of epigenetics and the immune system in aging.

Nine blockbuster drugs to watch are making their debut, aiming at a $16B prize in 2021

John Carroll / Endpoints News

Clarivate Analytics listed the 9 blockbusters their analysts expect to see approved by the FDA this year, and only 4 of them have yet to get the green light in early Q2, including Novo Nordisk’s semaglutide, their GLP-1 drug for diabetes, and AstraZeneca’s PD-L1 checkpoint durvalumab.

Will request for pause in FDA quality metrics plan lead to it being killed as unneeded regulation?

Eric Palmer / Fierce Pharma

Tired of dealing with constant, but avoidable, lapses in drug manufacturing, the FDA’s CDER Director Janet Woodcock several years ago decided having drugmakers regularly report quality metrics would help the agency to focus on problem plants before matters got out of control. But even after winning significant revisions to the proposal, the industry is now asking the agency to hit the “pause” button on enactment.