Industry news

Biotech's breathless quarter of IPOs brings in $2.1B for R&D

Damian Garde, FierceBiotech

Back in January, at the annual J.P. Morgan Healthcare Conference, across hotel lobbies and crowded hallways and standing-room-only cafes, one could hardly escape talk about the biotech IPO boom. More than 45 life sciences companies had made their way onto the public markets in the preceding year, banking more than $3 billion in the process, and many at the industry's annual sewing circle believed biotech was about to see its shadow on Wall Street. Furthermore, rumor had it at least 25 upstarts were already embarking on road shows and wooing underwriters, all looking to squeeze out of a shrinking window before it snapped shut and burst the biotech bubble in the process.

Biopharmaceuticals Approval Trends in 2013

Gary Walsh, PhD / BioPharm

In 2013, 19 products containing new biopharmaceutical molecular entities were approved in the United States and/or the European Union. Approval numbers for 2013 are above average as compared to the previous five years, which recorded a mean approval rate of 13 products. This annual approval rate was surpassed only in 2009, a year in which 20 new products came on the market.

Russia’s first commercial early-stage clinical trial center launched in St. Pete

Marchmont Innovation News

Russia’s first commercial R&D center for early-stage clinical trials opened in St. Petersburg last week as a joint project between the state-owned RVC Biofund and its portfolio company, BioEc, the RVC website  announced . 

New atherosclerosis therapy nears in vitro test phase in Siberia

Marchmont Innovation News

Scientists at Tomsk Polytechnic University and the local Research Institute of Cardiology are developing a new method of treating atherosclerosis using a coronary stent with a biodegradable coating,  reported  the website of Vesti-Tomsk, a regional TV and radio broadcasting company. 

05 April 2014

Duke spinout Regado files to raise up to $69M in new offering

Jason deBruyn, Triangle Business Journal

Duke University spinout Regado Biosciences has filed notice to sell new shares on the open market.

Siberians seek funding as they develop solution to many medical problems

Marchmont Innovation News

Scientists in Novosibirsk are seeking a Russian Scientific Fund grant in an effort to create a cell bank—a key to faster identification of most working therapies for a variety of human diseases, Nanonewsnet.ru  reported , citing Academician Valentin Vlasov, the director of the local Institute of Chemical Biology and Fundamental Medicine. 

Ministry of Health estimated the continued modernization of health trillion rubles

ITAR TASS

For modernization of fixed assets of the Russian health care system require more than one trillion rubles. So appreciated investment required deputy Sergei Regional Ministry of Health , according to ITAR -TASS.

Generic-Drug Testing Goes Widespread in U.S. FDA Effort

Anna Edney, Bloomberg

Generic drugs that make up almost 80 percent of U.S. prescriptions are being tested in the first widespread safety and quality evaluation run by the Food and Drug Administration.

FDA Drug Approvals 2013

Drugs.com

In 2013, the U.S. Food and Drug Administration (FDA) approved 27 New Molecular Entities (NMEs). 

EU Sets The Stage For Increased Pharmacovigilance Oversight And Harmonization

Amanda Sibley / Life Science Leader

With the overarching goal of improving transparency and accountability, the European Medicines Agency (EMA) has been taking a more comprehensive approach to pharmacovigilance, introducing a set of good pharmacovigilance practice (GVP) guidelines to the European market.