Industry news

FDA aknowledged hemophilia gene therapy as Breakthrough Designation

GMP News

BioMarin Pharmaceutical Inc. announced today that the U.S. Food and Drug Administration (FDA) granted valoctocogene roxaparvovec (formerly BMN 270) Breakthrough Therapy Designation. 

Chumakov Scientific Center starts clinical trials of inactivated polio vaccine

GMP News

M.P. Chumakov Federal Scientific Center for Research and Development of Immunobiological Products of the Russian Academy of Sciences submitted to the Russian Ministry of Health an application for clinical trials of the first Russian inactivated polio vaccine (IPV).

The Human Vaccines Project strives to gear up influenza vaccine development

GMP News

The Human Vaccines Project, a public-private partnership with a mission to decode the immune system to advance human health, announced the launch of the Universal Influenza Vaccine Initiative (UIVI), a first-of-its-kind program that will address the underlying scientific barrier impeding the development of broadly protective, universal influenza vaccines: the human immune response.

Center for Preclinical and Translational Research opened in St. Petersburg

GMP News

The working visit of the Russian Minister of Health Veronika Skvortsova to Saint-Petersburg was marked by the official opening of the Center for Preclinical and Translational Research of FSBI V.A. Almazov National Medical Research Center of the Ministry of Health of Russia, being the first organization of this type in the Russian Federation.

Sotex launches Russian-made medicines onto European market

GMP News

The production facility of Sotex, which is the core of the PROTEK Group manufacturing segment, received the European GMP certificate, expanding the capabilities of the company for global exports.

What’s driving the rapid growth of the top 20 biopharma companies in the world?

John Carroll / Endpoint News

I’ve been remarking for some time now that the whole biopharma sector globally has grown enormously over the past few years. And thanks to the investment bankers at Torreya I can add a few numbers to put that into perspective, along with the booming role that China has played and is likely to continue to play over the next generation.

Russian pharmaceutical market expands by 13.3% in September 2017

GMP News

According to DSM Group, in September 2017, the volume of commercial market for medicinal products was 59.6 billion rubles. Compared to August 2017, the market capacity increased by 13.3%. This year, the sales increased by 7.6% compared to September 2016.

Looking for a pharma marketing bump? Check out YouTube bumper ads, agency says

Beth Snyder Bulik / FiercePharma

Give Google six seconds and it’ll give your brand a bump. That’s the premise, anyway, behind the six-second video “bumper ads” it’s been selling on YouTube since last year. What kind of bump? Google said it tested 300 bumper ads in 2016, with 9 out of 10 driving “significant lift in ad recall.” While that might makes sense for consumer brands like Old Spice deodorant or Krispy Kreme donuts, what about more regulated pharma brands?

Russia becomes the first to register a new indication for botulinum toxin by Merz

GMP News

Merz, a pharmaceutical company, announced the expansion of indications for the use of Xeomin®, a botulinum toxin type A, in Russia. The Russian Ministry of Health has officially authorized its use for the treatment of certain types of foot deformity in children aged 2 to 18 years old with infantile cerebral palsy (ICP). This will substantially improve the opportunities for therapy of movement disorders and contribute to a more successful socialization of these children.

Without tax reform, pharma M&A's still sluggish—but biotech's red hot

Carly Helfand / Fierce Pharma

Back when the year began, the prospect of U.S. tax reform had pharma companies salivating for some M&A action. But with that reform still absent, drugmakers have put on the brakes instead.