Industry news

Indian pharma representatives will visit exhibition in St Petersburg

GMP News

Responding to Russia’s call for collaboration in the pharmaceutical sector, India is planning to turn an exhibition for domestic drug producers in St Petersburg in September into a hunting ground for companies interested in joint ventures to tap the vast Russian market.

New Guide Outlines Risks for Cross Contamination

BioPharm International

A new guidance document from the International Society for Pharmaceutical Engineering (ISPE) provides a scientific, risk-based approach for managing the risk of cross contamination within shared pharmaceutical manufacturing facilities.

BioPhorum Launches Biomanufacturing Technology Roadmap

BioPharm International

On July 20, 2017, the BioPhorum Operations Group (BPOG), a cross-industry collaboration, announced it published The Technology Roadmap for the Biopharmaceutical Manufacturing Industry, to address the pressure biomanufacturers face to innovate biomanufacturing platforms. Biomanufacturers are facing pressure from current biopharmaceutical industry trends, including continued market growth, the arrival of new product groups, cost pressure, and the trend toward localized manufacture. BPOG’s technology roadmap identifies common biomanufacturer needs and shares those needs with supply partners, academics, regional innovation hubs, regulators, and government agencies, to align directions and enable pre-competitive collaboration.

Drug spending in U.S. tops the world. Translation: No pricing-headache relief soon

Beth Snyder Bulik / FiercePharmaMarketing

What will it take for pharma to get the drug-pricing monkey off its back? A research report this month laid out the pricing landscape, tensions and problems pharma companies face. At the top of the list? The unrivaled access U.S. patients enjoy comes at a cost.

FDA assigns orphan status to a Russian drug

GMP News

The US Food and Drug Administration (FDA) assigned an orphan status to a drug for the treatment of myeloid leukemia, which is being developed by Fusion Pharma, a resident of Skolkovo Foundation’s biomed cluster. This means that the regulator recognized the uniqueness of the drug and importance of its trials, which guarantees increased attention and assistance in the process of further development from FDA. This is the first time when a drug fully developed in Russia received such status in the United States.

Pharma's U.S. reputation is bad—and Trump may be to blame: survey

Beth Snyder Bulik / FiercePharmaMarketing

The pharma industry’s reputation among patient groups in the U.S. has sunk to a recent low, and some are pointing to the country's leader as the reason.

FDA’s Scott Gottlieb is fielding a new team of recruiters to start scouting top talent

John Carroll / Endpoints News

Biotech execs have been bullish supporters of the FDA in recent years, offering their appreciation of faster review times with new programs like the breakthrough therapy designation. But if there’s one recurrent gripe you hear frequently, it’s that the regulators biopharma companies and patient advocates deal with don’t have the right kind of scientific experience for the drugs under review — especially as you stray outside of oncology.

EU watchdog asks if drugmakers influence EMA decisions

Nick Paul Taylor / Fierce Biotech

The European Union is investigating whether presubmission meetings with the EMA enable drug companies to influence marketing authorization approval decisions. Officials at the EMA must now allay concerns their meetings with sponsors introduce a source of bias into their decision-making.

Russian pharmaceutical products included in the priority export list

GMP News

Dmitry Medvedev signed the Order No. 1473-r of July 12, 2017, approving a list of products (goods, works, services), the export of which will be supported by federal executive authorities as being a priority.

Pharma’s best digital embracers? They’ve got these 4 traits in common: expert

Carly Helfand / FiercePharma

Pharma still lags behind other sectors when it comes to adopting digital technology. But some companies are doing better than others—and those companies have a few things in common, one consultant says.