Industry news

FDA breaks up international scam putting bogus FDA labels on drugs

Eric Palmer / Fierce Pharma

The FDA has put another operator out of business that was falsely selling foreign-made drugs as if they were FDA-approved, but this one put a new twist on the practice. He bought drugs manufactured in India and elsewhere, doctored them to appear as if they were made in the U.S. and FDA-approved, then sold them to unsuspecting clients in other countries instead of the U.S.

China's biopharma boom at tipping point for growth, WuXi's Li says

Explosive growth for China's biopharma industry spurred by the return of talent after high-profile stints at companies and universities in the U.S. will accelerate in the coming two decades, the chief of the country's top CRO tells Bloomberg.

28 June 2016

Results from Phase 2 Exploratory Clinical Study Support Continued Development of Ganaxolone in Fragile X Syndrome

Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today announced top-line data from a Phase 2 exploratory, investigator-sponsored study to evaluate the safety, tolerability and efficacy of ganaxolone for the treatment of anxiety and attention in children with Fragile X Syndrome (FXS). The investigator selected Clinical Global Impression of Improvement (CGI-I), which is a broad scale to assess the overall improvement  across the entire Fragile X Syndrome, as the primary endpoint of the study.

GlobalData on the difficulties and opportunities of Brexit for pharma

Victoria White / European Pharmaceutical Review

While the exit of the UK from the EU undoubtedly creates significant issues for the UK pharmaceutical industry in ensuring highly regulated European markets remain open to business, opportunities remain for the sector to thrive, according to research and consulting firm GlobalData.

Reactions to the EU Referendum

Victoria White / European Pharmaceutical Review

Steve Bates, Chief Executive of the UK BioIndustry Association (BIA), commented on the news: “This is not the outcome that the BIA wanted but we accept the views of the UK people. The life sciences sector is a resilient community, unfazed by new challenges and staffed by great management teams used to working in a global environment. The fundamentals of UK bioscience remain strong. In terms of potential new therapies in the pipeline, the UK is by far the strongest in Europe. But several key issues for our sector are now in flux.”

Japan biotech sector to benefit from delay in consumption tax hike

Richard Smart / BioWorld

Biopharmaceutical companies look to benefit, at least in the short term, after Japan's Prime Minister Shinzo Abe put off a planned 2 percent consumption tax hike scheduled for 2017. The increase now will not be introduced until at least October 2019. For biopharma companies, the move is likely to eliminate some uncertainty going forward.

‘A dark day for U.K. science’ as Britain votes to break with EU

Nuala Moran / BiWorld

 There is alarm, concern and even heartbreak across the biotech and pharma industry and among leading scientists at the vote to leave the EU. “This is not the outcome the Bioindustry Association wanted,” Steve Bates, CEO told BioWorld Today. “Key questions about the regulation of medicine, access to the single market and talent, intellectual property and the precise nature of the future relationship of the U.K. with Europe, are now upon us,” Bates said.

27 June 2016

Tobira’s Cenicriviroc Reduces Inflammation and Fibrosis in Animal Models of Chronic Liver and Kidney Disease Including NASH

Tobira Therapeutics, Inc. (NASDAQ: TBRA), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel treatments for liver and inflammatory diseases, today announced that data from multiple animal models showed that cenicriviroc (CVC), a potent inhibitor of two chemokine receptors, displayed potent anti-inflammatory and anti-fibrotic activity in multiple organs including liver and kidney.

Uncertainty for biotech as U.K. exits EU, prime minister to resign

Ben Adams / Fierce Biotech

It was a shock result for the U.K. this morning as the public decided by a narrow margin of 52-48 to leave the European Union, in what will have a profound impact on the economy and the life sciences industry--and has already claimed the scalp of the country's leader.

Cancer immunotherapy may increase risk of developing rheumatologic disorders: Johns Hopkins study

Stacy Lawrence / Fierce Biotech

Johns Hopkins University researchers have found a link between cancer immunotherapy drugs and an increased risk of developing rheumatologic disorders—that they expect to only be exacerbated as their use increases. They conducted what’s thought to be the largest published study of patients taking immunotherapies aimed at examining the potential connection between the drug class and these sorts of diseases.