LONDON – After years in the planning, a pan-European medicines authentication system, tracking drugs from production line to point of dispensing, went live last weekend. The European Medicines Verification System (EMVS) puts into effect the EU's falsified medicines directive, which was published in 2011. Between 10 billion and 14 billion packs of medicines moving around the EU each year will now have tamper-evident packaging and a unique identifier in a 2D barcode, that manufacturers will upload into EMVS, allowing individual packs to be tracked. Read More
The fear of being exposed to more public shame while Congress and states are scrutinizing the biopharma industry may be having an impact on at least one of the games brand companies have been playing. In its first update, the FDA added just three drugs to its list of innovators that allegedly have made it difficult for would-be competitors to get the 1,500 to 5,000 units of a reference drug generally needed to develop a generic, bringing the total list to 54 drugs Read More
The trillions of bacteria in the human gut microbiome have recently become slightly less gnomic, with a series of papers uncovering their identities, elucidating their exact contribution to drug metabolism and tracing potential links between the microbiome and the brain. Read More
NEW YORK – These days "it's almost mandatory to have a session" on immune-oncology, noted Roth Capital's Jotin Marango, kicking off the 21st annual BIO CEO & Investor meeting with a panel on reshaping the tumor microenvironment via immunotherapies. But, despite the excitement generated by what's happening in the field, there's "so much nuance and few people actually understand and appreciate it all," he added. Read More
The recent deal between Meiragtx Holdings plc and New Brunswick, N.J.-based Johnson & Johnson (J&J) arm Janssen Pharmaceuticals Inc. drew more eyeballs to companies targeting inherited retinal diseases (IRDs), which can only mean good things for the likes of Nightstar Therapeutics plc. Read More
DUBLIN – Finnish-Swiss firm Aurealis Pharma AG is spinning out its lead asset, AUP-16, a genetically engineered bacterial species in development for diabetic foot ulcer, into a new company, Aurealis Therapeutics AG, which has raised CHF7.8 million (US$7.8 million) in new cash to finance an upcoming phase I/IIa trial of the three-in-one combination therapy. Read More
HONG KONG – Samsung Bioepis Co. Ltd. has inked a deal for the mainland China market with investment firm C-Bridge Capital Partners LLC, which will generate a new company: Affamed Therapeutics. The licensing agreement covers multiple biosimilar candidates from Samsung Bioepis. This includes its third-wave biosimilars SB-11 and SB-12, which are ranibizumab and eculizumab candidates based on Genentech Inc.'s Lucentis and Alexion Pharmaceuticals Inc.'s Soliris, respectively. Read More
As part of its mutual recognition agreement with the EU, the FDA last week confirmed the capability of Poland and Slovenia to carry out good manufacturing practice inspections of biopharma facilities at a level equivalent to that of the U.S. Read More
Gossamer Bio Inc., of San Diego, said it priced its IPO of 17.25 million shares at $16 each for expected gross proceeds of $276 million. In addition, the company has granted the underwriters a 30-day option to purchase up to an additional 2.58 million shares at the IPO price. The shares are trading on the Nasdaq under the ticker symbol GOSS. Read More
3Sbio Inc., of Shenyang, China, and Boston-based Verseau Therapeutics Inc. said they have partnered to focus on the development and commercialization of monoclonal antibodies in the field of immuno-oncology for a broad range of cancers. Read More
