Shares of Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) gained $17.76, or 13.3 percent, to close at $151.31 Tuesday after briefing documents posted by the FDA ahead of Thursday's meeting of the Gastrointestinal Drugs Advisory Committee (adcom) suggested a favorable review of the new drug application for obeticholic acid (OCA). Read More
Stepping out Tuesday as the second biosimilar approved in the U.S., Pfizer Inc.'s Inflectra is decked out in a label, replete with extrapolated indications, that reflects the FDA's most recent guidance. Read More
LONDON – The EMA has given the nod to Glaxosmithkline plc's (GSK) Strimvelis, the second gene therapy to get regulatory endorsement in Europe and the first such product to offer an effective cure for an inherited disorder following one-off treatment. Read More
HONG KONG – South Korea's Samsung Bioepis Co. Ltd. has taken another step forward in its push to market biosimilars globally having received positive feedback from the EMA for its biosimilar to Remicade (infliximab, Janssen Biotech Inc.). The company is now expecting an approval soon. Read More
Their excitement is palpable: physicians, stem cell researchers and genome experts aglow over Ottawa's proposal to funnel up to C$800 million (US$608.9 million) for innovation networks and technology clusters across Canada. That includes more than C$237 million to Genome Canada and C$12 million over two years to support Canada's Stem Cell Networks (SCN). Read More
STOCKHOLM – The academic-industry interface emerged as a significant topic during discussions on day two of the BIO-Europe Spring meeting. And while one session focused on the perceived failings of academia – particularly Europe's universities and the surrounding innovation ecosystem – a later session on early stage drug development provided a salutary reminder that industry also has plenty of shortcomings to address if the drug development process is to become more efficient. Read More
STOCKHOLM – Speaking at the BIO-Europe Spring meeting in the heart of mobile communications giant Ericsson AB's Swedish headquarters complex, representatives of Merck KGaA, Abbvie Inc. and others suggested that while the platform for digital health technologies is strong in Sweden, much work remains left to be done to sort out how best to manage its technical complexities and assess its value. Read More
SHANGHAI – In China, meeting the country's unmet medical needs is a frequent topic of discussion. For biopharmas, that can mean filling the substantial gap between which drugs are available in developed markets and which are available for patients here. Read More
As part of its commitment to improve drug safety under PDUFA IV, which was signed into law more than eight years ago, the FDA revised its guidance on what sponsors should include in a complete submission for a proprietary name for a new drug or biologic. Read More
Iq3 Corp. Ltd., of Sydney, said it syndicated an investor consortium, which include Iq Group Global entities, to enter a joint venture to develop and commercialize an oncology biologic compound and biomarker. Read More
Achaogen Inc., of South San Francisco, accelerated the expected timeline to report results from its ongoing phase III EPIC (Evaluating plazomicin in cUTI) registration trial of plazomicin, its lead candidate to treat serious bacterial infections due to multidrug-resistant Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE). Read More
Sorrento Therapeutics Inc., of San Diego, said institutional investors and its strategic corporate partner, Yuhan Corp., of Seoul, South Korea, agreed to invest up to approximately $150 million in separate private placements in newly issued common stock priced at $5.55 per share and warrants to purchase additional common shares with an exercise price of $8.50 apiece. Read More
