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Home » Newsletters » BioWorld

BioWorld

Jan. 4, 2016

View Archived Issues

It was a record year for FDA approval of new molecular entities

It was a busy December for the FDA as it gave the green light to five more new molecular entities (NMEs), boosting the number of NME and new therapeutic biological products approved by the agency in 2015 to 45, an almost 10 percent increase over the 41 NMEs that were approved last year. Read More

Lancet transit: GW trip with cannabidiol eased by new epilepsy paper

An article in Lancet Neurology shed fresh light, appreciated by investors, on GW Pharma plc's Epidiolex, a purified form of cannabidiol (CBD), in the works for two orphan drug indications, Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), genetic forms of epilepsy that are resistant to existing drugs. Read More

Flagship Venturelabs' start-up Rubius moving RCTs toward clinic

Armed with an initial $25 million investment from Flagship Ventures, Rubius Therapeutics Inc. is on its way to the clinic with a new therapeutic modality designed to harness the natural ability of red blood cells to interact with and modulate the immune system. Read More

Asia's drugmakers need to invest in compliance as unrealistic sales targets breed fraud

HONG KONG – New regulations, tighter policies and stronger enforcement in Asia Pacific have increased the risks of fraud in the life science industries and the cost of non-compliance or corruption. Employees in the region are also more conscious of their employers' ethical record. The result is a need for better and sustainable compliance programs for companies operating across Asia Pacific. Read More

Three research groups correct Duchenne gene by using CRISPR

Three independent groups of researchers have reported improving the symptoms of Duchenne muscular dystrophy (DMD) in mice by deleting mutated exons from the dystrophin gene using the CRISPR/Cas9 gene editing system. Read More

Som's drug repurposing push fails to ignite crowdfunder campaign

DUBLIN – Crowdfunding and drug repurposing are two current buzz topics in biotech, and it is not difficult to see how the former could be harnessed in support of the latter. Spanish firm Som Biotech SL, however, is discovering that logic alone is not sufficient to guarantee a successful campaign. Read More

Financings

Cancer Prevention Pharmaceuticals Inc., a Tucson, Ariz.-based company developing a new drug designed to prevent various types of colon cancer, has filed to raise up to $30.1 million in an IPO on the NYSE under the proposed symbol CPP. Read More

Holiday Notice

BioWorld's offices were closed Friday, Jan. 1 in observance of the New Year. Read More

Other news to note

Araim Pharmaceuticals Inc., of Tarrytown, N.Y., formed a long-term strategic partnership with Vault Bioventures to help advance its peptide library, which targets injuries and chronic diseases with unmet medical needs. The collaboration, triggered by positive findings from proof-of-concept studies in patient populations in two indications, is designed to leverage Araim's expertise in scientific discovery and research with Vault's capabilities in clinical and regulatory development and commercialization. Financial terms were not disclosed. Read More

Bench Press: BioWorld looks at translational medicine

Scientists from the British University of Exeter have developed a machine learning program that was able to identify synergistic drug combinations. Read More

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