The principal investigator for the original proof-of-concept study with just-approved epilepsy drug Briviact (brivaracetam) told BioWorld Today she's campaigning to get the FDA to cut the "add-on" description for such therapies, because there is "no indication that a drug that works as an add-on would not work by itself," and the tag is confusing to everyone – including payers. Read More

In a telling example of the growing importance of the gastrointestinal market, the main quibbles during the recent Arthritis Advisory Committee (adcom) meeting to discuss the application for CT-P13 (infliximab) – Celltrion Inc.'s biosimilar to Remicade (infliximab, Janssen Biotech Inc.) – focused more on the FDA's willingness to extrapolate clinical findings in rheumatoid arthritis and ankylosing spondylitis to inflammatory bowel disease (IBD) and related GI conditions than to the indications supported by clinical studies. Read More

Using a nanoparticle-based approach, researchers have succeeded in triggering the formation of regulatory T cells in animal models of multiple autoimmune diseases. If the findings, which were published in the Feb. 17, 2016, advance online issue of Nature, pan out clinically, it may be possible to halt or reverse autoimmune disease by specifically dampening the maladaptive autoimmune response. Read More

HONG KONG – Three months after its first Chinese deal, South Korean clinical-stage biotech company Genexine Inc. (KOSDAQ:095700) is continuing its venture into China by out-licensing another drug candidate to one of the country's leading pharmaceutical companies. Read More

Strategia Therapeutics Inc., of Boston, has started a U.S.-based phase I trial of the antimetabolite agent FF-10502 in patients with advanced solid tumor cancers and lymphoma. Read More

Opioid-induced constipation (OIC) is among a handful of functional gastrointestinal disorders that have galvanized drug development efforts in recent years. Shionogi & Co. Ltd. is now looking to make its mark in the space. Read More

Ironwood Pharmaceuticals Inc., of Cambridge, Mass., reported U.S. net sales of Linzess (linaclotide), its drug for irritable bowel syndrome with constipation and chronic idiopathic constipation, totaling $129.7 million for the fourth quarter and $454.8 million for full-year 2015, as reported by partner Allergan plc, of Dublin. Read More

Effector Therapeutics Inc., of San Diego, said it increased its series B financing to a total of $56 million. The new funding came from new investor Sectoral Asset Management, as well as existing investors. Sectoral's Maha Ktabi was appointed to Effector's board. Read More

Mylan NV, of Canonsburg, Pa., said its abbreviated new drug application for fluticasone propionate 100 mcg, 250 mcg, 500 mcg and salmeterol 50 mcg inhalation powder has been accepted for filing by the FDA, which provided a GDUFA goal date of March 28, 2017. The product is the generic version of London-based Glaxosmithkline plc's Advair Diskus for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease. Read More

Kempharm Inc., of Coralville, Iowa, reported data from an oral human abuse liability, pharmacokinetic and safety study of KP201/APAP at the American Academy of Pain Medicine meeting in Palm Springs, Calif., showing that KP201/APAP was associated with lower exposure to hydrocodone at the eight- and 12-tablet doses compared to Norco (hydrocodone bitartrate/APAP), while exposure at the low-dose (four tablets) was bioequivalent. Read More

Scientists from Harvard University have engineered stomach cells to have functional similarities to pancreatic beta cells, including the ability to produce insulin and prevent hyperglycemia (high blood sugar) when they were transplanted into mice. Read More