07:00 , Mar 9, 2015 |  BC Week In Review  |  Company News

Ferring sales and marketing update

Ferring launched Cortiment MMX budesonide in Europe to treat adults with active mild to moderate ulcerative colitis in cases where mesalazine has not been sufficient. The approved dose is a 9 mg tablet taken...
08:00 , Nov 17, 2014 |  BC Week In Review  |  Clinical News

LT-02: Phase III started

Dr. Falk began the double-blind, placebo-controlled, German Phase III PROTECT-1 trial to evaluate 0.8 g LT-02 given 4 times daily and 1.6 g LT-02 twice daily in 762 adults with mesalazine-refractory UC. Patients who achieve...
08:00 , Dec 16, 2013 |  BioCentury  |  Strategy

Out in the cold

New excluded drugs lists devised by pharmacy benefits managers are raising the hurdle for reimbursement of drugs the PBMs' pharmacy and therapeutics committees consider to be clinically equivalent to cheaper drugs. Drugs that are not...
07:00 , Apr 2, 2012 |  BC Week In Review  |  Clinical News

Lialda mesalamine: Phase III data

Top-line data from the double-blind, international Phase III PREVENT2 trial in 592 patients showed that once-daily SPD476 missed the primary endpoint vs. placebo of a greater proportion of patients without recurrence of diverticulitis at week...
07:00 , Apr 2, 2012 |  BioCentury  |  Finance

Doubling down

Biotech investors lifted valuations across the board last quarter and made a handful of big bets that were driven by potential acquisitions, lawsuit settlements, strong earnings and positive clinical and regulatory news. At least one biotech...
08:00 , Dec 19, 2011 |  BC Week In Review  |  Clinical News

Asacol mesalamine regulatory update

FDA granted Warner Chilcott's request in a Citizen's Petition that the agency apply previously determined requirements to demonstrate bioequivalence to ANDA applications for generic versions of its Asacol mesalamine and Asacol HD to treat ulcerative...
07:00 , Sep 19, 2011 |  BioCentury  |  Finance

Abbott, Shire line up

Abbott, Shire line up AM-Pharma B.V. added two strategic investors in its latest funding round: the venture arms of Abbott Laboratories (NYSE:ABT) and Shire plc (LSE:SHP; NASDAQ:SHPGY). Ysios Capital Partners and Kurma Life Science Partners led the...
07:00 , Jul 25, 2011 |  BC Week In Review  |  Clinical News

Lialda mesalamine regulatory update

Shire said FDA approved an sNDA for Lialda mesalazine delayed release tablets for the maintenance of remission of ulcerative colitis (UC). The 5-aminosalicylate (5-ASA) mesalamine using Multi-Matrix system (MMX) technology is approved in the U.S....
07:00 , Jun 27, 2011 |  BC Week In Review  |  Clinical News

LT-02: Phase IIb data

Top-line data from a double-blind, international Phase IIb trial in 156 patients with mesalazine-refractory UC showed that 0.8 g LT-02 given 4 times per day met the primary endpoint of significantly reducing SCCAI scores from...
00:56 , Jun 22, 2011 |  BC Extra  |  Clinical News

High-dose LT-02 meets ulcerative colitis endpoint

Lipid Therapeutics GmbH (Heidelberg, Germany) said high-dose LT-02 given four times per day met the primary endpoint in a Phase IIb trial to treat mesalazine-refractory ulcerative colitis. A 0.8 g dose of LT-02 significantly reduced...