15:20 , May 9, 2018 |  BC Innovations  |  Distillery Therapeutics

Musculoskeletal

INDICATION: Muscular dystrophy Mouse studies suggest that COX-2 inhibition could help treat Duchenne muscular dystrophy (DMD). In a mouse model of DMD, the COX-2 inhibitor Celebrex celecoxib decreased immune cell infiltration in tibialis anterior muscle...
18:21 , Apr 3, 2018 |  BC Innovations  |  Distillery Therapeutics

Neurology

INDICATION: Epilepsy Mouse studies suggest inhibiting COX-2 could help treat autosomal dominant lateral temporal lobe epilepsy (ADLTE), which is caused by LGI1 mutations. In cortex samples from a LGI1-knockout mouse model of ADLTE, levels of...
08:00 , Jan 21, 2013 |  BC Week In Review  |  Clinical News

Arcoxia etoricoxib regulatory update

The Scottish Medicines Consortium recommended against the use of Merck's Arcoxia etoricoxib on the National Health Service (NHS) in Scotland for the short-term treatment of moderate pain associated with dental surgery - its approved indication....
07:00 , Oct 4, 2010 |  BioCentury  |  Finance

4Q10 milestones

4Q10 milestones Company Product Indication Event Milestone Adventrx Pharmaceuticals Inc. (NYSE-A:ANX) Exelbine vinorelbine emulsion (ANX-530) Non-small cell lung cancer (NSCLC) Resubmit NDA 4Q10 Alexza Pharmaceuticals Inc. (NASDAQ:ALXA)/Biovail Corp. (TSX:BVF; NYSE:BVF) Staccato loxapine (AZ-004) Agitation in...
07:00 , Jul 5, 2010 |  BioCentury  |  Finance

2H10 milestones

2H10 milestones Selected products with Phase III or regulatory milestones expected in 2H10 Company Product Indication Event Milestone Actelion Ltd. (SIX:ATLN) Pivlaz clazosentan Prevent the occurrence of cerebral vasospasm following aneurysmal subarachnoid hemorrhage (aSAH) Ph...
08:00 , Dec 22, 2008 |  BioCentury  |  Product Development

Taking homework seriously

Despite having top-line Phase IIa data in hand showing efficacy for its NSAID in osteoarthritis, CrystalGenomics Inc. 's CG Pharmaceuticals Inc. unit is not rushing to get to Phase III. Instead, it is fleshing out...
07:00 , Jun 30, 2008 |  BC Week In Review  |  Clinical News

Arcoxia etoricoxib regulatory update

EMEA's CHMP recommended approval of Arcoxia to include treating ankylosing spondylitis, but also recommended that the product information be updated to include the risk of cardiovascular side effects, specifically warning that high blood pressure should...
08:00 , Jan 21, 2008 |  BioCentury  |  Regulation

Differences of opinion

Differences of opinion Differences of opinion U.S. and European regulators have made different decisions about the same drugs. Increasing intolerance for risk is driving FDA to request additional data or reject drugs that the EMEA...
08:00 , Jan 21, 2008 |  BioCentury  |  Regulation

Political goalposts

Political goalposts Political goalposts FDA has shifted the goalposts at late stages in drug development for several products over the last two years. In each of the cases below, the shifts have followed intense political...
08:00 , Jan 21, 2008 |  BioCentury  |  Regulation

System reset in 2008

Years of negative publicity over adverse effects of drugs and unrelenting political pressure to minimize risks have reshaped the American regulatory environment, effectively creating new requirements for approval that sponsors and investors ignore at their...