Jazz Pharmaceuticals plc ended a nearly seven-year spat over its blockbuster narcolepsy treatment, Xyrem (sodium oxybate), by granting Hikma Pharmaceuticals plc the right to sell an authorized generic version of the drug under its new drug application (NDA) in the U.S., beginning Jan. 1, 2023. Read More
Investors may not have cherished high hopes for Allergan plc's phase II effort with Botox (onabotulinumtoxin type A) in major depressive disorder (MDD), nor are the results uniformly positive, but the company is forging ahead anyway with plans for a phase III experiment. Read More
With the off-label/intended use controversy still simmering, a bill has debuted in the U.S. House of Representatives that would restrict the federal government's ability to pursue charges against manufacturers of drugs and devices based merely on "actual or constructive knowledge" on the part of the manufacturer that the drug, device or biologic will be used outside the FDA-approved labeling. Read More
SHANGHAI – Shanghai-based biotech Zai Labs Ltd. is adding biologics manufacturing capabilities to its business model of developing new drugs for China via in-licensing assets and in-house biologics discovery. Read More
HONG KONG – The global market for traditional Chinese medicine (TCM) is growing rapidly as researchers make strides in applying modern drug development techniques to TCM development. However, regulatory hurdles for TCM clinical trials are slowing down progress. Read More
MGB Biopharma Ltd., of Glasgow, Scotland, raised $1.15 million in a financing round with existing investors. The company will use the funds to advance its lead product, MGB-BP-3, toward a phase II trial to investigate the safety and efficacy in patients with Clostridium difficile-associated disease, including disease caused by the most virulent ribotype, B1/NAP1/027. Read More
Blackthorn Therapeutics Inc., of South San Francisco, said preclinical study results for its kappa opioid receptor (KOR) antagonist BTRX-335140 were presented at the Therapeutic Potential of Kappa Opioids conference in Philadelphia. Read More
Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan, reported top-line results from a phase III trial testing Parkinson's disease candidate Trerief (zonisamide) in patients with Parkinsonism in dementia with lewy bodies (DLB), which met the primary endpoint. Read More
The U.S. Court of Appeals for the Federal Circuit cleared an obstacle Thursday to Mylan NV's pursuit of a generic version of The Medicine Co.'s anticoagulant drug Angiomax (bivalirudin). Read More
