Earlier this month, India's Supreme Court bemoaned that unregulated clinical trials were "causing havoc" in the country, demanding that the Central Drugs Standard Control Organization explain how it intends to fix the situation. Now the regulator has until the end of the mont to come up with some answers.
In the wake of Abbott Laboratories' initiation of a large clinical trial for its Absorb dissolvable drug-eluting stent, the smaller Biotronik is inching its way to a spot in the emerging market. But carving out that niche has proven difficult for the private German company.
Amgen, which has been riding a wave of investor goodwill, is looking to produce products in Asia to be closer to that rapidly growing market.
Privately-owned ophthalmic company Clearside Biomedical has gained the go-ahead from the FDA to begin clinical trials of CLS1001, an injectable formulation of triamcinolone using its microneedle technology.
In India, drug-related clinical trial deaths rose in 2012, and sponsors and CROs remain loath to pay compensation to families.
Abbott ($ABT) this week launched a massive U.S. clinical trial for its Absorb drug-eluting bioresorbable vascular scaffold, with plans to enroll up to 2,250 patients. If the results pass muster, they'll support the company's FDA approval bid.
The clamor for reform of India's clinical trial regulations has reached a fever pitch over the past year, and now the country's Supreme Court is ordering the Health Ministry to keep a close eye on applications for new studies.
With cloud-based software to get clinical trials off the ground faster, goBalto has reeled in $12 million in a new round of financing with backing from wireless giant Qualcomm's Life Fund and others. Its new investor hopes goBalto's platform can address the steep rise in the cost of developing new therapies.
India's clinical trial regulations (or lack thereof) have long been the subject of international debate, and now the country's National Commission for Protection of Child Rights is looking to enact standardized rules for trials on children, saying many are subjected to studies without their parents being made aware.
Strong Phase II data for Pfizer's dual-kinase blocker for breast cancer has analysts anticipating a "mega-blockbuster."