Topic:

Regulatory

Latest Headlines

Latest Headlines

TxCell halts drug production, a decision made with French regulator

TxCell, a French biotech working on T-cell treatments for chronic inflammatory and autoimmune diseases, named Stéphane Boissel as its new CEO in April. And one of the first issues Boissel gets to confront is regulatory concerns over a pilot manufacturing facility.

CRO M&A ticks up in India, fueling hopes of turnaround

Contract research in India has seen a boost that, along with other green shoots news, has lifted the tone for an industry that has run through a rough patch of regulator and civil society scrutiny over claims of poor management and allegations of a disregard for patient safety and informed consent.

Ascletis plans China, Taiwan PhIII trials on chronic hep C therapies

China-based Ascletis Pharmaceuticals has notched up a first with plans for Phase III trials of danoprevir (ASC08) and ASC16 (PPI-668) to treat chronic hepatitis C in China and Taiwan. If successful, the trials could represent a milestone that could reach an estimated patient population of 30 million to 40 million, the highest worldwide.

ACIP gives Glaxo, Pfizer a lukewarm decision for new meningitis B vaccines

The CDC's Advisory Committee on Immunization Practices (ACIP) voted on Wednesday to expand its recommendation for meningitis B vaccines, but it wasn't the broad recommendation that many were hoping to see.

FDA slaps U.S. drugmaker over drug testing issues

When a company isn't even familiar with common QC language, it raises red flags for inspectors. Add to that an indication that batch-testing records are riddled with errors and it is a recipe for a warning letter, which is what a South Carolina drug manufacturer has earned from the FDA.

Hackers are targeting biotech with eyes on insider trading

The SEC is investigating data breaches at publicly traded biotech companies, according to Reuters, worried that hackers are stealing proprietary information to fuel stock bets.

UPDATED: Hospira finally up and running at its cost-cutting India plant

After dealing with two preapproval inspections and two dozen FDA observations, injectables specialist Hospira says it has gotten FDA approval and is ramping up production at its new plant in India.

Has Lundbeck failed to sharpen Brintellix's marketing edge with payers?

Lundbeck's new CEO Kåre Schultz just wrapped up his first month on the job, and chances are he's brainstorming about how to jump-start the company's Brintellix launch. And as Forbes ' John LaMattina notes, the answer might lie with payers.

Australia's Benitec heading for Nasdaq IPO

Australia's Benitec Biopharma plans to list on the Nasdaq in an initial public offering in the United States that would raise as much as $70 million, according to a June 23 proxy notice to existing shareholders.

S. Korea sees extra $9B in spending to handle MERS outbreak

South Korea has set out plans to spend an additional KRW10 trillion ($9 billion) to manage the outbreak of Middle East respiratory syndrome that has afflicted 179 and caused 27 deaths since May, news reports said.