Topic:

Regulatory

Latest Headlines

Latest Headlines

PwC: Biopharma must turn to tech to address surge in data integrity violations

Over the past few years, regulators have frequently found fault with data integrity at manufacturers and CROs, which have been accused of everything from logging discrepancies in uncontrolled Excel files to the duplicating of electrocardiogram results. In response, PricewaterhouseCoopers is calling for adoption of technologies to identify and prevent fraudulent activities.

Alibaba Health drops China online pharmacy plans, blames complex regulatory environment

Exactly one year after Alibaba announced it wanted to integrate its pharmacy business into its health unit and sell more drugs online, the Chinese e-commerce giant has now dropped its plans citing growing concerns over its country's healthcare landscape.

Samsung Bioepis gets positive CHMP opinion on Remicade biosimilar

Incheon-based Samsung Bioepis won a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for its Remicade biosimilar, paving the way for more competition in reimbursed markets in Europe.

CMS report adds more pressure on embattled Theranos and its blood testing device

What began as a bad week for embattled blood-testing company and former Wall Street darling Theranos veered toward worse yesterday when a federal inspection report was released, finding the accuracy of the company's revolutionary device consistently failed to meet even its own standards.

Novartis says Turkish ministry deemed bribery allegations 'unsubstantiated'

Novartis says that whistleblower allegations that it used bribes in Turkey to win business is old news that has already been deemed unsubstantiated by labor authorities in that country. Maybe so, but the chief prosecutor's office in Ankara is taking its own look into the allegations.

FDA publishes more biosimilar labeling advice after pharma voices its concerns

The FDA has released further draft guidelines on how biopharma should name their new copycat biologics in what has been described as a "positive for the biosimilars industry," but problems over interchangeability remain.

FTC lassos Endo, Allergan and Impax in pay-for-delay suit

Just when it seemed like the Federal Trade Commission campaign against "pay-for-delay" pharma deals had gone quiet, the agency has sued Endo, Allergan and Impax Laboratories for striking a deal to prevent authorized generics of two drugs from hitting the market.

Congressional investigation says tainted Chinese heparin may still be in U.S.

In 2008, contaminated raw heparin from China was tied to the deaths of dozens of U.S. dialysis patients, leading the FDA to realize it needed inspectors in China to oversee manufacturers. But a House investigation, launched that year and still ongoing, is questioning whether the FDA has done enough and whether the tainted heparin may still be getting into the U.S.

UPDATED: Catalent issues lead to CRL for OPKO

Miami-based OPKO said on Wednesday that it has received a complete response letter for a drug it hopes to launch yet this year. But the reason for the CRL had nothing to do with the safety, efficacy or labeling of the drug. Instead, OPKO execs say, it was laid entirely at the feet of Catalent, the contract manufacturer that is manufacturing OPKO's candidate.

FTC digs deeper into Pfizer's proposed combo with Allergan

Not so fast, Pfizer and Allergan. Regulators are looking for more information on their agreed-upon megamerger before allowing it to proceed.