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.

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.

India's local rotavirus vaccine launched to combat death linked to diarrhea

A new rotavirus vaccine created under a joint public-private partnership in India has launched this week to fight the serious and often fatal diarrheal disease in young children.

Big Pharma finds second chance for failed drugs in China

Biopharma companies that have struggled to make a splash in the U.S. or European markets with their new treatments are increasingly turning to China for a reprieve.

AZ approval for Tagrisso in Japan a big change to NSCLC treatment options in Asia

The Japan approval of AstraZeneca's Tagrisso (osimertinib), a first-in-class drug used to treat non-small cell lung cancer (NSCLC), represents a potential major change in treatment options in the country and brings on a comparison with the state-of-play with therapies available in China.

FDA cites Lupin Indian facilities for what drugmaker calls 'minor' issues

India's Lupin said in a Bombay Stock Exchange filing on Tuesday that it had received four observations for two plants at its Mandideep site following a two-week inspection by the FDA in February.