Topic:

Regulatory

Latest Headlines

Latest Headlines

Regulator suspends Spanish drugmaker over 'critical quality defects'

Regulators in Spain are punishing a Barcelona-based drugmaker for a series of manufacturing shortfalls, recalling all batches produced by the company, Farma Mediterrania, from 2014 to present. The crackdown is the second in as many months by Spanish authorities on local producers.

Medicare may experiment with caps to cancer-drug reimbursements

Look out, cancer drugmakers--the U.S. is weighing changes to how Medicare reimburses docs for administering pricey oncology drugs.

FDA pushes CTI to pull app for myelofibrosis med after trial deaths

The FDA has decided that the adverse events and deaths recorded in CTI BioPharma's pivotal program of the myelofibrosis drug pacritinib are so alarming that they've imposed a full clinical hold on the trial, halting dosing and persuading the biotech to yank its newly completed drug application.

Patient deaths force FDA to slam the brakes on PhIII program for CTI/Baxalta's pacritinib

After a follow-up review, the FDA has decided that the adverse events and deaths recorded in CTI BioPharma's pivotal program of the myelofibrosis drug pacritinib are so alarming that they've imposed a full clinical hold on the trial, halting dosing and persuading the biotech to yank its newly completed drug application.

China drug safety improving, CFDA says

The China Food and Drug Administration (CFDA) said in a recent report that the country's food and drug safety industry has improved and that cases of illegal or bad drugs fell in 2015 compared to 2014.

FDA maintains tight grip on Indian and Chinese products

The U.S. Food and Drug Administration rejected more than 13,000 products made in India in the 5 years between 2010 and 2015, according to FDA data cited in an Economic Times report, and rejected slightly more than 15,000 products made in China.

American pharma group says IP protection in India is weak

The Pharmaceutical Research and Manufacturers of America (PhRMA), one of the top bodies representing American pharmaceutical and biotechnology companies, said in its annual report that India's intellectual property rights protection is weak and the group added India to its "priority watch list."

FDA panel backs Pfizer and Celltrion's Remicade biosimilar over J&J's objections

A group of independent FDA advisers voted in favor of OK'ing Pfizer and Celltrion's take on the blockbuster inflammation treatment Remicade for all of the reference drug's approved indications, unswayed by protests from Johnson & Johnson.

Startup raises $7M, adds execs for FDA-reviewed, antibacterial hospital scrubs

Orlando, FL-based Vestagen Technical Textiles has raised $7 million to back its antibacterial hospital garments that it hopes to get through the FDA. The cash is expected to enable the upstart to get to market with its Vestex antibacterial textile, which it said can reduce harmful contaminants on garments, thereby reducing the spread of pathogens.

FDA nod for LifeWatch wireless, patch-based vital signs monitoring system

Swiss remote diagnostic monitoring company LifeWatch has secured a clearance from the FDA for its wireless, patch-based vital signs monitoring system. It's expected to be used first in medical facilities such as hospitals and nursing homes, but eventually the company expects to target the ambulatory care market as well.
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