Topic:

Regulatory

Latest Headlines

Latest Headlines

EMA: Faulty device didn't distort study findings for Bayer's Xarelto

Last December, European regulators said they were no longer sure whether results from a trial of Bayer's new-age clot-buster Xarelto were accurate thanks to a defect in a blood-clotting testing device used in the study. But the German pharma can breathe easy now.

Celltrion's take on J&J's Remicade is 'highly similar' to the original, FDA says

FDA staff signaled support for Celltrion's biosimilar of Johnson & Johnson's Remicade in documents released ahead of a key panel vote, a positive development for the South Korean company as it works with Pfizer to tap the U.S. market.

Celltrion's biosimilar of J&J's Remicade reviewed favorably by FDA staffers

FDA staff reviewers were supportive of the Remicade biosimilar from Celltrion ahead of next week's advisory committee meeting. The reviewers said that the drug is "highly similar" to the branded product in terms of safety, purity and potency. 

FDA shoots down Vertex's latest bid for Kalydeco expansion

Vertex has so far had a lot of success widening the patient pool for orphan drug Kalydeco. But in its latest quest for a label expansion, the FDA has stopped it in its tracks.

Biologic exclusivity provisions could scupper U.S. plan for TPP

As expected and as FiercePharmaAsia reported in October 2015, provisions in the torturously negotiated Trans-Pacific Partnership (TPP) trade pact that deal with the exclusive period on biologics look set to derail plans to have the deal approved by the U.S. Congress as early as May or June.

SciClone Pharma settles China-related FCPA case, board to review 'strategic' options

China-focused SciClone Pharmaceuticals is reviewing a range of "strategic alternatives" to enhance shareholder value fresh off a settlement with the U.S. Securities and Exchange Commission on possible violations of the Foreign Corrupt Practices Act, or FCPA.

FDA's Califf calls for 'sweeping re-examination' of policies in effort to fight opioid abuse

The FDA has been repeatedly criticized for expanding approvals for opioids in the face of an "epidemic" of abuse and overdoses. Today Dr. Robert Calif, President Obama's pick to head the agency, took that matter head-on, calling for a sweeping review of the agency's policies.

FDA lists difficult-to-use devices that will be subject to human factors validation testing

The FDA just released a draft list of devices whose applications for marketing approval should include human factors data to ensure usability is considered during the design and regulatory process. It also finalized a guidance from 2000, providing updated information on the methods by which companies should collect and submit human factors data.

Valeant chief calls on Medicare to allow controversial copay help from pharma

Drug companies can't currently help Medicare patients pay for out-of-pocket drug costs. But Valeant, which has come under the lens for its price-hike strategy, wants to change that.

Pear nabs $20M to woo FDA, launch prescribable apps for substance abuse, medication adherence

Biopharmas may be able to command hundreds of dollars a month for prescription medications, but it can be tough to get payers to cough up even a few bucks for an app that may offer comparable levels of benefit. So, one startup, Pear Therapeutics, has adopted the language of biopharma and it is looking to work tightly in tandem with drug companies with medication adherence apps.