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Regulatory

Latest Headlines

Latest Headlines

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.

FDA panel backs game-changing cognitive claim for Lundbeck antidepressant Brintellix

Lundbeck is hoping that additional cognitive claims for its blockbuster-in-the-making Brintellix can help set the drug apart from its antidepressant competition. The Danish drugmaker recently got a boost after an FDA committee backed the drug's ability to improve thinking, attention and decision-making in patients.

Media-magnet hearing on Capitol Hill gets underway, with Valeant, Turing under spotlight

Pharma eyes are watching Capitol Hill on Thursday, where drug-price hikes will go on trial in a much-publicized congressional committee hearing. Valeant interim CEO Howard Schiller and ex-Turing Pharmaceuticals chief Martin Shkreli will get a grilling, though Schiller is the only one expected to answer any questions.

Abbott snags CE mark for continuous glucose monitor with no finger sticks for kids

Abbott has already made strides with its finger-stick free glucose monitoring system, snagging a CE mark for the product in 2014. Now the company is building on that success after the device recently won European approval for use in children, a feather in the company's cap as it aims for similar regulatory blessings in the U.S.

Two hep C patients strike back at insurers for limiting coverage of pricey treatments

Two patients in Washington state are suing insurers for restricting their access to the latest hep C treatments, the latest chapter in the saga over hep C pricing as insurers grapple with the meds' costs and often limit coverage as a result.

India's Sun Pharmaceutical meets Feb. 1 deadline for U.S. imatinib launch

Mumbai-based Sun Pharmaceutical Industries met an in-house deadline of Feb. 1 to launch sales of generic Gleevec/Glivec (imatinib) in the U.S. that included a savings card program to cut the co-payment out-of-pocket costs for the cancer treatment with certain pharmacies.

FDA hands Wockhardt and Ipca more disappointing news

It has been another tough week for some of India's troubled drugmakers. Wockhardt, which has two plants banned by the FDA, saw its hopes stymied for getting export approval for a different facility that it had hoped could help it recoup some of its lost U.S. revenues. And India's Ipca Laboratories, which has three plants on the import alert list, said Monday it has now gotten a warning letter for the facilities.

More link think? OPDP lists social media links as guidance item for 2016

The FDA's promotional police plan to address social media links for pharma again this year. Maybe. That is, the issue is on the agency's annual agenda of "new and revised draft guidances CDER is planning to publish during calendar year 2016." 

Amgen says it's awaiting reimbursement details after Japan Repatha nod

Amgen said that the approval for Repatha (evolocumab) in Japan filed by Amgen Astellas Biopharma K.K., a joint venture with Tokyo-based Astellas Pharma, could be launched within months pending reimbursement details.

India's patent office nixes Takeda diabetes application

The patent office in India has slapped down an application from Tokyo-based Takeda Pharmaceutical for its single-dose Type 2 diabetes treatment dipeptidyl peptidase 4 (DPP-4) inhibitor.
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