Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Alibaba health initiative takes it on the chin with CFDA move, lawsuit

Chinese Internet giant Alibaba suffered two blows this past week: the China Food and Drug Administration (CFDA) announced that it will no longer work with the company on an initiative to track medicines to ensure their authenticity, and a pharmacy chain has filed a lawsuit against the company saying the initiative gave it an unfair advantage over other drug sellers.

Merck sets $54K list price for hep C combo as it preps for battle with Gilead, AbbVie

Industry watchers have long been speculating on how Merck would take on heavyweights Gilead and AbbVie when it priced its new hep C regimen. And now, they have their answer: Undercut them. Big-time.

Canadian micro-cap Spectral nabs $7.1M to finalize PMA for septic shock device-Dx combo

Toronto-based Spectral Medical has raised CA$10 million ($7.1 million) in an offering to back its effort to earn FDA approval for its septic shock treatment device-diagnostic combination. The company said earlier this month that it expects to submit its final PMA module to the FDA in the second half of 2016; it added that it submitted the first three modules to the agency last year.

Struggling Eisai gets FDA approval for cancer drug Halaven for liposarcoma

Japan's Eisai got a much-needed boost on Thursday when the FDA approved its cancer drug, Halaven, for treatment of liposarcoma for patients in which the cancer has advanced to the point where surgery is not an option.

Allergan's depression drug bags a 'breakthrough' tag on the way to Phase III

The star of Allergan's pipeline, a ketamine-like drug for depression, secured the FDA's coveted breakthrough therapy designation, guaranteeing the company access to top agency officials as it moves toward late-stage development.