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Regulatory

Latest Headlines

Latest Headlines

Sun Pharma's revenues squeezed by plant issues

Sun Pharmaceutical's revenues have taken a double whammy from quality problems the FDA cited at a plant in India. The drugmaker said they were down, both because of the costs of fixing the plant and because the of supply interruption from that effort.

Indonesia's Kalbe Farma recalls anesthetic, cardio drugs for quality control

Kalbe Farma said it has ordered a recall two of its drugs in Indonesia, an anesthetic and cardiovascular treatment, but did not identify the problem other than to say it was a quality control procedure.

Japan mulls changing drug reimbursement policy on sales tax review

Japan reportedly is considering a change in its drug-pricing policy, setting price caps that would last for three fiscal years instead of the current two. 

Pennsylvania jury finds against Takeda in Actos lawsuit for $1.3 million in damages

It took a U.S. jury only two hours to decide to assess Takeda Pharmaceutical $1.3 million in punitive damages for the bladder cancer it ruled earlier were caused by Actos (pioglitazone) diabetes drug. 

Swine flu outbreak in India bumps demand for generic therapies

An outbreak of the H1N1A influenza--once known as "swine flu"--has led to a run on generic drugs relied on for treatment, prompting the government to urge local makers to step up production.

China FDA notes meeting with U.S. counterparts, but no details

China and U.S. drug officials held their first working meeting of the year recently, China's FDA revealed.

Eisai nabs quick FDA blessing for cancer blockbuster hopeful Lenvima

Eisai grabbed an early green light on Friday from U.S. regulators for thyroid cancer drug Lenvima, meaning the Japanese pharma can now get an earlier-than-expected start on trying to make its blockbuster dreams a reality.

Activists ready to fight for Ariad CEO's ouster: CNBC

Industry-watchers knew a shake-up could be in Ariad Pharmaceuticals' future when Alex Denner, founder of activist hedge fund Sarissa Capital and protégé of notorious corporate raider Carl Icahn, took a seat on the company's board of directors last year. Now, a proxy brawl looks to be around the corner.

Eisai wins an early FDA nod for its self-described cancer blockbuster

Eisai is counting on its new cancer drug to eventually bring in more than $1 billion a year, and now, thanks to an early FDA approval, the Japanese drugmaker has a head start on making that a reality.

Australian legislation paves way for compulsory licensing

Australia's Senate has passed two-year-old legislation that would afford drugmakers a bit of compulsory licensing and allow them to share patent application reviews and approvals with New Zealand, the decision of one being the decision of the other.