Topic:

Regulatory

Latest Headlines

Latest Headlines

Pharma wanted pricey orphan meds, and now it's got 'em in record numbers

New drug approvals were up last year, and orphan drug approvals were no exception. But by just how much did they climb? The  FDA Law Blog  has done some digging through the agency's Orphan Drug Designations and Approvals database, and it's got an answer.

Apotex targets Amgen's blockbuster with latest biosimilar app

The FDA accepted Apotex's application to copy an Amgen blockbuster, giving the Canadian drugmaker a chance to cash in on the coming biosimilar boom in the U.S.

UPDATED: FDA agrees to review Pfizer's abuse-deterring opioid candidate

Pharma bigwig Pfizer announced that the FDA has agreed to review the New Drug Application of its abuse-deterring extended-release opioid capsules, dubbed ALO-02.

Can Eisai pump its thyroid cancer pill to $1B in sales? Rival Bayer might object

Eisai won speedy FDA approval for its new cancer drug Lenvima, eyeing $1 billion in potential sales and setting the stage for a showdown with Bayer's cancer-fighter Nexavar.

Sprout resubmits its 'female Viagra' for FDA approval

Sprout Pharmaceuticals is heading back to the FDA with a twice-rejected treatment for female sexual dysfunction, betting that its follow-on studies will be enough to finally convince the agency.

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.