Topic:

Regulatory

Latest Headlines

Latest Headlines

Mylan's Bangalore unit cancer drug recall expanded as firm works M&A angles

Mylan has filled out details on an expanded recall of two drugs manufactured by Bangalore-based Agila Onco, which it bought from Strides Arcolab two years ago, as the company works to fend off a takeover offer from Teva Pharmaceuticals, while moving on its own unsolicited bid for Perrigo.

Sweden's Medivir deal lends support to embattled GVK

A deal by Sweden's Medivir to trim costs by entering into a partnership for drug research has thrown a bit of support to CRO GVK Biosciences, which faces a European Medicines Agency recommendation for the suspension of more than 700 products tied to its facility in India.

China FDA publishes online false ad sanctions on 8 local drug and device firms

China's FDA said it has sanctioned 8 firms that violated ad rules, part of a wider public campaign published online to heighten consumer safety awareness. Among those cited were Shaanxi Pharmaceutical for claiming a prescription skin treatment cured ringworm, psoriasis and eczema among other ailments within a day.

A 'Million Mutinies Now' against online drug sales in India highlights China's push

India's mom-and-pop grocery stores have already beaten back most of the challenge from big-box retailers like Wal-Mart by limiting them to wholesale business and even efforts by leading domestic companies such as Reliance Industries have faltered.

Ready to prescribe PCSK9 meds? Doctors say yes, yes, yes

After last week's expert panel meetings, the FDA may put some label limits on PCSK9 cholesterol drugs. But if word from doctor surveys is any indication, those limits won't put a huge damper on sales.

Deputy at China agency that probed GSK arrested for corruption, report says

The deputy head of China's State Administration for Industry and Commerce has been arrested for corruption, putting an agency that was at the center of the GlaxoSmithKline bribery probe into its own spotlight.

China plans to ensure private hospitals get subsidies, finance

China has moved to flesh out guidelines for an expansion of private hospitals by allowing subsidies and finance to flow to new companies as a way to allow patients access to newer services and ease demand on the public system.

PatientsLikeMe, FDA partner up to track online drug safety clues

PatientsLikeMe teamed up with U.S. regulators on a safety-monitoring project, hoping to pinpoint a new med's risks and benefits sooner than the FDA's current surveillance program does.

NanoCarrier aims for PhI study on neck cancer in Japan for NC-6004

In something of a surprise move, Japan's NanoCarrier submitted a Phase I application to the Pharmaceuticals and Medical Devices Agency for oncology candidate NC-6004, Nanoplatin, on June 9.

Japan's PAFSC backs Lilly's dulaglutide, among others, in latest round

Eli Lilly Japan's once-weekly glucagon-like peptide-1 receptor agonist dulaglutide was recommended for approval by Japan's Pharmaceutical Affairs and Food Sanitation Council's (PAFSC's) First Committee on Drugs, an advisory panel to the health minister, following a June 5 meeting, an official said.