Topic:

Regulatory

Latest Headlines

Latest Headlines

Glenmark move to clear sitagliptin stocks denied by India's top court

India's Glenmark Pharmaceuticals lost a bid before the country's top court to clear existing stocks of sitagliptin as it awaits a ruling over whether it can sell copies of Januvia and Janumet, Merck's innovative version of the Type 2 diabetes drug.

French regulator found 30 cases of mold contamination in biotech plant

When French biotech TxCell shut down its pilot manufacturing facility in Besançon in June, it said it was a decision made with regulators but didn't lay out exactly what an inspection by France's ANSM had found. Now ANSM has filed its report, and it turns out that what it found was a lot of cases of mold contamination and a number of facility problems that probably contributed to it.

DNAnexus teams up with FDA for Precision Medicine cloud-based genomics platform

DNAnexus has not wasted any time expanding the reach for its cloud-based data platform, roping in funds from the likes of Google and striking major deals to further its data hub ambitions. In its latest win, the company inked a deal with FDA to create the agency's new cloud-based genomics platform under President Obama's Precision Medicine initiative.

FDA spotlights PML cases in new addition to Gilenya label

Novartis has faced safety questions on its multiple sclerosis pill Gilenya before, prompted by reports of progressive multifocal leukoencephalopathy in its users. Now, the  FDA  is updating the drug's official label to highlight two more PML reports in patients not previously treated with immunosuppressant drugs.

FDA updates label for Novartis' MS pill Gilenya after reports of brain infection

Novartis is dealing with more regulatory pushback on its MS med Gilenya as the agency said it will update Gilenya's label to reflect cases of serious brain infections linked to the pill.

GSK rehires former China government affairs director Shi

Reuters reported that GlaxoSmithKline has rehired former China government affairs director Vivian Shi, who was at one point investigated internally by the company as a possible source of leaks into a bribery probe.

BeiGene receives first China trial approval nod for BGB-283

China-based oncology biotech BeiGene has received China FDA approval for a clinical trial application on small-molecule candidate BGB-283, a second-generation BRAF inhibitor, in the latest ramp-up across its pipeline this year since a successful funding round in May.

AstraZeneca stands out again in China, hails AZD9291 in Japan

AstraZeneca seems to be all over Asia in research and licensing deals, with CEO Pascal Soriot and his team also noting on the July 30 earnings call that it is one of the few companies confident of double-digit sales growth in China this year--even with a bit of a dip in the second quarter.

FDA doubles down on duodenoscope safety with list of cleaning recs

The FDA is unveiling its first detailed recommendations for cleaning duodenoscope devices, months after the agency held an expert panel meeting to hash out safety and cleaning procedures for the products.

Gore touts CMS move to increase payments for aneurysm repair procedures

The Centers for Medicare and Medicaid Services put endovascular abdominal aneurysm repair procedures into a new Diagnosis-Related Group that will result in increased reimbursement for the treatment, to the delight of W.L Gore & Associates and other providers of devices used to repair abdominal aortic aneurysms.