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Regulatory

Latest Headlines

Latest Headlines

Indonesia's Kalbe eyes Singapore, Thailand with ASEAN trade bloc ahead

Indonesia's Kalbe Farma is making this year an expansion year as it moves beyond its shores and into Singapore and Thailand and their over-the-counter drug markets as a regional trade pact looks set to start at the end of the year. It also has corporate eyes set on even more countries, with a focus on West Africa.

FDA clears BrainScope smartphone-based EEG device to detect traumatic brain injury

The FDA has cleared the Ahead 200 device from BrainScope to record and analyze patient electroencephalographs (EEGs) using a custom sensor that attaches to a smartphone.

J&J sees Invega franchise boost with FDA nod for longer-acting Trinza version

Johnson & Johnson's once-a-month antipsychotic med Invega Sustenna is already raking in blockbuster numbers, but the company is eyeing even bigger sales for its franchise with FDA approval for a longer acting formula.

Silk Road scores FDA approval for less invasive stent system

Silk Road Medical snagged FDA premarketing approval for its innovative transcarotid stent system, a big win for the company as it scores key regulatory signoffs for the device and forges ahead with product development.

FDA proposes new rules for animal drug compounding

On May 17, the FDA announced that it released a draft guidance that sets out rules for compounding animal drugs from bulk substances. In so doing, the FDA is recognizing that in some situations, treating animals with specially formulated versions of approved drugs would be impossible.

NEA startup ClarVista gets $14.5M to gain CE mark for intraocular lens

Startup ClarVista Medical expects to use a newly gleaned $14.5 million financing to get a CE mark for its Harmoni modular intraocular lens system. The design of the cataract IOL is intended to make it easier for surgeons to correctly position the lens, as well as to make it simpler to exchange the optical component when required because of a dual-component structure.

Bluebird beats a path to early approval for its pioneering gene therapy

Bluebird bio, developing a potential cure for a rare blood disorder, is angling for an accelerated approval as it works through clinical trials, setting out a regulatory framework that could get the gene therapy on the market sooner than expected.

Taiwan recalls batches of injectable sodium chloride made by Y.F. Chemical

Taiwanese authorities issued a nationwide advisory to hospitals to avoid certain batches of injectable sodium chloride made by Y.F. Chemical, a move that followed a spate of over-the-counter drug recalls in April.

India drug IP laws in spotlight again in local Fresenius Kabi-Pfizer case

India's policy regarding intellectual property protection has bounced back once again to deny an MNC patent challenged by a local drugmaker. This one was filed by the local unit of Fresenius Kabi Oncology against a Pfizer patent.

Wockhardt faces long haul on FDA travails, Business Today says

India's Wockhardt faces a tough road to travel to revive its fortunes after a spate of trouble with the U.S. FDA since 2013 that saw the closure of two plants and recent product recalls bedevil the company, India's Business Today magazine reports.