Topic:

Regulatory

Latest Headlines

Latest Headlines

India's drug industry faces $570.7M hit from fixed-dose ban

India's domestic drug market could see an INR38 billion ($570.7 million) hit from a ban on more than 300 fixed-dose drugs that combine therapies often without new clinical trials in a widely used method that has formulations running into the thousands, many of which are approved at the state level.

NEA's Senseonics aims to submit to FDA for diabetic monitor implant next half, as it raises $45M

Founded more than 20 years ago, glucose monitor implant startup Senseonicsy is now hoping that it can get regulators to sign off on its continuous glucose monitor Eversense that's based on a tiny implant to track diabetics for up to 90 days. That's much longer than the typical 5- to 7-day span that's available for popular patch-based CGMs.

Langer biopolymer, drug delivery startup nabs $25M+ to get approvals starting in cardio surgery

Gecko Biomedical has raised €22.5 million ($25.5 million) to get it through the clinic and gain regulatory approval for its biopolymer platform in several indications for tissue reconstruction. It's aiming for a first approval within a year--with the first focus on its cardiovascular reconstruction candidate, dubbed GB-02. The goal is to create an entire product portfolio based on its novel polymer that enables guided tissue repair and localized drug delivery.

European drug regulators report lots of plant issues in first quarter

Not even three months into 2016, the European Compliance Agency reports that drug regulators on the continent have taken to task a dozen pharma plants around the world for substandard manufacturing practices.

P&G joins Pfizer and Abbott in fighting India's cough med ban

Indian regulators over the weekend included some popular cough syrups containing codeine in a drug ban in what was deemed an effort to tighten up the nation's supply chain of opiates to fight smuggling and drug addiction. But the action by the Drug Controller General of India has unleashed a firestorm from Western drugmakers that dominate that market.

FDA castigates India's Emcure for routinely faking data

The other shoe has dropped for an Emcure Pharmaceuticals plant in India. After banning most of the sterile products coming out of the plant last year, the FDA has now issued a warning letter that says the company routinely used "fraudulent" test data to move drugs through the manufacturing process.

Startup gains FDA nod for wearable EKG cardiac arrhythmia monitor

The FDA has cleared the MoMe Kardia electrocardiogram device from startup InfoBionic to diagnose cardiac arrhythmias. It's a big step up from traditional cardiac monitors and includes three different monitoring types that typically require discrete devices.

Abbott India unit, others, get court stay on fixed-dose drug bans

The Delhi High Court granted a stay for the Indian unit of Abbott Laboratories and local firm Macleods Pharmaceuticals to respond to a regulator ban halting sales of products that fall under so-called fixed dose formulations that combine medicines, the Economic Times said.

India's Lupin hauled up by U.S. FDA for lapses at Goa plant

Mumbai-based Lupin Pharmaceuticals has been hauled up by the U.S. FDA on a manufacturing operation, this time at its Goa plant for failure to meet 9 areas of operating standards.

China FDA lays down new guidelines on bioequivalence for generics

China FDA has said that generic drugs need to show bioequivalence to the related branded products, adding that the current use of locally made generics will no longer suffice.