Topic:

Regulatory

Latest Headlines

Latest Headlines

India's Sun sees sharp Q1 profit drop, but Shanghvi not worried

India's top drugmaker and fifth largest in generics globally saw net profit plunge 60% in the first quarter of its financial year as it absorbed costs from its takeover of Ranbaxy Laboratories earlier in 2015, but founder and managing director Dilip Shanghvi pledged that integration would eventually bring greater rewards.

UPDATED: Kim Kardashian Instagram post lands Duchesnay in FDA hot water

It isn't too often that a celebrity spokesperson for Big Pharma goes off the reservation. But in the case of celebutante Kim Kardashian and Canadian pharma Duchesnay, that's exactly what happened. The FDA is coming down hard on the celeb's social media post for the company's morning sickness med, Diclegis, saying it violates the agency's branding rules.

Advantage Brintellix? Lundbeck advances bid for cognitive label claim

Lundbeck has long touted the cognitive benefits of its depression med, Brintellix, rolling out data that shows the drug improves patients' thinking, decision-making and attention better than its competition. Now the company could be gaining more of an edge for its med, as the FDA accepted a supplemental new drug application to add information about Brintellix's effect on cognitive problems to its label.

Taiwan pharma inspector arrested for taking drugmaker bribes

A Taiwan FDA plant inspector has been charged with taking more than $150,000 in bribes to pass on to Chinese drugmakers info on upcoming pharmaceutical inspections. The yearlong probe by Taiwan's Agency Against Corruption has also swept up the inspector's wife and executives and owners of 8 drug companies believed to have made payoffs in a scheme that some believe is much more widespread.

Samsung's NeuroLogica gets FDA nod for smart digital X-ray system

Samsung's NeuroLogica unit snagged an FDA OK for its digital radiography system, giving the company a boost as it aims for a top spot in the medical device imaging market.

Amarin case could unleash a flood of off-label promos

Off-label marketing has another legal stamp of approval, thanks to Amarin and its feisty pushback against the FDA. The Ireland-based pharma has been fighting for more than a year to promote its fish oil-derived pill for broader use, and it can now do so, even without FDA approval. And thanks to Amarin's legal maneuvering--and savvy choice of jurisdiction--any other drugmaker with truth on its side might soon do the same.

Big Pharma feeds controversy by routing big bucks to private CME

While pharma's gifts to physicians have dropped off thanks to the Sunshine Act, Big Pharma's undisclosed funding of continuing education for physicians remains a source of contention.

Australia drug exports drop 30% as industry lobby group cites high manufacturing costs

Drug exports from Australia are down 30% in the past few years, trade figures show, with industry warning solutions to high manufacturing costs need to be addressed to compete or risk losing out to a growing market in Asia, the Sydney Morning Herald said.

A new normal in China for pharmaceutical industry as reforms accumulate?

Second-quarter earnings from nearly all multinationals showed a drop in business in China from double-digit paces in recent years blamed on tough tender and reimbursement policies and domestic competition as well as an economic slowdown.

FDA picks DNAnexus for Precision Medicine genome data sharing program

The deal gives DNAnexus a starring role in the creation of precisionFDA, an open-source platform the FDA sees as a way to manage the anticipated surge in the amount of genomic data the industry has to handle.