Topic:

Regulatory

Latest Headlines

Latest Headlines

BioPharmaSpec plots Asian expansion with a focus on biosimilars

BioPharmaSpec is expanding its business into the potentially lucrative Asian market as new business development teams begin work in India and the Asia-Pacific region this month.

Sanders asks Treasury to 'block' Pfizer and Allergan merger

In between campaign stops, presidential candidate Sen. Bernie Sanders is finding time to keep pressure on the pharmaceutical industry. This time he is pushing the U.S. Treasury Department to try to stop Pfizer's $160 billion tax-avoiding merger with Dublin-based Allergan.

UPDATED: China FDA on the hunt for illegally sold vaccines in Shandong

A mother-and-daughter team allegedly behind a massive illegal sale of vaccines in Shandong province are under arrest as China FDA moves to track down the potentially harmful supplies by calling for immediate help from manufacturers and distributors.

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.

Senators lambaste Turing for 'unethical' price hikes at latest drug price hearing

Turing Pharmaceuticals was front and center again at a recent Senate hearing over drug price increases, and for the most part, it was the same old song and dance. The drugmaker came under fire by a bipartisan group of lawmakers, who lambasted the company for jacking up the price of an antiparasitic drug and compromising patients' access to the med.

FDA rejects Eagle Pharma's reformulated Angiomax

The FDA rejected Eagle Pharmaceuticals' ready-to-use version of the blood thinner Angiomax, requesting more information on the injectable treatment and putting off the company's hopes of a commercial launch.

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.

Chicago psychiatrist slapped with prison time in Teva kickbacks case

A Chicago doctor who took kickbacks from Big Pharma in exchange for prescribing antipsychotic meds is facing some prison time. A U.S. District judge sentenced Dr. Michael Reinstein to 9 months in federal prison after finding that Reinstein accepted payments from companies such as Teva Pharmaceuticals and Ivax Pharmaceuticals for promoting the drugs to elderly patients.

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.