TL-300 Tablet Based Non-Invasive Hemodynamic Monitoring System Soon Available in U.S.

By GENE OSTROVSKY Tensys Medical (San Diego, CA) received FDA 510(k) clearance for its latest non-invasive hemodynamic monitor in its T-Line of products, the TL-300. Just like the ...

Minnesota device group files citizen petition to prevent FDA from unlawfully changing 510(k)

By Arundhati Parmar A Minneapolis law firm has filed a joint petition on behalf of a group of pre-revenue, small and midsized device companies, venture capitalists and inventing physicians ...

Bayer’s Nexavar meets goal in thyroid cancer trial

By FRANKFURT (Reuters) – German drugmaker Bayer said its cancer treatment Nexavar reached a goal of improving the survival of patients with a certain type of thyroid cancer ...

Color Matters: Pills And Patient Adherence

By Ed Silverman There is a certain logic that suggests patients may have a different view of a new pill used to treat an existing malady from a pill taken previously, especially if ...

Worried about blood clots, France weighs new contraceptive limits

By Tracy Staton French regulators are tightening the purse strings on later-generation contraceptives–and studying limits on their use. Acting on concerns that the pills carry ...

Drug Approvals Reach 15-Year High on Smoother FDA Reviews

By Anna Edney & Catherine Larkin U.S. drug approvals in 2012 reached their highest level in 15 years, led by 11 new cancer therapies, including Ariad Pharmaceuticals Inc. (ARIA)’s ...

Dune wins FDA approval for MarginProbe

By Damian Garde Dune Medical Devices‘ headline-grabbing cancer tool has capped its rapid road through the FDA with a full pre-market approval, getting the agency’s sign-off ...

Biggest Biotech Trends of 2012

GEN takes a look back at some key biopharma developments of the past 12 months. The world didn’t come to an end in 2012, but the biopharma world ended the year holding its breath, ...

What The Fiscal Cliff Could Mean For The FDA

By Matthew Herper A lot of the discussion over the last-minute effort to come to a deal over the fiscal cliff have focused on whether congress and President Obama can stave off the ...

Pharmaceutical firm caught in kickback scheme

By  TERRY AMBROSE San Diego pharmaceutical company Victory Pharma Inc. agreed to pay $11.4 million to settle Anti-Kickback Statute and False Claims Act allegations. The deferred ...

Court mistaken in ruling on advertising of drugs

The real issue in advertising of drugs is not free speech; it’s making sure consumers are protected Two out of three federal judges on the U.S. Court of Appeals for the Second ...

Does Qsymia Have a Future After All?

By Meghan Foley  Poor sales of Vivus (NASDAQ:VVUS) Pharmaceuticals’ obesity drug Qsymia, which was released in mid-September, have depressed the company’s stock price by 23 percent ...
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