If Teva wanted a clear sign from Supreme Court on Copaxone, no such luck

Carly Helfand Teva's been waiting a long time to get its Copaxone patent appeal before the Supreme Court. And now that the court has heard oral arguments, it seems to be divided ...

Gilead wins FDA approval for its hep C combo pill, a blockbuster in the making

Damian Garde Gilead Sciences picked up a much-anticipated FDA approval for Harvoni, a combination therapy for hepatitis C that promises to cure the majority of patients without the ...

Australian docs launch anti-pharma rep campaign

Carly Helfand When it comes to interactions between doctors and pharmaceutical companies, there's a growing desire for transparency among those concerned that reps influence prescribing ...

AstraZeneca finally bails on troubled Targacept after years of failure

Damian Garde After 9 years of fruitless work on treatments for Alzheimer's disease and depression, AstraZeneca is dissolving its partnership with Targacept, leaving the battered ...

Impax gets products, manufacturing with $700M deal for allergy-drug makers

Carly Helfand Back in August, Impax Laboratories CEO Fred Wilkinson told investors on a conference call that the company was "well-positioned to execute on a number of transactions." ...

Amgen declares a head-to-head PhIII win for Humira biosimilar

John Carroll Amgen has taken a big stride toward gaining regulatory approval for its biosimilar of Humira, AbbVie's megablockbuster anti-inflammatory. The Big Biotech ...

Chantix litigation may be wrapped, but safety debate wears on

Tracy Staton Just as a federal judge says it's time to close the books on the Chantix litigation that's been moving through her Alabama court, Pfizer is preparing for another ...

Take your drugs, get a prize? West and HealthPrize test new adherence plot

Carly Helfand West Pharmaceutical Services and HealthPrize Technologies are taking gamification to the next level. The companies are teaming up on a new, interactive initiative that ...

Arrowhead tanks as its hep B treatment disappoints in Phase II

Damian Garde Arrowhead Research watched its shares nose-dive after a peek at Phase II data on its in-development treatment for hepatitis B revealed that the RNAi therapy isn't measuring ...

Sanofi joins list of Big Pharmas fielding bribery allegations

Tracy Staton Now, it's Sanofi digging into potential bribery in the Middle East. The French drugmaker told U.S. officials that it's eyeing allegations from an anonymous whistleblower ...

Positive PhIII PONV study brings little Acacia to a crossroads

John Carroll Acacia Pharma says it gleaned positive results from a Phase III study of its experimental therapy designed to prevent postoperative nausea and vomiting. And now it's ...

Genentech tightens distribution on top cancer meds, triggering blowback from hospitals

Tracy Staton Roche's Genentech unit is getting some high-profile blowback from a change to its distribution model on three top cancer meds. Hospital and pharmacy executives claim ...
© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS