Teva gets more than half of U.S. Copaxone patients converted to long-lasting version

Eric Palmer One of the key strategies being pursued by Teva Pharmaceutical Industries to protect itself against generic competition to Copaxone is to switch patients over to its new ...

Can Gilead break into cancer? With Zydelig approval, it gets its chance

Tracy Staton Armed with a brand-new FDA approval for its blood cancer drug Zydelig (idelalisib), Gilead will take on the oncology market. FiercePharma News

AbbVie finally gets Shire, its low tax base and enough new drugs to protect its future

Eric Palmer With a bid reaching nearly $ 55 billion and some goodies for the top execs, AbbVie was finally able to get Ireland-based Shire to surrender its independence, a portfolio ...

Concert’s spasticity drug gets out from under an FDA hold

Damian Garde The FDA has lifted a partial clinical hold on Concert Pharmaceuticals' treatment for spasticity, allowing the biotech to resume dosing in a Phase I trial. FierceBiotech ...

Baxter gets C-suite lined up ahead of pharma spinoff

Carly Helfand Baxter has tapped a couple of new execs for the biopharma unit it plans to spin off next year. And with new competition in one of the division's bigger markets, its ...

Eli Lilly gets on the trial transparency bandwagon

Damian Garde In keeping with changing industry standards, Eli Lilly has joined the host of drugmakers opening up their data vaults, going further than some but not quite baring it all. FierceBiotech ...

Acorda’s seizure spray gets the FDA blow-off

Damian Garde The FDA has rejected Acorda Therapeutics' nasal spray for epilepsy, throwing a wrench in the biotech's plan for a quick trip to the market with its orphan drug. FierceBiotech ...

Novo, Teva, Shire, Actavis and Mylan post Q1 growth as Endo gets pummeled

Carly Helfand Earnings were kind to many of pharma's midsize players between Wednesday and Thursday, with several drugmakers–Endo excluded–posting growth. But not all ...

Activist Denner gets his way with a board seat at troubled Ariad

Carly Helfand Alex Denner has taken a seat with the board of directors at Ariad–a position he demanded back in October when the company's only approved drug, Iclusig, ran ...

Novo gets a year-end win for Factor XIII blood-clotting product after two rejections

Eric Palmer Three's a charm for Novo Nordisk and its recombinant Factor XIII compound for a rare bleeding disorder. After receiving a complete response letter in 2012 and then again ...

Actelion gets second boost for Opsumit with EU approval

Eric Palmer The Swiss drugmaker said in a statement that the EC approved the drug for use by itself or in concert with another PAH drug. Actelion intends to begin selling it in Europe ...

AstraZeneca’s Nexium gets a Korean competitor to chase it over the patent cliff

Carly Helfand The difference between magnesium salt and strontium salt may be enough to threaten U.S. sales of AstraZeneca's blockbuster Nexium–starting now. Reports say South ...
© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS