News

FDA draws line in sand over its orphan drug policies

The FDA says it will abide by a court ruling stating it has to grant orphan drug exclusivity to Depomed's Gralise. But the agency has drawn a line in the sand, saying it does not intend to extend the same benefit to any other drugmakers under the same circumstances.

Court to give speedy answer in Actavis bid to yank old Namenda off market

Actavis is waiting eagerly to find out whether it can move forward with its plans to force patients over to a new, patent-protected version of blockbuster Alzheimer's treatment Namenda. And its waiting period just got shorter.

Drug groups ask Supreme Court to pull constitutionality out from under California drug disposal law

Having been unable to persuade a federal court or an appeals court that a California county's mandate that drugmakers pay for the disposal of unused meds was off base, PhRMA, BIO and GPhA are going to the ultimate arbiter of legal matters, the U.S. Supreme Court.

Valeant's still in the deal hunt, but it can grow 10%-plus without them, CEO says

Last month, rumors swirled that serial buyer Valeant would be swearing off its modus operandi for a little while to focus on cutting down debt in the wake of its Allergan bid failure. But according to CEO J. Michael Pearson, those who expect Valeant to stray from its dealmaking ways have another thing coming.

How much for docs speaking on Eliquis, Xarelto and Pradaxa? $20M and counting

If you've watched television lately, you know that Pfizer and Bristol-Myers have been spending a lot of money on advertising to back their new anticoagulant, Eliquis. So have rival Boehringer Ingelheim, with its Pradaxa drug, and Bayer and Johnson & Johnson with Xarelto.

Hedge fund exec aims new legal weapon at Big Pharma's 'evergreened' patents

As companies, regulators and advocacy groups lobby to bring certain branded products off-patent, a new voice is joining the chorus. U.S. hedge fund manager Kyle Bass, best known for predicting the subprime mortgage crisis in 2008, said he plans to challenge questionable drug patents from industry heavyweights.

Big Pharma threatens to sue U.K. fund as officials nix Novartis, Sanofi and Eisai meds

U.K. officials have decided which drugs to toss off the Cancer Drug Fund, which pays for drugs rejected by cost-effectiveness gatekeepers. Reportedly, Novartis, Sanofi and Eisai treatments are among them.

Ad watchdog slaps Novartis for Theraflu cold-fighting claim

Novartis claims its Theraflu Multi-Symptom Severe Cold "starts to get to work in your body in 5 minutes" after taking it. But Pfizer, which sells its own range of cold-fighters, has an issue with that--and so does National Advertising Division.

Express Scripts' Miller lays out manifesto to fight sky-high drug prices

It's no secret that Express Scripts Chief Medical Officer Steve Miller is hankering for some changes in the pharma business. But what many may not know, he told PharmExec, is that he's got a four-point solution to fix what he sees as the industry's biggest problems.

Lilly leans on diabetes, Cyramza in predictions for 2015 growth

Eli Lilly disappointed market-watchers Wednesday with its 2015 forecast, which fell short of predictions that analyst have been tossing around. But Lilly executives said their numbers aren't so different from the Street's; it's just a matter of assumptions.

New study clears Merck's blockbuster Gardasil of MS risk

Good news for Merck: According to a new study, its cash cow vaccine, HPV-blocker Gardasil, isn't linked to an increased risk of multiple sclerosis--or any other similar CNS diseases, for that matter.

Analysts expect M&A frenzy to continue with deals by Pfizer, AbbVie, Valeant likely in 2015

Pharma M&A in 2014 hit a record-breaking $234 billion in announced acquisitions. Actavis led the pack with its $66 billion bid for Botox maker Allergan and $25 billion buyout of Forest Laboratories. But investors and analysts say 2015 could generate as many or more deals, with Pfizer, Valeant Pharmaceuticals, AbbVie and Shire expected to be in the mix.

Roche and GSK set for sales growth in this year's fast-spreading flu epidemic

Bad flu seasons often mean increased sales for drugmakers producing influenza drugs, and companies such as Roche and GlaxoSmithKline stand to benefit the most from this year's growing epidemic.

Pharmacyclics chief puts his staff in training to be geniuses

Pharmacyclics CEO Bob Duggan thinks all his employees could become geniuses. Or so he tells Investor's Business Daily, citing research from psychologist Alfred Barrios. Duggan has Pharmacyclics staffers taking a 24-week training course to acquire the 24 personality traits Barrios identified in top achievers such as Einstein, Shakespeare and Socrates.

NICE again thwarts Celgene's bid for Abraxane in pancreatic cancer

The U.K.'s cost-effectiveness gatekeeper is known for its stinging rejection of cancer meds, and the watchdog is singing a familiar tune with Celgene's pancreatic cancer drug Abraxane.

Diovan generic floodgates open with FDA nods for Mylan, et al.

Novartis took its first big hit from new Diovan generics during last year's third quarter, when Ranbaxy Laboratories finally won approval for its exclusive generic of the blood pressure pill. And it was indeed a big hit: a 76% drop in U.S. sales for the franchise, to $97 million.

Salix CEO takes a hike in latest fallout from inventory snafu

On Monday afternoon, CEO Carolyn Logan became the second C-suite executive at Salix Pharmaceuticals to step down in the wake of an inventory snafu disclosed late last year. Logan will retire as of Jan. 30, the company said.

Hello, hep C pricing war: Gilead hits back at AbbVie with exclusive CVS deal

Gilead's got a message for you, AbbVie: It's on. Just a couple of weeks after the Illinois drugmaker struck an exclusive hep C pact with PBM Express Scripts, Gilead has come back with a deal of its own.

NPS is officially up for sale. Will deal-minded Shire bid?

After months of takeover speculation, New Jersey's NPS Pharmaceuticals is officially up for grabs. And now, all eyes are on rumored suitor Shire.

FDA reviewers back Novartis biosim of Amgen's blockbuster Neupogen

Those looking for a window into the FDA's thoughts on biosimilars got their first direct peek Monday. The agency released briefing documents for an upcoming panel meeting on Novartis' biosimilar of Amgen's Neupogen. The takeaway? The FDA seems to be softpedaling on whether the biosim is "interchangeable" with Neupogen itself, allowing approval to be based on biosimilarity instead.