News

Bayer, J&J aim to protect Xarelto's market lead with focus on clinical data

Bayer and Johnson & Johnson know that right now, there's an impression out there that rival drug Eliquis--from Pfizer and Bristol-Myers Squibb--is superior to their next-gen clot-fighter Xarelto, despite their drug's market-share lead.

Bad news for AstraZeneca: FDA lays out roadmap for would-be Symbicort copycats

The FDA has issued AstraZeneca's least favorite form of draft guidance--the kind that helps other drugmakers develop copies of a blockbuster seller.

Novo Nordisk pulls Tresiba in Germany on pricing dispute

Germany's tough price negotiators went too far for Novo Nordisk. The Danish drugmaker is pulling its new diabetes drug Tresiba off the market after authorities said they'd price the long-acting basal insulin on par with old human insulin injections.

Biogen to build $1B plant, add 400 jobs in Switzerland

Biogen has looked at its pipeline of promising drug candidates for things like Alzheimer's disease and multiple sclerosis, measured that against its manufacturing network and decided it is going to need more capacity. The company announced on Tuesday that it will start with a $1 billion plant in Switzerland, where it expects to add 400 jobs.

Sworn to end doc payments by 2016, GSK still shelled out $15M last year

In 2013, GlaxoSmithKline CEO Andrew Witty pledged to end doctor payments by 2016 as part of an effort to clean up the company's image. But so far, little has changed in that department.

Feds want Novartis to cough up $3.4B in damages, fines in kickback case

Kickback allegations against Novartis just got scarier. After years of investigating the Swiss drugmaker, the Justice Department and 11 states are demanding almost $3.4 billion in damages and fines in a False Claims Act lawsuit nearing trial.

Pharma to EU officials: We need 'contingency' supply plans in case of 'Grexit'

Drugmakers are raising an alarm about shortages in Greece as the possibility of a "Grexit" looms. That "worst-case scenario" could put supplies in peril, the European Federation of Pharmaceutical Industries and Associations warned European Commission officials, with suddenly cheap meds in Greece diverted for sale at higher prices in neighboring EU countries.

Allergan to close plant in Iceland, lay off 300

Allergan Chairman Paul Bisaro has been quick to cut what he sees as redundant operations and people to help pay for his aggressive buying. Now, he has set his sights on the company's ancestry, with plans to whack a plant, and 300 jobs, in Iceland. 

Valeant can have Zoetis, Bayer says. We have our hands full already

Whether animal health leader Zoetis receives any more buyout offers after Valeant's reported approach remains to be seen. But if it does, Bayer's leaders insist a competing bid won't be coming from them.

Novartis tests performance pricing for much-anticipated Entresto launch

Novartis has big plans for its much-anticipated heart failure remedy Entresto. The Swiss drugmaker figures it can parlay impressive trial data on the drug into its biggest launch in years--perhaps ever.

Boehringer charges ahead with sale of U.S. generics biz with bids from Hikma, Mallinckrodt

Earlier this year, Boehringer Ingelheim said it was considering selling its U.S.-based generics business for up to €2 billion ($2.2 billion) to lighten its load and focus on drug development. Now, the company is moving one step closer to a sale as companies such as Hikma Pharmaceuticals, Mallinckrodt and Perrigo approach the bidding table.

AdverseEvents flags TB reports, blood-disorder cases linked to RA drugs

Drugmakers are eager to jump on the rheumatoid arthritis (RA) bandwagon, concentrating on tried-and-true treatments to bring in sales or developing new therapies to stave off looming biosimilars competition. But the meds come with their own set of safety issues, as both TNF-alpha treatments and non-TNF alpha drugs continue to generate troubling side effect reports.

Bigger pharma may be scraping for good deals, but Horizon has plenty of options, analysts say

Horizon Pharma isn't exactly the only specialty pharma company hunting for deals. Allergan, Mallinckrodt, Endo and the ever-acquisitive Valeant have all been on shopping sprees lately, leaving some analysts wondering just what's left worth buying in the space.

Danny Glover signs up with Avanir to spotlight pseudobulbar affect

Actors cry and laugh on command, but people who have pseudobulbar affect can't control their crying jags or laughing fits.

More SCOTUS fallout: Appeals court revives Lamictal pay-for-delay fight against GSK, Teva

In the post-FTC v. Actavis world, cash doesn't have to change hands for a pay-for-delay deal to fall afoul of antitrust law. That's becoming clear as court rulings pile up. And a new U.S. appeals court decision specifically addresses a branded drugmaker's agreement not to launch an authorized generic of its branded drug.

Tougher regulations force Indian drugmakers to invest or divest

After more than 5 years of FDA regulatory issues kept Ranbaxy Laboratories from generating the kind of cash it once had, owner Daiichi Sankyo threw in the towel. It recently sold the Indian generics maker at a loss to Sun Pharmaceutical and moved on down the road. Analysts say a tougher regulatory world is, in fact, remaking India's vast drugmaking industry.

Will Mylan boost its Perrigo bid? New securities filing suggests it won't

Perrigo was none too fond of Mylan's most recent offer when it made it back in April. Yet it looks like that's the one Mylan's sticking with--at least for now.

EU stands by crackdown on drug spending in Ireland

The European Commission is standing by its latest attempt to reduce spending on patented drugs in Ireland--and it's not buckling under Big Pharma pressure.

UPDATED: Merck cancer drugs and Sanofi, Amgen cardio meds have formularies on high alert

U.S. drug payers have been able to beat back high prices for some COPD and diabetes drugs, much to the chagrin of GlaxoSmithKline and Sanofi. But several new categories promise to break out in a big way, and we are not talking just about hepatitis C drugs.

Alexion wins EMA nods for not one but two drugs

Rare-disease specialist Alexion Pharmaceuticals won a double header from the EMA today when the agency recommended approval of two of its drugs, including Kanuma, the enzyme replacement med it picked up in its $8.4 billion buyout of Synageva.