News

You're free to speak, FDA tells Amarin in bid to deflate free-speech suit

Pharma marketers are closely watching Amarin's lawsuit demanding the right to talk up the off-label uses for its cardiovascular drug Vascepa. After all, if the legal attack against FDA regulations succeeds, that gives credence to drugmakers' free speech argument--and could open up new worlds of drug promotion.

Does brand + generic really add up? Sandoz, Actavis execs count the ways

These days, companies are increasingly looking to put both branded and generic meds under one roof. And Peter Goldschmidt, the U.S. president of Novartis' Sandoz unit, doesn't know why they didn't do it sooner.

Mylan expands cancer drug recall on particle contamination worries

Sterile injectable drugs are notoriously tricky to manufacture. Mylan has found that out the hard way, and it's now expanding a recall of cancer drugs that it began in April because they may contain particulate.

No red flags in Januvia heart study means a big win for Merck

Last month, Merck & Co. said Januvia passed its heart safety test. Now, the much-anticipated TECOS trial has had its airing at the American Diabetes Association meeting, and the study authors say the drug is in the clear.

GSK-linked private eye released early from Chinese prison

Last summer, Chinese prosecutors sentenced Peter Humphrey--a private eye linked to GlaxoSmithKline's 2013 bribery scandal--to 2.5 years in prison. But now, after serving about two years, he's been released.

Pfizer scientist warned execs about Zoloft and birth defects, lawyers say

Pfizer executives were warned by one of their own scientists about a potential link between the antidepressant med Zoloft and birth defects, accordingly to a newly surfaced document cited by Bloomberg.

U.S. poised to spend $50B on just 10 'breakthrough' meds in 10 years

U.S. payers are striking out at drug spending again, highlighting the cost to taxpayers. According to a commissioned report, 10 hot new "breakthrough" meds are expected to cost publicly funded healthcare plans more than $50 billion over the next decade.

How to avoid the 'magic pill' issue with weight loss meds? Honesty, journal says

Weight Watchers figured it out and so did "The Biggest Loser." Dieting and exercise to lose weight is more effective when done with support.

Top Novartis brass backs results-based drug pricing

Novartis CEO Joe Jimenez and Chairman Joerg Reinhardt sang the same tune on drug prices in separate interviews over the weekend, backing performance-based drug deals while pointing the finger at other healthcare expenses for driving up overall spending.

GSK's Advair dogged again as Mylan launches first bioequivalent copy in U.K.

GlaxoSmithKline is already struggling with sales of aging respiratory superstar Advair, and Mylan just made its job more difficult.

Teva 'unclear'? Please, its leaders write. It's Mylan that's keeping investors in the dark

Watch who you're calling "unclear," Mylan. That's the message Teva's leaders had for their takeover target's chairman, Robert Coury, in a response to recent accusations that their company is "playing games" with its deal talk.

Orphan drugmaker Sobi tells potential buyer to take a walk

Specialty drugmaker Swedish Orphan Biovitrum (Sobi) has given the cold shoulder to a potential buyer, that may or may not be Pfizer, who was not giving it the kind of financial appreciation that it believes it deserves. But given the frenetic M&A market, an analyst says it is probably just a matter of time before someone snaps up the orphan drugmaker.

Could an $18.9B Shire bid convince Actelion to ditch its independence?

Deal-hungry Shire hasn't snagged any new marketed drugs since bagging NPS Pharma in a deal it announced in January. But the rumor mill is churning again, and word has it it's set its sights on Actelion.

Merck launches Sivextro in U.K.

Merck is launching Sivextro, the newly approved antibiotic it picked up in its $9.5 billion buyout of Cubist, in the U.K. Pharmafile reports it is the first oral treatment to be released in the oxazolidinone class of antibiotics in more than a decade.

Big data tells J&J that recent grads are more loyal than experienced hires

The "people analytics team" at drugmaker Johnson & Johnson used big data analysis techniques on employees to figure out whether hiring people with experience pays off better than picking up kids right out of college. The result is good news for all of those MBA still beating the bushes for a job.

Orexigen, Takeda slap Actavis with Contrave patent-infringement lawsuit

Orexigen and Takeda have already had their fair share of headaches over obesity med Contrave this year after a data leak forced the pair to abandon a postmarketing heart study. Now, though, they've got a generic to fend off, and they've sued maker Actavis in order to do just that.

U.K. cost watchdogs boost J&J's Stelara ahead of hefty competition

U.K. cost watchdogs, which late last year recommended Johnson & Johnson's Stelara in psoriatic arthritis for some patients, have confirmed the decision to cover the drug. It is providing J&J a boost when it needs it most.

NICE sings a different tune for Bayer's prostate cancer drug Xofigo

Bayer has had a tough time winning approval from U.K. cost-effectiveness gatekeepers for its prostate cancer therapy Xofigo. Now, the company is celebrating a bright point for Xofigo as NICE changed its tune and backed the drug for certain patients.

AstraZeneca takes its emerging markets push to Algeria with $125M expansion

AstraZeneca CEO Pascal Soriot has made emerging markets part of his 5-point campaign to rebuild the drugmaker's financial health. And now he is taking that piece of his campaign to North Africa, where AstraZeneca is part of a joint venture to build a $125 million plant.

Sanofi bags 'breakthrough' tag for new Genzyme rare disease med

Sanofi's rare disease-focused unit Genzyme picked up the FDA's coveted breakthrough-therapy designation for a drug designed to treat a form of Niemann-Pick disease.