News

FDA reviewers raise red flags for Amgen cancer vaccine ahead of AdComm

Wednesday's a big day for Amgen, whose dual-acting cancer vaccine/viral therapy is coming up for review by an FDA panel of experts.

Rare-disease specialist Sobi entertains suitors for potential $3.5B-plus deal

Orphan meds have been like catnip for drugmakers for several years, driving many an M&A deal. Now, Swedish Orphan Biovitrum might be next in line, at a price of more than $3.5 billion.

Here's an M&A strategy: Buy products, hike prices, watch sales grow

As the M&A wave sweeps over pharma, companies are wheeling and dealing for a number of different reasons. Slim-down strategies, tax break potential, portfolio diversification and other usual suspects have all driven transactions as of late--but the promise of price hikes has, too.

Undeterred by Perrigo rejection, Mylan tells Teva to step off

On Friday, Mylan all but rejected Teva's takeover bid with its own sweetened bid for Ireland's Perrigo. But now, it's made the snub official, delivering a resounding "no" to its generics rival.

Roche, Amgen, Novo top the ranks in biologics sales, with AbbVie, Sanofi close behind

The world's top sellers of the world's top biologic meds haven't changed much in the last few years. Ranked by 2014 sales, it's your usual suspects--Roche, Amgen, Novo Nordisk, AbbVie. But as PMLiVE notes in its annual ranking, times are a-changing.

What price MS therapy? Thanks to price hikes, $50K-plus, even for decades-old meds

The cost of multiple sclerosis drugs has skyrocketed over the past 20 years, and it's not just new drugs driving that increase. Not one MS drug has a list price of less than $50,000 per year in the U.S., and some treatments cost 7 times more now than they did in 1995, a new study found.

Hours after receiving new bid, Perrigo tells Mylan to take a hike

Just a couple hours after Mylan sweetened its original bid for Ireland's Perrigo to $31 billion-plus, Perrigo nixed the new offer. Why? The way the target sees it, it isn't quite so sweet.

Biogen sales, profit miss the mark as Tecfidera flags

Remember the days when Biogen's Tecfidera was trumping analyst expectation after analyst expectation? Well, they're in the past--at least for now.

Daiichi Sankyo gets EMA recommendation on clot buster

Japan's Daiichi Sankyo got some helpful news today as its works desperately to bring new revenue in the door ahead of next year's patent loss on its foundational product Benicar. The advisory group of the European Medicines Agency (EMA) recommended approval of Daiichi's new generation anticoagulant in Europe.

In an affront to Teva, Mylan hikes Perrigo offer past $31B

Mylan sent a message to Teva that it wasn't interested in becoming bait even before the Israeli drugmaker made its $40 billion bid earlier this week. Now, it's repeating that message loud and clear--and it's doing so with a sweetened offer for Irish target Perrigo.

Reckitt Benckiser makes out big time on the misery of U.S. flu sufferers

The fact that this flu season's vaccines were not very effective was bad news for people hoping to avoid the condition but great news for the U.K.'s Reckitt Benckiser Group, which racked up an impressive first quarter on sales of over-the-counter flu meds like Mucinex.

AstraZeneca sales retreat in its effort to achieve huge growth by 2023

AstraZeneca CEO Pascal Soriot, while fighting off the takeover attempt by Pfizer, promised that the company would hit annual revenue of $45 billion by 2023. Now he will be measured by that promise quarter by quarter and today he fell a little short.

BMS scores positive EMA opinion for Opdivo in advanced melanoma patients

Bristol-Myers Squibb's immuno-oncology med Opdivo is racking up positive data and earning regulatory gold stars in record time. Now, the drug is poised to gain even more ground after the European Medicines Agency gave Opdivo its marketing thumbs-up as a first-line treatment for advanced melanoma--an approval it has yet to earn in the U.S.--and in previously treated patients.

Watch out, Big Pharma: A Teva-Mylan combo would remake the industry Top 10

As of 2014, Teva is in the No. 11 spot on the list of pharma's top revenue generators. But if it gets its way and lands a deal for rival generics maker Mylan, just how much will it be moving up the charts?

J&J pulls contraceptives in Canada on potency worries

J&J's Janssen unit is recalling one lot of Ortho-Cept contraceptive tablets because of the potential that the potency of the two active ingredients may not meet specifications, Health Canada reports.

UPDATED: FDA gives Boehringer's Pradaxa antidote a boost with fast-track review

Boehringer Ingelheim already had the FDA's "breakthrough" designation on idarucizumab, an antidote to its blockbuster anticoagulant Pradaxa. Now, the reversal agent has stepped on the agency's fast track, which cuts review time by four months.

Stellar Humira sales underscore AbbVie's need for replacement meds

AbbVie's working toward solutions to protect its top line against Humira's inevitable decline. For now, though, its workhorse is still getting the job done, and it delivered yet another double-digit leap in Q1 to help the company beat expectations.

Novartis unleashes M&A scouts as GSK deal starts to deliver on margins

Novartis beat profit estimates for the first quarter, partly because of the big deal closing with GlaxoSmithKline March 2. Now, CEO Joe Jimenez says the Swiss drugmaker is back on the dealmaking trail.

Eli Lilly can thank Novartis--and low expectations--for its Q1 earnings beat

Eli Lilly faced its fair share of problems last year, struggling with slumping sales and patent expirations for two of its bestselling products. But Lilly is celebrating a bright point, bringing in Q1 2015 numbers boosted by the success of its recently acquired animal health unit.

Eyeing big niche in obesity, Novo rolls out Saxenda at $1,000 per month

Novo Nordisk says its new drug Saxenda has a niche in the U.S. obesity market. Now, the Danish drugmaker has the chance to prove it. Saxenda is rolling out across the country as we speak, and at a premium price.