News

Actelion exceeds profit estimates as Opsumit, Uptravi make up for aged Tracleer

Actelion may have a blockbuster on the decline--but it's also got two new launches that are keeping it in the game. For 2015, the Swiss company reported sales that were in line with analyst expectations and core earnings that beat them. Sales climbed 4% year over year to hit CHF 2.04 billion, while earnings rose to CHF 814 million ($827.24 million), besting predictions of CHF 813 million.

FDA warning letter puts Ipca Labs under fire for widespread data manipulation

A new FDA warning letter for three Ipca Laboratories plants shows that data manipulation and falsification were rampant there--and enforced by senior managers in the quality-control unit to keep product supply flowing.

Sanofi scarce on turnaround details, but left a few needles in the Q4 haystack

If you expected a catalog of detail on Sanofi's turnaround plans with Tuesday's earnings release, think again.

After a big 2015, Regeneron predicts slowing 2016 sales for launch superstar Eylea

Last month, Regeneron announced 2015 Eylea sales that had investors excited. But that didn't soften the blow on Tuesday, when it warned that the med's growth in the U.S. would slow down.

Top Senate Democrat grills HHS about opioid panel's alleged ties to industry

About a third of panelists at a Department of Health and Human Services (HHS) meeting on painkiller prescribing had financial ties to companies that make the drugs, a recent report showed. A top Senate Democrat is not pleased with those findings, and he's grilling the HHS about the members' relationships with the industry.

Sanofi's outlook less than sunny as key diabetes franchise continues to sag

Sanofi delivered a good-news, bad-news set of fourth-quarter results: Earnings better than expected and solid growth in emerging markets, but shortfalls in overall revenue and operating profits. Its follow-up to big-selling Lantus, Toujeo, beat projections, but its long-anticipated cholesterol fighter, Praluent, brought in just a few million euros.

Pfizer builds on early Ibrance lead as Novartis, Lilly rivals inch closer

Pfizer's Ibrance has already been prescribed to more than 20,000 patients, and the company says it has a "very heavy" clinical trial program testing it in multiple types of breast cancer and beyond.

Some top GSK investors aren't sold on a breakup--and they're backing CEO Witty, too

Some of GlaxoSmithKline's prominent investors may be pushing for a four-way breakup of the company. But others are just fine preserving the status quo--and keeping CEO Andrew Witty at the helm to do it.

Top exec exits as Pfizer redraws org chart for post-megamerger future

Pfizer is shaking up its corporate structure again as it prepares to merge with Allergan and further lays the groundwork for a potential split in a few years. The structural rejig pushes out Geno Germano, who has been leading Pfizer's global innovative pharma business, and elevates one top Allergan manager, Bill Meury, to the combined company's commercial leadership team.

UPDATED: NICE, in reversal, OKs Amgen's Repatha while snubbing Sanofi and Regeneron's Praluent

Amgen's Repatha is in a market brawl with Sanofi and Regeneron's Praluent as the competitors rush to sew up as many OKs around the world as possible for the new-gen cholesterol fighters following their FDA approval last year within weeks of one another. Now Amgen has pulled ahead in England after the country's drug pricing watchdog has both changed course to cover Repatha for some patients, while dealing its competitors a blow with a rejection for Praluent.

PhRMA kicks off new ad campaign to doctor pharma's tarred image

Big pharma knows that lawmakers are hopping mad over drug price increases. So the industry is launching an ad campaign to try to get back in politicians' good graces and repair its tarred image as the debate over drug pricing rages on.

 

Doctors pounce on 'alarmist,' 'horrifying' Novartis heart-failure ad

It's not often that a disease-awareness campaign makes unwanted waves. But Novartis' recently launched heart failure push is doing just that--literally and figuratively.

Takeda-Teva JV 'could be a trendsetter' as Japan pushes for generics: analyst

Japan's efforts to cut drug costs have prompted at least one big deal this past year, with Takeda Pharmaceutical saying that it would team up with Teva Pharmaceutical Industries to respond to the country's generics push. These kind of deals will become more common, some analysts say, as Japan shifts away from branded meds and spurs development of low-cost copycats.

EMA: Faulty device didn't distort study findings for Bayer's Xarelto

Last December, European regulators said they were no longer sure whether results from a trial of Bayer's new-age clot-buster Xarelto were accurate thanks to a defect in a blood-clotting testing device used in the study. But the German pharma can breathe easy now.

Celltrion's biosimilar of J&J's Remicade reviewed favorably by FDA staffers

FDA staff reviewers were supportive of the Remicade biosimilar from Celltrion ahead of next week's advisory committee meeting. The reviewers said that the drug is "highly similar" to the branded product in terms of safety, purity and potency. 

FDA shoots down Vertex's latest bid for Kalydeco expansion

Vertex has so far had a lot of success widening the patient pool for orphan drug Kalydeco. But in its latest quest for a label expansion, the FDA has stopped it in its tracks.

AstraZeneca CEO still interested in M&A but he is getting very picky

AstraZeneca recently plunked down $575 million to get from Takeda global rights to the chronic obstructive pulmonary disease treatment Daxas. It was the kind of deal that currently intrigues CEO Pascal Soriot, something that will immediately pay off and which falls into one of the three areas around which he is trying to rebuild the company.

FDA's Califf calls for 'sweeping re-examination' of policies in effort to fight opioid abuse

The FDA has been repeatedly criticized for expanding approvals for opioids in the face of an "epidemic" of abuse and overdoses. Today Dr. Robert Calif, President Obama's pick to head the agency, took that matter head-on, calling for a sweeping review of the agency's policies.

Valeant, Turing slammed for price hikes during congressional hearing

Industry watchers expected a show at Thursday's congressional drug price hearing, and the event did not disappoint. Members of Congress slammed Valeant and Turing Pharmaceuticals for dramatic prices increases, and also took shots at former Turing CEO Martin Shkreli, who remained close-lipped throughout the hearing.

Valeant chief calls on Medicare to allow controversial copay help from pharma

Drug companies can't currently help Medicare patients pay for out-of-pocket drug costs. But Valeant, which has come under the lens for its price-hike strategy, wants to change that.