News

Novartis and Roche now have France eyeing competition issues

Efforts to steer doctors away from off-label use of cancer drug Avastin in favor of the pricier Lucentis for treating sight issues have gotten Swiss drugmakers Roche and Novartis fined by the anticompetition authority in Italy, where prosecutors are also taking a look, and now French regulators say they are in the midst of a probe of their own.

Teva hit with $27.6M settlement in clozapine kickback case

Israel's Teva Pharmaceutical has agreed to pay $27.6 million to settle allegations that it illegally paid a Chicago doctor to prescribe the generic antipsychotic drug clozapine to Medicare and Medicaid patients.

With Big 5, Bayer aims for 8% annual pharma growth through 2016

The CEO of the German drugmaker is pinning some numbers on the medium term; the Big 5 will help Bayer aim for an average of 8% annual growth in its pharma unit through 2016, Marijn Dekkers said Wednesday.

GSK, J&J, TPI want Australia to ease their pain on poppy supplies

Australia accounts for nearly half of the global supply of opium poppy plants that produce the ingredients needed for pain drugs. But drugmakers are in the midst of a political fight there as they press the government to expand production from the island of Tasmania to Australia's mainland.

Teva's early Copaxone-switching success turns analysts into believers

Early progress doesn't always equal long-term success. But at least in the case of Teva Pharmaceutical Industries--which is firing on all cylinders to convert patients to a new, long-acting version of Copaxone--early results have some analysts thinking the Israeli company may deliver on its promise to switch 30% to 50% of patients.

AstraZeneca set for earnings boost if Ranbaxy can't deliver a Nexium generic

AstraZeneca may get lucky with Nexium. That's thanks to the embattled Ranbaxy Laboratories, the Indian generics maker that could launch a copycat version May 27.

Pharma wins battle against proposed Medicare reimbursement changes

Following a huge outcry from drugmakers, insurance companies, and patient advocates, the Obama administration said Monday it had abandoned proposed changes to the Medicare Part D drug benefit.

Bayer's Nexavar falls short in new liver cancer trial

Bayer and Onyx Pharmaceuticals' Nexavar has seen a lot of success as a liver cancer treatment, but as an adjuvant therapy for liver cancer, it could be awhile--if ever. On Tuesday, the drug missed its target in a Phase III trial, failing to meet the study's main goal of improving recurrence-free survival.

With Solvadi in the mix, the FDA's class of 2013 is set for chart-busting sales

The number of new drugs approved by the FDA last year may have been down considerably but some of them were humdingers. Eight are projected to hit blockbuster status 5 years out, and the entire group of 33 is forecast to have fifth-year projected sales of $25.4 billion. That is 50% more than the record breaking group of 43 drugs approved in 2012.

BTG recoils at rattlesnake roundup 'gassing'

A British drugmaker has landed in the middle of the controversy over Sweetwater, Texas' Rattlesnake RoundUp.

That's some reimbursement deal: Alexion hikes EPS, sales forecast on French agreement

Here's what a successful negotiation with a government payer will get you: An 18% hike in your earnings forecast, about $150 million in additional sales, and a quick spike in share price. That's what Alexion yielded from a new reimbursement deal with France on its pricey rare disease treatment Soliris.

Ranbaxy issues a recall, but so do Pfizer, Baxter, Gilead and Mylan

India's Ranbaxy Laboratories has issued another recall for its generic Lipitor, but a series of product recalls in recent weeks have come from plants around the world and companies as varied as Pfizer, Mylan and Gilead Sciences.

Long-acting hemophilia meds portend a pricing fight with older drugs

New, long-acting clotting factors are on their way, with Biogen Idec's hemophilia B drug Alprolix first in line. The new treatments promise to prevent bleeding for up to two weeks, and that means today's injections will have to find a way to compete.

Novartis orphan drug Jakavi nabs 'blockbuster' forecasts on new data

Novartis may have another cancer blockbuster on its hands. New Phase III data on Jakavi (ruxolitinib) has Wall Street analysts predicting that it will easily pass the $1 billion mark.

UPDATED: A key Actos trial revs up in Vegas with demands for a $1B-plus judgment

The latest trial over Actos' bladder-cancer risks is set to begin. With thousands of other Actos cases pending against Takeda, the case already was destined to be closely watched. And now, one of the plaintiff's lawyers says he's planning to seek the largest verdict in Nevada history.

AstraZeneca says Nexium pills with Ranbaxy ingredient are safe to use

While most drugs from India are generics, sometimes Indian products are used by Big Pharma for their top brands, like AstraZeneca's Nexium.

EU suggests new warning for same sleeping pill that landed a Kennedy before a jury

Sleep drugs have been the root of plenty of safety worries over the years, especially when it comes to driving while under their influence. Now, just a week after the wrap of one of the highest-profile cases to revolve around Ambien generic zolpidem--Kerry Kennedy's--the European Medicines Agency's Pharmacovigilance Risk Assessment Committee is recommending updates to its product information to underscore the drug's associated risks.

Bristol-Myers Squibb cuts more costs by whacking 160 jobs in Ireland

Bristol-Myers Squibb turned in improved financial results last year, in part by cutting costs after refining its focus, like its decision to drop its diabetes drug development partnership with AstraZeneca. The drugmaker is continuing that trend by tightening its manufacturing operations in Ireland and cutting about 160 jobs.

Gilead's Sovaldi sales through the roof already, analyst predicts at least $8B this year

With a revolutionary approach to hepatitis C and a price tag of $84,000 per 12-week treatment course, analysts expected big sales from Gilead's Sovaldi. Some even forecast it would reach $9 billion or more by 2017, at which level it would surpass Pfizer's Lipitor to take the crown for biggest-selling drug of all time. But none expected the exponential growth the drug is posting right now.

Novartis sees start of $2B dermatology opportunity with new EU Xolair approval

On Thursday, Novartis won European approval for its injectable Xolair to treat chronic hives--the first such product cleared there for patients who don't respond to antihistamines alone.