News

Colorado lawmakers pass biosim substitution bill

Colorado's house of representatives passed a bill allowing pharmacists to substitute biosimilar versions of biotech drugs, even when the brands are prescribed by name. The approach would almost mirror the substitutions allowed with standard generic meds, except for the fact that pharmacists would be required to notify doctors about the change.

Cost watchdogs back Novartis' Xolair for big new market in chronic hives

England's cost-effectiveness watchdogs have changed their mind on Xolair. The National Institute for Health and Care Excellence decided to back the Novartis asthma drug as a treatment for chronic hives, after sending the drugmaker back for more data last year.

Watchdog groups decry FDA's move to let reps hand out journal articles

The FDA rolled out some guidelines last June that would allow drugmakers to hand out medical-journal articles to doctors. And now, the consumer watchdogs at Public Citizen, along with a bevy of patient groups, are in full protest mode.

J&J boosts CEO pay to $25M, doubles R&D chief's haul

Johnson & Johnson CEO Alex Gorsky got a multimillion-dollar pat on the back for 2014. J&J's board upped his pay package to almost $25 million, with more cash, more options, and a much bigger chunk of J&J stock.

UPDATED: Endo aims to lure Salix from Valeant with $175-per-share offer

Last month, some industry watchers speculated that the low price Valeant agreed to pay for North Carolina's Salix could leave room for other bids. And now, one has arrived, courtesy of Endo International.

Should Teva buy Mylan? 'Close call,' analyst says

Rumors have been floating around for months that pickup-hungry Teva may be looking to buy generics competitor Mylan. Some analysts have dismissed the idea, pointing to reasons a buyout wouldn't work. But with the deal talk persisting, at least one analyst says the underlying logic for a tie-up is sound--as long as it doesn't happen right away.

Hopeful Merck execs talk up early Belsomra launch results

Last month, Merck & Co. finally rolled out its long-awaited sleep drug, Belsomra (suvorexant). After years of delays and disappointments at the FDA, it's safe to say that no one expects the drug to churn out big sales this year. But that's not to say Merck doesn't have its ambitions.

Merck's Keytruda snags inaugural approval in U.K.'s early-access scheme

Merck's Keytruda may still be waiting for regulatory approval in Europe, but some patients will soon have access to the therapy thanks to a new program in the U.K.

AstraZeneca adds hefty share grant to CEO's £3.5M pay

AstraZeneca CEO Pascal Soriot got a bit of a pay raise last year, with a 3% bump to his base salary. His bonus jumped, too, putting his salary, bonus and cash benefits at £3.5 million. But Soriot's real boost came in the form of equity that won't pay off for a few years: Some £4.8 million in shares, under the company's long-term incentive plan.

Ambitious Bayer puts up $27B sales goal for 2017, with OTC carrying a big load

Bayer has already said it plans to home in on life sciences after it carves out its plastics unit later this year for an IPO or spinoff. So what, exactly, does that mean for its HealthCare division, numbers-wise?

Zogenix jettisons controversial pain med Zohydro for $100M-plus

Zogenix has taken plenty of heat over Zohydro, the all-hydrocodone painkiller that critics say is too easy for opioid addicts to abuse. But under a deal announced Tuesday, those critics will no longer be the San Diego company's concern.

J&J pleads guilty, pays $25M tied to metal-tainted Children's Tylenol

Johnson & Johnson's McNeil Consumer Healthcare has pleaded guilty to a federal misdemeanor charge and will pay a $20 million fine and forfeit another $5 million for allowing Infants' Tylenol, Children's Tylenol and Children's Motrin products into the market that were tainted with metals.

Can Apple's new ResearchKit really transform drug R&D?

Amid all the pomp, circumstance and sans serif fonts in Apple's latest product launch, the company took a break from pumping expensive new gadgetry to unveil a piece of software with the potential to change the medical research landscape.

Drug spending surged 13% last year, with pricey hep C meds leading the charge

U.S. prescription drug spending shot up 13.1% last year, according to a new report from Express Scripts. And the vocal price critic says it knows just who's to blame.

FDA keeps black box on Pfizer's Chantix, adds new warning about alcohol

Pfizer has been lobbying the FDA to back off of the black-box warning on its stop-smoking drug Chantix. But patient groups and others have been pushing back--including a panel of FDA advisers, which voted last year to keep the agency's boldest warning on Chantix's official label.

Activist investor Ackman nabs $3B-plus stake in former takeover partner Valeant

Billionaire investor Bill Ackman spent quite a large chunk of 2014 talking up Valeant Pharmaceuticals and its business model--and now, he's putting his money where his mouth is.

New Bristol-Myers CEO on tap for $8.7M-plus pay package

Bristol-Myers Squibb's incoming CEO will get quite a raise with his new job. But it's likely to be awhile till Giovanni Caforio, now the company's chief operating officer, sees his pay catch up to that of current chief Lamberto Andreotti.

Concordia scores ex-Big Pharma drugs in $1.2B Covis buyout

Concordia Healthcare is snatching up Covis Pharma's pharma and injectables units for $1.2 billion in cash, beefing ups its generics portfolio and riding the recent wave of pharma M&A.

Astellas scores FDA approval for life-threatening fungus-fighter

The FDA offers incentives for developing products that target life-threatening infections, and Astellas just became the latest drugmaker to take advantage.

Opdivo's survival benefit inspired FDA to act fast on NSCLC approval: Pazdur

When Opdivo showed it could prolong the lives of lung cancer patients, Bristol-Myers Squibb quickly broadcast the data. And the pharma world was sufficiently impressed. But the FDA was so impressed with the survival data on the new immunotherapy, it was already working on a new approval for the drug.