News

Kalydeco in R117H patients? As AdComm nears, Vertex drug faces doubts

Vertex' orphan drug Kalydeco boasts a comparatively small patient pool that the drugmaker is trying to swell, with an eye on adding cystic fibrosis patients with the R117H mutation. But first, it'll have to get the FDA's OK, and new briefing documents suggest the agency still has some doubts.

Bristol-Myers catches a break as Indian agency delays Sprycel patent decision

Prime Minister Narendra Modi got an ear full from both constituents and the U.S. drug industry about India's approach to drug patents during his first visit to the U.S. last month. Three weeks later, there is evidence the government will take a considered approach to the contested issue.

Baxter prepping for HyQvia launch with spinoff's success on the line

It's been a long road for Baxter's primary immunodeficiency replacement therapy in the U.S., but the Illinois company is finally preparing to roll out the med in its home country. And with its biopharma spinoff on the calendar for next year, a solid launch is something the drugmaker could use.

AbbVie's $1.635B breakup fee to Shire, if paid, will run third highest ever

Breaking up is hard to do, and can be expensive. AbbVie is getting into record territory with the $1.635 billion breakup fee it will have to pay Shire for canceling their $55 billion deal.

Lilly will close Puerto Rico plant, affecting 100 workers

It has been a tale of two cities when it comes to Eli Lilly's operations in Puerto Rico. Its plant in Carolina has been slotted for $240 million in investments in the last year, benefiting from its buildup in insulin products, and its plant in Guayama is getting axed, a victim of patent losses.

UPDATED: FDA panel say Pfizer's Chantix should continue to wear a 'black box' label

Pfizer's controversial smoking-cessation drug Chantix will continue to be stuck with a black-box warning label at least until late next year, assuming the U.S. Food and Drug Administration follows the recommendations of its experts.

If Teva wanted a clear sign from Supreme Court on Copaxone, no such luck

Teva's been waiting a long time to get its Copaxone patent appeal before the Supreme Court. And now that the court has heard oral arguments, it seems to be divided on the issue.

Same-day approvals send Roche, Boehringer to IPF market battle

There's nothing like same-day FDA approvals to trigger a market showdown--and that's the case for a pair of new idiopathic pulmonary fibrosis (IPF) treatments. After snagging nods from the agency Wednesday, Roche's Esbriet and Boehringer Ingelhem's Ofev will be going head-to-head.

Matchmaking for Shire and AbbVie already? Try Allergan (of course) and Pfizer

Now that AbbVie has said it wants to dump Shire, we could soon have two companies back on the market--and both could prove popular as the dust settles. In fact, as Bloomberg reports, AbbVie could make a decent second choice to AstraZeneca if Pfizer so chooses.

Hospira says saline recall will not make shortage worse

Hospira, the country's largest producer of sterile drugs, is recalling two dozen lots of saline solution, along with 30 lots of other products, because the bags on one of its delivery systems can leak and products might get contaminated.

AbbVie calls it quits on $55B Shire takeover

Another one bites the dust in the Big Pharma megamerger craze. Weeks after the U.S. Treasury Department laid out new tax rules to limit the stream of corporate inversions, AbbVie called it quits on its proposed $55 billion takeover of Dublin-based Shire.

Once again, Roche breast cancer franchise shines, sending Q3 drug sales up 4%

Roche can thank its newly augmented breast cancer portfolio for powering third-quarter sales upward, far enough to surpass analyst estimates. And given the latest data on one of those drugs--Perjeta--more growth could be at hand.

Gilead, Allergan, Novo and Valeant chiefs make the list of world's top 10

Pharma CEOs are doing a pretty good job at the helm--at least where the Harvard Business Review is concerned.

Déjà vu for Celgene as NICE says 'no' to myeloma drug Imnovid

The U.K.'s cost-effectiveness watchdog has recently sounded a bit like a broken record when it comes to its cancer drug rejections. The latest to get a "no-go" from the gatekeeper? Celgene's Imnovid.

FDA grants a combo-med exclusivity wish. Why is that a problem?

What's two extra years of exclusivity worth? Enough to spark a legal fight. The FDA posted new guidance on its website Friday, awarding certain combo meds 5 years of exclusivity compared with the previous three. Drugmakers had lobbied for the change, but the timing--and the wording--are bound to be controversial.

Former Merck staffer charged in insider trading case

The latest pharma company to wind up in the middle of insider trading charges? Merck. A former employee at the drug giant has been charged after allegedly tipping off a former classmate about potential deals that scored him $683,000.

GSK starts unloading older meds by region, with $3B portfolio up for grabs

In its latest move to revive profits and slim down a sagging portfolio, GlaxoSmithKline is planning to put $3 billion worth of older drugs on the chopping block, shedding products by geographical region.

AbbVie-Shire deal in jeopardy, but not necessarily dead

Shire, which believed only a day ago that it would soon be bought out by AbbVie in a $54 billion deal prompted by tax advantages, is not going to just roll over and play dead now that its pursuer is getting cold feet. It insists the deal should go through.

Novartis' Russian growth plans get delayed

Novartis is reportedly caught between EU sanctions on Russia and the dictates of Russian President Vladimir Putin, who has told Western drugmakers that he expects them to build plants and transfer technology as the price of admission to the growing market.

FDA reviewers say Pfizer's Chantix should keep its black box

FDA staffers aren't as impressed with new safety data on Chantix as Pfizer wants them to be. In briefing documents filed in advance of Thursday's advisory committee meeting, reviewers say the stop-smoking remedy should keep its black-box warning about potential psychiatric side effects.