News

UPDATED: Novartis divvies up troubled Alcon; rejigs R&D and manufacturing to save $1B

Novartis has a problem with its eye-care unit Alcon: It's not performing. As expected, the division dragged down the Swiss drugmaker's fourth-quarter and full-year financials. But the company's sales and earnings didn't fall short just because of Alcon.

Amgen's Humira biosim is one step closer to FDA approval. But how close is it to market?

On Monday, Amgen said the FDA had accepted its application for its biosimilar of AbbVie's Humira, so-called ABP 501--but earlier this month, the U.S. Patent and Trademark Office shut down its challenge to Humira's patents.

U.K. cost watchdog nixes pricey biologics for moderate rheumatoid arthritis

The U.K.'s cost effectiveness gatekeepers are giving their final blessing to a slew of rheumatoid arthritis biologics--but only for patients with advanced forms of the disease. And drugmakers aren't exactly happy about it.

Novo Nordisk rolls out long-awaited Tresiba, aiming for blockbuster U.S. market share

Novo Nordisk finally launched its next-gen diabetes treatment Tresiba in the U.S., approved by the FDA last September. The Danish drugmaker has high hopes for sales, but the long-acting insulin faces new competitors that could get in the way of those ambitions.

J&J's new launches deliver, but overall sales fall short on hep C, strong dollar

Johnson & Johnson's hep C sales have been nosediving, and the fourth quarter provided more of the same on that front. But in the quarter, a strong dollar took a toll on the company's top line, too, dragging sales below analyst estimates.

Sanofi and Regeneron likely to cough up royalties to end Amgen's PCSK9 patent suit: Analyst

One of the hottest races for market share in pharma these days is between Amgen's cholesterol-fighter Repatha and Praluent, from Sanofi and Regeneron. They're apparently neck and neck with payers, and their script numbers aren't much different either, at least so far.

Big Pharma chalks up victory in Arizona Supreme Court over Rx safety warnings

Big Pharma can celebrate a bright point. Arizona's top court ruled that drugmakers don't have an obligation to warn patients directly about safety risks of their meds. Raising those warnings with doctors is enough, the court determined.

J&J loses bid to dismiss false advertising lawsuit over baby products

Johnson & Johnson was hoping to put a marketing case around its Bedtime Products for babies to rest, but a federal judge isn't having it.

BMS' Opdivo evens the score in melanoma with two new FDA green lights

Thanks to an FDA decision over the weekend, Bristol-Myers Squibb's immunotherapy Opdivo has caught back up to Merck's Keytruda in melanoma. And it won a new combination approval from the FDA to boot.

Valeant's ill CEO Pearson on the 'road to recovery,' but still no timeline for his return

Valeant's pneumonia-stricken CEO, J. Michael Pearson, is on the mend, according to a letter he penned to his colleagues on Monday. But as to when he'll be back at work, it's still up in the air.

Pressure mounts at GSK, with U.S. hedge fund leading calls for exec shakeup

Another big investor is putting the screws to GlaxoSmith Kline. Och-Ziff Capital Management has built up a sizable stake in the London-based drugmaker, The Sunday Times reports, and fund officials are leaning on Chairman Philip Hampton to shake up management.

Novartis adds 100 jobs at Lek site in Slovenia as it muscles up on biosimilars

Novartis was the first drugmaker to get a biosimilar approved in the U.S. and has set itself up to be a major player in the growth of the biologic copies. That is going to require more development muscle, and so it has expanded its Lek subsidiary in Slovenia, adding 100 jobs in the process.

Indian pharma mulls deal for U.S. injectables maker Sagent Pharma

U.S. injectables maker Sagent Pharmaceuticals is considering putting itself on the chopping block, and if or when it does, at least 5 Indian drugmakers could come calling.

Pfizer's Ibrance clears first hurdle to early access in U.K.

Pfizer's new cancer standout, Ibrance, has taken its first step toward joining the U.K.'s Early Access to Medicines program, winning the "promising innovative medicine" tag from the country's Medicines and Healthcare Regulatory Agency.

Amgen's Repatha wins first PCSK9 OK in Japan

Amgen and the Sanofi and Regeneron team have been duking it out with their PCSK9 meds in the U.S., racing to ink payer deals in an effort to get ahead. But now, Amgen has the chance to get ahead start in another of the world's largest pharma markets.

Yes, Gilead put superhigh prices on hep C drugs, but what can you do? Senators ask

After 18 months spent slicing and dicing 20,000 pages of Gilead Sciences documents and emails, a Senate investigation concluded that the drugmaker put very high price tags on its hep C cures Sovaldi and Harvoni, knowing full well that would keep some patients in need from affording them. Now the Senate sponsors of the inquiry are asking payers and public, based on what was learned, just what can the government do to discourage untenable drug prices without stepping all over pharma innovation.

Shkreli's 5th Amendment hall pass rejected for congressional drug pricing hearing

Pharma bro Martin Shkreli is requesting a hall pass to get out of testifying at a congressional hearing on drug pricing next week after receiving a subpoena ordering him to appear. But principals leading the price-fighting crusade including ringleader Rep. Elijah Cummings (D-MD) aren't letting Shkreli off the hook that easily.

Amgen's Kyprolis wins 'backbone therapy' FDA nod after trumping Velcade in trial

Back in March, Amgen's Kyprolis posted impressive results in a head-to-head trial with Takeda behemoth Velcade--and now, those results have helped it grab an important thumbs up from the FDA.

U.K.'s NICE says yes to Opdivo for advanced skin cancer

Last month the U.K. drug cost watchdog nixed Bristol-Myers Squibb's immunotherapy Opdivo for use against lung cancer, saying in draft guidance that it just cost too much to justify approval. But NICE feels differently when it comes to using Opdivo against skin cancer, today recommending it for approval without even extracting a price cut.

FDA bans products from China plant used by Big Pharma players

A Chinese ingredient maker who has produced ingredients for some of the big guns in pharma including Novartis, Sanofi and Pfizer is getting its products banned by the FDA.