Bayer sets up triumvirate of managers to run slimmed-down operation

Change is coming for Bayer--and with it, change at the top. The German pharma has outlined its plans for retooling, post-plastics division divestment--and they involve three operational arms, each headed up by a company vet.

Hillary Clinton to lay out her plan for cutting drug prices

Senator, and presidential candidate, Bernie Sanders and his cohort, Rep. Elijah Cummings, have gotten a lot of attention for their proposed legislation to cut spiraling drug prices in the U.S. One person who seems to have noticed is Hillary Clinton, who says she will unveil her own plan this week for controlling the "cost of skyrocketing prescription drugs."

Bloomberg: Sanofi, Pfizer mull potential deal for Mexican generics maker Rimsa

Big Pharma is having a dealmaking fiesta in Mexico, with companies such as Sanofi, Pfizer and Teva Pharmaceutical Industries considering buying local generic drugmaker Representaciones e Investigaciones Medicas, also known as Rimsa, to beef up business south of the border.

Intas CEO expects to break into U.S. biosimilar market yet this year

The CEO of Intas Pharmaceuticals expects his company to get FDA approval this year for its biosimilar of Amgen's Neulasta, a drug it developed with Canada's Apotex.

Novartis CEO stands by emerging markets even as China economy continues to weaken

China's economy is a mess and other emerging markets are flailing about as well. So what is pharma CEO to do if they have bet big on growth in the EM realm? Keep on keeping on, says Novartis CEO Joe Jimenez.

Perrigo CEO has slammed Mylan for months--but he owns its shares

Perrigo CEO Joseph Papa has cautioned investors against taking up an offer from hostile suitor Mylan. But Papa is already a Mylan shareholder himself.

UPDATED: FDA asks Pfizer for Zoloft label update highlighting birth defect risks

For years, Pfizer has shrugged off claims that its antidepressant Zoloft causes heart defects in newborns, fighting a raft of litigation alleging that the company did not adequately warn pregnant women taking the med about its potential risks. Now the FDA is weighing in on the issue, asking the company to acknowledge some studies that link Zoloft to heart defects in babies.

Allergan and Richter's antipsychotic gets FDA OK but faces stiff competition

On Thursday, Allergan snagged FDA approval for a sort-of-new antipsychotic, Vraylar, to treat schizophrenia and bipolar disorder in adults. But after about a two-year delay in which a raft of antipsychotics--both generic and branded--have made it to market, the question is where it will find a place of its own.

Lilly, BI's Jardiance posts 'amazing' 14% reduction in major CV events

Since Eli Lilly and Boehringer Ingelheim announced that their SGLT2 med, Jardiance, had become the first to show it could lower the risk of major cardiovascular events, the question on the minds of industry watchers has been "How much?"

Baxalta won't rush into M&A to fend off Shire takeover, CFO says

We've seen it plenty in recent pharma M&A: Unenthused deal target pursues its own pickup to dodge an unwanted suitor. But Baxalta, the object of Shire's interest, is not going to be that company.

Celgene's Abraxane takes another hit from cost-effectiveness gatekeepers

Celgene's Abraxane can't catch a break in England. Soon after losing coverage for pancreatic cancer on the country's dedicated Cancer Drugs Fund, the treatment got another thumbs-down from its official cost-effectiveness watchdogs.

Perrigo officially rejects Mylan's 'insulting,' 'ego'-driven buyout offer

Surprise, surprise. Perrigo, which has staunchly opposed suitor Mylan's buyout offers since the company first expressed interest back in April, has officially advised shareholders to shoot down the would-be buyer's proposal.

M&A-minded AbbVie snaps up JPMorgan's dealmaking hotshot

AbbVie could use some M&A to help it diversify beyond best-seller Humira, a popular biosimilar target. And that's something its newest hire knows a thing or two about.

BMJ: New analysis shows increased suicide rates in teens taking GSK's Paxil

GlaxoSmithKline has faced its fair share of scrutiny over a study of its antidepressant Paxil in teenagers, with some experts claiming that the company wrote off harmful side effects linked to the med. Now, a re-analysis of the original study shows that the trial trumpeted Paxil's benefits while downplaying serious side effects including suicide.

Newly vocal union targets Big Pharma's payments to AHA and its leaders

Workers union Unite Here is none-too-pleased with Big Pharma, pushing back in July against the industry's funding of CME courses. Now the union is going after pharma's relationship with the American Heart Association (AHA), pointing to large sums handed to the organization by top drugmakers as costs continue to climb for cardiovascular meds.

Victoza tops Sanofi's Lyxumia in trial, adding to Novo's GLP-1 arsenal

Competition is heating up in the GLP-1 diabetes market, and Novo Nordisk is doing what it can to line up data behind its long-dominant drug, Victoza. The latest: A study pitting the brand against Sanofi's Lyxumia (lixisenatide), which is lining up for an FDA filing this quarter.

Analysis: New Novartis heart failure med has consumers talking

Novartis has been talking up the potential of its brand-new heart failure therapy, Entresto, noting that it could be the company's biggest launch ever. And consumers are taking note.

BMS' Opdivo guns for kidney cancer nod with FDA 'breakthrough' tag

Last July, Bristol-Myers Squibb put an early end to a late-stage study that showed its immunotherapy drug, Opdivo, looked good in patients with advanced kidney cancer. And now, it's one step closer to landing a nod in that population.

Report: Cancer drug spending fuels large increases in Medicare discount drug program

Cancer drug spending has drawn the ire of payers, patients and doctors unhappy with skyrocketing costs for the meds. Now another voice is joining the chorus of naysayers, as a new report from a cancer community nonprofit organization found that a government discount drug program is profiting off the rising costs of cancer meds.

Dr. Califf nominated by president to lead the FDA

Dr. Robert Califf, who was seen as former FDA Commissioner Margaret Hamburg's pick to replace her when she brought him into the agency a month ahead of her departure, may now get the job for keeps. He was nominated Tuesday by President Barack Obama to be commissioner of the FDA.