News

New Zohydro formula gets FDA's blessing, but abuse-deterrent label has to wait

Since its FDA approval, the all-hydrocodone painkiller Zohydro has sparked outrage from officials and advocates trying to fight the tsunami of opioid addiction. But with its new Zohydro formula now approved, Zogenix is hoping it can put out the fire.

Big Pharma farms out safety monitoring to $2B-and-growing industry

Big Pharma has been hiring out all sorts of functions companies once did in-house: sales, manufacturing, and IT services, to name a few. But according to The Wall Street Journal, one of the fastest-growing fields for pharma contractors isn't any of these. It's drug safety.

Shire's ADHD star Vyvanse scores FDA's first binge eating approval

Shire's been working for awhile to expand its focus beyond ADHD. And now it's expanding blockbuster drug Vyvanse beyond ADHD, too.

J&J lawyers aim to discredit ex-FDA chief in Risperdal breast-development case

Johnson & Johnson has fired back against former FDA chief David Kessler, who testified against the company last week in a Risperdal liability case. Kessler can't be trusted on drug safety, J&J's lawyers said, because he's a "hired gun" known for attacking drugmakers in court.

UPDATED: Mylan's women's health biz leaps to fore in emerging markets with $750M Famy deal

Mylan will pay $750 million in cash to buy the women's healthcare businesses from India's Famy Care, placing it as the top seller of contraceptives in emerging markets.

Chinese square off against Alibaba in palace intrigue as online drug sales loom

Who knew that China FDA's planned lifting of a ban on online drug sales meant the global pharmaceutical industry could become a subject of a Chinese version of palace intrigue?

Amid new drug negotiations, China puts price-management vet in charge of CFDA

SINGAPORE--A change in leadership at the China Drug and Food Administration was announced on the Communist Party website last week: Bi Jingquan, who has more than 20 years of experience in pricing and management, will take over from Zhang Yong as CFDA minister.

Ranbaxy-Sun U.S. approval hinges on selling antibacterial drug as FTC notes reach of Indian generic giant

Ranbaxy Laboratories may soon be selling its generic minocycline antibacterial drug to Torrent Pharmaceuticals as a condition for U.S. approval for its merger with Sun Pharmaceuticals.

Valeant forays into oncology with stalking-horse bid for Dendreon's Provenge

Valeant has finally made a significant M&A move after its failed pursuit of Allergan, and bankrupt Dendreon has finally found a way to unload cancer vaccine Provenge. And they're one and the same.

AbbVie rides high on Humira sales in Q4 but looks to new products for success in 2015

AbbVie posted promising fourth-quarter earnings fueled by the strong performance of blockbuster Humira. But the company is looking beyond its top-selling med in 2015, focusing on the development of new products to bolster its bottom line as it counters generic competition to some of its key moneymakers.

Study of all data on Roche's highly debated Tamiflu says it does help

A significant new study of Roche's blockbuster flu fighter Tamiflu has found that, while it has side effects, it can reduce symptoms by a day and keep some patients out of the hospital with complications, Reuters reports.

Victoza powers Novo's strong year; CEO projects growth for 2015

Novo Nordisk CEO Lars Sorensen told investors today that 2014 had been a more challenging year than most, then rolled off a series of results that showed significant leaps in sales both in the U.S. and worldwide. He then waved off any worries about a price war in the U.S. being a significant issue for the world's largest maker of insulin products this year.

Viehbacher's ouster, severance raise red flags for CEO candidates

So far, Sanofi has come up empty-handed in its hunt for a CEO to replace the ousted Chris Viehbacher. And the mystery surrounding his firing may have something to do with it.

Lilly's sales and earnings continue their free-fall but CEO Lechleiter sees good things coming

Eli Lilly CEO John Lechleiter promised today that the company's finances will improve over the next decade. It would be hard for them to get much worse. Lilly's fourth-quarter net income was down 41%. Its revenue was down 12%. Its earnings were down 40% to $0.40 a share.

India warns drugmakers failure not an option for price data due next week

India's National Pharmaceutical Pricing Authority has told drugmakers that failure to hand in drug price and sales data by next week is not an option.

Branded drug prices leapt almost 15% last year, led by pain pills, COPD and heart meds

It's no secret that branded drugmakers often rely on price hikes to keep U.S. sales growth coming, especially on older meds whose patents are close to the ends of their lives. But according to new data, prices spiked more than 10% last year--a trend that may fuel the payer backlash that's been steadily mounting.

New Celgene meds power forward, but Revlimid's still the Big Kahuna

Celgene edged past analyst estimates for the fourth quarter and full year, with earnings of $3.71 per share and $7.67 billion in revenue for 2014. Its powerhouse remedy for multiple myeloma, Revlimid, still accounts for the lion's share of those sales, at $4.98 billion in 2014 revenue, an increase of 16%.

Looking to get out of the hot seat, Salix to restate financials for past 7 quarters

After completing a review of inventory issues that inflated sales figures for some of its products, Salix is going to tell it like it is. The company will restate its financial reports for the last 7 quarters, a move it thinks will put the issue to rest.

Ex-FDA chief testifies against J&J in Risperdal liability case

Johnson & Johnson knew as early as 2001 that its antipsychotic drug Risperdal could cause boys to grow breasts, former FDA chief David Kessler testified in Philadelphia court Wednesday. That's 5 years before the company added a warning about the side effect to the drug's official label.

Gilead zooms past AbbVie in hep C race with UnitedHealth deal

Gilead Sciences racked up another point in the pricing battle with its hep C rival AbbVie as UnitedHealth Group chose Harvoni as its preferred hepatitis C treatment over AbbVie's Viekira Pak, weeks after Gilead scored deals with three insurers to make Harvoni the primary option for patients.