News

UPDATED: Consumer groups urge FTC to take Mylan's side in Teva deal fight

Mylan is dead set against a buyout bid from generics rival Teva Pharmaceutical Industries. But some U.S. consumer groups are spooked by the very talk of a deal, and they're lobbying the Federal Trade Commission against it.

AZ's Iressa gets back in the game with first-line FDA approval in lung cancer

AstraZeneca's Iressa is back. After four years off the U.S. market, the lung cancer fighter has picked up an FDA approval as a first-line lung cancer therapy, specifically for patients whose tumors test positive for certain EGFR mutations, the company said Monday.

Sen. Sanders joins Maryland rep for game of pricing hardball with Amphastar

Amphastar is facing a growing chorus of discontent over its overdose drug naloxone, with U.S. officials urging the company to bring down its high prices for the med. Last week, Rep. Elijah Cummings of Maryland asked his state governor to play hardball with the company to negotiate a deal. Now, presidential hopeful Sen. Bernie Sanders (I-VT) is joining the fray, teaming up with Cummings to pressure all state governments to combat rising naloxone prices.

UPDATED: J&J's pharma biz takes Q2 hit on hep C slippage, but new meds keep delivering

Johnson & Johnson's second-quarter results might look bad on the surface--the strong dollar dragged down overall sales by 7.9%--but even without that hit, the top line grew by just 1.7%. Its fast-growing pharma business, which has been making up for shortfalls elsewhere in the company for some time, faltered because of collapsing Olysio sales.

Look out, Teva--Novartis' Copaxone generic is off to a speedy start

The launch for Glatopa, the new generic of Teva's Copaxone from Novartis' Sandoz, is still in the very early going. But so far, things look good--very good.

Endo, Mallinckrodt leverage different strengths in M&A hunt

Endo and Mallinckrodt have both been using M&A to help them head down the specialty pharma path. Both call Ireland home, helping them boast lower tax rates than many of their peers--and giving them a leg up in the dealmaking arena. And both generate the vast majority of their revenue in the U.S. But as Moody's points out, there are some important differences between them, too--and those will help determine their next M&A moves.

Panel to rule pricey hep C meds cost-effective, endangering payer pushback

Payers continue to grouse about the cost of hepatitis C fighters from Gilead Sciences and AbbVie, as more and more patients seek treatment with the pricey meds. But as Bloomberg reports, a forthcoming analysis could throw a big wrench into some insurers' ongoing efforts to limit access to the drugs.

UPDATED: Depomed swallows poison pill to keep hostile Horizon at bay

Depomed was serious when it said it wasn't interested in Horizon Pharma's $29.25-per-share bid. Following the Irish pharma's move to take its hostile overture public last week, the company has put up its takeover defenses.

European safety watchdog digs into HPV vaccines again

After years of fighting off safety concerns and a perceived sex-related stigma for their HPV vaccines, Merck and GlaxoSmithKline will face another test with their respective jabs in Europe.

Otsuka, Lundbeck bag blockbuster FDA approval for antipsychotic Rexulti

Otsuka is facing plenty of bleeding, now that its blockbuster antipsychotic Abilify has generic competition. But the company is working hard to soften the blow, and a brand-new FDA approval for a long-acting antipsychotic could help.

The top 20 highest-paid biopharma CEOs

After 7 years of compiling executive pay numbers, we at FiercePharma have learned a bit about the pharma compensation landscape. Rules to research by, let's call them. The first and biggest:...

Novartis' pay-for-performance Entresto plan has its critics--Express Scripts' Miller among them

Novartis has said it's planning to offer an outcomes-based plan for its new blockbuster-in-the-making to secure payers' favor. But skeptics see some kinks in the plan--and the CMO at leading PBM Express is one of them.

House passes 21st Century Cures bill

Members of U.S. House of Representatives voted 344 to 77 today to approve the 21st Century Cures bill. It now goes to the Senate for consideration. The bill provides more funds for the FDA and NIH, but detractors are concerned about provisions that change the way drugs and devices are developed and approved.

FDA scales up CV warnings on NSAIDs

The FDA already had a warning out about the cardiovascular safety of nonsteroidal anti-inflammatory drugs, or NSAIDs. But on Thursday, it strengthened that warning for both prescription and OTC meds.

DOJ criminal probe takes a look at trade associations

For more than a year, the Justice Department (DOJ) has been pursuing a criminal investigation into the possibility of pricing collusion among makers of generics. Three companies have acknowledged receiving subpoenas from the feds, and now a report says the probe may also be looking into whether trade associations were used as a conduit to trade drug-pricing information.

U.K. cost gatekeeper changes its tune on Entyvio for Crohn's

Takeda has hit a few speedbumps lately, struggling with sagging sales and less-than-stellar profits after losing the patent for one of its top sellers. But the company is enjoying a bright point as the U.K. cost gatekeeper gave its thumbs-up to the company's inflammatory bowel disease drug Entyvio, dealing the company some good news as it looks to its gastrointestinal meds to revive its flagging fortunes.

Fresenius companies fined £550,000 by U.K. court in patient death

Fresenius Kabi and a sister company were ordered by a U.K. court on Thursday to pay more than $860,000 in penalties after a diabetic patient died because the syringes the companies supplied contained no actual insulin. On top of that, the court found that Fresenius and Calea also supplied tobramycin syringes used on another patient that contained three times the prescribed daily dose.

Glaxo's HIV unit ViiV aims to steal share from Gilead before patents bite

GlaxoSmithKline's ViiV Healthcare stole the show in Q1, surpassing analyst expectations and prompting the pharma to hang on to the HIV drug business, canceling all plans for a potential spinoff. There's just one problem: ViiV may one day become a victim of its own success.

SC high court cuts J&J's Risperdal marketing penalty back again, to $124M

South Carolina's Supreme Court further cut the penalty against Johnson & Johnson stemming from a Risperdal deceptive-marketing lawsuit. Originally ordered to pay $327 million for violations of the state's Unfair Trade Practices Act, J&J's Janssen Pharmaceutica unit now faces a $124 million judgment.

Payers think they can squeeze prices on cancer immunotherapies? Not so fast, analyst says

Looking for an antidote to all the payer chest-thumping about cancer drug prices? Here's some news to suit pharma, at least when it comes to cancer immunotherapies. One big distinction in health insurance--between medicines patients take at home and those they receive at doctors' offices--should put a crimp in payers' efforts to squeeze out discounts on PD-1 and PD-L1 therapies.