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Bydureon, the once-weekly injection for treating patients with type 2 diabetes, has finally won the FDA’s okay.

As Dow Jones Newswires reports, it’s been a long, bumpy road to approval for the drug’s developer, Amylin Pharmaceuticals.

(Alkermes is behind the extended-release technology used to deliver the drug, a longer-acting version of Amylin’s twice-daily Byetta.)

Amylin started working on the drug in 1999 and first applied for FDA approval — with its then-partner Lilly — a decade later. But the agency in 2010 said ..read more

Seeking More Data: The FDA wants more information about an experimental diabetes drug from Bristol-Myers Squibb and AstraZeneca before considering it for approval, Dow Jones Newswires reports. The companies said the agency wants more clinical data in order to better assess the risks and benefits of dapagliflozin, which is a new type of therapy for diabetes, and that they remain committed to the drug. An FDA advisory panel voted against approving the drug in July, raising safety ..read more

CVS and FTC Settle: CVS Caremark will pay $5 million to settle FTC charges that the company’s Rx America unit posted prices for certain Medicare Part D prescription drugs that were far lower than the actual prices, Dow Jones Newswires reports. The mistaken rates were posted in 2007 and 2008 at CVS and Walgreen pharmacies and prompted Medicare consumers to choose Rx America without realizing how high their drug costs would be, DJN says. CVS says the ..read more

A Path to Approval: Reversing an earlier decision, the FDA has cleared a path to approval for a medical device made by Mela Sciences that aims to help doctors more accurately diagnose melanoma, the WSJ reports. MelaFind is “approvable” pending some final negotiations, the FDA told the company last week; previously the agency had called on the company to conduct a large new study. The device is already approved for use in 27 European countries, the paper ..read more

Asthmatics who rely on Primatene Mist to control their symptoms need to start stocking up on the over-the-counter medicine now — or find a new prescription alternative.

The FDA reminded us today the drug will no longer be available after Dec. 31 because the delivery system — a certain type of inhaler — uses chlorofluorocarbons. Those compounds, known as CFCs, damage the ozone layer, and are being removed in accordance with an international agreement, the descriptively-named Montreal Protocol on Substances That ..read more

Prostate biopsies are unpleasant — not many men look forward to having a needle passed through their rectal wall into their prostate gland — but they’re not typically perceived as dangerous.

A new study covering more than 152,000 Medicare beneficiaries, however, found that 6.9% of the men who underwent biopsies ended up in the hospital in the following 30 days. That’s more than double the 2.9% hospitalization rate for Medicare beneficiaries who weren’t biopsied.

“This implies there’s something about a biopsy that ..read more

Serial Killers: Genetically engineering certain immune-system cells to identify and then destroy a certain protein found on leukemia cells can put patients into sustained remission from their cancer, the WSJ reports. Research on three people published in the New England Journal of Medicine and Science Translational Medicine shows that the treatment has harsh side effects, however, and much larger studies are needed to prove that it works. The genetic immunotherapy will also be studied in other cancers.

Identifying ..read more

It’s Merck’s Turn: Merck reported a second-quarter profit increase in line with analysts’ expectations, affirmed its revenue guidance for the full year and said it would cut as many as 13,000 additional jobs by the end of 2015, Dow Jones Newswires reports. Profit rose to $2.02 billion, or 65 cents a share, up from $752.4 million, or 24 cents a share, a year earlier, helped by a $1.34 billion tax benefit. Excluding restructuring and other charges, earnings ..read more

Takeover Talks?: Valeant Pharmaceuticals has approached Meda AB in the last two weeks about a takeover, though the status of the talks is unclear, as is the amount Valeant might be willing to pay for the Swedish drug maker, the WSJ reports, citing people familiar with the matter. Assuming a premium of 30%, Meda could be sold for $4.4 billion, the paper says. Ontario-based Valeant previously made an unsuccessful hostile bid for Cephalon.

Pharma Earnings Roll In: Teva ..read more

All day we’ll be tracking the latest and greatest on Express Scripts’ plans to buy Medco Home Solutions for about $29 billion in cash and stock.

Here’s what our colleagues at the WSJ have been reporting:

Deal Journal reports that investors love the deal. Shares in Express Scripts were up 4.7% to $55.00 in recent trading, while Medco shares rose 12.9% to $63.00.

Wall Street analysts were also favorable, though several raised the issue of anti-trust hurdles, given that the combined company will ..read more