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As the specter of Amazon.com Inc. looms over the health-care industry, it’s easy to see the tech giant’s threat as a major factor behind the megadeal between CVS Health Corp. and Aetna Inc. Yet the $67.5 billion deal will build a company to match up against a rival that already has businesses spread deep across the sector: UnitedHealth Group Inc. (Tracer, 12/4)

Scrutiny of a key profit source for the drug industry is increasing. That means it is getting harder for investors to forecast industry growth. The Department of Health and Human Services’ Office of Inspector General last week revoked a key favorable advisory opinion for Caring Voice Coalition, one of the largest U.S. charities that helps patients afford insurance copayments for their medicine. The OIG said in a letter, first reported by Bloomberg News, that the charity had provided undue influence to its donors over how the charity was run. The charity said that the loss of the OIG stamp of approval would likely cause it to cease operating. (Grant, 12/6)

Over the past two years, the National Institutes of Health has been pressed by various lawmakers and advocacy groups to help alleviate the high cost of medicines. Citing federal law, they have urged the agency to take action when a prescription drug — one that was discovered with taxpayer dollars and later licensed to a drug maker — was not considered affordable. So far, though, the NIH has demurred. On Thursday, NIH Director Francis Collins explained why. In testimony before a House Energy  and Commerce subcommittee, he maintained federal law does not provide any “levers to pull.” (Silverman, 12/1)

U.S. FDA Commissioner Dr. Scott Gottlieb relayed a new guidance Tuesday that may shed some light on the path generic-drug manufacturers can take to get their products to market. The Food and Drug Administration aims to make it easier for generic-pharmaceutical developers to plan how they can copy complex drugs, which should ultimately lower pharmaceutical prices when more of the cheaper drugs enter the market. Certain drugs have been difficult to replicate and gain regulatory approval for, particularly drug-device combinations like EpiPen, because there has been minimal guidance from the FDA on how to adequately do so. (Kacik, 11/29)

U.S. patents on key components for some important HIV therapies are poised to expire starting in December and Laurus Labs Ltd. -- the Hyderabad, India-based company which owns the facility -- is gearing up to cash in. Laurus is one of the world’s biggest suppliers of ingredients used in anti-retrovirals, thanks to novel chemistry that delivers cheaper production costs than anyone else. Now, its chief executive officer, Satyanarayana Chava, wants to use the same strategy selling his own finished drugs in the U.S. and Europe. He predicts some generics that Laurus produces will eventually sell for 90 percent less than branded HIV drugs in the U.S., slashing expenditures for a disease that’s among the costliest for many insurers. (Altstedter, 12/4)

Avanir Pharmaceuticals is cutting 73 employees in “sales-related positions,” or roughly 11 percent of its workforce, according to a recent filing with California state officials. A spokesman confirmed the move and described it as an effort to “streamline our current approach to sales and better position Avanir to pursue its long-term mission.” The layoffs occur as that mission is coming under scrutiny. (Silverman, 12/5)

Inspired by a ProPublica story in April that described how nursing homes and their pharmacies nationwide throw away hundreds of tons of valuable medicines — and how one Iowa nonprofit successfully recycles them — two states are working to create similar programs. (Allen, 12/1)

In a bid to blunt criticism of drug pricing, Alnylam Pharmaceuticals (ALNY) is going back to the future. The drug maker plans to limit any future price hikes on a widely anticipated rare-disease drug to the inflation rate, a step that no drug maker has voluntarily embraced in more than two decades. “As we transition from being an innovative R&D-stage company to a commercial-stage company, we are launching a set of patient access principles,” Alnylam chief executive John Maraganore said. “We plan to grow through innovation, not through price increases. We’ll raise prices to match the Consumer Price Index, and that’s it. And otherwise, we’ll grow, as a company, through innovations.” (Silverman, 11/30)

Biogen Inc. has named a pharmaceuticals industry information-technology veteran as its new chief information officer, as the biotech firm seeks innovative IT tools to help develop treatments for Alzheimer’s, dementia and other neurological diseases, the company said. Mark Hernon joins the Cambridge, Mass., firm from Takeda Pharmaceuticals Co., Japan’s largest drugmaker by sales, where he served as a regional CIO for the Americas, as well as global head of R&D and a vice president of operations. He was previously CIO and vice president of operations at Millennial Pharmaceuticals. (Loten, 12/5)

For some opioid makers, the financial outlook is painful. Between falling prices for many of the medicines and fast-growing litigation, a few of these companies have only modest flexibility to cope with these mounting risks, according to a new analysis by Moody’s Investor Service. And the drug maker most likely to be impacted is Endo International (ENDP). (Silverman, 12/1)

A New York hedge fund that earlier this year flipped the board of Depomed Inc. and installed a new CEO to boost the company's value said Monday that it will cut 40 percent of its staff and move the drug company's headquarters out of California. The move is necessary, Depomed said in a Securities and Exchange Commission filing, because it is turning over sales of its best-selling pain drug, Nucynta, to Collegium Pharmaceutical Inc. and won't need as large of a workforce or as much space at its Newark headquarters. (Leuty, 12/4)

Medicaid patients with rheumatic diseases are not only battling their chronic conditions, but also their insurance providers in a fight for medications. (Christ, 12/4)