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Prescription drug spending has skyrocketed over the past few years, with many Americans struggling to access proper treatment. Lawmakers have attempted to address this issue, but it is likely that the trend of escalating drug spending will continue as costly specialty drugs dominate the market...All of the drugs that had the highest sales in 2016 are for specialty conditions, including autoimmune disorders and hepatitis C virus; however, the emergence of biosimilars may threaten their revenue into the future...

• 5. Infliximab (Remicade) - Johnson & Johnson and Merck report a 10.6% decrease in revenue from 2015, with infliximab generating nearly $7.83 billion in 2016...
• 4. Rituximab (Rituxan) - Partners Roche and Biogen reported total revenue of $8.58 billion for rituximab in 2016, which is a 2.7% increase from 2015. The drug is approved to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and granulomatosis with polyangiitis...
• 3. Etanercept (Enbrel) - This autoimmune disease drug treats rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis. Amgen and Pfizer reported $8.87 billion in total sales for etanercept in 2016.
• 2. Ledipasvir/sofosbuvir (Harvoni) - When this drug hit the shelves, many patients with HCV and healthcare providers experienced sticker shock. The high cost of the curative drug and the prevalence of HCV have driven the $9.08 billion sales for the drug, according to the article.
• 1. Adalimumab (Humira) - In 2016, adalimumab grossed $16.08 billion in sales, which is a 14.7% increase in revenue for AbbVie, according to the article. The drug is approved to treat several autoimmune conditions, including rheumatoid arthritis, ulcerative colitis, and psoriasis.

...Johnson & Johnson said...the U.S. Justice Department has opened an investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that bought two of its drugs...The...company said its Janssen Biotech Inc unit received a civil investigative demand from the Justice Department regarding an investigation under the False Claims Act related to its arthritis drugs Remicade and Simponi Aria...U.S. Attorney's Office...is seeking documents broadly relating to pharmaceutical co-payment support programs for hepatitis C drug Olysiotm, Simponi and Crohn's disease drug Stelara… also seeks documents relating to average manufacturer price and best price reporting to the Center for Medicare and Medicaid services related to those products...

California's attempt to curb drug prices, Proposition 61, could cause drug companies including Merck, Pfizer and Johnson & Johnson to raise prices, according to analysts, and the companies are already taken steps to block the bill's passage…According to analyst David Larsen...the major drug companies could choose to extend the prices they offer to the Department of Veterans Affairs to the state, while offsetting the discounts by raising the prices of other drugs...drug companies could risk a domino effect of having to discount other states...manufacturers could raise the prices they offer to the VA, which was threatened in 1992 when Congress considered doing something similar on a federal level...While drug companies stand to benefit politically from opposing this bill, they likely won't see an impact on their bottom lines if Proposition 61 passes - at least at first...Prop 61 addresses such a narrow portion of the California population - state agencies and non MCO Medi-Cal, the revenue and earnings exposure for the distributors and PBMs is minimal...likely that California's legislature will realize that companies can raise prices elsewhere, and will ultimately repeal the ballot measure.

J&J has thrown open its R&D doors — to all comers. Will this uber-open-access strategy work? ...Just five years ago, one of the last places one would have looked for innovation at Johnson & Johnson was in its Merryfield Road lab in La Jolla, Calif...The R&D facility for the healthcare giant, No. 103 on Fortune’s Global 500 list, had become something of a scientific wasteland...These days, the gleaming, state-of-the-art space is teeming with entrepreneurial spirit and cutting-edge science. What’s odd, though, is that these researchers toiling away within J&J’s walls—and making use of J&J’s abundant resources—do not work for the company. Nor do the findings or the discoveries they produce there belong to J&J. Some of these drug scientists even receive funding from J&J’s competitors. As for the venerable, 130-year-old company that’s paying for all this largesse, it claims it wants nothing more out of the arrangement than for its tenants—all life science start-ups—to succeed.

At the American Diabetes Association Scientific Sessions in San Diego, drugmakers have been rolling out studies that illustrate how competitive every class in the diabetes field has become. For instance, partners Merck & Co. and Pfizer, Eli Lilly and Boehringer Ingelheim, and solo flyer AstraZeneca all unveiled SGLT2 drug studies, with more to come...we’ve gathered the top stories here…

• Johnson & Johnson's Invokana outcomes study makes it the second heart-helping SGLT2 on the block.
• Novo Nordisk and its long-acting insulin Tresiba have a tough task: going up against Sanofi's blockbuster insulin Lantus.
• Lilly and Boehringer have reason to believe their SGLT2 inhibitor, Jardiance, may improve outcomes for chronic kidney disease patients—so they’re putting the med to the test.
• Sanofi’s Toujeo has plenty of competition in the basal insulin market, but new real-world data shows it may outdo its peers at cutting the risk of hypoglycemia for older patients.
• Sanofi and Regeneron still have months to wait for final data from a key cardiovascular outcomes study of their PCSK9 therapy Praluent, which is in a heated battle with Amgen’s Repatha.
• Novo Nordisk is in a tough market race against Sanofi with combo product Xultophy, which hit the market after the French drugmaker’s similar Soliqua.
• Boehringer and Lilly still don’t know what’s responsible for the dramatic reduction in cardiovascular death risk that Jardiance (empagliflozin) posted in the Empa-Reg outcomes trial.
• Merck and Pfizer last year rolled out positive results from two phase 3 studies they hoped would buoy SGLT2 candidate ertugliflozin once it got to market.

Opioid makers have had no shortage of critics in recent years as the United States suffers the sting of a painful addiction epidemic. Now, a top senate Democrat is throwing the weight of her office behind efforts to dig into the industry’s marketing practices for the risky painkillers...Sen. Claire McCaskill is targeting Johnson & Johnson, Mylan, Depomed, Insys and Purdue in her investigation, which is aimed at learning whether the companies had any role in the country’s "overutilization and overprescription" of the meds...Among the documents she’s requesting are internal opioid abuse estimates, info on marketing strategies, sales quotas and contributions to patient groups...McCaskill laid out evidence that suggests drug companies sought to downplay the risks of the painkillers and positively influence physicians’ perceptions of the meds. She wrote that the allegations "show an industry apparently focused not on preventing abuse but on fostering addiction as a central component of its business model."

You can add Suffolk County, N.Y., to the list of local and state governments that are filing lawsuits against the drug makers that market opioid painkillers...The Long Island county...accused several companies — Purdue Pharma, Johnson & Johnson, and Endo International, among others — of using deceptive marketing to downplay the risks of their painkillers, and of improperly encouraging physicians to prescribe the medicines in a way that caused some patients to become addicts…The allegations are...identical to lawsuits filed by the city of Chicago; Orange and Santa Clara counties in California; and the state of Mississippi. In each case, the governments have charged the drug makers with illegally widening markets for their opioid painkillers and, as a result, forcing taxpayers to pay for medicines that were often prescribed unnecessarily...The companies "sought to create a false perception of the safety and efficacy of opioids in the minds of medical professionals and members of the public that would encourage the use of opioids for longer periods of time and to treat a wider range of problems, including such common aches and pains as lower back pain, arthritis, and headaches…

The state of Ohio...sued five major drug manufacturers, accusing them of misrepresenting the risks of prescription opioid painkillers that have fueled a sky-rocketing drug addiction epidemic...The suit, filed by Attorney General Mike DeWine, comes as a growing number of state and local governments are suing drugmakers and distributors, seeking to hold them accountable for a deadly and costly opioid crisis...The five companies Ohio sued were Purdue Pharma LP, Johnson & Johnson's Janssen Pharmaceuticals Inc unit, a unit of Endo International Plc, Teva Pharmaceutical Industries Ltd's Cephalon unit and Allergan Plc...The suit...seeks to halt deceptive practices, a declaration the companies acted illegally and unspecified damages to the state and consumers...

The pharmaceutical industry is regularly chastised for failing to do enough to ensure that people in low and middle-income countries have access to its medicines. Yet the real picture is actually more nuanced, according to a newly released report that finds some — but not all — drug makers are making headway...Some companies...are partnering to develop needed medicines. Others are pledging to waive or abandon patent rights and granting licenses so that generic versions of their drugs become available. At the same time, the report finds that much more can be done…“...progress is slower than many of us would like,”...executive director of the Access to Medicine Foundation…The foundation...compiled an index...Here are some key findings: GlaxoSmithKline led the index for the fifth time and was followed by Johnson & Johnson and Novartis, while Astellas had the poorest showing...the number of companies using equitable pricing strategies increased from 16 in 2012, to 18 in 2014, to 19 in 2016. Ischemic heart disease replaced HIV/AIDS as the disease with the most products with equitable pricing...As for drugs being developed...420 R&D projects that address specific needs of people in low and middle-income countries, up from 93 in 2014. The pipeline focuses heavily on five diseases —lower respiratory infections, diabetes, malaria, viral hepatitis and HIV/AIDS — that cause relatively large burdens and either have large commercial markets or are high priorities.

When health care behemoth Johnson & Johnson decided last year to use Veeva Systems' software for gathering data from clinical trials needed to get a new drug approved, Veeva's rivals took notice..."They (J&J) said we're going to standardize this globally, and within 12 months we had 6 customers (among the 20 biggest drugmakers) do the exact same thing,"...one... goal in mind -- replace biopharma companies' legacy systems with cloud-based software designed to make their painstaking regulatory requirements a lot less painful...The cost of developing a new drug has soared to $2.6 billion, up from about $1 billion in 2000 in inflation-adjusted dollars, according to the Pharmaceutical Research and Manufacturers of America. Because the stakes are so high, more large drug developers have decided in rapid succession to junk their prior technology investments...The key to Veeva's success is that it has brought together enterprise software expertise with industry-specific expertise...