Drugmakers Hurrying To Get ‘Miracle Cures’ To Market Are Making Mistakes In Their Haste

The Wall Street Journal: The Startup That Manipulated Data To Get A Miracle Drug To Market
The startup had something incredible: a cure for babies with a deadly neurological disease. Last year, the company was snapped up by pharmaceutical giant Novartis AG NVS -2.79% , and by this past May, its drug was the most expensive on the market. In just a few years, the company, AveXis Inc., morphed from a handful of hospital-based researchers into one of the pharmaceutical industry’s most stunning success stories. But in the hurry to fulfill the drug’s promise, AveXis manipulated data that went into the drug’s approval, Novartis and the Food and Drug Administration now say. (Roland, 9/14)

Reuters: U.S. Senators Urge FTC To Scrutinize Multi-Billion Dollar Pharma Mergers
U.S. presidential hopeful Amy Klobuchar on Tuesday led a letter by U.S. senators that urged the Federal Trade Commission (FTC) to closely scrutinize pharma mergers, raising concerns about the potential harm to customers. The U.S. healthcare industry has seen a string of multi-billion dollar deals and consolidation is expected to remain a major theme for the rest of the year. (9/17)

Stat: Wholesale Drug Prices Have Been Falling, And So Have Net Prices
Amid continuing political pressure on drug makers, a new analysis finds that brand-name companies increased their wholesale prices by 3.1% in this year’s second quarter, a smaller boost than the 4.6% hike that occurred during the same time a year ago. Meanwhile, after subtracting certain allowances, net prices fell by 5.8% compared with a 6.1% decline in last year’s second quarter, according to Sector & Sovereign Research, which tracks the pharmaceutical industry. (Silverman, 9/16)

Stat: Medicare Part D Rebates ‘Substantially’ Reduced Drug Spending, But Not Enough To Offset Price Hikes
As controversy continues over prescription drug pricing, a new study finds that Medicare Part D spent $2 billion more for brand-name medicines in 2015 than four years earlier, even though drug makers offered rebates to win favorable coverage from health plans. Specifically, reimbursement to pharmacies for more than 1,500 brand-name medicines rose 19% from 2011 to 2015, while manufacturer rebates offered Medicare Part D plan sponsors increased 4% during that time, according to the Office of Inspector General of the Department of Health and Human Services, which ran the analysis in response to a request from Congress. (Silverman, 9/17)

Modern Healthcare: Medicaid Drug Spending Could Be Cut With New Payment Models
As states continue to see their healthcare budgets rise, some are turning to alternative payment models to control rising prescription drug costs and improve population health, according to a new report. State healthcare budgets increased 7.3% from 2017 to 2018, according to the Duke-Margolis Center for Health Policy. But their attempts to curb the prescription drug costs that contributed to that budget bump are facing some barriers, including operational issues such as a limited ability to collect data about peoples' health outcomes and an absence of proven contracting models. (Brady, 9/17)

Columbus Dispatch: Ohio's Pharmacy Benefit Managers Back In Spotlight Of Medicaid-Oversight Panel
The legislative committee that oversees Ohio’s $28 billion Medicaid program will meet Thursday for the first time this year, and legislators want to know whether the state has made progress in addressing long-standing concerns about pharmacy middlemen profiting off prescription drugs for the poor and disabled. After eight months on the job, Medicaid Director Maureen Corcoran will make her first appearance before the Joint Medicaid Oversight Committee to provide an update that might include the results of a long-awaited report on pharmacy drug pricing. (Candisky, 9/16)

FierceHealthcare: States Mull Value-Based Drug Pricing Models But Face Significant Barriers: Report
States are seeking to try value-based payment models to mitigate high drug costs, but there are plenty of barriers to implementing these programs, according to a new report. Several states have rolled out outcomes-based or population-based models for drug pricing in Medicaid. Louisiana and Washington, for example, operate “Netflix-style” subscription models for hepatitis C drugs. States such as Michigan and Oklahoma are testing outcomes-based approaches.  (Minemyer, 9/16)

NPR: Beyond Insulin: Insurance Rules Can Slow Delivery Of Crucial Diabetes Supplies
In the first three months after getting his Dexcom continuous glucose monitor, Ric Peralta managed to reduce his average blood sugar level by three percentage points. "It took me from not-very-well-managed blood sugar to something that was incredibly well managed," says Peralta, a 46-year-old optician in Whittier, Calif., who was diagnosed with Type 1 diabetes in 2008. Peralta was so enthused that he became a "Dexcom Warrior," a sort of grassroots spokesman for the product. (Sable-Smith, 9/18)

Stat: Martin Shkreli's Firm Is Losing Money — And Its Salesforce Feels Cheated
Phoenixus AG, the drug company founded and controlled by Martin Shkreli, has maintained a low public profile following the backlash over the Daraprim price hike and his federal conviction for securities fraud. While Shkreli has tried to steer Phoenixus’ operations from prison, the company formerly known as Vyera Pharmaceuticals (and Turing Pharmaceuticals before that) continues to lose money due to declining sales, according to financial documents obtained by STAT. (Feuerstein, 9/18)

Stat: FDA To Streamline Some Cancer Therapy Reviews With Canada, Australia
In an effort to speed the process of getting drugs to patients around the world, the Food and Drug Administration and its counterparts in Canada and Australia on Tuesday unveiled a new pilot program that will allow the agencies to review — and potentially greenlight — cancer therapies at the same time. (Joseph, 9/17)

Reuters: With A Backup To The Backup, Insulin Makers Say They're Primed For Brexit
For two men trained as scientists, the bosses of Britain's major insulin providers have had to become experts in ferry schedules, trucking laws and warehouse capacity as they seek to guarantee the supply of life-saving drugs through a chaotic Brexit. With Britain set to leave the European Union within weeks, Pinder Sahota at the world's biggest insulin maker Novo Nordisk, and Sanofi's Hugo Fry have rebuilt operations to withstand the most turbulent of events. (Holton and Sandle, 9/17)

The Wall Street Journal: Louisiana’s Deal For Hepatitis C Drugs May Serve As Model
The crowd at the New Orleans health clinic in late June filled the seats and overflowed into the wings. Louisiana Gov. John Bel Edwards was there, as were employees from Gilead Science ’s affiliate Asegua Therapeutics. They had gathered to launch a plan for the statewide elimination of hepatitis C, which killed more than 17,000 Americans in 2017. The event, however, wasn’t prompted by the discovery of a new cure. Officials were unveiling a new way of paying for an existing therapy. (Alcorn, 9/13)

The Wall Street Journal: Sienna Biopharmaceuticals Files For Bankruptcy
Sienna Biopharmaceuticals Inc. has filed for bankruptcy with plans to find a buyer or investor during its chapter 11 proceedings. The publicly traded drugmaker, whose major investors include Arch Venture Partners, filed its petition Monday in the U.S. Bankruptcy Court in Wilmington, Del. (Yerak, 9/17)

Stat: TV Personality Dr. Oz Is Now On The Board Of A Biotech Company
One biotech company’s newest director has a very familiar face. Dr. Mehmet Oz will be joining the board of directors of PanTheryx, a Colorado-based nutraceutical and biologics company, the company recently announced. Oz, the host of “The Dr. Oz Show,” commands a huge following. He has also drawn sharp criticism for his embrace of alternative medicine and for his “disdain for science and for evidence-based medicine,” as 10 physicians wrote in a 2015 letter to the dean of medicine at Columbia University, where Oz is a faculty member. (Sheridan, 9/17)