Morning Briefing
Summaries of health policy coverage from major news organizations
Appellate Judges Rule HHS Doesn't Have Authority To Require Prices In TV Ads For Drugs
Modern Healthcare: HHS Can't Require Drug Prices In TV Ads, Appeals Judges Rule
A panel of federal appellate judges on Tuesday ruled that HHS does not have authority to require drugmakers to disclose list prices in television advertisements. The decision is another blow to President Donald Trump's drug-pricing policy agenda in an election year. Other banner administration drug-pricing policies have been withdrawn or delayed indefinitely. A three-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit sided with drugmakers and upheld a lower court ruling that struck down HHS' regulation. (Cohrs, 6/16)
Stat: Supreme Court Deals A Series Of Blows To Generic Drug Companies
It’s a bad run for generic drug companies at the Supreme Court. The court on Monday denied three separate requests from generic drug makers hoping the justices would revisit lower-court decisions the industry doesn’t like. Two cases, Hospira v. Eli Lilly and Dr. Reddy’s Laboratories v. Eli Lilly, deal with a seemingly arcane decision from the Federal Circuit. Generic manufacturers say the decisions let brand companies sue them over patents they’ve previously abandoned — and that broadly, the rulings will make it harder to get more generic medicine into the world. (Florko, 6/16)
FiercePharma: Vaccine Heroes? COVID-19 Pitfalls, Pricing Put Pharma On The Spot
harma is looking to reset its image with COVID-19 vaccines and treatments, but landmines loom—with pricing likely the biggest. The halo from pharma’s rapid response in research and discovery—and the hope that a vaccine or effective treatments will allow the world to return to some sort of normal—has propelled the industry’s reputation at an all-time high. Forty percent of Americans say their opinion of the pharma industry has turned positive during the COVID-19 pandemic, according to The Harris Poll. (Bulik, 6/16)
The Wall Street Journal: Can These Drug Stocks Fly? It Depends On The Lawyers
Generic-drug stocks were relatively quiet during the worst of the coronavirus crisis so far. That may be about to change. Years of falling generic-drug prices as large buyers consolidated meant serious pain for shares of companies across the industry. Major manufacturers such as Teva Pharmaceutical Industries TEVA 4.96% and Mylan MYL 1.45% fell as much as 80% from records in 2015 while those of drug distributors such as McKesson MCK 3.03% and Cardinal Health, CAH 1.95% which benefit when prices paid by pharmacies and hospitals rise, lost over half of their value. (Grant, 6/15)
Stat: Antimicrobials Benefited From Expedited FDA Programs More Than Other Drugs
Amid concerns over the need for more antimicrobials, a new analysis finds these medicines benefited more often from expedited regulatory programs than other types of drugs over the last 35 years, suggesting the Food and Drug Administration is not a roadblock to development. To wit, 61% of 178 antimicrobials approved between 1984 and 2018 were assessed by the FDA under one or more expedited review programs, while 54% of 887 other medicines were evaluated as part of the same programs during that time. These included priority review, accelerated review, fast track review, breakthrough designation (for unmet medical needs), and orphan designation for rare diseases. (Silverman, 6/12)
CNBC: Walmart Buys Tech From Carezone To Help People Manage Prescriptions
Walmart is acquiring technology and intellectual property from CareZone, a start-up that makes it easier for people to manage multiple medications, Walmart confirmed to CNBC on Monday. CareZone, which got its start in 2010, develops apps to help people manage their medicines. It also built technology for users to scan insurance cards and prescription drug labels, making it easier to figure out what’s covered by their health plan or to organize a home delivery. The apps have about 3.5 million members, according to CareZone CEO Jonathan Schwartz. (Farr, 6/15)
Stat: Proteus Files For Bankruptcy, Says It Has Held Acquisition Talks With Otsuka
Smart pill maker Proteus Digital Health on Monday filed for Chapter 11 bankruptcy, the latest sign of trouble at the Silicon Valley company that was once seen as a showcase for how technology can revolutionize how patients take their medicine. The filing, first reported by CNBC, marks a dramatic turning point for Proteus, which was once valued at $1.5 billion. The move will allow Proteus to reorganize its business structure and pay down its debt without closing down. (Robbins, 6/16)
Stat: PhRMA’s Top Communicator Heads To ExxonMobil
The top spokesperson for the drug industry’s main lobbying group in Washington is taking a job at the oil giant ExxonMobil, STAT has confirmed. Robert Zirkelbach, who most recently served as executive vice president of public affairs at PhRMA, has been the organization’s top communicator since 2016. Zirkelbach has developed a reputation as a fierce defender of industry, oftentimes publicly sparring with drug pricing activists and rival industry groups in person and on Twitter, but he has also played a central role in the organization’s efforts to rebrand itself as a voice for scientists toiling in labs. (Florko, 6/12)
Markets Insider: Eli Lilly Soars 15% After Its Breast Cancer Drug Shows Efficacy Where A Treatment From Pfizer Failed
Eli Lilly soared as much as 14% on Tuesday after it announced that its breast cancer drug Verzenio in combination with endocrine therapy was successful in preventing the recurrence of breast cancer for patients in an open-label Phase 3 trial. Verzenio was originally approved in 2017 for treating certain forms of advanced breast cancer, and its revenue more than doubled to $579 million in 2019. Verzenio achieved its primary endpoint of invasive disease-free survival, and also demonstrated a significant decrease in the risk of breast cancer recurrence or death compared to the standard therapy alone. (Fox, 6/16)
Stat: California Supports Unusual Whistleblower Lawsuit Over 'Fraudulent' Patents
The California insurance commissioner is supporting an unusual gambit by a patent attorney who filed a whistleblower lawsuit alleging that Allergan fraudulently obtained patents in order to stifle generic rivals and maintain high prices for two of its medicines. In a May 2018 lawsuit, Zachery Silbersher accused Allergan, which was recently bought by AbbVie (ABBV), of providing false information to the U.S. Patent & Trademark Office concerning a pair of drugs used to combat Alzheimer’s symptoms. By doing so, the company won patents that, for a time, delayed generic competition and, as a result, allowed it to charge government health care programs monopoly prices. (Silverman, 6/10)
Stat: Royalty Pharma, Drug Firm That Doesn’t Develop Drugs, Shatters IPO Record
Royalty Pharma, a business built on investing in other people’s medicines, raised $2.2 billion in a record IPO on Tuesday, and the early hours of trading boosted its valuation to more than $25 billion. The company, founded in 1996, priced about 78 million shares at $28 each. Royalty Pharma opened trading at $44, an instant 57% increase, suggesting the company’s bankers left a fair amount of money on the table. (Garde, 6/16)
Stat: Momenta Pharma Drug Improves Symptoms Of Myasthenia Gravis
Momenta Pharmaceuticals reported Monday that in a mid-stage clinical trial, an experimental medicine significantly improved the symptoms of patients with generalized myasthenia gravis, a rare neuromuscular disease. Called nipocalimab, the Momenta drug works by blocking a molecule in the body called neonatal Fc receptor (FcRn), which can trigger certain types of autoimmune diseases. Generalized myasthenia gravis is a chronic and debilitating condition in which the body’s own antibodies disrupt the communication between nerve endings and muscles. (Feuerstein, 6/15)
Bloomberg: Biotechs Get Wall Street Nod On New Blood Disorder Drugs Data
Biotechnology stocks initially moved higher as Wall Street cheered updates for a range of therapies to treat blood disorders like sickle cell disease and beta thalassemia. While the gains evaporated as the broader market struggled to rebound from a rocky session on Thursday, biotechnology companies like Crispr Therapeutics AG and partner Vertex Pharmaceuticals Inc., and Bluebird Bio Inc. saw shares rally to start the morning on the back of promising updates. The Nasdaq Biotechnology Index rose as much as 2.4% on Friday before giving up the advance. (Lipschultz, 6/12)
Stat: As Quality Concerns Rise, FDA Report Shows Indian Plants Had More Issues
As concerns mount over the quality of the pharmaceutical supply chain, the Food and Drug Administration has released new data showing the agency inspected more manufacturing plants located in India during the past two fiscal years and found these facilities generally had more quality problems than sites located in the U.S. or the European Union. Specifically, the FDA inspected 6% more plants in India while examining 4% fewer sites in the U.S. and 6% fewer in the European Union from fiscal year 2017 to fiscal year 2019. (Silverman, 6/16)
Stat: YouTube 'Hit Job' About Catalyst Pharma Rival Is Posted Amid FDA Fight
In a move that resembles a scare tactic, a newly posted YouTube video shows a former 87-foot nuclear reactor dome jutting out from an isolated stretch of preserved woodlands in New Jersey. The clip then invokes Chernobyl before noting the dome, which was shuttered decades ago, has stood alongside a manufacturing plant run by a small drug maker since 1977. (Silverman, 6/15)
Bloomberg: Royalty Pharma Soars 59% After Year’s Biggest U.S. IPO
Royalty Pharma Plc, a buyer of biopharmaceutical royalties, rose 59% in its trading debut after its upsized initial public offering raised $2.18 billion with shares priced at the top the range. Shares of Royalty Pharma opened trading Tuesday in New York at $44 after the company and existing shareholders sold 77.68 million shares Monday for $28 each, after marketing 70 million of them for $25 to $28. The shares jumped as much as 65% in their debut and closed at $44.50. (Tse, 6/16)
Stat: Eli Lilly Gets An Edge Against Pfizer In Adjuvant Breast Cancer
Eli Lilly announced Tuesday that adding its drug Verzenio to hormone blockers decreased the risk of a relapse of breast cancer in women who had had their tumors removed. The result makes Verzenio the first drug in its class, a group of breast cancer medicines known as CDK 4/6 inhibitors, to work in this early stage of treatment, called the adjuvant setting. The drugs are currently used in women whose breast cancer is metastatic, meaning that tumors have spread to other parts of their bodies. (Herper, 6/16)
