Category:

Oswald Bilotta blew the whistle on Novartis’ alleged doctor kickback scheme while working as a sales rep at the Swiss drugmaker, leading to U.S. government intervention in a lawsuit in 2013...Now, as Novartis has agreed to resolve the case by paying a $678 million settlement, Bilotta stands to get $109.4 million, plus additional interest, for his role as the whistleblower...According to the complaint, Novartis set up sham speaker programs as venues for paying physicians kickbacks to boost scripts of its drugs Lotrel, Valturna, Starlix, Tekturna, Tekamlo, Diovan and Exforge. These events often involved lavish meals, fishing trips and other entertainment, according to the suit...READ MORE

The Patient Protection Commission plans to explore the issue of health care pricing transparency...specifically some sort of a proposal that would enhance “patient health care experience and state outcomes by implementing transparency measures that help understand data trends.” ...the commission’s work plan ...includes three potential suggestions ...required reporting of all medical claims, drug costs and hospital prices to the state; a database that makes that information accessible and digitally searchable; and a provision requiring hospital data to display the finer points of how their charges are negotiated...READ MORE

Only days after three governments said Russian hackers were targeting groups conducting COVID-19 vaccine research, the U.S. has indicted two Chinese nationals for hacking hundreds of companies, governments and other organizations in the U.S. and beyond, including those working to combat the pandemic...A grand jury in Washington state returned an 11-count indictment against Li Xiaoyu and Dong Jiazhi for a 10-year “hacking campaign” targeting high-tech industries in the U.S. and several other countries. Recently, the hackers shifted their focus to companies researching COVID-19 vaccines, drugs and tests, according to authorities...READ MORE

Khloe Kardashian’s pain—or rather, her relief from pain—may be Biohaven’s gain...The social media and reality TV super star, who has more than 100 million followers, suffers from debilitating migraines dating back to the sixth grade. A few months ago, though, she tried Nurtec ODT (dissolvable CGRP inhibitor ) and found pain relief she hadn’t had before...Kardashian is now the paid spokesperson in Biohaven’s just-launched “Take Back Today” campaign...READ MORE

The Trump administration unveiled four executive orders on Friday aimed at bringing down pharmaceutical prices...1) he (Trump) announced a one-month ultimatum for drug manufacturers to propose alternative plans to reduce drug prices...“We’re going to hold that until August 24, hoping that the pharmaceutical companies will come up with something that will substantially reduce drug prices,” Trump said...2) A second order...revives a...plan that would eliminate the rebates drug makers pay to insurers...The executive order...includes a caveat that the plan cannot be implemented if it will raise premiums...3)...the Trump administration is expanding its efforts to allow Americans to import medicines...the administration was now allowing personal importation, a phrase used to describe when individual consumers buy drugs from other countries...The order says HHS will facilitate “grants to individuals of waivers of the prohibition of importation of prescription drugs.”...4) The fourth order would force certain health centers to pass negotiated discounts on insulin and EpiPens to patients...READ MORE

Drug pricing legislation hasn’t gained any steam in Congress lately, but legislatures in dozens of states are chugging ahead...States nationwide are advancing bills focused on numerous topics, a new analysis from Deloitte found. Legislation to regulate pharmacy benefit managers is the most common... while many states have passed—or are considering—measures such as transparency requirements for price increases, importation, value-based contracting and more...Overall, Deloitte found that state legislation targeting drug price transparency and PBMs—not importation or other measures—is affecting companies the most right now...READ MORE

Industry has welcomed the launch of the Global AMR Action Fund, which aims to bring two to four new antibiotics to patients by 2030 to tackle antimicrobial resistance...More than 20 biopharmaceutical companies are involved in the fund and have raised US$1 billion so far in new funding to support the clinical research of innovative new antibiotics to address the most resistant bacteria and life-threatening infections. The fund is an initiative of the International Federation of Pharmaceutical Manufacturers and Associations...“Unlike COVID-19, AMR is a predictable and preventable crisis. We must act together to rebuild the pipeline and ensure that the most promising and innovative antibiotics make it from the lab to patients,” said Thomas Cueni, director general of IFPMA...READ MORE

Insurers are worried a raft of proposed changes to the Medicaid Drug Rebate Program could lead to drug manufacturers gaming the system to charge higher prices...Several insurer groups commented on the proposed rule that the Centers for Medicare & Medicaid Services released last month to get states and drugmakers to create more value-based payment arrangements...If finalized, the rule would relax some of the requirements for the average manufacturer price and best price that manufacturers must provide for Medicaid. Under the new rule, a manufacturer could report multiple best prices for a therapy under the Medicaid Drug Rebate Program, but any best price has to be tied to a value-based purchasing agreement...READ MORE

AbbVie grew Humira into the world’s bestselling medicine in part through price hikes and an aggressive patenting strategy to defend against competition. The company is now deploying similar tactics to bolster Imbruvica, a cancer drug with numerous uses and big sales, experts concluded in a new report...AbbVie has filed for 165 patents on Imbruvica, and officials have granted 88 of them, the Initiative for Medicines, Access & Knowledge reports. The company’s add-on patents have earned AbbVie another nine years of patent protections for a total of 29 years of commercial exclusivity...READ MORE

A highly anticipated clinical trial for a potential COVID-19 vaccine managed in part by the American drug company Moderna has resulted in some adverse effects in more than half of the trial's participants, with one test group reporting "severe" symptoms...The trial, which is also being sponsored by the National Institute of Allergy and Infectious Diseases...The vaccine "induced anti–SARS-CoV-2 immune responses in all participants," the research team reported...in the New England Journal of Medicine. Researchers said that "no trial-limiting safety concerns were identified." Yet a majority of participants still reported at least one side effect..."Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site," the report states. Fever, joint pain and nausea were also reported...READ MORE