- FiercePharmaPolitics—States still exploring drug pricing despite congressional gridlock (fiercepharma.com)
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
- U.S. indictment says Chinese hackers tried to steal COVID-19 vaccine and drug research (fiercepharma.com)
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
- Regulatory Authorities have Published a Report on COVID Vaccine Development (biopharminternational.com)
Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development...under the umbrella of the International Coalition of Medicines Regulatory Authorities...Emphasis was placed upon the requirement for Phase III clinical trials...should include those with underlying medical conditions so that relevant data can be generated. Additionally...clinical studies should be designed with stringent success criteria to ensure there is convincing demonstration of efficacy...READ MORE
- White House to hospitals: Bypass CDC, report COVID-19 data directly to HHS (healthcareitnews.com)
Centers for Disease Control and Prevention Director Dr. Robert Redfield says the controversial new process, which calls on hospitals to send capacity and utilization data to HHS, was made with CDC support...The Trump administration has directed hospitals to stop reporting COVID-19 data to the Centers for Disease Control and Prevention's National Healthcare Safety Network...Instead, starting Wednesday, they have been told to send capacity and utilization information – including patient numbers, remdesivir inventory and bed and ventilator usage rates – to the U.S. Department of Health and Human Services through the new HHS Protect system...HHS Protect has been aggregating data since April, with much of that information coming from the CDC...During the pandemic it became clear that we needed a central way to make data visible to first responders...READ MORE
- AstraZeneca confirms Russia vaccine deal days after COVID-19 hacking accusations surface (fiercepharma.com)
...Western intelligence officials pegged Russian hackers with an attempt to rip off leading research for a COVID-19 vaccine, linking the would-be thieves with the country's intelligence services...Russia itself denies involvement in any of those attacks—and with a new licensing deal for AstraZeneca's COVID-19 shot, the country says it doesn't need the secrets anyway...Russian drugmaker R-Pharm has signed a licensing deal with Britain's AstraZeneca to produce and distribute doses of its University of Oxford-partnered adenovirus-based COVID-19 shot, AZD1222...READ MORE
- Industry Welcomes Global AMR Action Fund (biopharminternational.com)
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
- CVS Pharmacy institutes face covering policy at all locations (chaindrugreview.com)
CVS Pharmacy has issued a face covering policy at all locations for customers...Since the pandemic began, we’ve done everything we can to keep people safe and healthy. This includes requiring that store employees wear face coverings and encouraging our customers to do so as well. In any community with state or local laws mandating the use of face coverings, we’ve made that very clear through signage and other reminders...With the recent spike in COVID-19 infections, we’re joining others in taking the next step and requiring all customers to wear face coverings when entering any of our stores throughout the country effective Monday, July 20...READ MORE
- AbbVie, already famous for its Humira strategy, forms another ‘patent wall’ around Imbruvica: report (fiercepharma.com)
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
- Court backs Trump expansion of cheap health insurance plans (apnews.com)
A divided federal appeals court...upheld the Trump administration’s expansion of cheaper short-term health insurance plans, derided by critics as “junk insurance,” as an alternative to the Affordable Care Act’s costlier comprehensive insurance...The U.S. Court of Appeals for the District of Columbia Circuit said in a 2-1 decision that the administration had the legal authority to increase the duration of the health plans from three to 12 months, with the option of renewing them for 36 months. The plans do not have to cover people with preexisting conditions or provide basic benefits like prescription drugs...READ MORE
- Moderna COVID-19 Vaccine Induced Adverse Reactions In “More Than Half” Of Trial Participants (zerohedge.com)
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