PhRMA

JUNE 7, 2023

The Inflation Reduction Act (IRA) makes significant changes to Part D’s benefit structure and coverage, which will require careful policy development and thoughtful implementation. On Monday, PhRMA submitted comments on the Calendar Year 2025 Part D Redesign changes, outlining key considerations for the Centers for Medicare and Medicaid Services (CMS) to help mitigate against potential disruptions to seniors’ access to medicines through Part D.

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Drug Topics

JUNE 7, 2023

The median annual cost for new oncology medicines launched in 2022 was $260,000, up from $63,534 10 years ago, an IQVIA report finds.

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STAT

JUNE 7, 2023

BOSTON — The drug industry has spent the past year speaking against new mechanisms that could limit how much governments or insurers pay for certain new medicines. Robert Califf, the Food and Drug Administration chief, walked on stage Wednesday and told a crowd of biotech leaders that drug costs needed fixing. “We don’t agree,” said Califf, referring to a conversation he had backstage with Ted Love , the new chair of the Biotechnology Innovation Organization.

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Drug Topics

JUNE 7, 2023

The role of pharmacy benefit managers in the health care space is being scrutinized more than ever before.

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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Patient Care

STAT

JUNE 7, 2023

An unusually early and ferocious outbreak of forest fires across Canada has sent unprecedented amounts of smoke pollution to regions of the eastern United States unaccustomed to such hazards. Three years after the onset of the Covid-19 pandemic, the ensuing air pollution has once again put respiratory health at the forefront of many North Americans’ minds.

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Drug Topics

JUNE 7, 2023

Air quality in New York City was the worst in the world on Tuesday morning.

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Fierce Pharma

JUNE 7, 2023

Merck has taken the lead, filing a lawsuit seeking to overturn drug pricing measures in the Inflation Reduction Act (IRA). | Merck has filed a lawsuit seeking to overturn drug-pricing measures in the Inflation Reduction Act (IRA). Now, emboldened by the New Jersey drugmaker, other biopharma CEOs are making their concerns known. At the BIO International Convention, Biogen CEO Chris Viehbacher registered severe criticism of the IRA and said his company was considering filing its own lawsuit.

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Pharmacy Times

JUNE 7, 2023

Having more severe sleep apneas was associated with having lower brain volume in the medial temporal lobe area of the brain, which could suggest loss of brain cells.

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Fierce Pharma

JUNE 7, 2023

As Alzheimer's disease partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. | As Alzheimer's partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. On Wednesday, that vision came into better focus as the FDA released a document showing how the agency views the drug.

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Drug Topics

JUNE 7, 2023

Cue Health gets FDA’s first de novo approval for at-home COVID-19 test, Novavax says its new vaccine will fight new variants and HHS creates new cert standards for peer support workers.

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Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

Pharmacy Times

JUNE 7, 2023

CCR5 mutation creates a challenge for HIV to infect more cells, thereby creating resistance to the virus.

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Fierce Pharma

JUNE 7, 2023

The rush to provide revolutionary weight-loss drugs to obese patients has reached the U.K. | The rush to provide revolutionary weight-loss drugs to obese patients has reached the U.K. On Wednesday, the government unveiled a two-year pilot program that will allow Novo Nordisk’s Wegovy to be given to more overweight participants, even though the treatment has yet to be launched there.

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STAT

JUNE 7, 2023

Wildfires blazing in and around Quebec are creating hazardous health conditions throughout North America. Over 100 million people were under alerts for unhealthy air quality as of Wednesday, and people in the Northeast and Midwest — areas that typically don’t deal with the effects of wildfires — are confronting orange-tinged, hazy skies and newly urgent questions about the harmful effects of air pollution.

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Drug Topics

JUNE 7, 2023

Existing evidence-evaluation frameworks are not sufficiently targeted toward the specific factors relevant to digital health products, they argue.

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Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

Pharmacy Times

JUNE 7, 2023

The combination also reduced the risk of developing distant metastasis or death by 65% in patients with high-risk stage 3/4 melanoma.

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Fierce Pharma

JUNE 7, 2023

As pharma supply chain problems drag on, a shortage of key cancer drugs has afflicted a large number of treatment centers and many patients. | The National Comprehensive Cancer Network's recent survey shows that nearly all of the treatment centers it polled are facing a carboplatin shortage. Meanwhile, 70% of them reported a cisplatin shortage.

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Pharmacy Times

JUNE 7, 2023

Levels of troponin were higher in people who had type 2 diabetes for a longer period than people with healthy blood levels.

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STAT

JUNE 7, 2023

Google will embed its generative AI technology into computer systems at Mayo Clinic and other health systems to make it easier to search vast repositories of patient data and automate administrative tasks, the organizations said Wednesday. The technology is designed to function like a super-charged Google search for health records, allowing hospitals to find and link information about patients to improve care and research.

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Fierce Pharma

JUNE 7, 2023

Legend Biotech and Johnson & Johnson are moving fast in their efforts to forward their CAR-T standout Carvykti. | Legend Biotech and Johnson & Johnson have filed with the FDA for expanded use of Carvykti. After gaining approval 16 months ago for the CAR-T to treat multiple myeloma patients following four or more lines of therapy, the companies hope to get the U.S. regulator to sign off on its use at an earlier stage of treatment.

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Fierce Healthcare

JUNE 7, 2023

Years of rising operating profits and cash reserves did not translate to greater charity care across the nation’s nonprofit hospitals, according to a study published this week in Health Affairs.

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STAT

JUNE 7, 2023

A new method of heart transplantation that uses machines to reanimate donor hearts from people who have died is just as good as traditional heart transplantation, a new study finds. If adopted broadly in the U.S., the procedure that could expand the donor pool by 30%. The adjusted six-month survival rate of patients undergoing the new method was 94%, compared with 91% among patients who underwent the traditional method, according to the study published in the New England Journal of Medicine Wedn

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The Checkup by Singlecare

JUNE 7, 2023

People have consumed vinegar for thousands of years. This potent, fermented liquid takes center stage in sauces, salad dressings, and marinades. Apple cider vinegar (ACV) is a type of vinegar that has gotten a lot of buzz over the last few years. Many wellness writers and influencers claim numerous apple cider vinegar benefits for men (and women). They say it’s a cure for everything from weight loss to erectile dysfunction.

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STAT

JUNE 7, 2023

In the new book “If I Betray These Words,” I tell the story, with Simon Talbot, of Rita Gallardo (a pseudonym): Deployed in the desert Middle East, confined to a military base ringed by Hesco barriers and razor wire, Dr. Rita Gallardo’s only escape from the horrors of the combat-shattered bodies of young service members was dreaming of the life she might build later.

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Pharmaceutical Technology

JUNE 7, 2023

Eli Lilly has achieved significant gains in the past quarter, leading to it becoming the most valuable pharmaceutical company in the world, with a market cap of $420bn, surpassing Johnson & Johnson. The recent rallying of Lilly’s market value has come as the result of two major announcements: its blockbuster type 2 diabetes (T2D) drug Mounjaro (tirzepatide) successfully completed its second final-stage trial for obesity, and its experimental treatment for Alzheimer’s disease completed its Ph

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European Pharmaceutical Review

JUNE 7, 2023

As its first facility in Scotland, the Cell and Gene Therapy Catapult (CGT Catapult) has opened new laboratories located in the Edinburgh BioQuarter, at the University of Edinburgh’s Institute of Regeneration and Repair. With its new 350m 2 high-specification laboratory space, CGT Catapult aims to provide expertise, resources and technology to help cell therapy developers improve their manufacturing processes and navigate the complex regulatory requirements involved in bringing these therapies t

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STAT

JUNE 7, 2023

CHICAGO — As a busy weekend at the American Society of Clinical Oncology annual meeting wound down, Lynn Schuchter accepted a gavel from Eric P. Winer, cueing the start of her one-year term as the society’s president. Come Monday, the first official day of her presidency, Schuchter was looking ahead to her year as president. She was also still energized from the plenary session the day before — which Schuchter said was one of the best she’d ever seen.

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Fierce Pharma

JUNE 7, 2023

After GSK nabbed a coveted world-first approval for its adult respiratory syncytial virus (RSV) vaccine in the U.S., it has scored the same title in Europe with Arexvy. | After scoring its world-first approval in May, GSK's RSV vaccine for older adults bagged a nod in Europe. The company and its rivals are gearing up to launch their products ahead of the fall RSV season.

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European Pharmaceutical Review

JUNE 7, 2023

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published its annual report , summarising the organisations 2022 highlights. Petra Doerr, Director of EDQM, Council of Europe, commented in the report on the current challenges of drug shortages in the pharmaceutical supply chain and its impact on the industry’s resilience and goals towards sustainability.

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Pharmaceutical Technology

JUNE 7, 2023

ZyVersa Therapeutics has received a notice of intention to grant from the European Patent Office for its patent application for the cholesterol efflux mediator VAR 200 (2-hydroxypropyl-beta-cyclodextrin). The application was filed for the treatment of diabetic nephropathy/diabetic kidney disease. The Phase IIa-ready VAR 200 is being developed to reduce renal cholesterol and the lipid accumulation that damages the filtration system of kidneys in glomerular diseases patients.

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STAT

JUNE 7, 2023

LONDON — The European Commission approved GSK’s RSV vaccine, the company said Wednesday, bringing to the market the first such tool that can protect older adults from the common respiratory bug.   The vaccine, Arexvy, was authorized for adults 60 and older. Arexvy won U.S. regulatory licensure last month , as did another RSV immunization , Pfizer’s Abrysvo.

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European Pharmaceutical Review

JUNE 7, 2023

The global biopharma industry’s resilience has decreased since 2021, a report by Cytiva has found. Using feedback from 1250 pharma and biopharma executives in 22 countries, the research sought to find out how has the biopharma industry has evolved over the past two years and what areas the industry should seek to improve. The five areas evaluated for resilience were: Supply chain resilience Access to talent Strength of the R&D ecosystem Manufacturing agility Effectiveness of government

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STAT

JUNE 7, 2023

When a loved one is living with serious substance use disorder and refuses to get help, sometimes it seems like the only solution is to force them into it. In many states, people can be “arrescued” — that is, forced under penalty of law into a treatment program that is nearly identical to being incarcerated, down to orange jumpsuits.

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pharmaphorum

JUNE 7, 2023

With a 51% reduction in deaths, AstraZeneca’s ADAURA trial was one of the breakout stories of this year’s ASCO. In Chicago, Editor in Chief Jonah Comstock was able to sit down with AstraZeneca Head of Lung Cancer Commercial Arun Krishna to dive in a little bit on this practice-changing study.

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