Tue.Dec 19, 2023

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U.S. government spent more on health care in 2022 than six countries with universal health care combined

STAT

American taxpayers footed the bill for at least $1.8 trillion in federal and state health care expenditures in 2022 — about 41% of the nearly $4.5 trillion in both public and private health care spending the U.S. recorded last year, according to the annual report released last week by the Centers for Medicare and Medicaid Services. On top of that $1.8 trillion, third-party programs, which are often government-funded, and public health programs accounted for another $600 billion in spendin

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5 noteworthy pharma AI investments in 2023

PharmaVoice

The last year showed how some of the world’s biggest pharma companies are leveraging AI tech.

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Trending Sources

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Here are the worst biopharma CEOs of 2023

STAT

Pfizer is this year’s anti-Eli Lilly. If David Ricks is the best biopharma CEO of 2023 , then Pfizer CEO Albert Bourla is, unfortunately, the worst. My annual Worst Biopharma CEO list is typically populated with blockheads and scoundrels. That’s not why Bourla is here. The reason is accountability. Strategic missteps , financial miscalculations, and scientific setbacks have plunged Pfizer into a deep crisis.

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This biotech aims to expand the CRISPR toolkit for more disease targets in the liver and brain

PharmaVoice

Arbor Biotechnologies is looking past CRISPR’s recent regulatory wins and into the next stage of gene editing.

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Position Your Pharmacy for Expansion

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.

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STAT+: In the U.S., scientists see barriers to the development of CAR-T therapies. In Spain, a hospital brews its own

STAT

BARCELONA, Spain — Some of the patients waiting in the oncology ward of a hospital here, with its green-tiled floor and white walls, had arrived for a newfangled remedy for blood cancers, what’s known as a CAR-T therapy. The patients were not here for one of the brand-name medicines — a Kymriah or Yescarta — that have shown the power of these cell-based approaches and helped reap their makers hundreds of millions of dollars.

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ASBM Comments on FDA Draft Guidance Removing Interchangeability Statement from Interchangeable Biosimilars

Safe Biologics

On November 17th, ASBM submitted comments to the Food and Drug Administration (FDA) on draft guidance released in September by the FDA. The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. Under U.S. state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber.

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Why digital therapeutics (DTx) are effective and safe, but not being prescribed

pharmaphorum

In a new episode of the pharmaphorum podcast, host Nicole Raleigh welcomes Joel Morse, CEO and co-founder of Curavit Clinical Research, and Andy Molnar, CEO of the Digital Therapeutics Alliance (DTA), for a discussion on why it is that digital therapeutics (DTx) are effective and safe, but not being prescribed.

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STAT+: Health care industry fights back against crackdowns on health data tracking

STAT

Wherever you go on the internet, trackers follow. These ubiquitous bits of code , invisibly embedded in most websites, are powerful tools that can reveal the pages you visit, the buttons you click, and the forms you fill to help advertisers tail and target you across the web. But put those trackers on a health care website, and they have the potential to leak sensitive medical information — a risk that, in the last year, has driven the Department of Health and Human Services and the Feder

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Pharma breakthroughs: 10 novel drug approvals that made headlines in 2023 

Pharmaceutical Technology

Pharmaceutical Technology outlines some of the biggest US Food and Drug Administration (FDA) drug approvals announced in 2023 that are set to make an impact in the coming years.

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STAT+: Pharmalittle: Weight loss drugs are being paired with bariatric surgery; Carl Icahn plans to oust Illumina directors

STAT

Top of the morning to you. And a fine one it is. Lots of sunshine and clear blue skies are enveloping the Pharmalot campus, where the official mascots are bounding about the grounds and the short person has departed for a challenging apprenticeship. As for us, we are as busy as ever hunting and gathering items of interest. We trust you have your own busy agendas.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Allay grants acute pain management drug license to Japan’s Maruishi Pharmaceutical

Pharmaceutical Business Review

ATX101 is designed for sustained, localised pain relief post total knee arthroplasty surgery. Under the agreement, Allay will receive an upfront payment and equity investment. It is also eligible to get future milestone payments related to pre-defined clinical and regulatory events, both in the US and Japan, as well as commercial milestones and royalties on Japanese sales.

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Opinion: There’s a public health crisis lurking in our data: the Census option ‘some other race’

STAT

According to the 2020 Census, the second most common race in America , after white, is “Some other race,” an option chosen by an astonishing one out of seven people. The nationwide failure to accurately measure the variety of races and ethnicities that make up the U.S. population makes underrepresented groups invisible in public health data, resulting in policies informed by inadequate or misleading information.

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The imperative of fridge-free vaccines

European Pharmaceutical Review

Many of today’s vaccines are produced in ready-to-inject liquid formulations that must be kept cold to maintain stability. A requisite cold chain has been designed and implemented to be uninterrupted from factory to patient. However, this greatly complicates both the worldwide distribution and stockpiling of vaccines and other drugs. Since only about 20 percent of the world’s population is lucky enough to live in areas where reliable refrigeration is available, 1 the remaining majority live with

Vaccines 101
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The biotech updates you need to read today

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Today, a hospital in Barcelona goes rogue with its own CAR-T treatments, we learn more about Wegovy’s anti-inflammatory mechanisms, and more. Oh! Another thing: Join STAT’s Adam Feuerstein and a panel of experts today for a deep-dive discussion into  precision cancer medicines.

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Big pharma places big bets on antibody-drug conjugates

pharmaphorum

Big pharma companies like Pfizer are making significant investments in antibody-drug conjugates, a promising class of therapies. This article explores the growing interest and recent developments, including FDA approvals and the potential impact on the pharmaceutical industry.

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Morning Rounds: Have regulations on digital trackers in health care gone too far?

STAT

Understand how science, health policy, and medicine shape the world everyday. Sign up for our Morning Rounds newsletter  here. Good morning. Today we have Andrew Joseph’s dispatch from a Barcelona hospital that developed its own CAR-T, an intriguing clue to how obesity drugs work in the (mouse) brain, and a win for toothbrushing vs. pneumonia.

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BioMed X and Ono Pharmaceutical enter joint cancer research project

Pharma Times

The BioMed X Institute and Ono Pharmaceutical have announced a new joint research collaboration for cancer research. The project, ‘New Strategies to Engage Neutrophils in Solid Tumors’, will help to design next-generation immunotherapies by advancing the antitumour effects of neutrophils. Neutrophils are a type of white blood cell that helps the immune system fight infections and heal injuries.

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FDA Approves Expanded Indication for Adbry in Atopic Dermatitis

Pharmaceutical Commerce

FDA expands indication for LEO Pharma’s Adbry (tralokinumab-ldrm) to include patients 12 to 17 years of age with moderate-to-severe atopic dermatitis.

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Heart vests to identify those at high risk of sudden cardiac death

Pharma Times

In the UK, heart rhythms affect around two million people and can cause sudden death - News - PharmaTimes

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FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies

World Pharma News

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted, under Priority Review, the company's supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adult and paediatric patients aged 1 year and older with food allergy.

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Otsuka to commercialise hereditary angioedema drug in Europe

European Pharmaceutical Review

Otsuka Pharmaceutical has agreed to acquire exclusive marketing rights to Ionis’ hereditary angioedema (HAE) drug candidate, donidalorsen, in Europe. Under the terms of the agreement, Otsuka will pay California-based Ionis $65 million upfront, along with additional milestone-related payments. Ionis is also eligible to earn tiered royalties ranging from 20 to 30 percent based on aggregate annual net sales.

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Investors still aren’t sold on UniQure’s gene therapy for Huntington’s

BioPharma Dive

The biotechnology company’s share price fell more than 10% Tuesday after the disclosure of more data from a small study.

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European regulators prepare for AI in pharma

European Pharmaceutical Review

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMAs) have published a plan, which sets out a “collaborative and coordinated strategy” to maximise the benefits of artificial intelligence in regulation. The workplan, which runs until 2028, will help the European medicines regulatory network (EMRN) embrace the opportunities of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust decision-making to benefit

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Merck gets FDA decision date for new pneumococcal vaccine

BioPharma Dive

The company’s shot targets 21 strains of pneumococcal bacteria and, if approved, would compete with Pfizer’s Prevnar 20.

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One of the game-changers with CPHI is its ability to draw global players into India

Express Pharma

An Express Pharma exclusive with Olga PonomarevaStepnaya, Brand Manager, CPHI India, on trends and challenges in pharma sector, and what to expect at this year’s CPHI India How would you describe the current pharma scene in India, and what imminent trends do you see coming out of the show floor at CPHI India 2023? We’re witnessing a fascinating evolution in India’s pharma sector.

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BioMed X and Ono Pharmaceutical enter joint cancer research project

Pharma Times

In 2020, there were over ten million deaths worldwide associated with cancer - News - PharmaTimes

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USV and Biogenomics launches Insuquick

Express Pharma

Insuquick is a “Make in India” product and is available in all metros, and tier I/II cities USV has announced a partnership with Biogenomics to launch Insuquick, a biosimilar insulin aspart for people with diabetes In India. Insuquick is a “Make in India” product and is available in all metros, and tier I/II cities. Prashant Tewari, Managing Director, USV said,” We are committed to improving the quality of lives of people with diabetes.

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Pharmacy First requires ‘effective’ relationships between GPs and pharmacists

The Pharmacist

Key to the success of Pharmacy First and the expanded contraception and hypertension services are ‘effective and sustainable’ relationships between general practice and community pharmacy teams at a local level, England’s chief pharmaceutical officer (CPhO) has said. In an end of year letter to community pharmacy teams, David Webb said NHS England (NHSE) was asking […] The post Pharmacy First requires ‘effective’ relationships between GPs and pharmacists appeared first on The Pharmacist.

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FDA says no to Checkpoint’s skin cancer drug cosibelimab

pharmaphorum

Checkpoint Therapeutics’ PD-L1 inhibitor cosibelimab has been turned down by the FDA as a treatment for skin cancer cSCC

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Sanofi licenses fourth NK cell engager from Innate Pharma

Pharmaceutical Technology

Sanofi and Innate’s cancer collaboration agreement stretches back to 2016, with two of Sanofi’s NK cell engagers in clinical studies.

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Agno Pharma snaps up Particle Sciences to beef up drug product formulation

Outsourcing Pharma

The US contract development and manufacturing organization (CDMO) Agno Pharma has taken over compatriot firm Lubrizol Particle Sciences to increase its drug product formulation offerings.

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New contraception service ‘requires mix of skills’

The Pharmacist

The expanded Pharmacy Contraception Service is ‘not only about pharmacists’ as the ‘whole team has a role to play’, viewers of a Community Pharmacy England (CPE) webinar have been told. The expansion of the contraception service went live on 1 December, meaning pharmacists can now initiate oral contraception, as well as continue to provide ongoing […] The post New contraception service ‘requires mix of skills’ appeared first on The Pharmacist.

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Bioburden and sterility testing: how to conserve gene therapy product

European Pharmaceutical Review

Gene therapy manufacturing processes produce low yields, particularly in early product development stages. Yet the products are subject to the same regulatory release criteria and expectations as those used for traditional microbiology testing on biologics/pharma products producing significantly higher yields. Often, if gene therapy manufacturers were to adhere to current release requirements, the outcome would be little, if any, remaining product for the clinic or patients who often have no oth

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Novo Nordisk Foundation puts $260m into vaccine drive

pharmaphorum

Novo Nordisk Foundation is providing $260m in funding for an R&D initiative to find vaccines for respiratory infectious diseases like TB and flu

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Peptris raises $1M in pre seed funding

Express Pharma

The company intends to leverage and capitalise on the recent maturation of AI technology in developing its proprietary drug discovery platform Peptris Technologies, a Bangalore-based AI drug discovery company, has announced $1M in pre seed round investment led by Speciale Invest. This strategic funding marks a pivotal step in boosting Peptris’ efforts in advancing AI-driven solutions in the drug development/discovery sector, with a special focus on developing novel therapies for undruggabl