STAT

DECEMBER 19, 2023

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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PharmaVoice

DECEMBER 19, 2023

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

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STAT

DECEMBER 19, 2023

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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PharmaVoice

DECEMBER 19, 2023

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

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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

Communication

STAT

DECEMBER 19, 2023

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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Hospitals 356

Safe Biologics

DECEMBER 19, 2023

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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European Pharmaceutical Review

DECEMBER 19, 2023

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

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STAT

DECEMBER 19, 2023

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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pharmaphorum

DECEMBER 19, 2023

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

DECEMBER 19, 2023

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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Pharmaceutical Technology

DECEMBER 19, 2023

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

DECEMBER 19, 2023

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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European Pharmaceutical Review

DECEMBER 19, 2023

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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Labelling 105

STAT

DECEMBER 19, 2023

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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Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

European Pharmaceutical Review

DECEMBER 19, 2023

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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STAT

DECEMBER 19, 2023

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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Hospitals 239

European Pharmaceutical Review

DECEMBER 19, 2023

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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Pharmaceutical Business Review

DECEMBER 19, 2023

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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pharmaphorum

DECEMBER 19, 2023

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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Pharma Times

DECEMBER 19, 2023

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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European Pharmaceutical Review

DECEMBER 19, 2023

Can you reflect a little on what’s happening from a technology standpoint in the bioproduction space? Mahesh Bhalgat (MB): We are seeing continued emphasis on use of technology, as we’ve seen historically, but even more so now on titer and productivity. And that is now translating into evaluating productivity of the overall process. As a result, you’re starting to see a trend of not only looking at titer at the expression stage, but also combining titer with downstream purifica

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Biosimilars 98

Pharmaceutical Commerce

DECEMBER 19, 2023

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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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.

Pharma Times

DECEMBER 19, 2023

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

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BioPharma Dive

DECEMBER 19, 2023

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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World Pharma News

DECEMBER 19, 2023

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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BioPharma Dive

DECEMBER 19, 2023

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

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Vaccines 109

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Pharmacy Management

Express Pharma

DECEMBER 19, 2023

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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Drug Development 95

Outsourcing Pharma

DECEMBER 19, 2023

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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Express Pharma

DECEMBER 19, 2023

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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Pharma Times

DECEMBER 19, 2023

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

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pharmaphorum

DECEMBER 19, 2023

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

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