Mon.Dec 02, 2024

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RFK Jr. could 'cost lives in this country' if he pursues changes to US vaccine policy, Gottlieb says

Fierce Pharma

Robert F. Kennedy Jr.’s appointment last month to lead the U.S. Department of Health and Human Services immediately sent waves of speculation swirling throughout the biopharma industry. | The former FDA Commissioner pointed to the threat of measles if vaccination rates were to decline by 5%.

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December 2, 2024: NCI-Supported LungSMART Trial Joins the NIH Pragmatic Trials Collaboratory

Rethinking Clinical Trials

From left to right: Drs. David Wetter, Guilherme Del Fiol, and Ken Kawamoto, principal investigators for LungSMART The NIH Pragmatic Trials Collaboratory is pleased to welcome LungSMART (Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers) to its portfolio of innovative NIH Collaboratory Trials. Lung cancer is the leading cause of cancer-related deaths in the United States, but only 6.5% of eligible individuals were screened for lung cancer in 20

Trials 144
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Diabetes advocacy group discourages use of compounded GLP-1 drugs

Bio Pharma Dive

The ADA recommended doctors avoid prescribing unapproved, off-brand versions of drugs like Wegovy, wading into a dispute that has gripped the FDA and compounding pharmacies over the past few months.

Pharmacy 304
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Rapiblyk (Landiolol): A New Fast-Acting Option for AFib in the ICU

XTalks

The US Food and Drug Administration (FDA) has approved AOP Health’s landiolol injection, marketed as Rapiblyk, for the treatment of atrial fibrillation (Afib) and atrial flutter in critical care settings. These conditions, collectively known as supraventricular tachycardias, involve the heart beating too fast or irregularly, leading to acute complications.

Trials 104
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Novartis wagers billions of dollars on PTC Huntington’s drug

Bio Pharma Dive

At the center of a new licensing deal is an experimental medicine, PTC518, which is currently being tested in a roughly 250-person study that should produce results next year.

Licensing 287
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FDA considers 'regulatory action' for bluebird's Skysona after blood cancer reports

Fierce Pharma

The FDA is investigating reports of patients develo | The FDA is investigating reports of patients developing blood cancer after receiving bluebird bio’s gene therapy Skysona and is evaluating the need for “further regulatory action,” the U.S. agency said last week. The FDA notification came seven weeks after the New England Journal of Medicine (NEJM) published a report that seven of 67 children who received Skysona during clinical trials had developed blood cancer.

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Scientists Predict 80% of American Adults Will Be Overweight or Obese by 2050

AuroBlog - Aurous Healthcare Clinical Trials blog

(Ivan Rodriguez Alba/E+/Getty Images) Nearly half of adolescents and three-quarters of adults in the US were classified as being clinically overweight or obese in 2021. The rates have more than doubled compared with 1990.

Scientist 241
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Are You Using Next-Gen Sequencing to inform AAV product and process quality? Here are 4 reasons you should

Bio Pharma Dive

Next-generation sequencing allows for critical insights into gene therapy products, which can help streamline and accelerate everything from process development and production to regulatory approval.

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Pharma giants vie for oral GLP-1R approval

Pharma Times

Race to create first oral drug for obesity intensifies

Drugs 146
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Faron Pharma secures UK innovation passport for blood cancer immunotherapy

Pharmaceutical Technology

The MHRA has also granted approval to Faron Pharmaceuticals to conduct the BEXMAB trial of Clevegen in the UK.

Trials 130
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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Applied’s rare disease drug rejected by FDA

Bio Pharma Dive

Executives at Applied Therapeutics told analysts they were surprised by the agency’s refusal to approve the company’s treatment for classic galactosemia.

Drugs 130
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Fate Therapeutics makes Bob Valamehr president and CEO

Pharmaceutical Technology

Fate has announced the retirement of president and CEO Scott Wolchko with Bob Valamehr set to assume the role from 1 January 2025.

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OGT launches enhanced genetic profiling panel for CLL

Pharma Times

new SureSeq CLL + CNV V3 panel improves understanding of CLL

Genetics 129
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CBC acquires UCB’s neurology and allergy business in China

Pharmaceutical Technology

CBC Group has completed the strategic acquisition of UCB's mature neurology and allergy business in China for $680m.

Allergies 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Novartis pays $1bn upfront for Huntington's drug from PTC

pharmaphorum

Novartis has made a return to the Huntington's disease stage by licensing an oral mRNA splicer from PTC Therapeutics for $1 billion upfront

Licensing 111
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CHMP recommends oral peanut allergy immunotherapy treatment for toddlers  

Pharmaceutical Technology

The EMA’s CHMP has endorsed expanding the use of Palforzia to toddlers aged one to three years with peanut allergies.

Allergies 130
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Orexo exits depression DTx alliance with GAIA

pharmaphorum

Four years after buying US rights to GAIA's digital therapeutic to help people with depression, Swedish drugmaker Orexo has terminated the deal.

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UQ secures funds for development of skin cancer prevention cream

Pharmaceutical Technology

The research team at UQ has secured a grant of $344,000 from the National Foundation for Medical Research and Innovation.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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BMS files legal challenge to HHS' 340B rebate decision

pharmaphorum

Bristol-Myers Squibb has become the latest pharma in the US to file a legal challenge to a block on a 340B drug rebate model opposed by HRSA.

Drugs 99
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United States Protests China’s Semiconductor Chip Industry, Announces Export Restrictions

Pharmaceutical Commerce

A total of 140 companies are being placed on the Entity List, in an effort to limit China’s effectiveness in the sector.

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Abingworth 'will launch $1.5bn fund for co-developed drugs'

pharmaphorum

Abingworth 'will launch $1.5bn fund for co-developed drugs' Phil.

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Machine Health in Pharmaceutical Production

Pharmaceutical Commerce

Predictive maintenance in pharmaceutical production can help reduce downtime and increase efficiency. Grundfos Machine Health (GMH) uses artificial intelligence (AI)-driven wireless sensors to monitor motor health in real-time, identifying potential issues. This approach not only reduces maintenance costs but also ensures compliance with industry standards.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Part Two: Navigating the complexities of global market access for rare and complex conditions

pharmaphorum

Part Two: Understand the challenges faced by drug manufacturers when navigating the complexities of global market access for rare and complex conditions. Learn how to overcome these obstacles successfully.

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Pharma Pulse 12/2/24: Addressing the Health Literacy Roadblock in Patient Recruitment & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Orexo exits depression DTx alliance with GAIA

pharmaphorum

Four years after buying US rights to GAIA's digital therapeutic to help people with depression, Swedish drugmaker Orexo has terminated the deal.

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Shaping the Future of Commercialization

Pharmaceutical Commerce

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Chase Feiger, MD, co-founder, Ostro, outlines the trends he expects to see over the next 10-15 years when it comes to the intersection of AI and life sciences.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Alligator eyes sweeping job cuts and pares down its pipeline

pharmaphorum

Alligator eyes sweeping job cuts and pares down its pipeline Phil.

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Parliamentary panel to delve into price rise of medicines, need for regulatory reforms among others

AuroBlog - Aurous Healthcare Clinical Trials blog

The Department Related Standing Committee on Chemicals and Fertilisers, recently reconstituted under the chairpersonship of Lok Sabha member Kirti Azad Jha, will be delving into various aspects of the pharmaceutical sector including the price rise of medicines, need for stringent regulatory reforms, among others as the main subjects during its tenure.

Medicine 189
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Alligator slashes workforce and pares down its pipeline

pharmaphorum

Faced with a cash crunch, Alligator Biosciences has said it plans to shed up to 70% of its workforce.

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Exact Sciences Teams Up with Lil Jon for Cologuard Awareness

XTalks

Grammy-winning artist Lil Jon has joined forces with Exact Sciences in a dynamic campaign to boost awareness about colon cancer screening. Dubbed “Get Low #2,” the initiative reimagines his iconic early 2000s hit to drive a critical message: encouraging the approximately 60 million Americans overdue for colon cancer screening to prioritize their health.

DNA 111
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud