Fri.Jan 17, 2025

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Medicare will negotiate Novo’s GLP-1 drug price. Here’s what that means for Ozempic, Wegovy.

Bio Pharma Dive

Novo sells semaglutide as Ozempic and Rybelsus for diabetes and as Wegovy for obesity. In price talks, CMS will treat the different forms as a single product.

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J&J Acquires Schizophrenia Drug Caplyta in $14.6 Billion Deal

XTalks

Johnson & Johnson (J&J) has announced its $14.6 billion acquisition of Intra-Cellular Therapies, which brings Caplyta (lumateperone) to its growing portfolio of mental health treatments. The deal also includes a cash payment of $132 per share for all outstanding shares of Intra-Cellular Therapies. Caplyta is an oral medication that was first approved in 2019 for the treatment of schizophrenia in adults, followed by a 2021 approval for depressive episodes associated with bipolar I and II

Drugs 105
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Shionogi awarded $375m from HHS for preventative Covid-19 injectable

Pharmaceutical Technology

Shionogis S-892216 is being developed as a pre-exposure prophylaxis (PrEP) drug for Covid-19. Credit: seksan Mongkhonkhamsao via Getty Images.

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Embracing the Future: Reflections on the Release of ICH E6(R3)

ACRP blog

The adoption of the ICH E6(R3) Guideline for Good Clinical Practice marks a defining moment in the evolution of clinical trial execution. As someone committed to advancing quality and innovation in clinical research, I see this milestone as an opportunity for our field to grow and adapt in meaningful ways. ICH E6(R3) isnt just an updateits a call to action.

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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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Novo shares high-dose Wegovy results; Amgen, AstraZeneca drugs get expanded OKs

Bio Pharma Dive

A high-dose form of Novo’s obesity drug led to 20% weight loss over 72 weeks. Meanwhile, Atara got a complete response letter and Boehringer reported a Phase 3 failure.

Drugs 159
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Unlocking Market Advantage Through Medical Communications

Intouch Solutions

In a recent article published by Med Ad News , Mary Anderson, Senior VP, Managing Director and Head of MedComm at EVERSANA INTOUCH, highlighted the pivotal role medical communications (MedComm) has played in giving brands a leg up in a competitive market. MedComms ability to leverage nonclinical trial data, including patient real-world evidence (RWE) and channel effectiveness analytics, is transformative for brands, especially in rare diseases.

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A chain reaction: HIV vaccines can lead to antibodies against antibodies

Medical Xpress

Many vaccines work by introducing a protein to the body that resembles part of a virus. Ideally, the immune system will produce long-lasting antibodies recognizing that specific virus, thereby providing protection.

Antibody 143
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IMPACT ovarian cancer capsules authorised in China

Pharmaceutical Technology

IMPACT Therapeutics has received the China NMPA marketing authorisation for Senaparib capsules in treating ovarian cancer.

Marketing 147
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Sepsis molecule discovery could lead to improved treatments for critically ill patients

Medical Xpress

Researchers at Oregon Health & Science University have uncovered how a molecule found on certain bacteria may drive blood clotting in sepsis, a life-threatening condition that causes about 8 million deaths per year.

Bacteria 132
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COPD market to expand with AstraZeneca’s focus on biologics and strong portfolio growth

Pharmaceutical Technology

The upcoming release of Phase III Fasenra data in COPD in 2025 is expected to solidify AstraZenecas position in the market.

Marketing 147
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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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CDC wants faster testing for bird flu in hospitals

pharmaphorum

Hospitals should expand and speed up testing of people hospitalised with influenza to see if they are suffering from bird flu, says CDC.

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FDA beats EMA to most approved new drugs in 2024

Pharmaceutical Technology

The FDA has narrowly beaten the European Medicines Agency (EMA) to the most approved drugs with a new active substance in 2024.

Drugs 147
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New article warns against restricting discussions on structural racism

Medical Xpress

A new Health Affairs article highlights the detrimental impact of recent state and federal policies that restrict discussions of "divisive concepts," including structural racism. It warns that these policies undermine efforts to address health inequities and improve population health.

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Charles River and Akron link to integrate cytokines into cell therapy

Pharmaceutical Technology

Charles River and Akron Bio have announced the integration of the latters CSS liquid cytokines into the former's Cell Therapy Flex Platform

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

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Retinal neurons provide insight into schizophrenia disease mechanisms

Medical Xpress

Researchers analyzed the genetic connection of retinal cells and several neuropsychiatric disorders. By combining different datasets, they found that schizophrenia risk genes were associated with specific neurons in the retina. The involved risk genes suggest an impairment of synapse biology, so the ability of neurons to communicate with each other.

Gene 111
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Mega M&A at JP Morgan Conference 2025 — is biopharma M&A poised for a rebound?

Pharmaceutical Technology

Potential antitrust deregulation could foster a more favourable environment for larger M&A deals in 2025, though skepticism remains.

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2025 Brand Drug Challenges: A GoodRx Perspective

Drug Channels

Todays guest post is from Dorothy Gemmell, Chief Commercial Officer and President, Manufacturer Solutions, at GoodRx. Dorothy highlights five trends to watch in 2025. She then describes how GoodRx's Cash Point-of-Sale Solution can help brands improve gross-to-net (GTN) while also making medications more affordable for patients. Click here to download the latest GoodRx data on copay, cash, and patient services programs.

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HEOR explained: Improving healthcare decisions with real-world evidence

Pharmaceutical Technology

How longitudinal, closed claims data is advancing regulatory, epidemiology, and health economics and outcomes research (HEOR).

Research 147
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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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Higher costs can limit attendance for life changing cardiac rehab

Medical Xpress

Despite the success cardiac rehabilitation has shown at reducing heart-related deaths and hospital readmissions, higher out-of-pocket costs may prevent patients from participating in the program, a Michigan Medicine study suggests.

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CDE grants BTD to Innovent’s IBI343 for pancreatic cancer

Pharmaceutical Technology

The CDE of China's NMPA has granted BTD to Innovent Biologics' IBI343 as a monotherapy treatment for CLDN18.2-positive PDAC patients.

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AI can guide acquisition of diagnostic-quality lung ultrasound images

Medical Xpress

Trained health care professionals (THCPs), including medical assistants, respiratory therapists, and nurses, with artificial intelligence (AI) assistance can achieve lung ultrasound (LUS) images with diagnostic quality that does not differ significantly from that achieved by experts, according to a study published online Jan. 15 in JAMA Cardiology.

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Pfizer believes in the metaverse: will healthcare thaw the technology’s winter?

Pharmaceutical Technology

The metaverse hype is over, but developer Cassette Group has been working with Pfizer to realise its forgotten potential.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Interdisciplinary research lays groundwork for predicting if bone cancer will spread

Medical Xpress

Bone pain. Joint pain. Bone swelling. These are symptoms that about 1,000 people in the United States begin to feel each year shortly before being diagnosed with osteosarcoma, a type of cancer that starts in the bones. Although any age can develop osteosarcoma, approximately half of diagnosed cases are in children and adolescents.

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Ozempic named in latest Medicare price negotiations

Pharmaceutical Technology

The negotiated prices of 15 Medicare Part D drugs, which include several blockbusters, will go into effect in 2027.

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Boehringer drug for brain fog in schizophrenia fails trial

pharmaphorum

Boehringer Ingelheim's bid to develop the first drug therapy for impaired cognitive function in schizophrenia looks like it has reached an end.

Drugs 98
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Leading Sales and Marketing Intelligence Providers and Technology Solutions for the Pharmaceutical Industry

Pharmaceutical Technology

Discover the leading sales intelligence tools & solutions for the pharmaceutical industry. Download the free Buyer's Guide for contact details.

Sales 130
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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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The power of cinema: Study shows film intervention reduces violence against children

Medical Xpress

A new study shows that screenings of a locally-produced narrative film about parenting led to a significant reduction in physical violence against children.

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AI 'can spot cognitive decline linked to menopause'

pharmaphorum

An AI can identify women who are at risk of experiencing a severe decline in cognitive function in menopause, which can be a risk factor for dementia.

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Megakaryocytes' immune characteristics and role elucidated

Medical Xpress

Megakaryocytes (MKs), known for their role in platelet production, have emerged as critical players in immune responses, showcasing versatility in both physiological and pathological contexts. Recent advances in technology have unveiled the diverse immune functions of MKs, which express immune sensors and participate in immune activities, thus expanding their traditional role beyond hemostasis and coagulation.

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AZ's Calquence gets first-line OK in mantle cell lymphoma

pharmaphorum

AstraZeneca's BTK inhibitor Calquence is the first drug in the class to be approved in the US for first-line treatment of mantle cell lymphoma.

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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