Thu.Oct 03, 2024

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FDA makes end of Zepbound, Mounjaro shortage official

Bio Pharma Dive

Removal of Lilly’s in-demand drugs from the FDA’s shortage list ramps up pressure on the companies selling compounded versions.

Drugs 301
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Social media algorithms are driving the GLP-1 drugs boom

Pharmaceutical Technology

GLP-1 RAs are being recommended on social media, raising questions about who can see the content and what the effects might be.

Drugs 264
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October 3, 2024: JAMA Commentary Highlights Gap Between Research Results and Implementation Decisions

Rethinking Clinical Trials

In a JAMA Viewpoint published online this week, leaders from the NIH Pragmatic Trials Collaboratory discuss the discordance between the results of pragmatic clinical trials and the implementation of those results in healthcare settings, even in settings that championed the work. Coauthors Richard Platt, Hayden Bosworth, and Gregory Simon posit that, to provide evidence that healthcare systems leaders will actually use, changes are necessary: Trials need to be faster (2 to 3 years) Trials should

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Social media algorithms are driving the the GLP-1 drugs boom

Pharmaceutical Technology

GLP-1 RAs are being recommended on social media, raising questions about who can see the content and what the effects might be.

Drugs 246
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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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Long COVID Fatigue Shows Up as Distinct Changes in Brain Scans

AuroBlog - Aurous Healthcare Clinical Trials blog

(Roxana Wegner/Getty Images) Fatigue is one of the most frequent and debilitating symptoms of long COVID, and yet it is also one of the hardest to measure objectively. A new study suggests the extreme mental and physical fatigue experienced by many long COVID patients is, in fact, observable in the central nervous system.

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Gilead signs agreements to facilitate access to HIV prevention drug

Pharmaceutical Technology

Gilead Sciences has announced the signing of voluntary licencing agreements with six generic pharmaceutical manufacturers to facilitate access to lenacapavir, a potential human immunodeficiency virus (HIV) prevention drug, in 120 resource-limited and high-incidence nations.

More Trending

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Novaliq and Laboratoires Théa announce EC approval for dry eye disease therapy

Pharmaceutical Technology

Novaliq and Laboratoires Théa have announced approval from the European Commission (EC) for Vevizye (ciclosporin 0.1% eye drops solution) for patients with dry eye disease (DED) in Europe.

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Medicare tweaks rules for second round of drug price talks

Bio Pharma Dive

The agency will offer earlier meetings with drugmakers as well as solicit more patient feedback on the process.

Drugs 167
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ImmunoPrecise and Biotheus partner on bispecific antibodies to treat cancer

Pharmaceutical Technology

ImmunoPrecise Antibodies, an AI-driven biotherapeutic research and technology company, has entered into a material transfer and evaluation agreement (MTEA) with Biotheus on bispecific antibodies to treat cancer.

Antibody 130
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Grand Rounds September 27, 2024: Azithromycin for Childhood Mortality: Randomizing Entire Countries (Thomas Lietman, MD)

Rethinking Clinical Trials

                      Speaker Thomas Lietman, MD Director Francis I. Proctor Foundation University of California, San Francisco Slides Keywords Child Mortality; Antibiotics; Large Simple Trial Key Points Trachoma is a disease that affects the human eye, caused by infection with a strain of chlamydia. The scar tissue that is left behind warps the shape of eyelid, irritating the cornea and eventually causing full blindness.

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

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Eli Lilly to invest $4.5bn for drug manufacturing and trial medicine production

Pharmaceutical Technology

Eli Lilly has announced a $4.5bn investment to establish the Lilly Medicine Foundry for drug production and manufacturing medicines for clinical trials.

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Eli Lilly's shortage of diabetes and obesity drugs is over, halting competition with knock-offs

Fierce Pharma

Eli Lilly’s juggernaut diabetes and obesity drugs Mounjaro and Zepbound have been erased from the FDA’s shortage list, | Eli Lilly’s juggernaut diabetes and obesity drugs Mounjaro and Zepbound have been erased from the FDA’s shortage list, freeing the company from competing with compounding pharmacies that have been producing copycat versions of the in-demand treatments.

Pharmacy 117
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Resolution scores $83m to develop macrophage cell therapies

Pharmaceutical Technology

Resolution plans to use Series B investment to advance the development of its macrophage therapies in inflammatory and fibrotic indications.

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Gilead strikes deal to expand HIV drug access in 120 countries

pharmaphorum

Gilead has partnered with six generic manufacturers to expand access to HIV Drug lenacapavir in high-incidence, resource-limited countries following promising clinical trial results.

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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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Healthcare Payers for the Pharmaceutical Industry

Pharmaceutical Technology

Discover the leading Healthcare Payers for the Pharmaceutical Industry. Download the free Buyer's Guide today for full contact details.

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For Bristol Myers Squibb's newly approved schizophrenia drug, what a long, strange trip it's been

Fierce Pharma

On its way to becoming the most highly anticipated approval of 2024, BMS’ schizophrenia treatment Cobenfy has had an unusual but instructive odyssey.

Drugs 112
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Chronic diseases “as urgent as climate change,” says Novo Nordisk CSO

Pharmaceutical Technology

Novo Nordisk’s chief scientific officer Marcus Schindler led the keynote address at ELRIG Drug Discovery 2024 in London, UK.

Drugs 130
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BMS' Opdivo joins the perioperative lung cancer treatment ring with key FDA approval

Fierce Pharma

Hot on the tail of AstraZeneca’s Imfinzi, Bristol Myers Squibb’s PD-1/L1 inhibitor Opdivo has expanded its non-small cell lung cancer (NSCLC) net with an

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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A rational design approach to RNA-targeting to target large-scale screening

Pharmaceutical Technology

At ELRIG 2024, Dr. Maria Duca described how her lab’s rational design approach bypasses lengthy screening protocols.

RNA 130
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After winning historic nod, Zevra CCO expects new drug Miplyffa to become 'cornerstone' of Niemann-Pick treatment

Fierce Pharma

Armed with what it sees as impressive clinical data and bolstered by long-standing ties to the Niemann-Pick disease type C (NPC) community, Zevra Therapeutics is confident that its new drug Miplyff | Armed with what it sees as impressive clinical data and bolstered by long-standing ties to the Niemann-Pick disease type C community, Zevra Therapeutics is confident that its new drug Miplyffa can become the “foundation and the cornerstone” for treatment of the debilitating rare disease going forwar

Drugs 100
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Enara Bio secures $32.5m for ‘Dark Antigen’ cancer therapies

Pharmaceutical Technology

Pfizer and Merck KGaA’s venture capital arms were among the backers in the Series B round.

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WuXi service providers weigh sales of certain assets amid BIOSECURE scrutiny: FT

Fierce Pharma

As the BIOSECURE Act works its way through the U.S. legislative branch, two companies named in the bill are reportedly weighing sales of certain units and facilities. | WuXi AppTec has put its cell and gene therapy manufacturing arm, WuXi Advanced Therapies, on the market, The Financial Times reported Thursday. At the same time, WuXi Biologics is working with advisors to gauge interest in some of its European production facilities, the news outlet added, citing sources.

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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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Investment outlook: Key takeaways from LSX USA

pharmaphorum

Discover the key takeaways from the LSX USA Congress with this podcast wrap-up, offering insights into investment outlook and trends discussed at the event.

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IRLAB’s new drug shows promise in treating apathy in Parkinson’s patients

Pharma Times

Phase 1 trial of IRL757 demonstrates good absorption and safety profile

Drugs 135
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AI pathology accelerates with Proscia Concentriq launch

pharmaphorum

Proscia announces launch of Concentriq Embeddings and Proscia AI Toolkit, hoping to accelerate precision medicine R&D.

Medicine 111
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Ferring opens doors to Finnish manufacturing hub as supply of its bladder cancer gene therapy continues to grow

Fierce Pharma

After unlocking commercial supply and enlisting a manufacturing partner earlier this year, Ferring Pharmaceuticals has reached a new turning point on its quest to satisfy current and future demand | Ferring on Thursday opened a new global manufacturing hub in Kuopio, Finland, to help produce drug substance for Adstiladrin, which was approved by the FDA in late 2022 as the first gene therapy to target high-risk and non-muscle invasive bladder cancer in patients who no longer respond to therapy.

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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

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The Top 10 Longest-Running Drug Patents

Drug Patent Watch

Humira, used to treat various autoimmune diseases, has become the world’s best-selling drug. AbbVie has fiercely protected its patent through a strategy known as “patent thickets,” filing over 100 additional patents related to the drug’s manufacturing process, formulation, and methods of treatment[1].

Drugs 89
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NHS England proposes phased rollout for Eli Lilly's star obesity drug

Fierce Pharma

As officials consider how to distribute Eli Lilly’s Mounjaro to a nation that has a rapidly growing (PDF) o | As officials consider how to distribute Eli Lilly’s Mounjaro to a nation that has a rapidly growing obesity problem, England’s National Health Service is proposing that those who need it most should get it first.

Drugs 88
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Research shows NHS, industry partnership benefits patients

pharmaphorum

A new report commissioned by ABPI found hospitals engaging in industry partnerships more likely to follow NICE recommendations.

Research 105
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SK pharmteco to strengthen small molecule and peptide capacity with $260 million investment

Outsourcing Pharma

SK Groupâs contract development and manufacturing organization (CDMO) arm SK pharmteco is spending $260 million to expand its small molecule and peptide manufacturing muscle in South Korea.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.