FDA makes end of Zepbound, Mounjaro shortage official
Bio Pharma Dive
OCTOBER 3, 2024
Removal of Lilly’s in-demand drugs from the FDA’s shortage list ramps up pressure on the companies selling compounded versions.
Thu.Oct 03, 2024
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Social media algorithms are driving the GLP-1 drugs boom
Pharmaceutical Technology
OCTOBER 3, 2024
GLP-1 RAs are being recommended on social media, raising questions about who can see the content and what the effects might be.
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Long COVID Fatigue Shows Up as Distinct Changes in Brain Scans
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 3, 2024
(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.
Social media algorithms are driving the the GLP-1 drugs boom
Pharmaceutical Technology
OCTOBER 3, 2024
GLP-1 RAs are being recommended on social media, raising questions about who can see the content and what the effects might be.
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
October 3, 2024: JAMA Commentary Highlights Gap Between Research Results and Implementation Decisions
Rethinking Clinical Trials
OCTOBER 3, 2024
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
CDSCO declares 59 drugs tested in August as Not of Standard Quality
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 3, 2024
The Central Drugs Standard Control Organisation (CDSCO) has released a list of 59 drug samples declared as Not of Standard Quality (NSQ) during the month of August, with samples of drugs labelled as manufactured by some of the major companies failing the quality test.
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Enara Bio secures $32.5m for ‘Dark Antigen’ cancer therapies
Pharmaceutical Technology
OCTOBER 3, 2024
Pfizer and Merck KGaA’s venture capital arms were among the backers in the Series B round.
IRLAB’s new drug shows promise in treating apathy in Parkinson’s patients
Pharma Times
OCTOBER 3, 2024
Phase 1 trial of IRL757 demonstrates good absorption and safety profile
A rational design approach to RNA-targeting to target large-scale screening
Pharmaceutical Technology
OCTOBER 3, 2024
At ELRIG 2024, Dr. Maria Duca described how her lab’s rational design approach bypasses lengthy screening protocols.
ERLEADA shows 23% survival benefit over enzalutamide in prostate cancer study
Pharma Times
OCTOBER 3, 2024
Largest real-world study demonstrates significant survival advantage
Resolution scores $83m to develop macrophage cell therapies
Pharmaceutical Technology
OCTOBER 3, 2024
Resolution plans to use Series B investment to advance the development of its macrophage therapies in inflammatory and fibrotic indications.
Eli Lilly's shortage of diabetes and obesity drugs is over, halting competition with knock-offs
Fierce Pharma
OCTOBER 3, 2024
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.
Chronic diseases “as urgent as climate change,” says Novo Nordisk CSO
Pharmaceutical Technology
OCTOBER 3, 2024
Novo Nordisk’s chief scientific officer Marcus Schindler led the keynote address at ELRIG Drug Discovery 2024 in London, UK.
After winning historic nod, Zevra CCO expects new drug Miplyffa to become 'cornerstone' of Niemann-Pick treatment
Fierce Pharma
OCTOBER 3, 2024
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
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Healthcare Payers for the Pharmaceutical Industry
Pharmaceutical Technology
OCTOBER 3, 2024
Discover the leading Healthcare Payers for the Pharmaceutical Industry. Download the free Buyer's Guide today for full contact details.
For Bristol Myers Squibb's newly approved schizophrenia drug, what a long, strange trip it's been
Fierce Pharma
OCTOBER 3, 2024
On its way to becoming the most highly anticipated approval of 2024, BMS’ schizophrenia treatment Cobenfy has had an unusual but instructive odyssey.
Eli Lilly to invest $4.5bn for drug manufacturing and trial medicine production
Pharmaceutical Technology
OCTOBER 3, 2024
Eli Lilly has announced a $4.5bn investment to establish the Lilly Medicine Foundry for drug production and manufacturing medicines for clinical trials.
BMS' Opdivo joins the perioperative lung cancer treatment ring with key FDA approval
Fierce Pharma
OCTOBER 3, 2024
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
Gilead signs agreements to facilitate access to HIV prevention drug
Pharmaceutical Technology
OCTOBER 3, 2024
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.
Gilead strikes deal to expand HIV drug access in 120 countries
pharmaphorum
OCTOBER 3, 2024
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.
Novaliq and Laboratoires Théa announce EC approval for dry eye disease therapy
Pharmaceutical Technology
OCTOBER 3, 2024
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.
AI pathology accelerates with Proscia Concentriq launch
pharmaphorum
OCTOBER 3, 2024
Proscia announces launch of Concentriq Embeddings and Proscia AI Toolkit, hoping to accelerate precision medicine R&D.
The New Age of Decentralized Clinical Trials
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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.
ImmunoPrecise and Biotheus partner on bispecific antibodies to treat cancer
Pharmaceutical Technology
OCTOBER 3, 2024
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.
WuXi service providers weigh sales of certain assets amid BIOSECURE scrutiny: FT
Fierce Pharma
OCTOBER 3, 2024
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.
Research shows NHS, industry partnership benefits patients
pharmaphorum
OCTOBER 3, 2024
A new report commissioned by ABPI found hospitals engaging in industry partnerships more likely to follow NICE recommendations.
NHS England proposes phased rollout for Eli Lilly's star obesity drug
Fierce Pharma
OCTOBER 3, 2024
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.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
The Top 10 Longest-Running Drug Patents
Drug Patent Watch
OCTOBER 3, 2024
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].
Argenx widens its Halozyme Therapeutics-partnered net with 4 new targets in $30M license expansion
Fierce Pharma
OCTOBER 3, 2024
With a recently acquired FDA nod for its Halozyme Therapeutics-partnered Vyvgat Hytrulo, argenx is looking to take Halozyme’s delivery tech to new heights through a $30 million licensing deal that | The company's collaboration with drug delivery partner Halozyme Therapeutics now totals six targets and could result in milestone payments of up to $85 million per target for Halozyme.
Changing Faces – Digital and supplier hires for September 2024
pharmaphorum
OCTOBER 3, 2024
Changing Faces – Digital and supplier hires for September 2024 featuring HALIX, Tanvex BioPharma, Avania, Oxford Biomedica, and more. Stay updated on the latest recruitment news and opportunities in the pharmaceutical industry.
Grand Rounds September 27, 2024: Azithromycin for Childhood Mortality: Randomizing Entire Countries (Thomas Lietman, MD)
Rethinking Clinical Trials
OCTOBER 3, 2024
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.
How Machine Learning Drives Clinical Trial Efficiency
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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.
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