Fri.Nov 08, 2024

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Athira exploring strategic alternatives after Alzheimer’s failure

Bio Pharma Dive

On the heels of its most advanced medicine flunking a key study, the drugmaker is looking at the different paths it could take to “maximizing stockholder value.

Medicine 167
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Ultra-processed food is causing a boom for obesity drug Ozempic

Pharmaceutical Technology

The seemingly inexorable rise in global obesity is being reflected in the sales of diabetes and weight-loss drugs, including Ozempic.

Drugs 264
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Tezspire succeeds in chronic rhinosinusitis; Gilead writes down Trodelvy value

Bio Pharma Dive

AstraZeneca and Amgen's drug could have a new use after positive Phase 3 study results. Elsewhere, Jazz set new plans for a narcolepsy drug and CDMO Avid Bioservices agreed to be taken private.

Drugs 157
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AstraZeneca and Amgen’s Tezspire succeeds in Phase III nasal polyps trial

Pharmaceutical Technology

A Phase III trial with the companies’ monoclonal antibody in patients with chronic rhinosinusitis with nasal polyps met its primary endpoint.

Trials 264
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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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Kalaris to go public via reverse merger with AlloVir

Bio Pharma Dive

After Kalaris and AlloVir combine, the new company will have about $100 million to advance a treatment for age-related macular degeneration.

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Eisai lowers Leqembi revenue forecast after rocky entry to market

Pharmaceutical Technology

Leqembi is approved for Alzheimer’s patients in multiple territories, but questions remain over its cost-effectiveness.

Marketing 240

More Trending

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Mustang Bio’s MB-108 receives FDA orphan drug status for glioma treatment

Pharmaceutical Technology

Mustang Bio has received orphan drug designation from the US Food and Drug Administration (FDA) for MB-108, a herpes simplex virus type 1 oncolytic virus and a component of MB-109, designed to treat malignant glioma.

Drugs 147
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AZ confirms China president has been detained

pharmaphorum

AstraZeneca has revealed that its top executive in China, Leon Wang, has been detained by Chinese authorities

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Pharma cold chains: Major trends shaping the next decade

Pharmaceutical Technology

Analysis of future trends highlights that the cold chain logistics sector is at a critical juncture, with tech advancements driving change.

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Eisai dials back forecasts for Alzheimer's drug Leqembi

pharmaphorum

Eisai has scaled down its sales expectations for Alzheimer's disease drug Leqembi after sluggish sales growth in the first half of the current fiscal year.

Drugs 124
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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The fundamentals of developing parenteral drug products 

Pharmaceutical Technology

Advancing to first-in-human clinical trials requires formulation development to design a successful sterile formulation that meets your TPP.

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Daiichi Sankyo partners Alteogen on subcutaneous Enhertu

pharmaphorum

Daiichi Sankyo signs a $300m deal with Alteogen to develop a subcutaneous version of anti-HER2 cancer drug Enhertu.

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LakeShore commences BLA submission to DRAP for rabies vaccine

Pharmaceutical Technology

LakeShore Biopharma has commenced the submission of its biologics license application (BLA) to the Drug Regulatory Authority of Pakistan (DRAP) seeking conditional approval for its PIKA Rabies Vaccine for post-exposure prophylaxis (PEP).

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GSK calls it quits on trade group BIO for 2025, following exits by Takeda, UCB and more

Fierce Pharma

GSK is the latest to turn its back on prominent industry lobbying group Biotechnology Innovation Organization (BIO), following a string of exits by companies including Pfizer, UCB, WuXi AppTec and | The company opted not to renew its membership for 2025 following an annual review of its trade group associations, a spokesperson said.

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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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Aurinia slashes workforce by 45% to focus on lupus and autoimmune assets

Pharmaceutical Technology

Aurinia has announced a 45% workforce reduction to bolster sales of the lupus drug Lupkynis and advance the development of AUR200.

Sales 130
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It’s time to end America’s testosterone paranoia

pharmaphorum

Explore the controversial issue of Testosterone Deficiency Syndrome (TDS) and the impact of America's testosterone paranoia with insightful analysis and perspectives on the topic.

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Sonnet BioTherapeutics secures US patent covering two drug candidates

Pharmaceutical Technology

Sonnet BioTherapeutics has announced the issuance of US Patent No. 12,134,635 covering its two new drug candidates, SON-1411 and SON-1400, expected to advance treatment options for cancer.

Drugs 130
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How to conduct a cybersecurity audit on your pharma supply chain

pharmaphorum

Conducting a cybersecurity audit on your pharmaceutical supply chain is crucial for protecting sensitive data. Learn how to properly assess and strengthen your cybersecurity measures with this guide.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA proposes ban on main ingredient in many OTC decongestants

Fierce Pharma

Common oral medicines that have been used for decades as decongestants such as Sudafed, NyQuil and Benadryl may soon be cleared from shelves as the FDA has

Medicine 100
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NHS Wales partners with Illumina on genomics drive

pharmaphorum

Wales has extended a scheme to harness the power of genomics to improve cancer care and prevention via an alliance with gene-sequencing giant Illumina.

Genomics 103
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Top 10 Healthcare Innovations of 2024, Per TIME’s Best Inventions List

XTalks

This blog is the fourth in our series exploring TIME’s “Best Inventions of 2024” list, following our deep dives into some of the most transformative medical devices , pharma and food innovations. Today, we spotlight healthcare inventions transforming clinical and at-home care, selected by TIME for their potential to tackle major healthcare challenges and elevate patient care.

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Ensuring product authenticity in the pharmaceutical industry with cloud technology

pharmaphorum

Implementing cloud technology can help ensure the authenticity of pharmaceutical products like Ozempic, used for type 2 diabetes treatment. Learn how this technology is enhancing product security in the pharmaceutical industry generally.

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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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AstraZeneca, Amgen's Tezspire scores in rhinosinusitis study

Fierce Pharma

Six months after Amgen and AstraZeneca reported promising results for Tezspire (t | A phase 3 study has shown that AstraZeneca and Amgen's Tezspire provided a statistically significant and clinically meaningful reduction in polyp size and nasal congestion in patients with severe chronic rhinosinusitis with nasal polyps.

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UK health data ecosystem 'is hampering research'

pharmaphorum

The UK is squandering the vast resource of NHS patient data because too many obstacles are being placed in front of researchers trying to tap into it – holding back medical advances. That is the conclusion of the much-anticipated Sudlow Review – carried out by Prof Cathie Sudlow, chief scientist of Health Data Research (HDR) UK – which found that accessing patient data can take months or even years, hampering research into areas like dementia, cancer and heart disease.

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J&J angles Darzalex for first move into early-stage myeloma with trial win, FDA filing

Fierce Pharma

After a positive phase 3 trial, Johnson & Johnson hopes its Darzalex could become the first treatment option for patients with smoldering multiple myeloma, an early-stage form of the blood diso | After a positive phase 3 trial, Johnson & Johnson hopes its Darzalex could become the first treatment option for patients with smoldering multiple myeloma, an early-stage form of the blood disorder.

Trials 99
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Insights from Tjoapack’s CEO: 35 years of pharma packaging:

Outsourcing Pharma

Celebrating 35 years of innovation, Tjoapack has evolved into a leading force in pharmaceutical packaging.

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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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Future Fields looks to solve industry's biomanufacturing woes with fruit fly-based protein production

Fierce Pharma

With biomanufacturing often a limiting factor for drug developers, Canada’s Future Fields is heralding its bug-based approach to protein production as a potential salve. | With biomanufacturing often a limiting factor for drug developers, Canada’s Future Fields is heralding its bug-based approach to protein production as a potential salve. Now, after several years spent validating its manufacturing platform, the company is expanding in a big way with the debut of a new service line and factory i

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Don’t Let Clinical Study Delays Derail Timelines

Imperical Blog

Delays can be small or big, from minor misfortunes that make us late for dinner to major study setbacks that mangle study timelines and jeopardize study goals. While delays in life are expected and inevitable, clinical study delays don’t have to send a trial off… The post Don’t Let Clinical Study Delays Derail Timelines appeared first on Imperial Clinical Research Services Blog.

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Fierce Pharma Asia—AstraZeneca's China fallout; Pfizer's $1B plan in China; Incyte-Sun JAK dispute

Fierce Pharma

AstraZeneca's China president has been detained by Chinese authorities amid investigation into illegal importation and improper collection of patient data. | AstraZeneca confirmed its China president has been detained by Chinese authorities. Pfizer plans to invest $1 billion in China in the next five years. Sun Pharma's JAK inhibitor Leqselvi was slapped with an injunction in a lawsuit with Incyte.

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Make an Impact: Help Shape the Future of Diabetes Treatment!

Trialfacts

Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details About the Research Center Study Location Research Center: Yale School of Nursing Location: 400 West Campus Drive Orange, CT 06477 Lead Researchers: Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN, Robin Whittemore, PhD, APRN, FAAN, Sangchoon Jeon, PhD, Garrett Ash, PhD, Stuart Alan Weinzimer, MD, and Anna Sajdlowska IRB: This study has been reviewed and approved by an Institutional Review Board (ID: 20000307

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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.