Sat.Jun 08, 2024 - Fri.Jun 14, 2024

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Pfizer, Flagship Pioneering to Target Obesity Treatments Under 2023 Partnership

BioSpace

Building on last year’s potential $7 billion partnership with Flagship Pioneering, Pfizer and Flagship-founded ProFound Therapeutics will work on discovering new obesity candidates.

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Ipsen drug for rare liver disease approved by FDA

Bio Pharma Dive

The medicine will join Intercept’s Ocaliva as a treatment option for primary biliary cholangitis. Another drug, from the now Gilead-owned CymaBay, could be cleared for the condition by August.

Drugs 290
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AstraZeneca Tagrisso sNDA gains FDA priority review for lung cancer

Pharmaceutical Technology

AstraZeneca's sNDA for Tagrisso has obtained FDA priority review for unresectable, Stage III EGFRm non-small cell lung cancer.

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Tailor-made Solution for Collagenase

Pharma Mirror

By Michael von Papen, Chief Expert at Pharmatec GmbH – a Syntegon Company When a leading global collagenase manufacturer wants to renew and optimize a system at the heart of its production, technical expertise, and engineering competence is paramount. Moreover, cooperation within the project team needs to be well organized. Nordmark and Pharmatec, a subsidiary of Syntegon, have shown how this helps to master even unexpected challenges during the construction of a new filtration and concent

Engineer 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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Europe taps CSL Seqirus to produce bird flu vaccines for pandemic preparedness efforts

Fierce Pharma

Right after signing on to help with bird flu pandemic preparedness efforts in the U.S., CSL Seqirus has agreed to do the same in Europe through a vaccine supply pact. | The vaccine maker will deliver 665,000 doses of its avian flu-matched pre-pandemic vaccine. Under a 4-year contract, authorities can purchase up to 40 million doses.

Vaccine 133
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Moderna says combination flu, COVID shot succeeds in study

Bio Pharma Dive

Positive results from the trial could position Moderna to bring the two-in-one vaccine to market in 2025.

Vaccine 306

More Trending

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Unlocking the Future of Personalized Medicine: Blood vs. Buccal Swab in Pharmacogenomics Testing

Worldwide Clinical Trials

Pharmacogenomics (PGx), the study of how genes affect a person’s response to drugs, has brought significant changes to the clinical trial industry. This groundbreaking approach can help tailor medical treatments to an individual’s genetic makeup, considerably enhancing drug efficacy and safety while minimizing adverse drug reactions. At Worldwide, our recent study delved into the intricacies of PGx, comparing two common methods of DNA sample collection: buccal swabs and blood samples.

Medicine 182
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June 13, 2024: Burgess to Present Results of LAMP Trial, Precursor of NIH Collaboratory’s RAMP Trial

Rethinking Clinical Trials

Dr. Diana Burgess Diana Burgess, a co–principal investigator of the NIH Pragmatic Trials Collaboratory’s RAMP trial, will present the results of the precursor LAMP trial as part of the Veterans Affairs (VA) Health Systems Research Cyberseminars series. The Learning to Apply Mindfulness to Pain (LAMP) trial is a multisite pragmatic clinical trial that compared 2 approaches for delivering mindfulness-based interventions via telehealth for veterans with chronic pain.

Trials 162
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Pfizer gene therapy for Duchenne fails to meet goals of key trial

Bio Pharma Dive

The negative results from the Phase 3 study, called Ciffreo, come a little more than a month after Pfizer said a patient died in another trial of the gene therapy.

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FDA approves AstraZeneca’s Farxiga for paediatric T2D patients

Pharmaceutical Technology

The US FDA has granted approval for AstraZeneca's Farxiga for paediatric patients aged 10 years and above with type-2 diabetes.

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

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New study reveals how brain cell communication is linked to Alzheimer’s disease

Pharma Times

Two support cells, microglia and astrocytes, were found to communicate with each other

Research 148
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June 12, 2024: Registry-Based DAPA-MI Trial to Be Featured in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Stefan James and Dr. Jonas Oldgren In this Friday’s PCT Grand Rounds, Stefan James and Jonas Oldgren of Uppsala University will present “DAPA-MI – A Pragmatic Registry-Based Double-Blind RCT Trial Designed for Regulatory Evaluation.” The Grand Rounds session will be held on Friday, June 14, 2024, at 1:00 pm eastern. DAPA-MI (Dapagliflozin in Patients With MI) was a registry-based, placebo-controlled trial of dapagliflozin in patients hospitalized for myocardial infarction a

Trials 147
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Avidity drug for muscular dystrophy shows promise; Syntis takes new approach to weight loss

Bio Pharma Dive

Study results indicated Avidity’s medicine muted target genes. Elsewhere, Syntis revealed obesity drug plans and Nodthera chalked up more positive data for its NLRP3 inhibitor.

Drugs 292
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AbbVie and FutureGen link on inflammatory bowel disease

Pharmaceutical Technology

AbbVie has made a licence agreement with FutureGen Biopharmaceutical for developing FG-M701 for inflammatory bowel disease (IBD).

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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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New paediatric blood test to prevent sudden death from hereditary heart condition

Pharma Times

Hypertrophic cardiomyopathy is a rare condition that affects up to 1,000 children in the UK

Research 144
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June 11, 2024: Many Older Participants in Acupuncture Research Have Prior Acupuncture Experience, BackInAction Data Suggest

Rethinking Clinical Trials

Dr. Andrea Cook and Dr. Lynn DeBar, principal investigators of BackInAction Many older adults who participate in acupuncture research may have prior experience with acupuncture, according to an analysis of data from the BackInAction trial. The finding has implications for the design and conduct of future pragmatic clinical trials involving acupuncture.

Research 147
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ADCs are in focus. Here’s where AstraZeneca, AbbVie hope to take the field next.

Bio Pharma Dive

Newer components and drug combinations could expand use of the targeted cancer medicines, according to company executives.

Medicine 278
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Data sharing will be key in repairing the UK clinical ecosystem

Pharmaceutical Technology

Lord James O'Shaughnessy, the former health minister, outlines places where the UK is falling behind other countries with clinical research.

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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.

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Francis Crick, UCL and AZ identify why treatment fails for NSCLC patients

Pharma Times

NSCLC accounts for around 85% of all lung cancer cases, particularly in non-smoking patients

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BMS chief Boerner says company is still hungry for deals after spending more than $20B on M&A last year

Fierce Pharma

As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target | As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target comes along.

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Regenxbio CEO to step down after 15 years

Bio Pharma Dive

Kenneth Mills will become chair of the gene therapy developer's board while Curran Simpson, the current chief operating officer, will take his place as company head.

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Pre-diabetes rates increase amidst a renaissance for type 2 diabetes research

Pharmaceutical Technology

England’s NHS has reported an 18% increase in the number of people with non-diabetic hyperglycaemia, also known as pre-diabetes.

Research 246
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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ICL receives £10m donation to advance heart and lung research

Pharma Times

The donation will help scientists and clinicians collaborate and make new advances in research

Research 136
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Amid FTC crackdown, judge says Teva inhaler patents are 'improperly listed' in FDA Orange Book

Fierce Pharma

After being called out on some intellectual property claims late last year, Teva has fallen victim to the Federal Trade Commission’s (FTC’s) ongoing crusade against questionable drug patents. | A federal judge in New Jersey ruled that five of Teva’s patents on the metered dose inhaler for its asthma med ProAir HFA are “improperly listed” in the FDA’s Orange Book.

Drugs 134
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Health economics and outcomes research: Biopharma and the shift to value-based care

Bio Pharma Dive

Of the changes sparked by value-based care, perhaps the most valuable for the biopharmaceutical industry to embrace is the use of health economics and outcomes research (HEOR) to better understand a product’s value.

Research 263
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Alzheon secures $100m to advance Alzheimer’s disease treatment

Pharmaceutical Technology

Alzheon has secured $100m in a Series E funding round to develop and commercialise ALZ-801 for Alzheimer's disease (AD).

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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The Evolution of Oncology Trials: Project Optimus and Study Design Trends

Worldwide Clinical Trials

In the last few decades, oncology research has witnessed countless innovations and breakthroughs, significantly extending the lives of those affected by cancer and improving their quality of life. The FDA Oncology Center of Excellence (OCE) is committed to further enhancing oncology research and as a result, has recently implemented several projects aimed to revolutionize oncology clinical trials.

Trials 130
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Junshi, Coherus' PD-1 inhibitor Loqtorzi scores in phase 3 liver cancer trial

Fierce Pharma

Junshi revealed that a phase 3 trial of Loqtorzi plus Avastin prolonged the survival of first-line patients with hepatocellular carcinoma.

Trials 129
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Lilly Alzheimer’s drug gets unanimous backing of FDA panel

Bio Pharma Dive

The expert committee concluded donanemab’s benefits outweigh its risks, despite some concern over the drug’s safety.

Drugs 262
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Aligos Therapeutics gets grant for patent granted for compounds treating diseases and conditions

Pharmaceutical Technology

Discover the groundbreaking patent by Aligos Therapeutics for compounds targeting hepatitis B and D. Learn about the innovative methods for treatment and synthesis.

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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.