Sat.Aug 10, 2024 - Fri.Aug 16, 2024

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Era of ADCs: Pharma companies innovate to stand out in a buzzing market

Pharmaceutical Technology

As antibody drug conjugate (ADC)-centred deals dominate the oncology space, biotechs are using newer targets and linkers to differentiate themselves.

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Africa on high alert as mpox cases rise quickly

pharmaphorum

The rapid spread of a new variant of mpox – previously known as monkeypox – has prompted the Africa Centers for Disease Control and Prevention (Africa CDC) to declare a public health emergency.

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J&J and Roche are the strongest companies in the biopharma industry, says S&P Global

Fierce Pharma

Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers. | Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers.

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Medicare reveals results of drug price negotiations

Bio Pharma Dive

The agency said the first round of pricing talks, which involved drugs like the blood thinners Eliquis and Xarelto, will result in $6 billion in savings for taxpayers.

Drugs 306
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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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August 14, 2024: In This Week’s PCT Grand Rounds, Insights From a Pragmatic Trial of Surgical Face Masks

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Runar Solberg of the Norwegian Institute of Public Health will present “Methodological Insights and Lessons Learned From Conducting a Pragmatic Randomized Trial on Surgical Face Masks.” The Grand Rounds session will be held on Friday, August 16, 2024, at 1:00 pm eastern. Solberg is a research scientist in the Centre for Epidemic Interventions Research at the Norwegian Institute of Public Health.

Trials 130
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Incyte builds GvHD presence with Niktimvo approval

pharmaphorum

FDA clears Incyte's potential blockbuster Niktimvo as a treatment for chronic GvHD, making it a companion to the company's Jakafi for the disorder.

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More Trending

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Certa’s CEO Jag Lamba on enhancing pharma supply chain traceability and compliance

Outsourcing Pharma

In an increasingly complex regulatory landscape, pharmaceutical companies face significant challenges in maintaining transparency and accountability across their global supply chains.

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Complying with the DSCSA

Pharmaceutical Commerce

In this part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, describes the outcome of the joint public meeting held by the Partnership for DSCSA Governance and the FDA.

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Hypercube — Tackling AI Hallucinations in Medical Summaries

XTalks

Mendel AI and the University of Massachusetts Amherst (UMass Amherst) have published key data on addressing the critical issue of hallucinations in AI-generated medical summaries using a pioneering artificial intelligence (AI) framework called “Hypercube”. This collaboration is a step forward in ensuring the reliability and safety of AI applications in healthcare.

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Pfizer, BioNTech stumble in effort to develop combination flu, COVID shot

Bio Pharma Dive

The vaccine didn’t spur a strong enough immune response against a particular flu strain in a Phase 3 trial, leading the companies to ponder adjustments.

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

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How clinical trials can use AI responsibly and effectively

Pharmaceutical Technology

Strong measures must be in place to safeguard confidential patient data when deploying AI to optimise clinical trial translations.

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The Role of Oncology Biomarkers in Personalizing Hematology Treatment Plans

Worldwide Clinical Trials

By: Simran Padam, Medical Director, Medical Affairs Personalized treatment approaches have emerged as pivotal in improving outcomes for hematological cancers. Central to this advancement are biomarkers, which are measurable indicators that signal biological processes or pathological changes within the body. They play a crucial role in tailoring hematology oncology therapeutic strategies to individual patients and have transformed personalized medicine in oncology.

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Study finds AI reduces underdiagnosis of Black patients with common heart failure

Pharma Times

Heart failure with preserved ejection fraction makes up 50% of all UK heart failure cases

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Lykos to cut 75% of staff after FDA rejection of MDMA-based therapy

Bio Pharma Dive

The layoffs are part of a larger reorganization that will also see the departure of Lykos’ founder, the psychedelics advocate Rick Doblin.

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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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AstraZeneca wins approval for Imfinzi in NSCLC perioperative setting

Pharmaceutical Technology

The FDA approval of Imfinzi in this indication comes a month after the agency called for an overhaul of perioperative lung cancer trials.

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With FDA approval of Livdelzi, Gilead launches an inflammatory drug for the first time

Fierce Pharma

With an FDA appro | The FDA has approved Gilead's primary biliary cholangitis treatment Livdelzi. The drug, which was acquired in a $4.3 billion buyout of CymaBay Therapeutics six months ago, is the first inflammatory treatment launched by Gilead.

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New research reveals AI bowel cancer test can help patients avoid chemotherapy

Pharma Times

This form of cancer was responsible for 1.

Research 129
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FDA approves Ascendis drug for rare endocrine condition

Bio Pharma Dive

The clearance of Yorvipath for hypoparathyroidism was some time coming for Ascendis, which had resubmitted after receiving a rejection last year.

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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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The Genomic Medicine Revolution: Multi-Modality Approaches in Advanced Therapies 

Pharmaceutical Technology

Genomic medicines offer new techniques for treating conditions once thought to be intractable - a world of opportunity awaits.

Genome 246
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To approve Amgen's lung cancer med Imdelltra, FDA saw past 'large number' of missing adverse events

Fierce Pharma

When the FDA approved Amgen’s Imdelltra in May, the T-cell engager was hailed as a breakthrough for the treatment of small cell lung cancer (SCLC) and as the first DLL3-targeting therapy of potenti | In granting an accelerated approval to Amgen's first-in-class DLL3 bispecific Imdelltra, the FDA had to work through a “large number” of missing adverse events from a pivotal trial.

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Researchers map interactions of 144 active substances to identify drug benefits

Pharma Times

The study yielded over one million dose-responsive curves for existing cancer drugs

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Following FDA rejection, a journal retracts papers on MDMA-assisted therapy

Bio Pharma Dive

Editors at Psychopharmacology cited "unethical conduct" that the study authors didn't disclose when submitting the papers. Lykos Therapeutics says it filed a complaint with a third party to review the way the journal came to its decision.

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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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Pfizer and BioNTech’s Covid-19/flu combination vaccine falters in Phase III readout

Pharmaceutical Technology

While the vaccine demonstrated high responses for neutralizing influenza A titers, it failed to show sufficient efficacy against influenza B.

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Ascendis scores hard-fought FDA nod for hormone replacement therapy Yorvipath

Fierce Pharma

Ascendis Pharma should be well prepared for the U.S. | After two delays, the FDA has finally signed off on Ascendis Pharma's hormone replacement therapy Yorvipath, also known as TransCon PTH, which is the first approved product for hypoparathyroidism in adults in the U.S.

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UCL study reveals routine blood tests could improve early cancer diagnosis

Pharma Times

Bowel cancer was the most common cancer to be identified in both men and women

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Pfizer builds case for RSV shot with data from immunocompromised adults

Bio Pharma Dive

Results from a Phase 3 study could help Pfizer broaden use of its vaccine Abrysvo to younger adults whose medical history puts them at higher risk.

Vaccine 278
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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China approves AstraZeneca-Daiichi Sankyo’s gastric cancer therapy

Pharmaceutical Technology

AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan), has received conditional approval in China for gastric cancer.

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Fiercest Women in Life Sciences 2024: Nominations open now

Fierce Pharma

It’s time once again to nominate the fiercest women you know in the life science industry for our annual list. | It’s time once again to nominate the fiercest women you know in the life science industry for our annual list.

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Not if, but when: Pandemic preparedness is crucial

pharmaphorum

On Wednesday, 14th August, the World Health Organization (WHO) announced the mpox outbreak in Africa as a public health emergency of international concern (PHEIC). By Thursday, 15th August, the first case of the severe variant was reported in Sweden, marking its emergence outside of Africa.

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Evotec, citing research spending slowdown, cuts jobs and exits gene therapy

Bio Pharma Dive

The company's new CEO announced layoffs that will affect about 7% of company’s workforce.

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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.