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 301
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How to Turn “Check-the-Box” Compliance Trainings Into Real Learning

Speaker: Brian Richardson, Brian Richardson, Founder and CEO of Richardson Consulting Group

Let’s face it—most ethics and compliance training programs aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, captivating, and maybe even enjoyable! Join learning design expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training. We'll explore innovative strategies to bring traditionally dry topics to life, making them resonate with learners and drive tangible change.

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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.

Doctor 98
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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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Clinical Research White Paper – Enhancing Transparency & Efficiency Throughout the Trial Lifecycle

Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

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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.

Genetics 195
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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

Drugs 156
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Galderma wins FDA approval for skin condition treatment

Bio Pharma Dive

Nemluvio is now cleared for adults with the chronic itching condition prurigo nodularis, making it a competitor to Sanofi and Regeneron’s Dupixent.

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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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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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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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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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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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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Study suggests COVID-19 vaccination lowers incidence of arterial thromboses

Pharma Times

A second dose of the vaccine lowered the incidence of conditions such as heart attack or stroke

Vaccine 154
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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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Can Your Organization Spot a Conflict Before It’s a Crisis?

Speaker: Amie Phillips Pablo, VP, Corporate Compliance & Privacy Officer at Novo Nordisk

In today’s complex healthcare environment, navigating third-party relationships has become even more challenging—whether it’s vendor relationships, employee activities, or patient-facing interactions. Left unmanaged, these conflicts can compromise trust, regulatory compliance, and even organizational reputation. So, how can healthcare teams stay ahead?

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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.

Vaccine 246
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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.

Hormones 127
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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 149
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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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White Paper - A Roadmap to AI Data Readiness in R&D Labs

Download this comprehensive guide to AI and ML in the R&D Laboratory Setting.

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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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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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Medicare drug price cuts could have limited early impact, but grow with time

Bio Pharma Dive

Some industry watchers described the level of price discounts announced by Medicare as a "relief," though they warned of bigger future implications for drug research.

Drugs 184
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model