Sat.Oct 07, 2023 - Fri.Oct 13, 2023

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New FDA SaMD Guidance Will Bring Monumental Changes to Industry

PharmExec

A discussion of the impact the new FDA SaMD guidance, identifying the differences between companion apps and SaMD, and what to expect from this combination in the future.

FDA 105
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Gates Foundation spends $40M to boost mRNA vaccine production in Africa and beyond

Fierce Pharma

Following similar initiatives to bolster mRNA vaccine production and access in Africa, the Bill & Melinda Gates Foundation is providing new funding to a clutch of drugmakers. | Following similar initiatives to bolster mRNA vaccine production and access in Africa, the Bill & Melinda Gates Foundation is providing new funding to a clutch of drugmakers.

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Is Medicare Advantage a Failed Experiment? Experts Debate

MedCity News

Enrollment in Medicare Advantage is increasing, but the program has been drawing scrutiny from the government. Can the program be saved? One expert believes Medicare Advantage is a failed experiment. Another thinks that while the program has its flaws, it shows tremendous potential.

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Life Sciences Innovation Day – Accelerating Digital Transformation Ambition

European Pharmaceutical Review

Schneider Electric, a leader in digital transformation, energy management and automation, has announced the speaker lineup for its exclusive event, Life Sciences Innovation Day – Accelerating Digital Transformation Ambition. Set at the world-renowned Silverstone F1 Racetrack on 18 October 2023, it promises to be a day of immersive insights and top rate networking.

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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An Evolving ‘Opinion’ Landscape: New Paths—and Synergies—for Pharma KOLs & DOLs

PharmExec

Industry experts discuss the relationship between digital and traditional (key) opinion leaders and how companies are adjusting their strategies to harness the unique brand engagement benefits each role can provide in driving better patient outcomes.

Pharma 119
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Novo Nordisk's unstoppable semaglutide clears kidney disease trial early on positive efficacy

Fierce Pharma

For a study weighing the injectable semaglutide in chronic kidney disease, an early end appears to give Novo Nordisk cause to celebrate. | For a study weighing the injectable semaglutide in chronic kidney disease, an early end appears to give Novo Nordisk cause to celebrate.

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Sanofi Adds Biologics to Its AI Ambitions, Striking Up R&D Alliance With BioMap

MedCity News

Formed by Baidu founder and CEO Robin Li, BioMap uses artificial intelligence technology to glean insight into proteins to guide biologic drug discovery. The startup is the latest company to join a growing list of Sanofi partners as the pharmaceutical giant continues investing in AI-enabled drug discovery.

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Roche multiple sclerosis subcutaneous injection: late-breaking data

European Pharmaceutical Review

Late-breaking data from Roche’s Phase III OCARINA II study have revealed that OCREVUS® (ocrelizumab) subcutaneous injection was comparable to IV infusion in providing near-complete suppression of MRI brain lesion activity over 24 weeks, for relapsing or primary progressive multiple sclerosis (RMS or PPMS) patients. OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, which are thought to be a key contributor to myelin and axonal (nerve cell) damage, noted Roche.

Safety 111
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Merck's Keytruda hits overall survival goal in early lung cancer as FDA decision nears

Fierce Pharma

What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer (NSCLC) could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Ke | What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Keytruda.

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How Pharma Companies Can – And Should – Improve Social Determinants of Health

Eversana Intouch

Social determinants of health (SDOH) are the non-medical factors that affect people’s health. They can include the conditions in which people are born, live, learn, work, play, worship, and age 1,2 — as well as factors like economic policies and systems, development agendas, social norms, social policies and political systems. 1 Why are SDOH important?

Pharma 105
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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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Pfizer Expands in Immunology With FDA Approval of New Ulcerative Colitis Drug

MedCity News

Pfizer’s new FDA-approved ulcerative colitis drug Velsipity comes from its $6.7 billion Arena Pharmaceuticals acquisition. The small molecule will compete against blockbuster Bristol Myers Squibb drug Zeposia, which addresses the same target.

FDA 118
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Follicular lymphoma BTK inhibitor recommended by CHMP

European Pharmaceutical Review

The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of BRUKINSA ® (zanubrutinib), a Bruton’s tyrosine kinase inhibitor (BTKi), in combination with obinutuzumab. BeiGene’s anti-cancer treatment is indicated for adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy.

Medicine 111
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Bayer christens $250M cell therapy 'launch facility' in Berkeley

Fierce Pharma

Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. | Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. Now, as BlueRock Therapeutics advances its lead prospect, its parent company Bayer is ready to kick production into high gear.

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Move Over, White Whales – Zebras Are Here

Eversana Intouch

Fact 1: Pharma is in the business of discovering, developing, and producing drugs with the aim of treating, curing, or preventing diseases…ultimately leading to healthier communities around the world. Fact 2: Pharma is just that – a business. Both facts are true. Both facts co-exist. And both facts impact how society views our industry. On that last point, there have clearly been times where Fact 2 has a direct influence on Fact 1.

Pharma 105
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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3 Questions This Healthcare Investor Finds Herself Asking Startups All The Time

MedCity News

At HLTH, General Catalyst Principal Candace Richardson discussed some of the questions she frequently asks startups during investment meetings. Some of these include “Do you stratify your outcomes data by different populations to ensure your model works well for everyone?” and “Is serving Medicaid populations on your roadmap?

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Pharma pushes for UK medicine scheme revision

European Pharmaceutical Review

According to the Association of the British Pharmaceutical Industry (ABPI), a consultation by the UK Government proposing radical changes to the Statutory Scheme for branded medicines has been heavily criticised by the pharmaceutical industry. The fundamental concern, ABPI highlighted, is the proposed continuation of an arbitrary cap on growth for branded medicines in the UK, which has led to soaring revenue clawbacks in the country.

Medicine 111
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Pfizer inks another EpiPen antitrust settlement, this one worth $50M

Fierce Pharma

Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief m | Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief medicine.

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FDA Creates Advisory Committee on Digital Health Technologies

PharmaTech

The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.

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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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Patient-Centric Digital Transformation: Rethinking Remote Monitoring for Comprehensive Care [Sponsored]

MedCity News

A recent webinar sponsored by AVIA Health and Seamless MD examined how health systems use remote patient monitoring beyond the usual chronic condition applications, including surgical prep and recovery, women’s health, and more.

Patients 115
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Novel anti-epileptic drug demonstrates efficacy

European Pharmaceutical Review

A new drug, part of a class of chemicals called potassium-channel openers, has demonstrated potential in offering relief to patients with focal epilepsy. Key data from a clinical trial, published in a report in JAMA Neurology, has revealed that adding the drug XEN1101 to a patient’s current antiseizure treatments saw a 33 percent to 53 percent drop in monthly seizures, depending on dose.

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After Novo's Ozempic logs victory in kidney disease trial, dialysis heavyweight DaVita raises doubts

Fierce Pharma

An apparent win for Novo Nordisk’s GLP-1 blockbuster Ozempic in chronic kidney disease (CKD) could herald a shift in how the condition has been treated for decades. | Based on the inclusion criteria for Novo Nordisk’s chronic kidney disease trial, dialysis bigwig DaVita believes there may only be “limited application” of the study’s findings to the overall CKD population.

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Biopharma Stock Check: Market Review and Outlook

PharmExec

Exploring the pharma and biotech financing, M&A, and stock market pictures through the first half of 2023—and implications for the future, as market challenges continue to weigh heavily in senior management decision-making.

Marketing 104
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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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From Promise to Impact: The Evolution of AI in Medical Imaging for Population Health and ROI

MedCity News

The ultimate challenge for the broader adoption of AI in medical imaging remains the same: demonstrating to healthcare institutions that it provides a clear ROI.

Medical 122
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ECNP 2023: new esketamine NS safety data for depression

European Pharmaceutical Review

The Janssen Pharmaceutical Companies of Johnson & Johnson has revealed that according to new safety data, SPRAVATO ® (esketamine nasal spray [NS]) has demonstrated superior efficacy compared to quetiapine extended-release (Quetiapine XR) for treatment-resistant depression (TRD). This treatment is an antagonist of the N-methyl-D-aspartate (NMDA) glutamate receptor.

Safety 109
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After repeat Humira biosimilar snubs, FDA turns down Teva and Alvotech's Stelara copycat

Fierce Pharma

Even as Teva Pharmaceuticals’ Icelandic counterpart Alvotech works to get its Reykjavik manufacturing facility back up to snuff, lingering problems at the plant—which derailed approval of the partn | The FDA shot down Alvotech and Teva's biosimilar candidate to Johnson & Johnson's Stelara over “certain deficiencies” uncovered by the FDA during a reinspection of the company's factory in Iceland earlier this year.

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Why are haemophilia gene therapies so expensive?

Pharmaceutical Technology

Biomarin and CSL Behring’s haemophilia gene therapies have boosted innovation in the field, but assessing their cost effectiveness is less than straightforward.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Why the AMA President Thinks Scope of Practice Expansions Are a ‘Terrible Idea’

MedCity News

To address the growing physician shortage, some people argue that the scope of practice should be expanded for skilled healthcare professionals like nurse practitioners and pharmacists. American Medical Association President Dr. Jesse Ehrenfeld said this is a “terrible idea.” He argued that throwing other professionals into physicians’ roles will have poor ramifications of patient safety.

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Study reports rapid method for microbial contaminant detection

European Pharmaceutical Review

A paper published in Pharmaceuticals has reported the first demonstration of the possibility of using fluorescent optical respirometry (FOR) to detect aerobic bacteria in selected sterile pharmaceutical products. Rapid , real-time measurement of living aerobic microorganism cells was achieved using the fluorescent sensor tris-[(4,7-diphenyl-1,10 phenanthroline)ruthenium(II)] dichloride (Ru(DPP) 3 Cl 2 ).

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Amylyx's ALS drug Albrioza rebuffed by EU regulator—again

Fierce Pharma

Even as Amylyx’s ALS drug gains steam in the U.S. after a long-awaited FDA approval, the company is struggling with regulatory hurdles overseas. | Europe's drug regulator wasn't swayed by Amylyx's phase 2 data. The European Commission will make the final call on the drug's approval in the bloc by the end of the year.

FDA 290
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Roche to Develop Two Novel RNA-targeted Programs from Ionis for CNS Diseases

PharmaTech

Roche will gain exclusive worldwide rights to develop, manufacture, and commercialize Ionis’ investigational RNA-based therapeutic candidates for Alzheimer's and Huntington's disease.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time