Mon.Jan 08, 2024

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JPM24: As cancer players jump head-first into ADC field, Novartis CEO explains how he's resisted the temptation

Fierce Pharma

San Francisco—Nearly all top cancer drugmakers have struck deals in the sizzling antibody-drug conjugate field—but not Novartis. | Nearly all top cancer drugmakers have struck deals in the sizzling antibody-drug conjugate field—but not Novartis. On Monday, the Swiss pharma’s CEO Vas Narasimhan explained how he's resisted the temptation.

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How Quantum Computing Will Impact Pharma in 2024: Q&A With Erik Huestis, Partner at Foley Hoag

PharmExec

Huestis discusses the ways that quantum simulation and quantum systems can be used in areas such as drug discovery and the creation and protection of intellectual property in the life sciences industry.

Pharma 126
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JPM24: Merck expects $20B+ in post-Keytruda cancer sales thanks to Daiichi ADC deal, Moderna vaccine

Fierce Pharma

While some Merck & Co. investors may still get the heebie-jeebies when thinking about Keytruda’s patent cliff in 2028, but the company’s CEO Rob Davis now thinks “it’s just another year.” | While some Merck & Co. investors may still get the heebie-jeebies when thinking about Keytruda’s patent cliff in 2028, but the company’s CEO Rob Davis now thinks “it’s just another year.

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Uber Health, Socially Determined Strike Partnership

MedCity News

Through a new partnership, payers and providers will be able to leverage Socially Determined’s social risk data to identify which patients have barriers to accessing healthcare and what those barriers are. Uber Health will then be able to offer its services to support those patients’ specific needs, whether it’s non-emergency medical transportation, same-day prescription delivery or grocery and over-the-counter item delivery.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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JPM24: Bristol Myers Squibb CEO Boerner emphasizes organic pipeline over recent M&A deals

Fierce Pharma

It took Bristol Myers Squibb’s new CEO Chris Boerner 16 minutes into his 24-minute presentation to address the big news the company made last month, with its holiday

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A Smoke Screen: Why Dying From Lung Cancer Isn’t Inevitable

MedCity News

It’s high time we reframe how we think about lung cancer by ending the shame and judgment. I care less about if you quit smoking, I care more that you get screened. No one should have to die, period.

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What Was the Most-Repeated Word in CVS Health CEO’s JPM Presentation?

MedCity News

The word has gained greater urgency in recent years as the consumer trend in healthcare has forced payers, providers and all other kinds of healthcare stakeholders to swear by it.

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Pharma firepower, M&A surge last year bode well for dealmaking prospects in 2024: EY

Fierce Pharma

Biopharma companies looking to maximize the visibility of their M&A activity often reveal deals during the J.P. Morgan Healthcare Conference. | In it’s annual Firepower report, EY says the biopharma industry enters 2024 with the capability and motivation to increase M&A activity. The late surge of activity in 2023 also bodes well for a 2024 uptick, the group said.

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Why Omada’s CEO Thinks Amazon Selected His Startup as the 1st Partner for Its New Program

MedCity News

Amazon launched a new initiative to help connect people to digital health benefits that they may not know are available to them. Omada Health is its first partner. CEO Sean Duffy said his company stood out from the many other virtual diabetes care companies out there because about 20 million Americans — many of whom shop on Amazon — are eligible for Omada’s programs.

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JPM24: Amgen CEO hopes to take a bite of competitive obesity market with unique approach

Fierce Pharma

After last year saw the rise of popular obesity treatments, biopharma's interest in the field only appears to only be growing. | With Novo Nordisk and Eli Lilly dominating the obesity field, Amgen's CEO Robert Bradway knows a new offering will have to offer a unique benefit. Amgen's phase 2 candidate MariTide, plus a myriad of preclinical assets, could stand out from the crowd with a differentiated approach, the CEO figures.

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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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AstraZeneca Vice President, Head of Breast Cancer Franchise, Discusses Impact of Truqap Approval

PharmExec

In an interview with Pharmaceutical Executive associate editor Don Tracy, Ashley Gaines, VP, head of breast cancer franchise, discusses newly approved Truqap.

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Regeneron hands off certain Libtayo rights in Europe to Medison Pharma

Fierce Pharma

After Regeneron took over full Libtayo rights from former partner Sanofi, Medison is now set to commercialize the oncology med in certain European and international markets. | After Regeneron took over full Libtayo rights from former partner Sanofi, Medison is now set to commercialize the oncology med in certain European and international markets.

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Medtronic CEO On the Company’s AI: This Isn’t About ChatGPT

MedCity News

Geoff Martha sought to establish a clear line between popular understanding of AI created by apps like ChatGPT and what he believes is the significant impact that Medtronic’s AI-enabled products are already having on patients and other healthcare stakeholders today.

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Innovative biologic for myasthenia gravis granted European approval

European Pharmaceutical Review

RYSTIGGO ® (rozanolixizumab) is the first therapy approved in Europe for adults with anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive generalised myasthenia gravis (gMG). The European Commission (EC) has now granted a marketing authorisation for biopharma company UCB’s treatment, as an add-on to standard therapy in patients who have this rare autoimmune condition.

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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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Will We Close the Medicare Advantage Primary Care Gap in 2024?

MedCity News

Medicare Advantage patients without a primary care physician are perhaps the greatest risk to health plans in 2024. Health plans must adopt best practices to reach and engage MA patients, especially those with multiple, complex conditions. Here are six best practices to consider.

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Sustainability in milling: A greener future for 2024?

Pharmaceutical Technology

With micronisation required for 30% of APIs on the market, there is a need for more sustainable methods of milling these vital drug products.

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J&J Joins the Cancer ADC Dealmaking Spree With $2B Ambrx Acquisition

MedCity News

Johnson & Johnson’s acquisition of antibody drug conjugate developer Ambrx Biopharma comes as Novartis and Merck also unveiled M&A deals on the first day of the J.P. Morgan Healthcare conference. In a report, the investment bank said big pharmas are looking for deals involving de-risked assets.

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With Most Fortune 500 Companies Unprepared for New SEC Cyber Regulations, What Should Their Board of Directors Do? A Q&A with Dr. Herb Lin, Senior Research Scholar for Cybersecurity at Stanford University

PharmExec

As the use of emerging technologies such as generative artificial intelligence continues to grow to support the innovation goals of Fortune 500 companies, so too does the risk of cybersecurity breaches.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Boston Scientific Continues Buying Spree with $3.7B Axonics Acquisition

MedCity News

Medical device giant Boston Scientific added to its string of recent acquisitions by announcing its plan to buy Axonics, a maker of neurostimulation devices that treat urinary and bowel dysfunction, for $3.7 billion. Experts agree that this deal will make a profitable impact on Boston Scientific’s urology business.

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Isomorphic signs up Lilly, Novartis for $3bn AI drug hunt

pharmaphorum

Alphabet’s AI in drug discovery startup Isomorphic Labs signs collaborations with Eli Lilly and Novartis worth up to $3bn, its first two pharma partnerships

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CureVac announces positive Phase II Covid-19 vaccine trial data 

Pharmaceutical Technology

The CureVac and GSK Covid-19 collaboration was first announced in February 2021, with regulatory discussions already in motion.

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JPM kicks off with takeovers by J&J, Novartis and MSD

pharmaphorum

JPM24 starts with three takeovers including J&J's $2bn bid for Ambrx, Merck’s $680m play for Harpoon Therapeutics and a $425m offer from Novartis for Calypso Biotech

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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FDA grants approval for Ligand’s molluscum contagiosum treatment

Pharmaceutical Technology

The FDA has granted approval for Ligand Pharmaceuticals’ Zelsuvmi (berdazimer topical gel, 10.3%) for molluscum contagiosum.

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Servier will apply ‘digital twin’ tech to Parkinson’s drug

pharmaphorum

Servier has added a third digital twin project to its collaboration with AI specialist Aitia, trying to identify Parkinson's patients who will respond to its LRRK2 inhibitor in clinical trials.

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A Closer Look at PBM Spread Pricing

Pharmaceutical Commerce

While often portrayed in a negative light, it is important to find a balanced perspective on its role in the pharma sector.

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FDA allows Florida to import medicines from Canada

Pharmaceutical Technology

The US FDA has granted authorisation for Florida's drug importation programme under section 804 of the FD&C Act.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Florida is first US state cleared to import Canadian drugs

pharmaphorum

The FDA has approved the first request from a US state to import prescription medicines from Canada, giving the green light to Florida for a programme that aims to reduce its spending on drugs.

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Expanded Pluvicto production gets FDA go-ahead

European Pharmaceutical Review

Commercial manufacturing of Novartis’ radioligand therapy Pluvicto TM (INN: lutetium ( 177 Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its largest and most advanced manufacturing facility for these treatments manufacturing in the world, has been approved the US Food and Drug Administration (FDA). The 70,000ft 2 site facility in Indianapolis, Indiana, US, facilitates substantial supply increases “for the foreseeable future”, Novartis noted.

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Regulatory twists and turns are coming for biopharma in 2024

PharmaVoice

New FDA requirements and the IRA will create complexity in the coming year. Here’s how the industry can navigate the changes.

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ProfoundBio's Rinatabart Sesutecan Granted FDA Fast Track Designation for Ovarian Cancer

PharmExec

Rinatabart sesutecan (Rina-S; PRO1184) is under evaluation for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.