Thu.Feb 08, 2024

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PBMs take bulk of blame as senators question BMS, J&J and Merck CEOs on high drug prices in US

Fierce Pharma

Thursday, when senators questioned three Big Pharma CEOs about the high price of drugs in the U.S., Health, Education, Labor and Pensions (HELP) committee chairman Bernie Sanders, I-Vermont, put th | CEOs from Bristol Myers Squibb, Johnson & Johnson and Merck faced tough questions from senators on why prices for drugs in the U.S. exceed those in other countries.

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Five Ways AI Will Impact Clinical Trials This Year

MedCity News

The integration of AI technologies holds promise for enhancing outreach efforts, streamlining recruitment processes, and addressing long-standing barriers and biases that hinder diversity and inclusion in clinical trials.

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AstraZeneca hit CEO Pascal Soriot's $45B revenue goal after all. But is Enhertu approaching a plateau?

Fierce Pharma

With $45.8 billion in 2023 revenues, AstraZeneca has met the $45 billion-by-2023 goal CEO Pascal Soriot established in 2014 when he was fending off a takeover bid from Pfizer. | AstraZeneca has met the $45 billion-by-2023 revenue goal that CEO Pascal Soriot established in 2014. But questions have emerged for one of the company's key growth drivers.

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Gilead drops CD47 drug magrolimab for blood cancers

pharmaphorum

Gilead Sciences has said it will no longer develop its CD47-targeting antibody magrolimab in blood cancers after data suggested that patients taking the drug in clinical trials were more likely to die than those in control groups.

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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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Eli Lilly agrees to provide free and lower-priced insulin in Minnesota to resolve 2018 lawsuit

Fierce Pharma

After reaching a settlement with Minnesota’s attorney general, Eli Lilly can close the book on a yearslong lawsuit in the state. | The company will provide its insulin products at $35 per month and donate free insulin at 15 clinics over the next five years. Meanwhile, Minnesota's claims against Novo Nordisk and Sanofi remain ongoing.

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Upsized Kyverna IPO Gets $319M to Bring CAR T-Therapy to Autoimmune Diseases

MedCity News

Cell therapies were first validated in cancer, but Kyverna Therapeutics aims to show they’re safe enough for autoimmune diseases. The biotech plans to deploy its IPO cash across clinical trials in lupus nephritis, multiple sclerosis, systemic sclerosis, and myasthenia gravis.

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More Trending

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Why Experts Saw Cano Health’s Bankruptcy Coming From A Mile Away

MedCity News

Cano Health filed for bankruptcy this week — about three years after going public $4.4 billion SPAC merger. The industry reacted without surprise, with experts calling the bankruptcy a direct result of mismanagement, a quixotic growth strategy and poor market selection.

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‘The Top Line’: The most anticipated drug launches of 2024

Fierce Pharma

This week on “The Top Line,” we explore the most anticipated drug launches of 2024. | This week on “The Top Line,” we explore the most anticipated drug launches of 2024. Editor-in-Chief Ayla Ellison engages in a conversation with Fierce Pharma Marketing Senior Editor Ben Adams about the drugs likely to launch this year with the most significant sales potential by 2028.

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BioNTech Pact and Stock Sale Infuse Autolus With $600M for Its Cell Therapies

MedCity News

Autolus will apply the capital to its CAR T-cell therapy currently under FDA review in cancer and in early clinical development in lupus. Meanwhile, BioNTech will gain access to Autolus’s cell therapy manufacturing assets as well as technologies that could support the R&D of in vivo therapies and antibody drug conjugates.

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Roche's subcutaneous answer to AstraZeneca PNH drugs wins world-first approval in China

Fierce Pharma

China has become the first country to sign off on Roche’s paroxysmal nocturnal hemo | China has become the first country to sign off on Roche’s paroxysmal nocturnal hemoglobinuria (PNH) drug crovalimab, a subcutaneous answer to AstraZeneca’s infused treatments Soliris and Ultomiris. Roche’s subsidiary Chugai Pharmaceutical, which developed crovalimab and owns its rights in Japan and Taiwan, announced the approval of the humanized complement inhibitor C5 monoclonal antibody.

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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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Roche gets first world okay for PNH drug crovalimab

pharmaphorum

China has become the first country in the world to approve Roche’s anti-complement C5 antibody crovalimab, the only treatment for the rare disorder paroxysmal nocturnal haemoglobinuria (PNH) that can be given by subcutaneous injection.

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Fierce Pharma Asia—Leqembi’s slow uptake; Takeda’s pipeline culls; Roche’s world-first nod

Fierce Pharma

Eisai said uptake of its Biogen-partnered Alzheimer's drug, Leqembi, will likely miss an early launch target. Takeda cut several cancer candidates in its latest pipeline clear-out. | Eisai said uptake of its Biogen-partnered Alzheimer's drug, Leqembi, will likely miss an early launch target. Takeda cut several cancer candidates in its latest pipeline clear-out.

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RegenxBio advances two candidates to make waves in the CNS space

Pharmaceutical Technology

AFFINITY data has spurred RegenxBio towards a pivotal study for DMD while pivotal CAMPSIITE data has the company moving towards an FDA BLA.

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Papa Launches Programs To Address Health-Related Social Needs, Improve Star Ratings

MedCity News

Companion care company Papa has created two programs for health plans: one that addresses social drivers of health and one that aims to improve health plans’ star ratings.

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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.

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BioNTech adds CAR-T manufacturing with $250m Autolus deal

pharmaphorum

BioNTech has taken a $200 million stake in Autolus in a private placement that will allow it to tap into the UK company’s manufacturing capacity for CAR-T therapies

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Next-in-class combination treatment shows potential in cystic fibrosis

European Pharmaceutical Review

Vertex Pharmaceuticals’ once-daily small molecule vanzacaftor/tezacaftor/deutivacaftor (vanza triple) for cystic fibrosis (CF) has gleaned positive results in Phase III trials. The Phase III trials The clinical programme for the once daily vanza triple was comprised of two Phase III trials: SKYLINE 102 and SKYLINE 103, evaluating the efficacy of vanzacaftor (20 mg)/tezacaftor (100 mg)/deutivacaftor (250 mg) in cystic fibrosis patients 12 years and older with at least one F508del mutation or a m

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Astellas adds digital to its top management team

pharmaphorum

Astellas appoints Nick Eshkenazi as chief digital and transformation officer (CTDO), the first time the pharma has included a digital role in its top management team

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MedCity News Launches Debunked, A Show Where We Slaughter Myths, Bad Practices and Sacred Cows in Healthcare

MedCity News

MedCity News is launching a new ongoing show called Debunked: Slaughtering Myths, Bad Practices and Sacred Cows in Healthcare. In this show, co-hosts Arundhati Parmar and Samir Batra will discuss healthcare news and call out things that seem utterly insane to us. The goal is to inspire change in the healthcare industry.

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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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Kyverna prices its IPO, seeking $319m for its cell therapies

pharmaphorum

Autoimmune disease CAR-T therapy specialist Kyverna has upsized its IPO to $319m in another sign of an improving #biotech financing environment

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Medicines access: Unlocking the immense potential in cell and gene therapy  

Pharmaceutical Technology

Despite several ground-breaking developments, pharmaceutical and biotech companies are often reluctant to invest in cell and gene therapy.

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Rapid microbiology testing market to value nearly $13bn by 2034

European Pharmaceutical Review

A report from Prophecy Market Insights on rapid microbiology testing has predicted that the market is anticipated to surpass $12.7 billion by 2034. Growth drivers of the global rapid microbiology testing market A rise in infectious diseases worldwide has increased demand for rapid and precise diagnostics. This has in turn accelerated growth of this market, the report stated.

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DX-126262 by Hangzhou DAC Biotech for Breast Cancer: Likelihood of Approval

Pharmaceutical Technology

DX-126262 is under clinical development by Hangzhou DAC Biotech and currently in Phase I for Breast Cancer.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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Early Phase Trial Shows Promise of Amgen’s MariTide in Producing More Durable Weight Loss Results

Pharmaceutical Commerce

Data suggest that dosing of MariTide may be effectively tapered down and the drug may be taken less frequently over time compared with GLP-1 agonists such as Wegovy and Zepbound.

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JCVI announces advice for 2024 spring COVID-19 vaccine programme

PharmaTimes

The committee has advised that the vaccine should be given to those at the highest risk

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Anvatabart opadotin by Ambrx Biopharma for Adenocarcinoma Of The Gastroesophageal Junction: Likelihood of Approval

Pharmaceutical Technology

Anvatabart opadotin is under clinical development by Ambrx Biopharma and currently in Phase I for Adenocarcinoma Of The Gastroesophageal Junction.

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Researchers discover new type of memory B cell that remembers allergies

PharmaTimes

The cell could be a target for new immunotherapies for the chronic disease

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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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How payers and providers can leverage data analytics to provide better care for aging populations

Clarify Health

It is no exaggeration that the American healthcare industry faces a looming crisis: an increasing number of older adults with complex healthcare needs. Today, the 65-and-older population in the U.S. is just 13 percent but accounts for more than a third of healthcare expenditures. That number will increase significantly over the next 25 years. It’s estimated that by 2050, one-fifth of the total population in the United States will be aged 65 and older, and healthcare costs will rise at a simila

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The 2024 PM360 Pharma Choice Awards – Sales Aid Gold Winner

PM360

Elevate Healthcare and LivaNova USA, Inc. VNS Therapy is a Life-changer VNS (vagus nerve stimulation) Therapy is designed for people living with seizures despite trying multiple medications. The campaign helped showcase the ability of VNS patients to experience improved quality of life by illustrating everyday activities. The interactive visual aid enhanced the campaign by covering progressive intervention and seizure control.

Pharma 52
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Jonathan Miller, General Counsel, US Hemp Roundtable Discusses FDA Regulation of the Hemp Market

PharmExec

In an interview with Pharm Exec Associate Editor Don Tracy, Jonathan Miller, General Counsel, US Hemp Roundtable, discusses recent efforts that urge the House Energy and Commerce Committee to expedite an FDA hearing on the hemp market.

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The 2024 PM360 Pharma Choice Awards – Professional Website Silver & Bronze Winner

PM360

Silver Winner – 21Grams and Alexion Pharmaceuticals ALPD (Alkaline Phosphatase Detectives) Campaign HCPs needed to be more suspicious of low ALP, the smoking gun in a hypophosphatasia diagnosis. We created a campaign that took HCPs inside the body for an immersive investigation to interview suspects, uncover evidence, and even upload their photo to see themselves in the campaign—a first in health. 21GRAMS TEAM MEMBERS: Tom Richards Global Chief Creative Officer Frank Mazzola Global Chief C

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.