2024

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Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus

Fierce Pharma

One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.

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Two CVS Locations Make Moves To Join National Pharmacy Union Movement

MedCity News

Two CVS stores in Rhode Island have filed petitions to join the Pharmacy Guild, which is building a national pharmacy union. The locations are close to CVS Health’s headquarters in Woonsocket, Rhode Island. The post Two CVS Locations Make Moves To Join National Pharmacy Union Movement appeared first on MedCity News.

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Enhancing Patient Care: 4 Strategies for Life Sciences Companies

Salesforce

For many people, a sudden tingling in the leg or a feeling of numbness in the arm isn’t too much cause for alarm. The tingling or the numbness goes away after a little while, and they go on with their lives. But for Brooke Eby, an abrupt limp on her way to a conference one day ultimately led to a diagnosis of amyotrophic lateral sclerosis (ALS) at the age of 33.

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Cannabinoids show promise in acute migraine clinical trial

pharmaphorum

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

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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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EMA Says No Evidence for Link between Type 2 Diabetes Drugs and Suicidal Tendencies

PharmaTech

The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.

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As antimicrobial resistance looms large, a nonprofit teams up with Big Pharma to intervene

PharmaVoice

AMR is a growing threat, but with little financial incentive to pick up the torch, government and nonprofit collaborations are keeping the R&D flames burning.

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India’s Tata Institute develops tablet for cancer recurrence prevention

Pharmaceutical Technology

India’s Tata Institute has developed a tablet combining resveratrol and copper that has the potential to prevent the recurrence of cancer.

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Return-to-Office Pushes Can Cause a ‘Riot’

Copyright Clearance Center

A growing number of managers want workers in the office more often, citing the connections, collaborations, and innovations that in-person work can bring.

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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.

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ICR collaboration forms national NHS patient database registry for Lynch syndrome patients

PharmaTimes

The genetic condition affects one in 279 people in England and significantly increases cancer risk

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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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With Pfizer struggling in 2023, CEO Bourla hit with 35% pay cut to $21.6M

Fierce Pharma

Pfizer knew 2023 was going to be a challenging year of transition. But even the drugmaker was surprised by the plummeting demand for its COVID-19 products, missing badly on its 2023 guidance. | After a difficult year for Pfizer, in which its share price fell by 44%, CEO Albert Bourla’s compensation fell by 35% from $33 million in 2022 to $21.6 million in 2023.

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Should the DOJ Break Up UnitedHealth Group?

MedCity News

The U.S. Department of Justice has reportedly recently launched an antitrust investigation of UnitedHealth Group, which begs the question of whether the healthcare giant should be broken up. Experts have varying opinions.

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Pharma Pulse 4/17/24: At-Home Patients and AI, Psychedelics Present Unique Ethical Challenges & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Nanoscope preps filing for retinitis pigmentosa gene therapy

pharmaphorum

Nanoscope Therapeutics is on the brink of filing for FDA approval of what could be the first gene therapy for incurable eye disease retinitis pigmentosa (RP) that can be used regardless of underlying genetic mutations.

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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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FDA Grants Breakthrough Device Designation to Assay Supporting Earlier Diagnosis of Alzheimer Disease

Pharmacy Times

If approved, the test could provide more timely and accurate diagnosis, hopefully mitigating the impact of Alzheimer disease (AD) on individuals and the community.

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PharmaVoice’s Crystal Ball: What’s next in drug innovation and clinical trials

PharmaVoice

As advanced therapies and patient perspectives strengthen their foothold in R&D, pharma is poised to deliver impactful treatments in record time.

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2024 Journal Citation Reports: Changes in Journal Impact Factor category rankings to enhance transparency and inclusivity

Clarivate

New – unified rankings for each of our 229 science and social science categories; no Journal Impact Factor (JIF) rankings for the arts and humanities categories The scholarly landscape is witnessing a significant increase in both the quantity and sophistication of fraudulent behaviors, posing a substantial threat to the integrity of the scholarly record.

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Merck is on the lookout for more opportunities within immunology

Pharmaceutical Technology

At the JP Morgan Healthcare conference, Merck (MSD) indicated its eagerness to continue to establish its place in the immunological space.

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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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BioNTech hit with 'notice of default' from NIH in COVID-19 vaccine royalty dispute

Fierce Pharma

Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. | Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. officials are pressing the company to pay royalties linked to the commercialization of its lucrative Pfizer-partnered COVID-19 vaccine.

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AstraZeneca pledges £650M in UK investments to boost vaccine capabilities, expand near HQ

Fierce Pharma

AstraZeneca CEO Pascal Soriot, who has been critical of the U.K.’s business environment for the life sciences industry, is directing a big chunk of money into the Big Pharma’s home country. | AstraZeneca CEO Pascal Soriot, who has been critical of the U.K.’s business environment for the life sciences industry, is directing £650 million into the Big Pharma’s home country.

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Pfizer, BioNTech win pause in patent infringement case from rival Moderna

Fierce Pharma

After nearly two years of legal back and forth, Pfizer and its German partner BioNTech have won a brief reprieve in their patent fight against mRNA rival Moderna. | In a docket entry dated Friday, Massachusetts federal judge Richard G. Stearns granted a stay on Moderna's COVID-19 vaccine patent infringement lawsuit against Pfizer and BioNTech. The move will give the Patent Trial and Appeal Board more time to review challenges against two of the three relevant patents in the litigation.

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FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard

Fierce Pharma

The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. | The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended. The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.

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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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In banner year, Lilly rewards CEO David Ricks with 24% boost in total pay to $26.6M

Fierce Pharma

In 2023, Eli Lilly CEO David Ricks received a 24% boost in pay from $21.4 million to $26.6 million. The increase coincides with the company's booming sales.

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Former Pfizer statistician found guilty of insider trading on Paxlovid trial results

Fierce Pharma

A jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in federal court in the Southern District of New York. | A federal jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in Manhattan. The jury convicted Amit Dagar, 44, of Hillsborough, N.J., of using advance information on successful trial results for Pfizer’s COVID-19 treatment Paxlovid to make more than $270,000 in stock trades.

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Millions of doses of Pfizer's Paxlovid will go to waste in UK, EU as COVID demand plummets

Fierce Pharma

On the heels of a major Paxlovid inventory write-off in the United States, many more doses of Pfizer's COVID-fighting antiviral are going to waste overseas. | At the end of November, more than 1.5 million courses of Pfizer’s Paxlovid had expired unused in European countries, analysts at Airfinity said in a new report. The total tally of expired doses in Europe is expected to hit 3.1 million by the end of next month, representing a value of $2.2 billion.

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BioNTech's shares tumble—again—amid continued COVID vaccine sales slide

Fierce Pharma

Four months ago, when BioNTech slashed its 2023 revenue projection from 5 billi | When BioNTech reported its fourth-quarter earnings Wednesday, it was another harsh reminder of the plummeting demand for COVID-19 vaccines. Sales came to 1.5 billion euros ($1.6 billion) for the fourth quarter and 3.8 billion euros ($4.1 billion) for 2023, coming up short of expectations.

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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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FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor

Fierce Pharma

The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunotherapy developed by Iovance Biotherapeutics.

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FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe

Fierce Pharma

As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning. | As many have feared, the FDA's investigation into secondary T-cell malignancies following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning.

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FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies

Fierce Pharma

People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. | People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. The FDA has blessed Roche and Novartis’ Xolair as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods.

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Novo's obesity superstar Wegovy wins FDA nod to cut cardio risks in key label expansion

Fierce Pharma

Novo Nordisk’s fast-growing weight loss med Wegovy just added a new cardiovascular FDA approval to its label, likely enabling the med's superstar status to reach new levels. | The drug is the first weight loss treatment to win FDA approval to reduce the risk of severe cardiovascular outcomes, giving it an edge over rival Zepbound from Eli Lilly.

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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.