Sat.Jan 13, 2024 - Fri.Jan 19, 2024

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AI could revolutionise pharma compound synthesis

pharmaphorum

Researchers at the University of Cambridge and Pfizer have developed an AI-powered approach to make it easier to design and make pharma molecules

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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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Ex-Pfizer Employee Convicted for Insider Trades Ahead of Positive Paxlovid Data

MedCity News

The former Pfizer statistician worked on the clinical trial for the Covid-19 drug Paxlovid. A jury found the employee guilty of insider trading for transactions made before clinical data for the antiviral were publicly announced.

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Three ways research offices can lead researchers to more funding

Clarivate

Over half of research office leaders say researchers are disengaged. How can you close the gap to win more funding? In late 2023, Research Professional News, an editorially independent part of Clarivate , surveyed research office leaders and staff as well as researchers around the world, taking a close look at the challenges facing them today and in the future.

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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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Women’s health gap estimated at $1trn in new report

pharmaphorum

The disparity in access to healthcare between women and men around the world is often talked about but has never been given a dollar value – until now.

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After row with Hungary and Poland, Pfizer sues Romania over missed COVID vaccine payments

Fierce Pharma

Following public spats with Hungary and Poland, Pfizer and its German mRNA partner BioNTech have kicked off legal proceedings against Romania. | Following public spats with Hungary and Poland, Pfizer and its German mRNA partner BioNTech have kicked off legal proceedings against Romania. The lawsuit marks the latest move in Pfizer’s campaign to press countries to honor COVID-19 vaccine contracts inked by the European Commission in May 2021.

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More Trending

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Keytruda Granted Latest FDA Approval in Cervical Cancer

Pharmaceutical Commerce

FDA approves Keytruda (pembrolizumab) combined with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer, which is the 39th overall approved indication for the drug in the United States.

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New anti-smoking drug set for rapid NHS rollout

pharmaphorum

Oral cytisine therapy for smoking cessation from Consilient Health will launch in the UK next week, helping to alleviate a shortage of prescription drugs to help people quit

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Bristol Myers shows power of Opdivo-Yervoy combo in first-line colorectal cancer subset

Fierce Pharma

More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its checkpoint inhibitor doublet in newly diagnose | More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its checkpoint inhibitor doublet in newly diagnosed patients.

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Vertex’s CRISPR Gene Therapy Lands Another FDA Nod in a Rare Blood Disease

MedCity News

The FDA approved Vertex Pharmaceuticals’ gene therapy Casgevy for treating beta thalassemia, an inherited blood disease that leads to low levels of functioning hemoglobin. Last month, the one-time treatment won its first FDA nod for treating sickle cell disease.

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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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The Impact of Eli Lilly's New DTC Platform on Rx Drug Sales and Patient Access: An Interview with Bill Roth, General Manager, Managing Partner, Blue Fin Group

Pharmaceutical Commerce

In an interview with Pharma Commerce editor Nicholas Saraceno, Bill Roth, General Manager, Managing Partner, Blue Fin Group, discusses changes that will come with the pharma giant's new platform.

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NICE backs Pfizer’s Talzenna for advanced breast cancer

pharmaphorum

Pfizer’s PARP inhibitor Talzenna has become the first targeted treatment for HER2-negative locally advanced or metastatic breast cancer with BRCA1/2 mutations to be recommended by NICE for routine NHS use.

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Bayer CEO Bill Anderson makes his mark with major restructuring, 'significant' job cuts

Fierce Pharma

Bayer is launching a sweeping business overhaul as the German conglomerate sees “no viable alternative.” | Bayer is launching a sweeping business overhaul that will “come at the expense of many managerial employees,” as the German conglomerate sees “no viable alternative.

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9 Hot Takes from JPM24

MedCity News

I didn’t make it to this year’s J.P. Morgan Healthcare Conference in San Francisco, so I reached out to leaders from across the industry to hear how it went and learn about their takeaways from the event. This is a list of the nine most interesting responses that I received.

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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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UK ATMP sector “robust”, research finds

European Pharmaceutical Review

An attractive destination for ATMP clinical trials Based on the Cell and Gene Therapy Catapult (CGT Catapult)’s recently published UK 2023 Advanced Therapy Medicinal Product (ATMP) Clinical Trials Database , the UK is an attractive location for ATMP clinical trials. This is largely due to the number of ongoing ATMP clinical trials in the UK remaining “largely stable” over the past three years.

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Vivek Ramaswamy exits presidential race after Iowa result

pharmaphorum

Biotech entrepreneur Vivek Ramaswamy’s campaign to become the Republican candidate for the US presidency in the 2024 election has been suspended after a disappointing result in the Iowa caucuses.

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Vertex, CRISPR's gene-editing therapy Casgevy wins early FDA nod to treat beta thalassemia

Fierce Pharma

Vertex Pharmaceuticals and CRISPR Therapeutics have scored an FD | Vertex Pharmaceuticals and CRISPR Therapeutics have scored an FDA approval for their gene-editing therapy Casgevy (exa-cel) to treat transfusion-dependent beta thalassemia (TDT). The approval came more than two months ahead of the FDA's March 30 decision date.

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Boulder Care Extends Virtual Substance Use Disorder Treatment to Adolescents

MedCity News

As the opioid crisis grows for teens, Boulder Care has expanded its substance use disorder treatment to support adolescents. The company is starting its adolescent services in Washington with UnitedHealthcare Community Plan.

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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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MHRA approves ‘safer’ medicine alternative for rare disease

European Pharmaceutical Review

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Agamree ® (vamorolone), as a safer alternative to corticosteroids, for Duchenne muscular dystrophy (DMD). “In addition to its anti-inflammatory efficacy, both the EMA and the MHRA recognise the benefits of treatment with Agamree for bone health and growth,” Dr Shabir Hasham, Chief Medical Officer of Santhera Pharmaceuticals shared.

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Roche bags EU okay for subcutaneous Tecentriq

pharmaphorum

Roche’s Tecentriq has become the first PD-1/PD-L1 inhibitor to be cleared in the EU in a subcutaneous form that will make dosing easier for patients and healthcare providers

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AstraZeneca adds to rare blood disease portfolio with world-first Voydeya approval in Japan

Fierce Pharma

A month after Novartis made its entry into the paroxysmal nocturnal haemoglobinuria (PNH) field, AstraZeneca’s newest contender Voydeya bolsters the company’s presence in the disease area with a wo | The drug bolsters the company's portfolio in paroxysmal nocturnal haemoglobinuria (PNH) just as the market heats up thanks to new competitors from Novartis and Apellis.

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CMS Finalizes Rule Streamlining Prior Authorization Process

MedCity News

CMS finalized a rule on Wednesday that included set deadlines for affected payers to complete prior authorization requests. Several organizations came out in support of the rule.

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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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Maximizing Patient Care with Referral Management

Referral MD

How do healthcare providers benefit from patient engagement tools and other healthcare software solutions? Patient-centric care is more critical than ever in today’s fast-paced healthcare landscape. Healthcare providers must deliver high-quality medical services and engage with patients effectively and efficiently. Patient engagement, referral management, and Customer Relationship Management (CRM) software have become powerful tools to achieve these goals.

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FDA clears AI skin cancer detection device from DermaSensor

pharmaphorum

Medtech company DermaSensor gets FDA approval for a handheld device, powered by AI, that can be used to detect skin cancer at the point of care

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GSK pumps £200M+ into UK manufacturing network to bolster commercial ambitions, API supply

Fierce Pharma

As British pharma giant AstraZeneca looks abroad to build new factories, GSK is sticking close to home, where it plans to plug hundreds of millions of pounds into the United Kingdom over the next t | As other British drugmakers like AstraZeneca look abroad to build new factories, GSK is sticking close to home, where it plans to plug hundreds of millions of pounds into the United Kingdom over the next two years.

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More Than a Survey: How to Holistically Embrace the Patient Experience

MedCity News

Despite the challenges that healthcare providers face and declining patient experience scores, several effective strategies can enhance their work to improve the patient experience and sufficiently satisfy expectations for care.

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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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Roche cancer immunotherapy receives new EU approval

European Pharmaceutical Review

The European Commission (EC) has approved the EU’s first PD-(L)1 cancer immunotherapy for subcutaneous injection. Roche’s Tecentriq ® (atezolizumab) was first approved in Great Britain in August 2023. Compared with standard intravenous (IV) delivery, Roche stated that its monoclonal antibody biologic shortens treatment time by approximately 80 percent.

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AZ bags first approval for PNH therapy danicopan, in Japan

pharmaphorum

AstraZeneca gets its first approval for oral Factor D inhibitor danicopan, in Japan, for treatment of paroxysmal nocturnal haemoglobinuria

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After Pfizer offers discount, NICE gives thumbs up to breast cancer drug Talzenna

Fierce Pharma

Six months after England’s National Institute for Health and Care Excellence (NICE) spurned Pfizer’s breast cancer treatment Talzenna (talazoparib) because it was not cost effective, the agency has | Six months after England’s National Institute for Health and Care Excellence spurned Pfizer’s breast cancer treatment Talzenna because it was not cost effective, the agency has reversed course following the company’s offer to slash the price.

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AMA President: Medicare Physician Pay Cuts Will Have ‘Dire’ Impact if Not Reversed

MedCity News

The Medicare physician pay cuts that went into effect January 1 is a “disaster for the profession,” said Dr. Jesse Ehrenfeld, president of the AMA, during an interview at CES 2024. Getting the pay cut reversed is a top priority for the organization.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.