Fri.Apr 26, 2024

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Moderna banks on OpenAI to accelerate mRNA research 

pharmaphorum

In an ambitious move, Moderna has teamed up with OpenAI, the artificial intelligence company behind ChatGPT, to further integrate generative AI (GenAI) across its mRNA drug development and manufacturing operations.

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Pfizer hemophilia gene therapy arrives in US to uncertain future

Bio Pharma Dive

The Food and Drug Administration approval of Beqvez comes as other gene therapies for the bleeding condition that were approved earlier struggle to gain traction.

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Top 20 biopharma kick off 9.6% market cap surge in Q1 2024 amid Medicare price talks

Pharmaceutical Technology

The top 20 biopharmaceutical companies witnessed a promising first quarter (Q1) this year amid ongoing macroeconomic uncertainties, fluctuating interest rates, and evolving Medicare drug price negotiations.

Marketing 130
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AbbVie tries to reassure investors on Humira biosimilar threat

Bio Pharma Dive

Prescription volume erosion is tracking with company forecasts, executives claimed, even as more insurers could exclude the branded drug.

Branding 164
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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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Regeneron and Mammoth team up to develop gene editing therapies

Pharmaceutical Technology

Regeneron Pharmaceuticals has collaborated with Mammoth Biosciences to develop in vivo clustered regularly interspaced short palindromic repeats (CRISPR)-based gene editing therapies.

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GSK pulls Pfizer and BioNTech into another vaccine patent lawsuit, this time surrounding the partners' mRNA-based COVID shots

Fierce Pharma

GSK pulls Pfizer and BioNTech into another vaccine patent lawsuit, this time surrounding the partners' mRNA-based COVID shots fkansteiner Fri, 04/26/2024 - 10:07

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Gilead writes $2.4B off Trodelvy as CEO underscores ‘time of focused execution’

Fierce Pharma

After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. | After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on the antibody-drug conjugate Trodelvy. With a busy year ahead across therapeutic areas, CEO Dan O'Day emphasized a "time of focused execution.

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Merck’s net income for Q1 2024 increases by 69% to $4.76bn

Pharmaceutical Technology

Merck has reported a significant increase in net income attributable to shareholders, reaching $4.76bn in Q1 2024, a 69% rise from $2.82bn in the same period last year.

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AbbVie's Skyrizi proves a worthy Humira successor with nearly matching sales ahead of potential UC nod

Fierce Pharma

AbbVie’s immunology heirs Skyrizi and Rinvoq are proving booming growth to make up for once-king Humira’s continuous sales slide. | As Humira continues its sales free fall, newer Skyrizi is proving a worthy successor with nearly matching sales ahead of an upcoming FDA decision in ulcerative colitis.

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The privileged status of orphan medicines in Germany

Pharmaceutical Technology

In Germany, new measures have come into effect as part of the GKV-FinStG Act in 2022 that put into question this market’s desirability for orphan drug developers.

Medicine 130
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Owlstone secures $6.5M for breath-based diagnostics for infectious disease

pharmaphorum

Owlstone Medical has secured a $5 million equity investment and initial $1.5 million grant funding, committed by the Bill and Melinda Gates Foundation, for development of breath-based diagnostic solutions to improve outcomes in the developing world.

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AstraZeneca posts $2.18bn profit after tax in Q1 2024

Pharmaceutical Technology

AstraZeneca has reported profit after tax of $2.18bn for the first quarter (Q1) of 2024, a notable rise from $1.80bn reported in the same period last year.

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Two RNA-binding proteins could contribute to cancer therapy development

Pharma Times

The paper identifies the roles of LARP4A and LARP4B in sarcoma and carcinoma cancers

RNA 84
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Cerevance raises $47m to fund Phase III trial for lead Parkinson’s therapy

Pharmaceutical Technology

The Series B extension proceeds will fund Phase III trial for Cerevance’s lead CNS therapy, CVN424, in patients with Parkinson’s disease.

Trials 130
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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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Spotlight on kidney disease: Driving change for patients

pharmaphorum

Explore the latest advancements and initiatives in kidney disease research, driving change for patients with kidney conditions. Learn more about the current research landscape and potential breakthroughs in treatment from Kidney Research UK.

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Pioneer Institute study finds IRA discourages non-opioid drug innovation

Pharmaceutical Technology

The IRA adds another hurdle to an already challenging research landscape, according to a study from the Pioneer Institute.

Drugs 130
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ETH develops AI algorithm for drug discovery based on 3D protein surface

pharmaphorum

Chemists at ETH Zurich have developed a new computer process that enables the generation of active pharmaceutical ingredients at speed, based on a protein’s three-dimensional surface.

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Scientists reveal new method that could reduce waste from drug manufacturing

Pharma Times

The new method could help to prevent severe side effects caused by enantiomer drugs

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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New patent for Exeltis Usa drug DROSPIRENONE

Drug Patent Watch

Annual Drug Patent Expirations for DROSPIRENONE Drospirenone is a drug marketed by Exeltis Usa Inc, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Mylan Labs Ltd, Watson Labs, Apotex,… Source

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Bernie Sanders Launches Investigation into the “Outrageously High” Prices of Ozempic and Wegovy, Making Them “Luxury Goods”

XTalks

After grilling the CEOs of Merck, J&J and Bristol Myers Squibb (BMS) about high drug prices earlier this year, Bernie Sanders is now going after Novo Nordisk and the high prices of its blockbuster GLP-1 drugs Ozempic and Wegovy. Sanders announced this week that he was launching an investigation into the “outrageously high” prices of the semaglutide products.

Drugs 52
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This week in drug discovery (22-26 April) 

Drug Discovery World

News round-up for 22-26 April by DDW Digital Content Editor Diana Spencer. The leading news story this week has been the launch of a new clinical trial in the UK for a melanoma personalised mRNA cancer vaccine, but there have been a number of other interesting developments in cancer drug discovery. These include the detection of new targets for skin cancer treatment, the benefits of vitamin D for cancer prevention, an extended approval in the EU for a CAR-T myeloma therapy and the discovery of a

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AbbVie's Rinvoq conquers Regeneron and Sanofi's Dupixent in eczema trial—again

Fierce Pharma

For the second time in four years, AbbVie’s Rinvoq (upadacitinib) has shown superior efficacy to Regeneron and Sanofi’s powerhouse Dupixent (dupilumab) in a head-to-head study in patients with atop | For the second time in four years, AbbVie’s Rinvoq (upadacitinib) has shown better skin clearance than Regeneron and Sanofi’s powerhouse Dupixent (dupilumab) in a head-to-head study in patients with atopic dermatitis (AD).

Trials 52
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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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Reuters Pharma USA 2024 – Meruno Perugini

pharmaphorum

Merino Perugini from Nestlé Health Science sat down for an exclusive interview with Jonah Comstock from Reuters Pharma USA to discuss the company's latest innovations and successes in the healthcare industry. Get insights into their strategies and future plans.

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CN Bio raises $21 million in Series B investment round

Drug Discovery World

Organ-on-a-chip (OOC) company CN Bio has raised a $21 million investment in the first close of its Series B fundraising round. The funding has been secured from several new investors; including $10 million from Bayland Capital, and $5.5 million from founding shareholder, CN Innovations Holdings Ltd. The investment will be used to accelerate the company’s expanding product portfolio and to scale the business to support commercial expansion across key global markets.

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Deep Dive: Market Access 2024

pharmaphorum

Gain insights into market access strategies for 2024 with a deep dive featuring perspectives from industry leaders such as Alexion, Putnam, Inizio Advisory, and insights from Reuters Pharma US.

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“Game-changing” personalised cancer vaccine enters UK clinical trials   

Drug Discovery World

A clinical trial of a personalised mRNA cancer vaccine for melanoma patients has been launched in the UK. As reported by The Guardian , the global Phase III clinical trial is being led by University College London Hospitals NHS Foundation Trust (UCLH) and will include around 1,100 people, with the UK arm taking place across eight centres in the UK.

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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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Breaking Down Barriers: Helping Patients Get Therapies Quickly

Drug Channels

Today’s guest post comes from Kevin Kettler, President of CoverMyMeds. Kevin asks: What if there were no barriers across the therapy access and reimbursement process? In his view, eliminating barriers requires a combination of expert insight, actionable data, and simplification of the providers' experiences. Click here to learn more about CoverMyMeds’ comprehensive technology solutions.

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Unlocking Synergies: LGM Pharma's strategic approach to sourcing and growth in India

Outsourcing Pharma

In an extensive and enlightening chat with Prasad Rajeev, the CEO of LGM Pharma, OSP gained profound insights into the company's trajectory within the pharmaceutical industry.

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Vitamin D boosts ‘good’ bacteria and improves immunity to cancer

Drug Discovery World

Researchers have found that vitamin D encourages the growth of a type of gut bacteria in mice which improves immunity to cancer. The researchers from the Francis Crick Institute, the National Cancer Institute (NCI) of the US National Institutes of Health (NIH) and Aalborg University in Denmark, found that mice given a diet rich in vitamin D had better immune resistance to experimentally transplanted cancers and improved responses to immunotherapy treatment.

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Jetted resin revolution: Purolite's biopharma breakthroughs

BioPharma Reporter

In a recent interview, Hayley Crowe, head of Ecolab's global life sciences business, shed light on Purolite's latest developments and its significant contributions to the biopharmaceutical industry.

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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.