Thu.Jul 25, 2024

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Sanofi’s immunology bet starts to pay off

Bio Pharma Dive

Some analysts described Sanofi’s pipeline of immune system therapies, which includes more than half a dozen drugs in mid- to late-stage testing, as “underappreciated” by investors, as sales of Dupixent rose over the last quarter.

Sales 295
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AC Immune wins FDA fast track for Alzheimer’s vaccine candidate

Pharmaceutical Technology

JNJ-2056 is being investigated in the Phase IIb ReTain study which enrols participants who are yet to show Alzheimer’s symptoms.

Vaccine 246
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Does a Shot of Olive Oil Really Prevent Hangovers? Here’s The Science.

AuroBlog - Aurous Healthcare Clinical Trials blog

The search for alcohol hangover cures is as old as alcohol itself. Many cures and remedies are sold, but scientific evidence for their effectiveness is lacking. Recently, the notion that taking a shot of olive oil before consuming alcohol can prevent hangovers has garnered attention.

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Roche says it’ll move quickly with ‘differentiated’ obesity drugs

Bio Pharma Dive

CEO Thomas Schinecker claimed the company has “many opportunities” to stand out in the competitive field, and can get to market “much faster” than investors expect.

Drugs 189
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Industry calls for increased funding to support early diagnosis of autism, neurodevelopmental delays

AuroBlog - Aurous Healthcare Clinical Trials blog

Ahead of the upcoming Union Budget, prominent voices in the healthcare sector are urging the government to allocate substantial funds to support early diagnosis and intervention for children with autism and neurodevelopmental delays, alongside enhanced training for medical personnel on early disease detection.

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Viking shares jump on plans to speed obesity drug into late-stage testing

Bio Pharma Dive

The drug’s advancement continued what one analyst described as a “torrid” pace for Viking’s closely watched medicine, which started human testing in 2022 and could reach a Phase 3 trial next year.

Drugs 189

More Trending

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KCL study finds cell ageing could reveal early signs of neurodegenerative disease

Pharma Times

Conditions such as Alzheimer’s and Parkinson’s affect over one million people in the UK

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FDA agrees wider use of BioMarin’s BRINEURA for CLN2

Pharmaceutical Technology

The US FDA has expanded approval to BioMarin Pharmaceutical's BRINEURA to include children aged below three years with neuronal CLN2.

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Enhertu stalls as AstraZeneca, Daiichi navigate 'harder yards' for ADC star

Fierce Pharma

Among AstraZeneca’s growth drivers with $5 billion or more in peak sales potential, the company is counting on Daiichi Sankyo-partnered Enhertu to chart new territory. | Among AstraZeneca's growth drivers with $5 billion or more in peak sales potential, the company is counting on Daiichi Sankyo-partnered Enhertu to chart new territory. And stalling sales underscore the challenges facing the HER2 drug.

Sales 120
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MHRA approves Pfizer-BioNTech’s Comirnaty JN.1 vaccine

Pharmaceutical Technology

The UK MHRA has authorised Pfizer-BioNTech’s adapted Comirnaty vaccine against the JN.1 Covid-19 subvariant for adults and children.

Vaccine 147
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Pfizer quickly expands its hemophilia B gene therapy's reach with EU approval

Fierce Pharma

Three months after bagging FDA approval, Pfizer’s hemophilia B gene therapy has been cleared to expand its reach across the pond. | The company's first gene therapy will debut in Europe as Durveqtix. In the U.S., the drug is approved under the brand name Beqvez.

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Ipsen outlines $461m for ex-US rights to Day One’s glioma therapy

Pharmaceutical Technology

Ipsen will pay $111m in cash and equity upfront to gain the global rights, excluding the US, to Day One’s paediatric glioma therapy, Ojemda.

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AbbVie boosts profit outlook as Humira successors branch into gastroenterology market

Fierce Pharma

With a new chief at the helm and higher profit projections in sight, AbbVie is entering a “new chapter," CEO Robert Michael told analysts Thursday. | Skyrizi's recent ulcerative colitis nod sets it up as a first-line option, while Rinvoq is poised to handle later lines.

Marketing 116
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ConSynance wins FDA designation for Prader-Willi syndrome therapy

Pharmaceutical Technology

A Phase II study for ConSynance’s triple monoamine reuptake inhibitor CSTI-500 is slated to begin in 2025.

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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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FDA advisers, frustrated by AZ's Imfinzi design, call for revamp of perioperative lung cancer trials

Fierce Pharma

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously called for a revamp of perioperative clinical trial designs in resectable non-small cell lung cancer (NSCLC) to include assessmen | In a discussion prompted by AstraZeneca's application for Imfinzi, the FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously called for a revamp of perioperative clinical trial designs in resectable non-small cell lung cancer.

Trials 116
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NICE recommends Boehringer’s tenecteplase for NHS stroke care

Pharmaceutical Technology

The UK NICE has issued final guidance endorsing Boehringer Ingelheim’s tenecteplase for acute ischaemic stroke for NHS use.

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Amid Eylea clash, Roche's Vabysmo keeps climbing despite a slowdown in its momentum

Fierce Pharma

While Roche touted sales and market share increases for eye disease drug Vabysmo on Thursday, there is evidence of a slowdown of its momentum as it battles Regeneron and Bayer’s powerhouse Eylea fr | While Roche touted sales and market share increases for eye disease drug Vabysmo on Thursday, there is evidence of a slowdown of its momentum as it battles Regeneron and Bayer’s powerhouse Eylea.

Sales 116
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Dren Bio and Novartis link on bispecific antibodies for cancer

Pharmaceutical Technology

Dren Bio has entered a strategic partnership with Novartis Pharma to develop therapeutic bispecific antibodies to treat cancer.

Antibody 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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With capacity upgrades ready to roll, Sanofi stands firm on blockbuster sales goal for RSV drug in 2024

Fierce Pharma

While manufacturing and supply hitches have troubled the rollout of Sanofi’s key respiratory syncytial virus (RSV) drug, the near-term expected approval of a pair of new filling lines is giving the | While manufacturing and supply hitches have troubled the rollout of Sanofi’s key respiratory syncytial virus drug, the near-term expected approval of a pair of new filling lines is giving the French pharma assurance that its AstraZeneca-partnered antibody Beyfortus can breach the billion-dollar thre

Sales 111
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Can Pfizer, Sangamo energise haemophilia A gene therapy?

pharmaphorum

There has been a gene therapy on the market for people with the bleeding disorder haemophilia A since 2022, but take-up has been very slow. Pfizer and Sangamo are hoping for a faster trajectory with their experimental treatment.The partners' one-shot giroctocogene fitelparvovec therapy has cleared a phase 3 trial, showing it was better than regular prophylaxis injections with Factor VIII (FVIII) replacement therapies at reducing bleeding episodes, and could now be heading for regulatory review.

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With $111M upfront investment, Ipsen secures ex-US rights to Day One's pediatric cancer med

Fierce Pharma

Just three months after scoring an accelerated FDA approval for Ojemda, Day One Biopharmaceuticals is teaming up with another fellow oncology specialist to grow the medicine's global reach.

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MRC grants researcher £1.2m to further understand complex secretory processes

Pharma Times

The research will help to better understand how this pathway is coordinated in the cell

Research 110
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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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Argenx's Vyvgart holds its own against AstraZeneca rivals in myasthenia gravis clash

Fierce Pharma

Following last week’s R&D day, argenx continues to demonstrate that its flagship drug, FcRn inhibitor Vyvgart, has plenty of room to grow in its inaugural generalized myasthenia gravis (gMG) in | Following last week’s R&D day, argenx continues to demonstrate that its flagship drug, FcRn inhibitor Vyvgart, has plenty of room to grow in its inaugural generalized myasthenia gravis (gMG) indication.

Drugs 111
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Patient engagement throughout the product lifecycle

pharmaphorum

Tune in to the Reverba podcast featuring CEO Cheryl Lubbert as she discusses patient engagement throughout the product lifecycle, sharing insights and strategies for success.

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How to Develop a Competitive Edge in Generic Drug Development

Drug Patent Watch

Developing a competitive edge in generic drug development is crucial for companies to gain a significant market share and dominate the market.

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Ageing Europe - It’s time we prioritised neurological conditions

pharmaphorum

Exploring the impact of ageing on Europe and the need to prioritise neurological conditions. Understand the role of neuroscience in addressing these issues.

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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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Pharma Pulse 7/25/24: CrowdStrike Explains What Went Wrong Days After Global Tech Outage, The Future of Biosimilars & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Ipsen builds again, licensing Day One glioma drug

pharmaphorum

Ipsen has signed yet another portfolio-expanding deal – its fifth of the year so far – claiming rights outside the US to a drug for common brain cancer glioma from Day One Biopharmaceuticals.

Licensing 105
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How to Navigate the Generic Drug Market Post-COVID

Drug Patent Watch

The generic drug market has been significantly impacted by the COVID-19 pandemic, with both challenges and opportunities arising from the crisis.

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European big pharmas raise guidance on stronger sales

pharmaphorum

European pharma groups AstraZeneca, Sanofi, and Roche all raise their financial guidance for the year on stronger sales growth.

Sales 105
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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.