Mon.Jul 01, 2024

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10 clinical trials to watch in the second half of 2024

Bio Pharma Dive

Study results are expected for a pair of closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.

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UK’s antibiotic subscription funding model – a route to market sustainability?

Pharmaceutical Technology

On 8 May, the UK was the world's first government to formally implement a new model for the funding and support of novel antibiotic commercialisation.

Marketing 299
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Eisai and Bristol Myers cancel cancer ADC deal

Bio Pharma Dive

The Japan-based drugmaker said its U.S. partner’s “portfolio prioritization efforts” led to the termination. It will refund part of an upfront payment.

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Risk adjusted net present value: What is the current valuation of Vertex Pharmaceuticals’s Suzetrigine?

Pharmaceutical Technology

Suzetrigine is a small molecule commercialized by Vertex Pharmaceuticals, with a leading Phase III program in Post-Operative Pain.

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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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Eli Lilly inks another radiopharma deal, gaining option to buy startup

Bio Pharma Dive

Under an arrangement with Radionetics, Lilly will have rights to acquire the San Diego biotechnology company for $1 billion.

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Risk adjusted net present value: What is the current valuation of Pfizer’s Idrebormilast?

Pharmaceutical Technology

Idrebormilast is a small molecule commercialized by Pfizer, with a leading Phase II program in Rosacea.

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Risk adjusted net present value: What is the current valuation of Pfizer’s Atirmociclib?

Pharmaceutical Technology

Atirmociclib is a small molecule commercialized by Pfizer, with a leading Phase III program in Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer).

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UniQure, with sale of plant, outsources Hemgenix manufacturing

Bio Pharma Dive

The gene therapy developer, which cut jobs in October, expects the sale of a Lexington, Massachusetts, facility to Genezen to lower its cash burn.

Sales 189
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Risk adjusted net present value: What is the current valuation of Pfizer’s Osivelotor?

Pharmaceutical Technology

Osivelotor is a small molecule commercialized by Pfizer, with a leading Phase III program in Sickle Cell Disease.

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July 1, 2024: Latest Podcast Features Michael Pencina and Brian Anderson of Coalition for Health AI

Rethinking Clinical Trials

In a new episode of our Rethinking Clinical Trials podcast, Drs. Michael Pencina and Brian Anderson of the Coalition for Health AI speak with host Dr. Adrian Hernandez about public-private partnerships in a trustworthy health AI ecosystem. Pencina and Anderson presented on their experiences during the March 8 session of PCT Grand Rounds. Listen and subscribe to the podcast on SoundCloud or Apple Podcasts , and view the full March 8 PCT Grand Rounds webinar.

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

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Risk adjusted net present value: What is the current valuation of Atai Life Sciences’s RL-007?

Pharmaceutical Technology

RL-007 is a small molecule commercialized by Atai Life Sciences, with a leading Phase II program in Diabetic Neuropathic Pain.

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The right viral safety program can guard against costly bioburden incidents in biopharma development

Bio Pharma Dive

Viral contamination threatens biopharmaceutical development, making viral clearance and safety essential for risk mitigation.

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TauRx seeks UK MHRA approval for Alzheimer’s treatment

Pharmaceutical Technology

TauRx Pharmaceuticals has filed an application with the UK MHRA seeking approval for hydromethylthionine mesylate (HMTM) to treat Alzheimer’s.

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Are you meeting safety standards for residual host cell DNA?

Bio Pharma Dive

Ensure the safety of gene therapies with accurate HEK293 DNA measurement using Vericheck ddPCR kits.

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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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Valneva’s chikungunya vaccine gains EC’s market authorisation

Pharmaceutical Technology

Valneva has secured marketing authorisation from the European Commission (EC) for IXCHIQ, a single-dose vaccine for preventing chikungunya.

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ICL granted £150,000 to explore link between breast cancer and breastfeeding

Pharma Times

Breast cancer is the most common cancer in the UK, accounting for 15% of all cancers

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Dianthus reveals preclinical data for its Phase II neuromuscular candidate 

Pharmaceutical Technology

The preclinical data was presented at the European Academy of Neurology (EAN) 2024 Congress in Helsinki, Finland.

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University of Liverpool launches new biotech spin-out company Galytx

Pharma Times

The biotech company will develop novel therapeutic drugs for the treatment of fatal diseases

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Orion to hand over exclusive rights to MSD for prostate cancer therapy

Pharmaceutical Technology

Opevesostat will now be globally developed and commercialised exclusively by MSD, with Orion set to receive milestone payments.

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Why informed patient consent is vital for successful clinical trials

pharmaphorum

Informed patient consent is crucial for the success of clinical trials. Learn about the importance of consent in clinical trials and how it impacts the outcomes.

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FDA shuns Rocket’s immune disorder gene therapy over manufacturing shortcomings

Pharmaceutical Technology

This is the second hit this year to Rocket’s approval plans for the genel therapy Kresladi.

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ASCO 2024: Emphasising the art and science behind enhanced cancer care

pharmaphorum

ASCO 2024 conference highlights the latest advancements in oncology, emphasising the art and science behind enhanced cancer care. Stay updated on the latest research, treatments, and innovations in the field of oncology.

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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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FDA approves Shorla Oncology’s TEPYLUTE for cancer treatment

Pharmaceutical Technology

The US FDA has approved speciality pharmaceutical company Shorla Oncology’s NDA for TEPYLUTE to treat breast and ovarian cancer.

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France agrees to fund experimental glioblastoma therapy

pharmaphorum

France's HAS agrees to fund treatment with Carthera's ultrasound device for French subjects enrolled in a glioblastoma trial.

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EMA CHMP recommends approval for Roche’s PNH therapy

Pharmaceutical Technology

The EMA CHMP has recommended granting approval for Roche's PiaSky to treat paroxysmal nocturnal haemoglobinuria (PNH).

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AstraZeneca files rival to Pemgarda for COVID PrEP

pharmaphorum

AstraZeneca may have exited the COVID-19 vaccine market, but it is still hoping to protect vulnerable patients with its antibody sipavibart for pre-exposure prophylaxis (PrEP).The drugmaker said this morning that an application for sipavibart (AZD3152) has been accepted for review by the EMA as PrEP for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.

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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 sector votes for post-Brexit clarity under new government

Pharmaceutical Technology

As the 4 July election approaches, the UK pharmaceutical sector wants the new government to prioritise the UK’s commercial clinical landscape.

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Is the UK’s healthcare spending drop sustainable?

pharmaphorum

Explore the reasons behind the drop in the UK's healthcare spending and analyse whether this trend is sustainable for the NHS in the long term. Learn about the potential impacts and future implications.

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J&J looks to challenge argenx’s Vyvgart with positive Phase III data

Pharmaceutical Technology

The Phase III data for J&J’s nipocalimab shows the antibody's efficacy in improving symptoms of myasthenia gravis.

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Veeva R&D and Quality 2024: Chris Moore

pharmaphorum

An interview with Chris Moore about Veeva R&D and Quality, looking ahead to 2024. Explore insights and predictions for the industry from this expert perspective.

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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.