Mon.Jul 01, 2024

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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 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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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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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 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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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.

More Trending

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With new IPO pitch, Artiva touts ‘natural killer’ cell therapy for autoimmune disease

Bio Pharma Dive

Like many of its cell therapy peers, Artiva, which originally sought an IPO in 2021, has shifted its strategy in hopes of riding a recent wave of investor interest in autoimmune disease research.

Research 177
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Risk adjusted net present value: What is the current valuation of AstraZeneca’s Rilvegostomig?

Pharmaceutical Technology

Rilvegostomig is a monoclonal antibody commercialized by AstraZeneca, with a leading Phase III program in Non-Small Cell Lung Cancer.

Antibody 189
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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 171
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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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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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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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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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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.

DNA 139
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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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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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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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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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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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How can pharmaceutical marketing evolve with generic entry? The example of Lipitor

Drug Patent Watch

Lipitor’s marketing strategy underwent a significant evolution as generic competition emerged, employing aggressive tactics to retain market share and brand […] Source

Marketing 105
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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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Regulatory tracker: Sandoz, Samsung Bioepis gain FDA approval for biosimilar to J&J's Stelara

Fierce Pharma

Welcome to Fierce Pharma's regulatory tracker for the second half of 2024. | In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.

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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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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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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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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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GSK takes another Zantac personal injury case off its plate with settlement in Illinois

Fierce Pharma

GSK scratched another Zantac lawsuit off the list with a confidential settlement in Illinois as it continues to work through the mountain of personal injury litigation related to the heartburn pill | Following a win and a separate dismissal in Illinois, GSK agreed to a confidential settlement to resolve prostate cancer claims put forward by plaintiff Martin Gross.

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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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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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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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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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After Gilead and J&J lawsuits, distributor Safe Chain sees its owners charged with wire fraud, conspiracy

Fierce Pharma

In yet another legal development surrounding counterfeit HIV drugs, a Florida court has handed down an indictment for the owners of a wholesale distributor that allegedly bought and redistribu | The wholesaler Safe Chain allegedly purchased $90 million of misbranded, diverted and adulterated HIV meds, according to U.S. authorities. The indictment of the company's three owners follows separate lawsuits from Gilead and Johnson & Johnson.

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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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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.