Fri.Mar 01, 2024

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Simtra BioPharma to invest more than $250m in US facility

Pharmaceutical Technology

Simtra BioPharma has announced plans invest $250m for an expansion of its sterile fill/finish manufacturing site in Bloomington, Indiana, US.

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CDC panel mulls changes to RSV vaccine recommendation

Bio Pharma Dive

The expert committee is discussing whether, for certain older adults, to make a universal recommendation for vaccination, rather than the current policy of “shared decisionmaking.

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Green granulation: Tracking energy efficiency in pharmaceutical granulation

Pharmaceutical Technology

Experts say that dry granulation is 10x more efficient than wet granulation, which could make substantial progress towards making this pharmaceutical process greener.

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Gritstone to lay off 40% of workforce after costly study delay

Bio Pharma Dive

The restructuring comes ahead of a key study readout for Gritstone, which, like Moderna, is developing a type of personalized vaccine for cancer.

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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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Biotech funding optimism rises as 44% predict recovery in 2024

Pharmaceutical Technology

During 2023, funding decreased by 43.2% compared to 2022 and by 52.3% compared to 2021, attributed to macroeconomic pressures.

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Pfizer, looking for a jumpstart, leans into cancer drug research

Bio Pharma Dive

Reeling from a difficult year financially, the pharma unveiled a new oncology division it says will produce eight billion-dollar medicines by 2030.

Research 299

More Trending

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FogPharma pulls in $145M to support cancer drug research

Bio Pharma Dive

The cash will be used to advance development of FOG-001, the company’s lead drug that’s now being tested in an early-stage trial for solid tumors.

Drugs 169
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Panama updates their medicine regulatory system

Pharmaceutical Technology

Panama’s government expects to be a pioneer in the area through the centralisation of drug procurement with an emphasis on pharmacovigilance.

Medicine 147
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Moderna lays off parts of manufacturing team after resizing COVID footprint

Fierce Pharma

Moderna is laying off employees within its manufacturing unit, with the move tied to a resizing of its COVID production work. | Moderna is laying off some employees within its manufacturing unit after shaving COVID production costs. The company previously disclosed plans to rightsize its COVID vaccine production footprint.

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1910 Genetics and Microsoft partner to enhance pharmaceutical R&D

Pharmaceutical Technology

1910 Genetics has entered an agreement with Microsoft, aiming to revitalise pharmaceutical research and development (R&D) productivity.

Genetics 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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With Sanofi left as the lone supplier of tetanus shots in the US, CDC warns of shortage

Fierce Pharma

It’s time to add another vaccine to the shortage list in the U.S. | It’s time to add another vaccine to the shortage list in the United States as the CDC has urged healthcare providers to conserve their supply of tetanus shots. The warning from the national public health agency comes after one of the two providers of tetanus shots in the U.S., MassBiologics, discontinued production of its tetanus and diphtheria vaccine.

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FDA lifts two-year clinical hold on CytoDyn’s HIV trial

Pharmaceutical Technology

US FDA placed a partial clinical hold on HIV programme and a full hold on Covid-19 trials for CytoDyn’s monoclonal antibody, leronlimab.

Trials 130
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Planning strategies for transitioning to the Clinical Trials Regulation

pharmaphorum

There is a pressing need for companies to transition their EU clinical trials that are ongoing under the “old” regulatory framework of the Clinical Trials Directive to the Clinical Trials Regulation. The risk for those that don’t meet the 30th January 2025 deadline for transition is that they will lose their legal basis.

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Cullinan advances multiple myeloma drug CLN-619 to a Phase I study

Pharmaceutical Technology

In addition to r/r multiple myeloma, the biotech is evaluating the drug as a treatment for advanced solid tumours alongside Keytruda.

Drugs 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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Pfizer’s new cancer unit sees eight new blockbusters by 2030

pharmaphorum

Pfizer says new oncology division will generate eight new blockbusters by 2030, in first R&D update after its $43bn takeover of Seagen.

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UK MHRA approves new formulation of Amgen’s XGEVA

Pharmaceutical Technology

The UK MHRA has granted marketing authorisation for a new formulation of Amgen’s XGEVA to prevent serious bone-related complications.

Marketing 130
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After PhRMA loss, AstraZeneca's challenge to IRA price negotiations is rejected

Fierce Pharma

Less than three weeks after a Texas judge tossed a lawsuit b | Less than three weeks after a Texas judge tossed a lawsuit by industry lobbying group PhRMA that challenged the constitutionality of the Inflation Reduction Act, a federal court in Delaware has done the same with a similar action brought by AstraZeneca.

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BlossomHill secures $100m for cancer discovery programmes 

Pharmaceutical Technology

BlossomHill has secured $100m in a Series B financing round to advance its programmes targeting cancer and autoimmune diseases.

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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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This week in clinical trials: 5th Feb to 9th Feb 2024

pharmaphorum

Stay up to date with the latest news in the life sciences industry with highlights from clinical trials involving CSL, Arcturus, Sanofi, Nexviazyme, and REGENXBIO from the week of 5th to 9th February 2024.

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Market cap upturn for top 20 biopharma companies with obesity drug successes in 2023

Pharmaceutical Technology

The top 20 biopharmaceutical companies saw prominent shifts in market capitalisation over 2023 despite various obstacles.

Marketing 130
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New film aims to raise awareness of rare disease cALD

pharmaphorum

Rare Disease Day saw the debut of a film that aims to raise awareness of cerebral adrenoleukodystrophy (cALD), a devastating and fatal condition with no pharmacological treatments available.

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Researchers reveal COVID-19 could have small impacts on cognition and memory

Pharma Times

Different factors, such as illness duration and virus variant, impacted patients cognitive abilities

Research 128
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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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MHRA okays first drug under new mutual recognition scheme

pharmaphorum

A new formulation of Amgen’s cancer treatment Xgeva is the first to be approved in the UK under a new procedure designed to speed up access to new therapies.

Drugs 110
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CAR-T boxed warnings: What comes next?

Fierce Pharma

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. | The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This week on "The Top Line," Fierce Pharma’s Angus Liu talks with regulatory experts to understand the rationale behind the FDA’s decision and to discuss its implications for CAR-T c

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Cresset and Enamine partner to develop virtual screening technology for drug discovery

Outsourcing Pharma

Cresset, a leading provider of integrated in silico solutions for drug discovery, announced last month (February 21) a global collaboration with Enamine, one of the front providers of chemical building blocks and drug discovery services.

Drugs 97
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Ahead of strategy reveal, Bayer taps activist investor Jeffrey Ubben for board seat

Fierce Pharma

In the latest shake-up amid waves of changes at Bayer, the company is planning to add new expertise to its board room, including a prominent activist investor. | The company's supervisory board proposed the appointments of activist investor Jeffrey Ubben, legal expert Lori Schecter and biotech leader Nancy Simonian, M.D. Bayer also swapped in a new head of its consumer health division.

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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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Metabolon introduces ‘groundbreaking’ bioinformatics platform

Outsourcing Pharma

Metabolon, Inc., a prominent figure in metabolomics solutions, has launched a seminal integrated bioinformatics platform, aiming to redefine metabolomics analysis in life sciences research.

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ICL uses AI to help doctors assess lung cancer from ‘virtual biopsies’

Pharma Times

TMR-CT will help doctors select treatment and predict the spread of lung cancer in patients

Doctors 121
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As Imbruvica stumbles, BeiGene's Brukinsa steps up with FDA nod in follicular lymphoma

Fierce Pharma

With a new FDA nod, BeiGene has filled the follicular lymphoma approval gap for BTK inhibitors. | BeiGene has filled the follicular lymphoma gap for BTK inhibitors with an FDA approval for Brukinsa about a year after AbbVie and Johnson & Johnson's Imbruvica stumbled in a phase 3 trial. But tough competition with CAR-T therapies and bispecifics lies ahead.

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Enhancing clinical trial engagement: an exploration with James Riddle of Advarra

Outsourcing Pharma

In the dynamic realm of clinical trials, where innovation and patient care intersect, Advarra believes it stands as a beacon of progress, continually revolutionizing how medical research is conducted.

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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.