Simtra BioPharma to invest more than $250m in US facility
Pharmaceutical Technology
MARCH 1, 2024
Simtra BioPharma has announced plans invest $250m for an expansion of its sterile fill/finish manufacturing site in Bloomington, Indiana, US.
Fri.Mar 01, 2024
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CDC panel mulls changes to RSV vaccine recommendation
Bio Pharma Dive
MARCH 1, 2024
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
MARCH 1, 2024
Experts say that dry granulation is 10x more efficient than wet granulation, which could make substantial progress towards making this pharmaceutical process greener.
Gritstone to lay off 40% of workforce after costly study delay
Bio Pharma Dive
MARCH 1, 2024
The restructuring comes ahead of a key study readout for Gritstone, which, like Moderna, is developing a type of personalized vaccine for cancer.
Biotech funding optimism rises as 44% predict recovery in 2024
Pharmaceutical Technology
MARCH 1, 2024
During 2023, funding decreased by 43.2% compared to 2022 and by 52.3% compared to 2021, attributed to macroeconomic pressures.
Pfizer, looking for a jumpstart, leans into cancer drug research
Bio Pharma Dive
MARCH 1, 2024
Reeling from a difficult year financially, the pharma unveiled a new oncology division it says will produce eight billion-dollar medicines by 2030.
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FogPharma pulls in $145M to support cancer drug research
Bio Pharma Dive
MARCH 1, 2024
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.
1910 Genetics and Microsoft partner to enhance pharmaceutical R&D
Pharmaceutical Technology
MARCH 1, 2024
1910 Genetics has entered an agreement with Microsoft, aiming to revitalise pharmaceutical research and development (R&D) productivity.
Planning strategies for transitioning to the Clinical Trials Regulation
pharmaphorum
MARCH 1, 2024
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.
FDA lifts two-year clinical hold on CytoDyn’s HIV trial
Pharmaceutical Technology
MARCH 1, 2024
US FDA placed a partial clinical hold on HIV programme and a full hold on Covid-19 trials for CytoDyn’s monoclonal antibody, leronlimab.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pfizer’s new cancer unit sees eight new blockbusters by 2030
pharmaphorum
MARCH 1, 2024
Pfizer says new oncology division will generate eight new blockbusters by 2030, in first R&D update after its $43bn takeover of Seagen.
Cullinan advances multiple myeloma drug CLN-619 to a Phase I study
Pharmaceutical Technology
MARCH 1, 2024
In addition to r/r multiple myeloma, the biotech is evaluating the drug as a treatment for advanced solid tumours alongside Keytruda.
This week in clinical trials: 5th Feb to 9th Feb 2024
pharmaphorum
MARCH 1, 2024
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.
UK MHRA approves new formulation of Amgen’s XGEVA
Pharmaceutical Technology
MARCH 1, 2024
The UK MHRA has granted marketing authorisation for a new formulation of Amgen’s XGEVA to prevent serious bone-related complications.
With Sanofi left as the lone supplier of tetanus shots in the US, CDC warns of shortage
Fierce Pharma
MARCH 1, 2024
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.
BlossomHill secures $100m for cancer discovery programmes
Pharmaceutical Technology
MARCH 1, 2024
BlossomHill has secured $100m in a Series B financing round to advance its programmes targeting cancer and autoimmune diseases.
Moderna lays off parts of manufacturing team after resizing COVID footprint
Fierce Pharma
MARCH 1, 2024
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.
Market cap upturn for top 20 biopharma companies with obesity drug successes in 2023
Pharmaceutical Technology
MARCH 1, 2024
The top 20 biopharmaceutical companies saw prominent shifts in market capitalisation over 2023 despite various obstacles.
The New Age of Decentralized Clinical Trials
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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.
New film aims to raise awareness of rare disease cALD
pharmaphorum
MARCH 1, 2024
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.
Celebrating Black History Month 2024
Intouch Solutions
MARCH 1, 2024
To honor Black History Month, we’re proud to share some of the inspiring and impactful events that were hosted throughout the month. This year’s theme was “Mapping the Black Experience,” where we took a deeper look into exploring Black Culture and its history through art, food and travel. Our Black Professional Network co-chairs, Eric Terry, Director, Quality Control and Martika Chappell, People Specialist, focused this year’s theme on what it means to move through the world while Black, aiming
MHRA okays first drug under new mutual recognition scheme
pharmaphorum
MARCH 1, 2024
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.
Cresset and Enamine partner to develop virtual screening technology for drug discovery
Outsourcing Pharma
MARCH 1, 2024
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.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Researchers reveal COVID-19 could have small impacts on cognition and memory
Pharma Times
MARCH 1, 2024
Different factors, such as illness duration and virus variant, impacted patients cognitive abilities
Metabolon introduces ‘groundbreaking’ bioinformatics platform
Outsourcing Pharma
MARCH 1, 2024
Metabolon, Inc., a prominent figure in metabolomics solutions, has launched a seminal integrated bioinformatics platform, aiming to redefine metabolomics analysis in life sciences research.
4SC files maintenance CTCL therapy Kinselby in EU
pharmaphorum
MARCH 1, 2024
German biotech 4SC has filed its oral HDAC inhibitor Kinselby as a maintenance therapy for rare cancer CTCL in the EU
Enhancing clinical trial engagement: an exploration with James Riddle of Advarra
Outsourcing Pharma
MARCH 1, 2024
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.
How Machine Learning Drives Clinical Trial Efficiency
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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.
ICL uses AI to help doctors assess lung cancer from ‘virtual biopsies’
Pharma Times
MARCH 1, 2024
TMR-CT will help doctors select treatment and predict the spread of lung cancer in patients
Genome Edited Foods: Understanding the New FDA Guidance
XTalks
MARCH 1, 2024
In a pivotal move for the food industry, the US Food and Drug Administration (FDA) has unveiled industry guidance for genome edited foods derived from plants. This landmark guidance aims to demystify the FDA’s risk-based approach towards both genome edited foods and all new plant varieties. At the same time, the EU is also advancing in this domain, poised to ease its genetically modified organisms (GMO) legislation , marking a significant shift in global food regulation perspectives.
After PhRMA loss, AstraZeneca's challenge to IRA price negotiations is rejected
Fierce Pharma
MARCH 1, 2024
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.
Enhancing clinical trial engagement: a deepdive with insights from James Riddle of Medidata
Outsourcing Pharma
MARCH 1, 2024
In the dynamic realm of clinical trials, where innovation and patient care intersect, Medidata believes it stands as a beacon of progress, continually revolutionizing how medical research is conducted.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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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