Documentary highlights new targets to potentially treat motor neurone disease
Pharma Times
NOVEMBER 14, 2023
The terminal condition currently affects around 5,000 people in the UK - News - PharmaTimes
Tue.Nov 14, 2023
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Forbion-backed biotech raises $138M to develop ALS drug
Bio Pharma Dive
NOVEMBER 14, 2023
The Series A round for three-year-old startup VectorY is one of the largest private financings in Europe this year, Forbion said.
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Four-Week Experiment Reveals an Ingeniously Simple Way to Boost Your Sleep Quality
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 14, 2023
So much of our health is tied to banking good quality sleep every night, and a new four-week experiment has revealed a simple way anyone can improve the quality of their slumber: keeping the bedroom well-ventilated.
New AMA policies target GLP-1 coverage, corporate medicine
Bio Pharma Dive
NOVEMBER 14, 2023
The lobbying group urged broader health insurance coverage for treating obesity, including with GLP-1 agonists like Wegovy.
FDA oversees rise in awarded orphan drug designations for myelofibrosis
Pharmaceutical Technology
NOVEMBER 14, 2023
Concerns have been raised over the suitability of current FDA-approved treatments for myelofibrosis, due to the negative associations with anaemia.
Indian healthcare looks at pharmacogenomics in patient care as comprehensive genetic tests gain ground
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 14, 2023
Indian healthcare looks at pharmacogenomics, the study of influence of genetic factors on drug response, in patient care as comprehensive genetic tests gain ground. Global healthcare sector has witnessed a paradigm shift with the emergence of pharmacogenomics (PGx) as a game changing trend.
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Pfizer's cost-cutting campaign hits Sandwich site in UK, where 500 workers will lose jobs
Fierce Pharma
NOVEMBER 14, 2023
Earlier this month, Pfizer’s $3.5 billion cost-cutting campaign crossed overseas to Ireland. Now, just a week later, Pfizer is announcing hundreds more job cuts in the U.K. | Pfizer plans to cut approximately 500 roles and ax its Pharmaceutical Sciences Small Molecule capabilities at its site in Sandwich in Kent in the U.K. The move is a consequence of Pfizer’s enterprisewide cost realignment program, which the drugmaker unveiled in mid-October.
Novartis signs agreement for Legend Biotech’s CAR-T therapies
Pharmaceutical Technology
NOVEMBER 14, 2023
Novartis Pharma has signed an exclusive worldwide licence agreement for Legend Biotech Ireland’s DLL3-targeting CAR-T cell therapies.
A researcher's perspective: Linking scientific discovery to clinical medicine
Antidote
NOVEMBER 14, 2023
For Carla Greenbaum, M.D., growing up in the era of space travel and the moon landing kindled a lifelong interest in science. That interest influenced her career trajectory, and she’s now a leading investigator at Benaroya Research Institute where she has studied the natural history of type 1 diabetes (T1D) since 2000. Her work focuses on finding the cause of autoimmunity and developing targets for treatment, which she finds “incredibly exciting and inspiring—like landing on the moon!
VectorY secures $138m to develop neurodegenerative disease therapies
Pharmaceutical Technology
NOVEMBER 14, 2023
VectorY Therapeutics secured $138m in a Series A funding round to progress its vectorised antibody programmes in neurodegenerative diseases.
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
Alkermes Spins Off Oncology Business with $275M to Focus on Neuroscience
BioSpace
NOVEMBER 14, 2023
The new company, Mural Oncology, will continue registrational studies of its IL-2 cytokine in melanoma and ovarian cancer utilizing a $275 million cash runway expected to take them to the end of 2025.
Teva and Royalty Pharma to expedite olanzapine LAI research programme
Pharmaceutical Technology
NOVEMBER 14, 2023
Teva Pharmaceuticals and Royalty Pharma have partnered on a clinical research programme for olanzapine LAI (TEV-‘749), for schizophrenia.
Best Food Inventions of 2023, According to TIME Magazine
XTalks
NOVEMBER 14, 2023
Last month, TIME Magazine unveiled its “ Best Inventions of 2023 ” list, which included 13 food inventions (up from nine last year). The magazine spotlighted 200 groundbreaking inventions that promise to transform our daily interactions, work methodologies and overall future outlook. To select the winners, TIME gathered nominations from its global network of editors and correspondents, complemented by an online application process for submissions.
Health Canada approves Ipsen-Medison’s Bylvay for PFIC-linked pruritus
Pharmaceutical Technology
NOVEMBER 14, 2023
Health Canada has approved Ipsen-Medison Pharma’s Bylvay to treat pruritus associated with progressive familial intrahepatic cholestasis.
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
Wegovy Obesity Drug Could Offer Heart Benefits According to Latest Trial Data
XTalks
NOVEMBER 14, 2023
Novo Nordisk shared new clinical trial data that shows its obesity drug Wegovy (semaglutide) can also reduce the risk of various heart complications, including heart attack, in certain individuals. Novo presented the results of the study at the American Heart Association (AHA) Scientific Sessions this past weekend in Philadelphia, which were also published in the New England Journal of Medicine.
Reform in South Korea means progression in improving time to reimbursement
Pharmaceutical Technology
NOVEMBER 14, 2023
South Korea has been busy with reforms that aim to expedite the introduction of new innovative drugs into its national insurance system.
BBSRC to invest £12m into 62 UK bioscience research projects
Pharma Times
NOVEMBER 14, 2023
The projects will explore early-stage ideas at the frontiers of bioscience - News - PharmaTimes
AstraZeneca announces GLP-1 combo to treat obesity and co-morbidities
Pharmaceutical Technology
NOVEMBER 14, 2023
AstraZeneca has announced its strategy for the cardiometabolic market, in particular for treating obesity and its co-morbidities
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.
Gilead’s Kite Expands Arcellx Pact with $285M Equity Investment, Upfront Cash
BioSpace
NOVEMBER 14, 2023
Months after the FDA lifted its partial hold on their Phase II multiple myeloma program, Kite and Arcellx are expanding their existing development and commercialization collaboration in the blood cancer space.
MBrace secures $85m to develop ADCs for oncology targets
Pharmaceutical Technology
NOVEMBER 14, 2023
MBrace Therapeutics has secured $85m in a Series B funding round to advance clinical development of ADCs for oncology targets.
J&J and Bayer's Xarelto proves its worth across PAD subgroups in 2 new analyses
Fierce Pharma
NOVEMBER 14, 2023
Johnson & Johnson and Bayer’s wide-spanning VOYAGER PAD study continues to be a gold mine for proving its Xarelto’s worth in several subsets of patients with peripheral artery disease (PAD).
Nouscom raises $72m in Series C financing round to develop cancer vaccines
Pharmaceutical Technology
NOVEMBER 14, 2023
The company intends to use the funds to advance its cancer vaccine clinical pipeline, including a colorectal cancer vaccine.
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.
Breath test can reveal signs of liver cirrhosis and portal hypertension
Outsourcing Pharma
NOVEMBER 14, 2023
Owlstone Medical's exegenous volatile organic compound (EVOC) breath test can reveal signs of liver cirrhosis and portal hypertension, a study has found.
Sustainability in biopharma: The challenges of ESG 2.0
Pharmaceutical Technology
NOVEMBER 14, 2023
With demand for drug products high, biopharma will need bold strategies to address sustainability challenges of the future.
Pfizer to Cut 500 Jobs at UK Site as Part of $3.5B Cost-Savings Campaign
BioSpace
NOVEMBER 14, 2023
On the heels of cutting 100 jobs in Ireland, Pfizer is laying off around 500 workers from its Sandwich, Kent facility in the U.K. under its cost-reduction plan to save $3.5 billion through 2024.
Telix plans $125m acquisition of radiopharmaceuticals company QSAM
Pharmaceutical Technology
NOVEMBER 14, 2023
Telix with pay $2m upfront, with $33m on closing and up to $90m in milestone-based payments.
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.
ZZ Biotech Hit with Data Manipulation Allegations Regarding Stroke Trial
BioSpace
NOVEMBER 14, 2023
Whistleblowers allege that ZZ Biotech co-founder Berislav Zlokovic pressured his scientists to adjust data in favor of the investigational stroke therapy 3K3A-APC, according to a dossier obtained by Science.
Orphelia pushes boundaries with regulatory barriers for pediatric indications
Pharmaceutical Technology
NOVEMBER 14, 2023
Orphelia has lined its discovery pipeline with a number of pediatric CNS and rare cancer indications.
Bayer’s Lymphoma Treatment Aliqopa to be Pulled from US Market
BioSpace
NOVEMBER 14, 2023
After a Phase III trial did not meet its primary endpoint, Bayer will voluntarily withdraw Aliqopa (copanlisib) from the U.S. market following discussions with the FDA.
Analytical testing: Ten questions that accelerate drug development
Pharmaceutical Technology
NOVEMBER 14, 2023
When it comes to drug development, there's no substitute for speed.
Accelerating Clinical Supply Through Integrated Drug Development
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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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