The top biopharma conferences in 2024
Bio Pharma Dive
OCTOBER 16, 2023
A few key meetings remain this year, like ESMO and ASH, while next year’s events are already being planned. Here’s a list of conferences to keep in mind.
Mon.Oct 16, 2023
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This Protein May Protect Against Alzheimer’s, Scientists Say
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 16, 2023
In the search for a treatment for Alzheimer’s disease, researchers have zeroed in on a protein with protective effects. A new study reveals how cholesterol and inflammation in different types of human brain cells interact with a protein called ABCA7, which regulates how molecules pass through cell membranes.
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Pfizer and BioNTech face 2023 revenue hits amid Covid product write-offs
Pharmaceutical Technology
OCTOBER 16, 2023
Pfizer is launching a $3.5bn cost-saving programme and BioNTech expects 2023 revenues to decrease as demand for Covid treatments wanes.
5 steps to help increase the odds of clinical trial success
Bio Pharma Dive
OCTOBER 16, 2023
There are many common reasons clinical trials fail, including failure to demonstrate efficacy, safety concerns, issues with inclusion and exclusion criteria and patient recruitment. Follow these five steps to increase the odds of clinical trial success.
CHMP recommends European authorisation for seven new drugs
Pharmaceutical Technology
OCTOBER 16, 2023
Pfizer’s Elrexfio and Astellas’ Veozah are among the seven drugs recommended for approval by the European regulatory committee.
Landing a CRO that’s an extension of your team
Bio Pharma Dive
OCTOBER 16, 2023
In an industry where the convergence of cutting-edge science and a human-centered approach is equally imperative, Worldwide Clinical Trials has found the sweet spot, delivering excellence in the clinical trial experience.
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MDC to call Sanofi India in next meeting before price fixation of its anti-diabetes combination
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 16, 2023
The Multi Disciplinary Committee (MDC) of Experts, which advices the National Pharmaceutical Pricing Authority (NPPA) on pricing related matters, has decided to call Sanofi India in its next meeting to present the company’s case with regard to its application for higher price for certain combinations of its diabetes drug Soliqua.
Bristol Myers Squibb Expands Oncology Portfolio with Mirati Acquisition
Pharmaceutical Technology
OCTOBER 16, 2023
On October 9, Bristol Myers Squibb announced it had an agreement to acquire Mirati Therapeutics, a targeted oncology biotech company.
Quotient Sciences Appoints Thierry Van Nieuwenhove as New CEO
Pharma Mirror
OCTOBER 16, 2023
Van Nieuwenhove succeeds Mark Egerton, who retires after 18 years in the role Wayne Hewett also joins Quotient Board of Directors as Non-Executive Chairman NOTTINGHAM, UK: Quotient Sciences (“Quotient” or the “Company”), a leading global pharmaceutical drug development and manufacturing accelerator, is pleased to announce the appointment of Thierry Van Nieuwenhove as its new Chief Executive Officer (CEO), effective 16th October 2023.
How the life sciences sector can defend against the top five data protection challenges
Pharmaceutical Technology
OCTOBER 16, 2023
Pharma and healthcare organisations use patient data to deliver personalised treatments and efficient care, but the digitalisation of the industry raises new privacy and cybersecurity concerns. We explore how the life sciences industry can address these challenges to create a secure and compliant health data ecosystem.
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
mRNA Drugs: Pros, Cons, and Prospects
Pharma Mirror
OCTOBER 16, 2023
by Carrie Taylor, Director of Research & Development of BOCSCI. Globally, the COVID-19 pandemic has significantly accelerated the development of mRNA technology platforms and mRNA industry chains. The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021. mRNA drugs mRNA drugs encode mRNA based on the selection of targets or antigens and enter the cytoplasm through specific delivery systems (such as LN
Illumina vows to challenge European Commission order to give up GRAIL
Pharmaceutical Technology
OCTOBER 16, 2023
Illumina has said that it intends to challenge the European Commission’s ruling calling for the company to divest itself of its newly acquired cancer detection firm, GRAIL
Concentra makes bid for struggling biotech Rain
Bio Pharma Dive
OCTOBER 16, 2023
The takeout offer, from Concentra owner Tang Capital, comes after a difficult year for Rain, which has cut back its spending and trimmed staff.
Signal: Project NextGen continues with $500m funding for vaccine research
Pharmaceutical Technology
OCTOBER 16, 2023
The US government's Covid-19 research programme has announced the vaccine candidates for its latest round of funding.
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
Novo adds to deal spree with blood pressure drug buy
Bio Pharma Dive
OCTOBER 16, 2023
Worth up to $1.3 billion, the deal with Singapore-based KBP Biosciences builds the Ozempic maker’s armory of metabolic disease drugs.
Sterling Pharma acquires contract services provider NewChem
Pharmaceutical Technology
OCTOBER 16, 2023
Sterling Pharma Solutions has concluded the acquisition of UK-based contract services provider NewChem Technologies for an undisclosed sum.
With COVID sales in free-fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts
Fierce Pharma
OCTOBER 16, 2023
As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. | Pfizer has slashed its 2023 revenue projection by $9 billion because of declining demand for COVID products. The company now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion.
Pfizer gains FDA approval for ulcerative colitis therapy VELSIPITY
Pharmaceutical Technology
OCTOBER 16, 2023
Pfizer has received approval from the US FDA for its VELSIPITY to treat adults with moderately to severely active ulcerative colitis (UC).
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.
Merck’s Keytruda wins coveted FDA nod around surgery for early lung cancer—with a surprise
Fierce Pharma
OCTOBER 16, 2023
Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. | Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. The drug's label already includes an overall survival win from a key trial.
CHMP affirms Mundipharma and Cidara’s candidiasis therapy
Pharmaceutical Technology
OCTOBER 16, 2023
Mundipharma and Cidara Therapeutics have received a positive opinion from EMA CHMP for rezafungin to treat invasive candidiasis.
What Are Endpoints And Outcomes?
Rethinking Clinical Trials
OCTOBER 16, 2023
What Are Endpoints And Outcomes? Description Dr. Devon Check discusses endpoint and outcomes in pragmatic clinical trials. Speaker Devon Check, PhD Assistant Professor, Population Health Sciences Duke University School of Medicine Implementation Science Core Co-Chair The post What Are Endpoints And Outcomes? appeared first on Rethinking Clinical Trials.
EMA rejects Amylyx’s ALS drug MAA following reevaluation
Pharmaceutical Technology
OCTOBER 16, 2023
The EMA gave a negative approval decision for Amylyx’s Albrioza due to concerns surrounding Phase II results.
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.
What Do Endpoints and Outcomes Look Like in Pragmatic Trials?
Rethinking Clinical Trials
OCTOBER 16, 2023
What Do Endpoints and Outcomes Look Like in Pragmatic Trials? Description Dr. Devon Check discusses what endpoints and outcomes look like in pragmatic clinical trials. Speaker Devon Check, PhD Assistant Professor, Population Health Sciences Duke University School of Medicine Implementation Science Core Co-Chair The post What Do Endpoints and Outcomes Look Like in Pragmatic Trials?
AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s
FDA Law Blog
OCTOBER 16, 2023
By Gail H. Javitt & Steven J. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The first article—“Is the Eye the Window to Alzheimer’s?
How Do Data Sources inform the Choice of Endpoints and Outcomes in Pragmatic Trials?
Rethinking Clinical Trials
OCTOBER 16, 2023
How Do Data Sources inform the Choice of Endpoints and Outcomes in Pragmatic Trials? Description Dr. Devon Check discusses how data sources inform the choice of endpoints and outcomes in pragmatic trials. Speaker Devon Check, PhD Assistant Professor, Population Health Sciences Duke University School of Medicine Implementation Science Core Co-Chair The post How Do Data Sources inform the Choice of Endpoints and Outcomes in Pragmatic Trials?
UCL study suggests changes to improve MRI scans for prostate cancer
Pharma Times
OCTOBER 16, 2023
The research aims to make MRIs more available to men and improve treatment decisions - News - PharmaTimes
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.
Podcast: The British start-up taking psychedelic therapy mainstream
BioPharma Reporter
OCTOBER 16, 2023
In our first podcast interview of 2023, BioPharma Reporter spoke with Dr Sarah Bateup, therapy lead at Clerkenwell Health, about the potential of psychedelic medicine and her work within the psychedelic therapy training space.
Influencers of Generic Drug Utilization
Drug Patent Watch
OCTOBER 16, 2023
In a systematic review titled “Influencers of Generic Drug Utilization,” researchers aimed to shed light on the key factors influencing the use of generic prescription drugs in the United States.… The post Influencers of Generic Drug Utilization appeared first on DrugPatentWatch - Make Better Decisions.
Foodborne Illness from Raw Milk On the Rise
XTalks
OCTOBER 16, 2023
Public health officials in Utah and Wyoming are investigating separate outbreaks of foodborne illness from raw milk consumption. These outbreaks come at a time when raw milk is growing in legality. The Salt Lake County Health Department in Utah confirmed that 14 people have been infected with Campylobacter , a bacteria that causes foodborne illness from the consumption of raw or undercooked food.
Bristol Myers Squibb's Opdivo reign expands with new earlier-stage melanoma nod
Fierce Pharma
OCTOBER 16, 2023
Bristol Myers Squibb’s star Opdivo now can lay claim to an earlier melanoma stage with a new approval that “reinforces the company’s legacy” in treating the cancer type, it said. | Bristol Myers Squibb's Opdivo can now treat completely resected stage 2B or 2C melanoma, adding to its existing approvals in stages 3 and 4 tumors and setting up an expanded market battle with Merck & Co.'s star Keytruda.
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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