ALS drug from Denali, Sanofi falls short in mid-stage study
Bio Pharma Dive
FEBRUARY 16, 2024
The disclosure the experimental therapy missed its trial goal comes after Sanofi had earmarked the drug for advancement into Phase 3.
Fri.Feb 16, 2024
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Otsuka wins FDA breakthrough therapy designation for IgAN drug
Pharmaceutical Technology
FEBRUARY 16, 2024
This positive news comes after Otsuka’s Phase III Alzheimer’s agitation trial failed to meet its primary endpoint, announced earlier this week.
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Astellas teams up with startup Kelonia to make ‘in vivo’ cell therapies
Bio Pharma Dive
FEBRUARY 16, 2024
Kelonia will receive $40 million upfront through a partnership to develop “off-the-shelf” cell therapies for cancer.
GSK concludes Aiolos Bio acquisition for $1.4bn
Pharmaceutical Technology
FEBRUARY 16, 2024
GSK has successfully concluded the acquisition of Aiolos Bio in a deal that could reach $1.4bn, expanding its respiratory portfolio.
FDA to consider expanding use of Sarepta Duchenne gene therapy
Bio Pharma Dive
FEBRUARY 16, 2024
The agency will decide by June 21 whether to enable more patients with the disease to receive Elevidys, and won’t convene a group of outside experts beforehand.
Dragonfly and Gilead enter partnership for cancer therapy
Pharmaceutical Technology
FEBRUARY 16, 2024
Dragonfly Therapeutics has entered a clinical collaboration with Gilead Sciences to assess DF1001 plus Trodelvy for cancer indications.
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Regeneron and Sanofi’s Dupixent bags fifth drug label in Japan
Pharmaceutical Technology
FEBRUARY 16, 2024
Regeneron and Sanofi's Dupixent has been approved for the treatment of chronic spontaneous urticaria (CSU) or itching in Japan.
FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor
Fierce Pharma
FEBRUARY 16, 2024
The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunotherapy developed by Iovance Biotherapeutics.
Sarepta’s Elevidys makes advances towards expanded DMD label
Pharmaceutical Technology
FEBRUARY 16, 2024
Despite failing its primary endpoint in the EMBARK confirmatory study, Elevidys’ efficacy supplement has gained FDA priority review.
FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies
Fierce Pharma
FEBRUARY 16, 2024
People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. | People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. The FDA has blessed Roche and Novartis’ Xolair as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods.
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
FDA grants orphan drug status to Ionis’ olezarsen for FCS treatment
Pharmaceutical Technology
FEBRUARY 16, 2024
The US FDA has granted orphan drug designation to Ionis Pharmaceuticals’ olezarsen for familial chylomicronemia syndrome (FCS).
'The Top Line': Gene editing's next act
Fierce Pharma
FEBRUARY 16, 2024
Gene editing’s therapeutic application has transitioned from hypothetical to reality, marked by the recent approval of a CRISPR-based therapy for sickle cell and beta thalassemia. | This week on "The Top Line," Max Bayer from Fierce Biotech explores the future of gene editing in an interview with the CEO of Verve Therapeutics.
Xyphos and Kelonia link for immuno-oncology drug development
Pharmaceutical Technology
FEBRUARY 16, 2024
Xyphos Biosciences has entered an agreement with Kelonia Therapeutics to develop immuno-oncology therapeutics for $875m.
Study backs safety of Gilead CAR-T as outpatient therapy
pharmaphorum
FEBRUARY 16, 2024
CAR-T therapies can achieve remarkable efficacy in the treatment of haematological cancers, but the risk of side effects means that the cell infusions are almost always administered to inpatients under close supervision in clinics.
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
QBiotics wins FDA orphan status for rainforest-derived cancer drug
Pharmaceutical Technology
FEBRUARY 16, 2024
Though the designation is for soft tissue sarcoma, tigilanol tiglate is in clinical trials for multiple cancer types.
Freenome raises $254m for cancer tests, and other financings
pharmaphorum
FEBRUARY 16, 2024
Recent biotech financings include a $245m raise for cancer blood test company Freenome, plus big rounds for Cogent Biosciences, BioAge Labs, Latigo Biotherapeutics, ProfoundBio, and Firefly Bio
Novartis, zeroing in on innovative meds, launches strategic review of India outfit
Fierce Pharma
FEBRUARY 16, 2024
A Novartis subsidiary in India has become the target of a strategic review as the Swiss pharma focuses its efforts on newer medicines. | A Novartis subsidiary handling old products in India has become the target of a strategic review as the Swiss pharma focuses its efforts on newer medicines.
Gilead’s CD47 woes continue, this time in solid tumours
pharmaphorum
FEBRUARY 16, 2024
Gilead Sciences has paused enrolment in clinical trials of its CD47 drug magrolimab in solid tumours, a week after dropping it for blood cancers.
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.
J&J consumer health spinoff Kenvue telegraphs 100-plus layoffs in California, New Jersey
Fierce Pharma
FEBRUARY 16, 2024
While Johnson & Johnson’s consumer health spinoff Kenvue prepares to move into a swanky new headquarters in Summit, New Jersey, it appears some staffers won’t be joining the company in the tran | While Johnson & Johnson’s consumer health spinoff Kenvue prepares to move into a new headquarters in Summit, New Jersey, it appears some staffers won’t be joining the company in the transition.
Astellas pledges $800m to Kelonia CAR-T alliance in cancer
pharmaphorum
FEBRUARY 16, 2024
Astellas has signed a deal with Kelonia Therapeutics that aims to push the boundaries of what can be achieved with CAR-T therapies in immuno-oncology
Researchers investigate new technique for diagnosing cardiac conditions
Pharma Times
FEBRUARY 16, 2024
Cardiac quantitative susceptibility mapping successfully visualised iron deposits in patients
Industry can support clinicians with prescribing decisions
pharmaphorum
FEBRUARY 16, 2024
The ABPI has released a new guide on how the industry can support clinicians with prescribing decisions. Find out more about how pharmaceutical companies can assist healthcare professionals in providing optimal patient care.
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.
Following FDA rejection, Sanofi and Regeneron's Dupixent gains Japanese approval in hives condition
Fierce Pharma
FEBRUARY 16, 2024
Four months after the FDA rejected Sanofi and Regeneron’s Dupixent to treat chr | Four months after the FDA rejected Sanofi and Regeneron’s Dupixent to treat chronic spontaneous urticaria, Japan’s health regulators have signed off on the drug in the indication.
Patentability and predictability in AI-assisted drug discovery
pharmaphorum
FEBRUARY 16, 2024
Explore the role of artificial intelligence and machine learning in drug discovery and the challenges associated with patentability and predictability. Learn how AI is revolutionising the pharmaceutical industry.
The Drug Discount Ecosystem Needs Clarity in 2024 and Beyond
Drug Channels
FEBRUARY 16, 2024
Today’s guest post comes from Gavin Magaha, Senior Director of Value Delivery at Kalderos. Gavin discusses the problems manufacturers face in accessing and standardizing drug discount data. These data are necessary to avoid duplicate discounts and comply with regulatory requirements. To learn more about how the Inflation Reduction Act adds to challenges of drug discount programs, download Kalderos’ whitepaper: Operational Complexity and Evolving Challenges: What Drug Manufacturers Need to Know N
Patterns of behaviour: Using AI-based algorithms to improve outcomes for patients with atrial fibrillation
pharmaphorum
FEBRUARY 16, 2024
Patterns of behaviour: Using AI-based algorithms to improve outcomes for patients with atrial fibrillation Mike.
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.
DHL Supply Chain Invests $200M Toward Expanding its Life Sciences and Healthcare Services
Pharmaceutical Commerce
FEBRUARY 16, 2024
The financial commitment features construction of new warehouses in Pennsylvania and North Carolina.
JP Morgan 2024 – Xavier Duportet
pharmaphorum
FEBRUARY 16, 2024
In this interview, Jonah Comstock speaks with Xavier Duportet, the founder and CEO of the biotech company, Eligo Bioscience, about the future of CRISPR gene editing at JP Morgan in 2024. Dive into the discussion to gain insights into this cutting-edge technology and its potential impact on the healthcare industry.
Neurona secures $120m to advance lead cell therapy candidate for epilepsy
Pharma Times
FEBRUARY 16, 2024
NRTX-1001 is being assessed for drug-resistant mesial temporal lobe epilepsy
First biologic approved in Scotland for hidradenitis suppurativa since 2016
Drug Discovery World
FEBRUARY 16, 2024
Novartis’ Cosentyx (secukinumab) is now available in Scotland, following positive advice from the Scottish Medicines Consortium (SMC). It is licensed for adults with active moderate to severe hidradenitis suppurativa (HS) (acne inversa) who have responded inadequately to conventional systemic HS therapy. The advice applies for use in adult patients with active moderate to severe HS for whom adalimumab is contraindicated or otherwise unsuitable, including those who have failed to respond or have
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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