Genevoyager opens CDMO facility for gene therapy development
Pharmaceutical Technology
DECEMBER 21, 2023
Genevoyager has announced the opening of contract development and manufacturing organisation facility to manufacture gene therapy products.
Thu.Dec 21, 2023
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Landmark Melanoma Vaccine Could Be Available in Just 2 Years
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 21, 2023
Moderna CEO Stephane Bancel told AFP his company’s experimental vaccine against melanoma could be available in as little as two years, in what would amount to a landmark step against the most serious form of skin cancer. Globally there were an estimated 325,000 new melanoma cases and 57 ,000 deaths from the disease in 2020.
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J&J bets bigger on MeiraGTx’s eye gene therapy
Bio Pharma Dive
DECEMBER 21, 2023
Ahead of a Phase 3 readout that could come next year, the pharma is paying $130 million in upfront and near-term cash for rights to the retinitis pigmentosa treatment that it didn’t already own.
QCI introduces innovative solution ‘Quality Setu’ to streamline NABH complaints redressal process
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 21, 2023
In order to streamline the National Accreditation Board for Hospitals and Healthcare Providers (NABH) helpdesk and complaints redressal process, the Quality Council of India (QCI) and all its boards have introduced an innovative solution for addressing concerns promptly and transparently through “Quality Setu”.
Clene says its ALS drug data is not yet enough for FDA
Bio Pharma Dive
DECEMBER 21, 2023
The agency said initial trial evidence wouldn’t support an accelerated approval, according to the company, which plans to provide more data next year.
MEI Pharma files patent for a cancer treatment method using mitochondrial and bcl-2 inhibitors
Pharmaceutical Technology
DECEMBER 21, 2023
Discover a groundbreaking method to treat cancer using a combination of mitochondrial and Bcl-2 inhibitors. Learn more about this patent's innovative approach.
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FDA grants orphan drug status to Ocelot Bio’s OCE-205 for ascites
Pharmaceutical Technology
DECEMBER 21, 2023
The US FDA has granted orphan drug designation for Ocelot Bio’s lead candidate OCE-205 to treat ascites, excluding cancer-associated cases.
BioMarin strikes deal with Elliott, agrees to review business
Bio Pharma Dive
DECEMBER 21, 2023
Under pressure from the activist investor, BioMarin will add more independent directors and set up an operational review committee.
BI-1701963 by Boehringer Ingelheim International for Metastatic Colorectal Cancer: Likelihood of Approval
Pharmaceutical Technology
DECEMBER 21, 2023
BI-1701963 is under clinical development by Boehringer Ingelheim International and currently in Phase II for Metastatic Colorectal Cancer.
Merck's path toward pharmacovigilance transformation
BioPharma Reporter
DECEMBER 21, 2023
At Veeva R&D and Quality Summit 2023, Bio Pharma Reporter caught up with Courtney Gilbert, senior director, business system management and innovation, PV operations and global process enablement, at Merck.
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
GSK signs licence deal for Hansoh Pharma’s cancer drug
Pharmaceutical Technology
DECEMBER 21, 2023
GSK has signed an exclusive licence agreement for Hansoh Pharma’s B7-H3-targeting ADC, HS-20093, for potential treatment of solid tumours.
BMS Closes the Year with $14B Karuna Buy to Bolster Neuro Portfolio
BioSpace
DECEMBER 21, 2023
The acquisition announced on Friday will give Bristol Myers Squibb ownership of Karuna Therapeutics’ investigational antipsychotic KarXT, which is being tested for schizophrenia and Alzheimer’s disease psychosis.
FDA rejects MSD’s gefapixant for chronic cough
Pharmaceutical Technology
DECEMBER 21, 2023
Despite approvals in Europe and Japan, the FDA rejected the oral drug, citing a lack of substantial evidence for treatment effectiveness.
Wearable technology to be offered to thousands with type 1 diabetes in UK
Pharma Times
DECEMBER 21, 2023
The condition affects around 270,935 people in England and 16,090 people in Wales - News - PharmaTimes
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
Calliditas receives FDA approval for Tarpeyo to treat IgAN
Pharmaceutical Technology
DECEMBER 21, 2023
Calliditas Therapeutics has received the US FDA approval for Tarpeyo to treat adult primary immunoglobulin A nephropathy (IgAN) patients.
Jazz’s Future in PTSD Left Uncertain Following Mid-Stage Trial Failure
BioSpace
DECEMBER 21, 2023
In a Phase II study, Jazz Pharmaceuticals’ investigational fatty acid amide hydrolase inhibitor JZP150 did not significantly improve post-traumatic stress disorder symptoms compared to placebo.
Sudo raises $116m to advance TYK2 programmes
Pharmaceutical Technology
DECEMBER 21, 2023
Sudo plans to advance two TYK2 candidates into clinical testing next year for the treatment of autoimmune and neurologic conditions.
2023 Year in Review: Biopharma Takes One Step Forward, Two Steps Back
BioSpace
DECEMBER 21, 2023
It has been a topsy-turvy year marked by record bankruptcies, a sharp drop in funding, few IPOs, and a steady stream of layoffs and regulatory challenges offset by M&A deals and the hot weight loss and antibody-drug conjugate markets.
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.
Cadonilimab by Akeso for Transitional Cell Cancer (Urothelial Cell Cancer): Likelihood of Approval
Pharmaceutical Technology
DECEMBER 21, 2023
Cadonilimab is under clinical development by Akeso and currently in Phase II for Transitional Cell Cancer (Urothelial Cell Cancer).
Lilly, Fauna Bio Ink Potential $494M Deal to Find Obesity Drug Targets
BioSpace
DECEMBER 21, 2023
Eli Lilly has signed a multi-year contract with animal genomics biotech Fauna Bio to use its artificial intelligence platform to discover drug targets for obesity in a deal worth nearly half a billion dollars.
Olaparib by AstraZeneca for Bile Duct Cancer (Cholangiocarcinoma): Likelihood of Approval
Pharmaceutical Technology
DECEMBER 21, 2023
Olaparib is under clinical development by AstraZeneca and currently in Phase II for Bile Duct Cancer (Cholangiocarcinoma).
Wearable technology to be offered to thousands with type 1 diabetes in UK
Pharma Times
DECEMBER 21, 2023
The National Institute for Health and Care Excellence (NICE) has published final guidance announcing a five-year roll-out of a wearable technology for patients living with type 1 diabetes. The new hybrid closed loop systems have proven to be more effective in maintaining healthy blood glucose levels than standard care. The new guidance followed a review of a clinical trial and real-world evidence by the University of Warwick and Warwick Medical School, funded by the National Institute for Health
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.
FDA revamps EUA guidance for Covid-19 monoclonal antibodies
Pharmaceutical Technology
DECEMBER 21, 2023
The FDA released an updated guidance for developing Covid-19 monoclonal antibody treatments for EUAs as variants evolve.
Three Key Elements to Win the Gold – Advice From Award-Winning Creative Experts
Intouch Solutions
DECEMBER 21, 2023
Recently, three of our creative leaders at EVERSANA INTOUCH had the honor of participating in a webinar hosted by Cannes Lions, exploring the theme of “Health and the Health-Conscious Consumer.” This insightful session featured Susan Perlbachs, Chief Creative Officer; Nick Capanear, Managing Director, Executive Creative Director; and Ivan Blotta, Group Creative Director, Head of Art.
(Nivolumab + relatlimab) by Bristol-Myers Squibb for Melanoma: Likelihood of Approval
Pharmaceutical Technology
DECEMBER 21, 2023
(Nivolumab + relatlimab) is under clinical development by Bristol-Myers Squibb and currently in Phase III for Melanoma.
Five decentralized clinical trial organizations raising big VC cash
Outsourcing Pharma
DECEMBER 21, 2023
Decentralized clinical trials (DCTs) are gaining increasing interest as they have the potential to make clinical trial operations quicker, more efficient and more accessible to patients. Check out five DCT organizations that have raised big venture capital investments in the last few years.
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.
Diakine-DK210 (EGFR) by Deka Biosciences for Pancreatic Cancer: Likelihood of Approval
Pharmaceutical Technology
DECEMBER 21, 2023
Diakine-DK210 (EGFR) is under clinical development by Deka Biosciences and currently in Phase I for Pancreatic Cancer.
NHS expands home-testing kits to detect bowel cancer earlier
Pharma Times
DECEMBER 21, 2023
Bowel cancer is currently the third most common type of cancer in England - News - PharmaTimes
BT-8009 by Bicycle Therapeutics for Fallopian Tube Cancer: Likelihood of Approval
Pharmaceutical Technology
DECEMBER 21, 2023
BT-8009 is under clinical development by Bicycle Therapeutics and currently in Phase II for Fallopian Tube Cancer.
2024 forecast: Big Pharma reworks China strategy, and job cuts are part of it
Fierce Pharma
DECEMBER 21, 2023
Big Pharma companies have often talked about the major opportunities that await in China. | Big Pharma companies have often talked about the major opportunities that await in China. But as price cuts play out and internal priorities shift, multinational companies are reworking their business models in the country.
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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