10 clinical trials to watch in the second half of 2023
Bio Pharma Dive
JUNE 27, 2023
A Duchenne gene therapy faces a crucial test, while highly anticipated study results are expected in lung cancer, obesity and heart disease.
Tue.Jun 27, 2023
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Vertex and Lonza to establish T1D cell therapy manufacturing facility
Pharmaceutical Technology
JUNE 27, 2023
Vertex and Lonza have entered a partnership to establish a facility in Portsmouth, US, to manufacture cell therapies for type 1 diabetes.
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Pfizer’s hemophilia B gene therapy inches closer to regulatory approval
Bio Pharma Dive
JUNE 27, 2023
The treatment could become Pfizer’s first marketed gene therapy, an area the pharma has poured significant resources into in recent years.
Pfizer takes on haemophilia B gene therapy market with new FDA application
Pharmaceutical Technology
JUNE 27, 2023
The FDA has accepted a biologics license application (BLA) for Pfizer's fidanacogene elaparvovec to treat adults with haemophilia B.
A Daily Multivitamin May Help Your Memory, But Only if You’re in This Age Group
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 27, 2023
Research Checks interrogate newly published studies and how they’re reported in the media. The analysis is undertaken by one or more academics not involved with the study, and reviewed by another, to make sure it’s accurate. Don’t we all want to do what we can to reduce the impact of age-related decline on our memory?
Rystiggo receives FDA approval, strengthening UCB’s myasthenia gravis portfolio
Pharmaceutical Technology
JUNE 27, 2023
UCB's Rystiggo has been granted FDA approval to treat myasthenia gravis in anti-AchR or anti-MuSK antibody-positive adults.
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GSK obtains approval in Japan for shingles vaccine
Pharmaceutical Technology
JUNE 27, 2023
The Japanese MHLW has granted approval for a renewed indication of GSK's shingles (herpes zoster) vaccine, Shingrix.
Nkarta data adds to doubts facing ‘off-the-shelf’ cell therapies
Bio Pharma Dive
JUNE 27, 2023
Though a newer regimen being tested showed promise in patients with acute myeloid leukemia, earlier remissions haven’t held up as well as the company had hoped.
ICMR soon to begin research on ambulatory care for NCDs in public health care systems in India
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 27, 2023
The Indian Council of Medical Research (ICMR) has invited Expression of Interest (EOI) for Implementation Research Study on Ambulatory Care for Non-Communicable Diseases (NCDs) in Public Health Care Systems in India.
Lilly sets ‘high bar’ with new obesity drug data
Bio Pharma Dive
JUNE 27, 2023
The company’s triple-acting drug retatrutide helped Phase 2 study participants lose a quarter of their body weight, more than what’s been observed in testing of other medicines.
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
Inflation reduction act boosts biologic drug venture financing over small molecules
Pharmaceutical Technology
JUNE 27, 2023
In August 2022, the US Congress passed the Inflation Reduction Act (IRA), which allows Medicare to negotiate lower prescription drug prices.
AbbVie's Imbruvica-Brukinsa patent suit may have merit, and BeiGene will likely settle: expert
Fierce Pharma
JUNE 27, 2023
AbbVie recently filed a patent infring | AbbVie recently filed a patent infringement lawsuit against BeiGene over their blockbuster BTK franchises. Although the litigation was launched right after a patent’s issuance, AbbVie may actually have a case here, according to one expert.
Tonix to acquire Upsher-Smith’s migraine products
Pharmaceutical Technology
JUNE 27, 2023
Tonix Pharmaceuticals and Tonix Medicines have signed an agreement for the acquisition of Upsher-Smith Laboratories’ two migraine products.
Getting the Right Evidence to Decision-Makers Faster: NIH-Hosted Workshop (June 2023)
Rethinking Clinical Trials
JUNE 27, 2023
Getting the Right Evidence to Decision-Makers Faster: Insights From the NIH Pragmatic Trials Collaboratory June 20-21, 2023: This two-day workshop explores the critical cycle of evidence generation to decision by health system leaders to implement the findings of pragmatic clinical trials (PCTs) conducted within health care systems. Workshop Agenda Workshop Summary Videocast Recording: Day 1 Videocast Recording: Day 2 Agenda & Slides Day 1: June 20, 2023 Welcome and Introduction Wendy Weber,
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
Lisata shares pipeline update of anticancer lead candidate drug
Pharmaceutical Technology
JUNE 27, 2023
Lisata aims to finish enrolment of its Phase II trial in solid tumours by the end of 2024, with plans for a further study later this year.
June 27, 2023: Reflections on Health Equity in the Pragmatic Trials Landscape From the Annual Steering Committee Meeting
Rethinking Clinical Trials
JUNE 27, 2023
Anne Trontell and Ana Quiñones A focus of the 2023 NIH Pragmatic Trials Collaboratory Annual Steering Committee Meeting was health equity in embedded pragmatic clinical trials (ePCTs). In an interview during the meeting, Drs. Anne Trontell and Ana Quiñones reflected on health equity in the ePCT landscape. Trontell, who is the associate director for comparative clinical effectiveness research at the Patient-Centered Outcomes Research Institute (PCORI), said that health equity is a key component o
EMA CHMP issues positive opinion for AstraZeneca’s Soliris
Pharmaceutical Technology
JUNE 27, 2023
The EMA CHMP has issued a positive opinion recommending marketing authorisation for expanded use of AstraZeneca’s Soliris (eculizumab).
UCB finally gets a win with the FDA, scoring approval for myasthenia gravis drug Rystiggo
Fierce Pharma
JUNE 27, 2023
This has been a second straight year of regulatory struggles in the United States for UCB with one of the those issues revolving around the FDA needing additional time to
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.
EC approves BMS’ Camzyos for hypertrophic cardiomyopathy
Pharmaceutical Technology
JUNE 27, 2023
The European Commission has approved Bristol Myers Squibb’s Camzyos to treat symptomatic obstructive hypertrophic cardiomyopathy.
Shionogi acquires QPex to harness antimicrobial pipeline
Outsourcing Pharma
JUNE 27, 2023
The Japanese company Shionogi has taken over the US biotech Qpex Biopharma for up to $140 million in a bid to expand its pipeline of antimicrobial drugs and boost its R&D muscle in infectious disease.
Wane in Covid demand hurts Walgreens as profits drop to $118m
Pharmaceutical Technology
JUNE 27, 2023
Walgreens Boots Alliance readjusted its 2023 outlook amidst mixed fiscal Q3 results.
Regeneron's high-dose Eylea hit with surprise FDA rejection over manufacturing hiccups
Fierce Pharma
JUNE 27, 2023
Despite Regeneron’s impressive high-dose Eylea data, its high-stakes launch is delayed thanks to an unexpected FDA rejection. | In a surprise decision, the FDA issued powerhouse Eylea's high-dose version a complete response letter. But the company said it has nothing to do with the drug's efficacy or safety.
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.
Pfizer, OPKO Get FDA Nod for Pediatric Growth Hormone Deficiency Drug
BioSpace
JUNE 27, 2023
Overcoming an FDA rejection in January 2022, Pfizer and OPKO’s Ngenla will provide a long-acting, reduced-frequency treatment option for children with growth hormone deficiency.
Lilly forks over $2.4M to settle federal agency's age discrimination lawsuit
Fierce Pharma
JUNE 27, 2023
Eli Lilly is no stranger to age discrimination claims. | Eli Lilly will pay out $2.4 million as part of a settlement agreement with the U.S. Equal Employment Opportunity Commission, which sued the company in September over claims it had changed its hiring preferences in 2017 to prioritize recruitment of more millennials to its workforce.
Bayer’s BlueRock Reports Positive Early Data for Parkinson’s Stem Cell Therapy
BioSpace
JUNE 27, 2023
While early, the Phase I study results for 12 patients represent a promising return on Bayer’s investment in BlueRock, which it launched with Versant Ventures in 2016 and fully acquired three years later.
NICE puts kibosh on Mounjaro coverage over GLP-1 comparison and cost model uncertainties
Fierce Pharma
JUNE 27, 2023
Diabetes patients in the United Kingdom may have to wait a bit longer to get their hands on Eli Lilly’s Mounjaro after the country’s drug value watchdog kiboshed its coverage recommendation. | England’s National Institute for Health and Care Excellence (NICE) on Tuesday said more evidence is needed on the clinical efficacy and cost-effectiveness of Mounjaro, also known as tirzepatide, before the health technology assessor can recommend Lilly's dual GIP/GLP-1 drug for use by the country’s Na
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.
How Do Biopharma Investors Navigate Advisory Board Conflicts of Interest?
BioSpace
JUNE 27, 2023
Recent changes in the board of directors at Biogen has garnered attention due to potential conflicts of interest. Such conflicts vary widely, but one thing is clear: perception matters.
DocGo Explains How On-Demand Urgent Care Can Help Payers Reduce Costs
XTalks
JUNE 27, 2023
The emergence of on-demand urgent care services has been a game changer in the healthcare industry. With the advent of new technology and changing consumer preferences, patients can now access urgent care services on their terms and at their convenience. On-demand urgent care provides patients with a quick and efficient way to receive medical attention for non-life-threatening illnesses or injuries, without the need for an appointment or a lengthy wait in a crowded emergency room (ER).
'World-first' anti-fibrotic inhibitor to treat IPF continues to gain traction
Outsourcing Pharma
JUNE 27, 2023
The worldâs first anti-fibrotic small molecule inhibitor, discovered and designed by generative artificial intelligence (AI) has completed the first patient dose in a phase 2 clinical trial.
FDA Blocks Regeneron’s Bid for Higher Eylea Dose
BioSpace
JUNE 27, 2023
Citing issues with a third-party contractor, the FDA rejected Regeneron’s regulatory application for a higher-dose regimen of Eylea, the company’s blockbuster eye injection treatment.
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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