WestGene wins FDA approval for mRNA vaccine to treat certain cancers
Pharmaceutical Technology
MAY 10, 2024
The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.
Fri.May 10, 2024
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iTeos shares jump on TIGIT update; Acelyrin swaps CEOs
Bio Pharma Dive
MAY 10, 2024
Interim data surpassed expectations, iTeos said. Elsewhere, Acelyrin revealed chief executive officer Shao-Lee Lin is departing and Bluebird bio gave a fuller account of its gene therapy launches.
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Including Patients with Borderline Personality Disorder in Clinical Trials
Worldwide Clinical Trials
MAY 10, 2024
By: Christine Moore, PhD, Vice President, Neuroscience, Scientific Solutions Patients with borderline personality disorder (BPD) face a heightened risk of substance abuse and suicide, as well as substantial delays in receiving treatment. Despite these risks, there are no medications specifically approved to target the core symptoms of BPD; current treatments are limited to managing underlying affective symptoms.
FDA delays decision on Moderna RSV vaccine
Bio Pharma Dive
MAY 10, 2024
The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.
Shionogi secures licence for Maze’s Pompe disease treatment
Pharmaceutical Technology
MAY 10, 2024
Shionogi has concluded an exclusive global licence agreement for Maze Therapeutics’ MZE001 aimed at treating Pompe disease.
Novavax gets a lifeline with Sanofi vaccine pact
Bio Pharma Dive
MAY 10, 2024
Sanofi will ally with the under-pressure biotech, paying $500 million upfront for rights to co-commercialize Novavax’s COVID shot and develop combination influenza vaccines.
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Maze lands new partner for Pompe drug, after Sanofi pact came apart
Bio Pharma Dive
MAY 10, 2024
An alliance with Shionogi involves similar terms as a deal Sanofi canceled in response to an unusual challenge from the Federal Trade Commission.
RAPT terminates Phase II trials for lead candidate following clinical hold
Pharmaceutical Technology
MAY 10, 2024
RAPT is closing two Phase II trials for Rapt’s lead candidate, zelnecirnon, three months after the FDA placed a clinical hold on them.
House's updated biosecurity bill sets 2032 decoupling deadline for industry's work with WuXi AppTec
Fierce Pharma
MAY 10, 2024
Right after an industry survey suggested that switching away from Chinese CDMOs could take biopharma companies up to eight years, lawmakers have adjusted the BIOSECURE Act. | Right after an industry survey suggested that switching away from Chinese CDMOs could take biopharma companies up to eight years, lawmakers have adjusted the BIOSECURE Act. The new draft lays out a 2032 deadline for the separation mandate.
Four ways the vaccine rush will define infectious disease trends for CROs in 2024
Pharmaceutical Technology
MAY 10, 2024
GlobalData examines four of the key trends affecting contract research organizations (CROs) involved with infectious 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
World Lupus Day 2024: The Importance of Advocacy to Make Lupus Visible
XTalks
MAY 10, 2024
According to the Lupus Foundation of America , approximately 1.5 million Americans, and at least 5 million people worldwide, suffer from a form of lupus. The disease predominantly affects women, particularly women of color, who are two to three times more likely to develop lupus than caucasian women. Despite its prevalence, lupus remains one of the world’s least recognizable diseases, often leading to significant delays in diagnosis and appropriate treatment.
Formosa and Tabuk sign deal for FDA-approved ophthalmic suspension
Pharmaceutical Technology
MAY 10, 2024
Tabuk obatined rights to commercialise Formosacs l'obetasol propionate ophthalmic suspension 0.05% for inflammation after ocular surgery.
Sanofi keeps Novavax afloat with $1.2B bet on its vaccine platform
Fierce Pharma
MAY 10, 2024
After years of missteps in developing and commercializing its coronavirus shot, Novavax is turning to one of the biopharma industry’s most experienced vaccine companies to help salvage its COVID ef | After years of missteps in developing and commercializing its coronavirus shot, Novavax is turning to one of the biopharma industry’s most experienced vaccine companies to help salvage its COVID efforts.
Novo Nordisk enters deal to develop obesity therapy
Pharmaceutical Technology
MAY 10, 2024
Novo Nordisk has entered into a deal with Flagship Pioneering and Metaphore Biotechnologies to develop therapeutics for obesity.
Novavax Soars on $1.4B Deal With Sanofi for COVID Vaccine
BioSpace
MAY 10, 2024
Sanofi will hand Novavax $500 million upfront for its COVID-19 vaccine, which it will co-commercialize and develop into a combination flu-COVID vaccine.
Sanofi signs $1.2bn licensing agreement for Novavax’s Covid-19 vaccine
Pharmaceutical Technology
MAY 10, 2024
Sanofi has signed a $1.2bn licensing agreement with Novavax to co-commercialise its stand-alone adjuvanted Covid-19 vaccine.
What are the key immigration changes facing the pharma industry?
pharmaphorum
MAY 10, 2024
The pharma industry is facing major immigration policy changes that will impact hiring of skilled talent. This blog examines new visa and salary requirements for life sciences roles and their effect on the industry.
Attovia secures $105m to advance development of lead programmes
Pharmaceutical Technology
MAY 10, 2024
Attovia Therapeutics has secured $105m in a Series B financing round to expedite the development of its lead programmes.
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.
Bluebird Boasts Nearly 140% Revenue Jump, Still Misses Target
BioSpace
MAY 10, 2024
With 15 patients started across its three gene therapies, bluebird bio claims a 138% year-over-year revenue growth and aims to initiate up to around 100 new patients in the current year.
Freeline touts positive data for Gaucher disease therapy
Pharmaceutical Technology
MAY 10, 2024
The positive Phase I/II data has supported a RMAT designation from the FDA and a PRIME designation by the EMA.
AGC Biologics plots roughly 100 layoffs as CDMO industry's post-COVID hangover persists
Fierce Pharma
MAY 10, 2024
While some biopharma contract manufacturers have been able to weather a tough business environment in recent months, many others continue to struggle against financing headwinds affecting the great | AGC Biologics, which employs more than 2,500 workers worldwide, has “had to reduce positions at our Seattle and Colorado sites and global functional areas,” a spokesperson confirmed Friday in an emailed statement.
Shionogi and Maze seal worldwide exclusive in bid to cure Pompe disease
Outsourcing Pharma
MAY 10, 2024
In an interesting development in the field of rare disease therapeutics, Shionogi & Co., Ltd., and Maze Therapeutics, Inc. have sealed an exclusive worldwide license agreement for MZE001, a novel therapeutic candidate aimed at tackling Pompe disease.
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
Royalty Pharma Drops $525M for Royalties and Milestones on Sanofi-Licensed MS Therapy
BioSpace
MAY 10, 2024
With its $525 million investment, Royalty Pharma will acquire the royalties and milestones for ImmuNext’s anti-CD40 therapy frexalimab, which is currently in Phase III trials for multiple sclerosis.
Sanofi forges $1.2bn alliance with vaccines firm Novavax
pharmaphorum
MAY 10, 2024
Sanofi has licensed joint commercial rights to Novavax’s COVID-19 vaccine and will work with the biotech on the development of combined flu/COVID shots in a deal worth up to $1.2 billion.
Cell and Gene Therapies Still Have Long Way to Go in Fulfilling Promise
BioSpace
MAY 10, 2024
While these technologies are now a therapeutic reality, the ASGCT 2024 annual meeting this week was a reminder of just how far we are from widespread use.
Shinogi and Maze seal worldwide exclusive in bid to cure Pompe disease
Outsourcing Pharma
MAY 10, 2024
In an interesting development in the field of rare disease therapeutics, Shionogi & Co., Ltd., and Maze Therapeutics, Inc. have sealed an exclusive worldwide license agreement for MZE001, a novel therapeutic candidate aimed at tackling Pompe disease.
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.
Verona Secures Up To $650M in Funding as it Gears Up for Potential COPD Approval and Launch
BioSpace
MAY 10, 2024
Anticipating approval for its COPD therapy ensifentrine, Verona has entered into a $650 million financing deal with Oaktree Capital Management and OMERS Life Sciences.
London’s life sciences scene upbeat as 2024 conference season begins
pharmaphorum
MAY 10, 2024
London's burgeoning life sciences scene is kicking off 2024 with optimism as the city prepares to host major conferences like Anglonordic. Discover how antibody discovery biotechs like Alchemab are driving growth and innovation in the sector.
Five Deaths in Prostate Cancer Trial Send MacroGenics’ Stock Plummeting
BioSpace
MAY 10, 2024
Two of the five fatalities were found to be unrelated to MacroGenics’ investigational antibody-drug conjugate vobra duo, while the other three are still under investigation.
Reuters Pharma Europe 2024 – Peter Stenico
pharmaphorum
MAY 10, 2024
An insightful interview with Peter Stenico, global head of biosimilars and country president, Sandoz Austria at Reuters Pharma Europe, Barcelona 2024
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.
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