pharmaphorum
JULY 3, 2024
GSK has upgraded its longstanding alliance with CureVac on mRNA-based vaccines for respiratory infections, paying €400 million ($429 million) upfront for global rights to its influenza and COVID-19 jabs.
Bio Pharma Dive
JULY 3, 2024
Multibillion-dollar buyouts from Bristol Myers Squibb and Gilead could yield new drugs for brain and liver diseases, while a new cell therapy may reach market.
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Pharmaceutical Technology
JULY 3, 2024
Academic institutions and nonprofit organisations are jumping in to save access to complex gene therapies.
Bio Pharma Dive
JULY 3, 2024
The mRNA specialist plans to eliminate 30% of its workforce as part of a restructuring that will prioritize “high-value” projects like its cancer vaccines.
Pharmaceutical Technology
JULY 3, 2024
Johnson & Johnson (J&J) has received the US FDA and EC approvals for SIRTURO (bedaquiline) to treat pulmonary tuberculosis (TB).
Bio Pharma Dive
JULY 3, 2024
Forbion led the startup’s Series B round. Elsewhere, Vertex got an FDA decision date for its “vanza triple” and Dupixent won a marketing green light in Europe for COPD.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
JULY 3, 2024
The US Food and Drug Administration (FDA) Foods Program has released an update on its priority guidance topics for 2024. The update includes a list of draft and final guidance documents that the agency aims to complete this year. Since January, the FDA has issued several important guidelines on this list, providing crucial insights for industry stakeholders.
Pharmaceutical Technology
JULY 3, 2024
Beacon’s lead candidate AGTC-501 is currently in a Phase II/III clinical trial for the treatment of X-linked retinitis pigmentosa (XLRP).
XTalks
JULY 3, 2024
Verona Pharma has received US Food and Drug Administration (FDA) approval for Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disorder (COPD). COPD is a progressive lung disease that results in breathing problems, chronic coughs and fatigue. It includes conditions like emphysema and chronic bronchitis. According to the World Health Organization (WHO), COPD is the third leading cause of death worldwide with 3.23 million deaths in 2019 alone.
Pharmaceutical Technology
JULY 3, 2024
Metal contamination in pharmaceutical products is a huge problem. Detection and removal of these contaminants is critical during milling.
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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
pharmaphorum
JULY 3, 2024
Eli Lilly finally has FDA approval for its amyloid-busting Alzheimer’s disease therapy donanemab and will launch it at a cost it claims could deliver savings compared to a rival therapy from Eisai/Biogen.
Pharmaceutical Technology
JULY 3, 2024
Moderna has received a grant of $176m through the RRPV Consortium to expedite the development of mRNA-based pandemic influenza vaccines.
pharmaphorum
JULY 3, 2024
Beacon Therapeutics raises $170m for a pivotal trial of its gene therapy for X-linked retinitis pigmentosa, an inherited cause of blindness
Pharmaceutical Technology
JULY 3, 2024
Emergent will supply vaccines for anthrax and smallpox, VIV for treating smallpox vaccine complications, and a botulism antitoxin.
Pharma Times
JULY 3, 2024
Dementias, including Alzheimer’s disease, are estimated to affect 944,000 people in the UK
Pharmaceutical Technology
JULY 3, 2024
The EMA has granted approval to Sanofi's Dupixent for adults with uncontrolled chronic obstructive pulmonary disease (COPD).
Pharma Times
JULY 3, 2024
Chronic migraine is a neurological condition estimated to affect up to 2.
Pharmaceutical Technology
JULY 3, 2024
The takeover, which includes the candidate felzartamab, for immune-mediated diseases, diversifies Biogen’s scope.
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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.
XTalks
JULY 3, 2024
Eli Lilly’s anti-amyloid therapy Kisunla (donanemab-azbt) finally meets success as it received full approval from the US Food and Drug Administration (FDA) for the treatment of individuals with mild cognitive impairment (MCI) or mild dementia stage of Alzheimer’s disease (AD). The once-monthly injection for intravenous (IV) infusion is specifically approved for adults with early symptomatic AD, which includes people with MCI as well as people with the mild dementia stage of AD, with confirmed am
pharmaphorum
JULY 3, 2024
EU is first to approve Sanofi and Regeneron's Dupixent for COPD, ending a 10-year hiatus in new therapies
Fierce Pharma
JULY 3, 2024
After more than a decade with no treatment advances for chronic obstructive pulmonary disease (COPD), two have been approved by regulators on either side of the Atlantic within a week. | After more than a decade with no treatment advances for chronic obstructive pulmonary disease (COPD), two have been approved by regulators on either side of the Atlantic within a week.
pharmaphorum
JULY 3, 2024
J&J’s multiple myeloma CAR-T Carvykti improves survival when used as a second-line or later therapy, raising the pressure on BMS’ rival Abecma
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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
Drug Patent Watch
JULY 3, 2024
Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.
Drug Discovery World
JULY 3, 2024
Circio has announced updated in vivo data that demonstrates a substantial durability advantage of Circio’s circVec technology over conventional mRNA expression. In addition, Circio has undertaken sequence optimisation resulting in a new circVec 2.2 design. “The circVec 2.1 design is performing very well in vivo , and Circio has now validated expression for up to five months.
Drug Patent Watch
JULY 3, 2024
Annual Drug Patent Expirations for AKEEGA Akeega is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug.
Drug Discovery World
JULY 3, 2024
DDW’s Megan Thomas talks to Nicola McCarthy, Head of Research at the Milner Therapeutics Institute. MT: Could you start by giving me your name, your job title and what you do? NM: I’m Head of Research at the Milner Therapeutics Institute, which is part of the University of Cambridge, and I oversee both wet and dry labs of the institute. MT: Can you provide a top-line summary of your research?
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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.
XTalks
JULY 3, 2024
In this episode, Ayesha spoke with Lawrence Blatt, PhD, MBA, Chairman and CEO of Aligos Therapeutics , a company developing targeted therapies for liver diseases like MASH (metabolic dysfunction-associated steatohepatitis) and viral diseases to address important unmet medical needs. Prior to co-founding Aligos Therapeutics, Dr. Blatt served as the Global Head of Infectious Diseases and Vaccines at Janssen Pharmaceutical Companies of Johnson & Johnson from 2014 to 2018.
Drug Discovery World
JULY 3, 2024
By DDW Editor Reece Armstrong The upcoming general election in the UK has placed the priorities of the country into the spotlight and the drug discovery sector should in no way be forgotten. Economic uncertainty, challenging global conditions and a healthcare system facing serious pressures, means that whatever government takes the reigns come 4 July, they’ll be indebted with numerous burdens.
Intouch Solutions
JULY 3, 2024
This year’s Worldwide Developers Conference (WWDC) wasn’t just about the next iPhone. Apple unveiled a range of exciting developments, including visionOS 2 for enhanced augmented reality, intuitive AirPod gestures and even personalized Genmoji (generative Emojis) you can create at will. But the true star of the show was Apple Intelligence, a significant investment in on-device AI that promises to transform how we interact with our Apple devices.
Drug Discovery World
JULY 3, 2024
Researchers in Japan have revealed why geometric variants of doxepin have markedly different efficacies, paving the way to next-generation antihistamines with fewer side effects. Doxepin is an antihistaminic, antidepressant, and sleeping aid that has two geometric isomers – molecules with equal chemical formulas but different 3D arrangements. While its Z-isomer is known to be more effective than its E-isomer, the precise nature of its binding to the histamine H1 receptor previously remained elu
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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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