5 FDA decisions to watch in the third quarter
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.
Sat.Jun 29, 2024 - Fri.Jul 05, 2024
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Left in limbo: When pharma halts rare disease research
Pharmaceutical Technology
JULY 3, 2024
Academic institutions and nonprofit organisations are jumping in to save access to complex gene therapies.
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Study reveals cardiovascular health could be biggest risk factor for dementia
Pharma Times
JULY 3, 2024
Dementias, including Alzheimer’s disease, are estimated to affect 944,000 people in the UK
July 1, 2024: Latest Podcast Features Michael Pencina and Brian Anderson of Coalition for Health AI
Rethinking Clinical Trials
JULY 1, 2024
In a new episode of our Rethinking Clinical Trials podcast, Drs. Michael Pencina and Brian Anderson of the Coalition for Health AI speak with host Dr. Adrian Hernandez about public-private partnerships in a trustworthy health AI ecosystem. Pencina and Anderson presented on their experiences during the March 8 session of PCT Grand Rounds. Listen and subscribe to the podcast on SoundCloud or Apple Podcasts , and view the full March 8 PCT Grand Rounds webinar.
Which pharmaceutical drugs have the most drug patents in Slovakia?
Drug Patent Watch
JULY 2, 2024
This chart shows the drugs with the most patents in Slovakia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.
Verona’s COPD Drug Ohtuvayre (ensifentrine) Gets FDA Nod
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.
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Gene therapy halts progression of rare genetic condition
Drug Discovery World
JULY 3, 2024
The findings from a single-patient gene therapy trial in Canada show promise in halting the progression of spastic paraplegia type 50 (SPG50). SPG50 is an ultra-rare progressive neurodegenerative disorder that causes developmental delays, speech impairment, seizures, progressive paralysis of all four limbs, and is typically fatal by adulthood. Approximately 80 children around the world are affected by the condition.
The Power of Patience: Delaying Patents to Enhance Pharma Market Exclusivity
Drug Patent Watch
JULY 2, 2024
The pharmaceutical industry is a high-stakes arena where innovation, investment, and intellectual property (IP) protection intersect.
ALS treatment PrimeC slows disease progression by 36% phase 2b trial results show
Outsourcing Pharma
JULY 2, 2024
NeuroSense Therapeutics has announced positive phase 2b results for a drug combination designed to treat amyotrophic lateral sclerosis (ALS).
Beacon lights up with $170m for retinal disease gene therapy
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
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
Cartesian data add to progress, questions for CAR-T in autoimmune disease
Bio Pharma Dive
JULY 2, 2024
The company claimed Phase 2 study results prove the therapy’s promise treating myasthenia gravis. But shares lost more than a quarter of their value amid questions about the data.
UK’s antibiotic subscription funding model – a route to market sustainability?
Pharmaceutical Technology
JULY 1, 2024
On 8 May, the UK was the world's first government to formally implement a new model for the funding and support of novel antibiotic commercialisation.
Game on: Lilly's Alzheimer's drug Kisunla, a challenger to Biogen and Eisai's Leqembi, gains full FDA nod
Fierce Pharma
JULY 2, 2024
After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy—and a competitor to Eisai and Bioge | After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy, a competitor to Eisai and Biogen’s Leqembi, a full approval.
Changing Faces: Digital and supplier hires from April 2024
pharmaphorum
JULY 4, 2024
Changing Faces explores the digital and supplier hires from April 2024, with a focus on companies like SPT Labtech, Sphere Fluidics, Newel Health, and Diaceutics. Stay updated on the latest developments in the industry.
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.
Lilly drug for Alzheimer’s approved by FDA
Bio Pharma Dive
JULY 2, 2024
The drug, which Lilly will sell as Kinsunla, carries a warning for the risk of a certain kind of imaging abnormality that can be serious in rare cases.
EMA fast-tracks review of AstraZeneca’s sipavibart to stop Covid
Pharmaceutical Technology
JULY 2, 2024
The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.
Drug’s unique mechanism of action targets schizophrenia abnormalities
Drug Discovery World
JULY 5, 2024
Newron Pharmaceuticals has reported new findings of mechanism of action that indicate its drug candidate evenamide could be uniquely effective in patients with treatment resistant schizophrenia (TRS). The drug’s unique mechanism of action targets the core abnormalities in patients with schizophrenia and reduces hippocampal dopaminergic activity, improving symptoms of psychosis, social interactions and cognition.
Frontiers Health 2024: The foundational pillars
pharmaphorum
JULY 3, 2024
Frontiers Health, a prominent event in health innovation, has unveiled the foundational pillars that will define its legacy and future trajectory. The announcement of these pillars precedes their global conference, scheduled for the 17th and 18th of October in Berlin.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Eisai and Bristol Myers cancel cancer ADC deal
Bio Pharma Dive
JULY 1, 2024
The Japan-based drugmaker said its U.S. partner’s “portfolio prioritization efforts” led to the termination. It will refund part of an upfront payment.
Innovent sells its share in CAR T-cell therapy to IASO Bio for 18% equity
Pharmaceutical Technology
JULY 5, 2024
Fucaso, a BCMA CAR T-cell therapy, is co-developed by Innovent and IASO Bio and was approved to treat multiple myeloma in China last month.
FDA Foods Program: Key Priority Guidance Updates for 2024
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.
Labour, the NHS, and life sciences: Partnerships and people
pharmaphorum
JULY 5, 2024
Explore the vital partnerships and people involved in shaping Labour's policies on the NHS, healthcare, and life sciences during the general election. Learn more about the key areas of focus and priorities.
Moderna gets US funding for bird flu vaccine development
Bio Pharma Dive
JULY 2, 2024
BARDA will provide Moderna with $176 million to advance late-stage testing of an H5 influenza shot, as health officials monitor animal outbreaks.
Eisai and Bristol Myers Squibb terminate ADC development deal
Pharmaceutical Technology
JULY 2, 2024
Eisai has announced the termination of a deal with Bristol Myers Squibb to jointly develop and commercialise farletuzumab ecteribulin (FZEC).
Emergent BioSolutions bags $250M in contract modifications to help boost US supply of medical countermeasures
Fierce Pharma
JULY 2, 2024
With four contract modifications totaling more than $250 million, the government is leveling up its agreements with long-time medical countermeasures supplier Emergent BioSolutions. | The drugmaker will supply its anthrax vaccine Cyfendus, its smallpox vaccine and two other drugs to help bolster the U.S. government's medical countermeasures stockpile.
Innovation in generics: Increased efficiency through peptide API synthesis expertise
pharmaphorum
JULY 5, 2024
Discover how innovative approaches and specialised expertise in peptide API synthesis are increasing efficiency and driving advancements in the manufacturing of Active Pharmaceutical Ingredients (API).
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.
Eli Lilly inks another radiopharma deal, gaining option to buy startup
Bio Pharma Dive
JULY 1, 2024
Under an arrangement with Radionetics, Lilly will have rights to acquire the San Diego biotechnology company for $1 billion.
AstraZeneca’s Tagrisso plus chemotherapy wins EU approval for NSCLC
Pharmaceutical Technology
JULY 5, 2024
Approval is based on positive data from the Phase III FLAURA2 trial where Tagrisso plus chemotherapy showed PFS of 24.4 months.
NeuroSense Therapeutics shares positive results of lead candidate in ALS
Pharma Times
JULY 5, 2024
The neurodegenerative disease currently affects more than 200,000 people worldwide
GSK goes all-in on CureVac’s mRNA vaccines
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.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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