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.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
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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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
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.
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.
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
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.
10 clinical trials to watch in the second half of 2024
Bio Pharma Dive
JULY 1, 2024
Study results are expected for a pair of closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.
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
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.
Study reveals mobile phone data can help map the spread of pathogens
Pharma Times
JULY 5, 2024
Pneumococcus is the leading cause of pneumonia, meningitis and sepsis worldwide
Sobi starts rolling FDA filing for chronic gout drug
pharmaphorum
JULY 2, 2024
Sobi starts rolling application for refractory gout drug SEL-212 in the US, hoping to take on Amgen’s Krystexxa in the market.
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.
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.
Eli Lilly’s donanemab wins FDA approval for Alzheimer’s disease
Pharmaceutical Technology
JULY 2, 2024
Leqembi will now face a challenger as donanemab enters the market under the brand name Kisunla.
ICL granted £150,000 to explore link between breast cancer and breastfeeding
Pharma Times
JULY 1, 2024
Breast cancer is the most common cancer in the UK, accounting for 15% of all cancers
Sanofi and Regeneron's Dupixent scores in Europe as the first biologic to treat COPD
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.
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.
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.
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.
Study reveals genetic mutations associated with aggressive prostate cancer
Pharma Times
JULY 4, 2024
Aggressive prostate cancer accounts for up to 15% of all prostate cancer diagnoses
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.
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.
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).
Researchers find whole genome sequencing improves care for paediatric cancer
Pharma Times
JULY 2, 2024
Affecting around 3,755 young people in the UK every year, leukaemia is the most commonly diagnosed cancer in children
Why informed patient consent is vital for successful clinical trials
pharmaphorum
JULY 1, 2024
Informed patient consent is crucial for the success of clinical trials. Learn about the importance of consent in clinical trials and how it impacts the outcomes.
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.
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.
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