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.
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.
Pharmaceutical Technology
JULY 3, 2024
Academic institutions and nonprofit organisations are jumping in to save access to complex gene therapies.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Pharma Times
JULY 3, 2024
Dementias, including Alzheimer’s disease, are estimated to affect 944,000 people in the UK
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.
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
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.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Drug Patent Watch
JULY 2, 2024
The pharmaceutical industry is a high-stakes arena where innovation, investment, and intellectual property (IP) protection intersect.
Outsourcing Pharma
JULY 2, 2024
NeuroSense Therapeutics has announced positive phase 2b results for a drug combination designed to treat amyotrophic lateral sclerosis (ALS).
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
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.
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.
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.
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.
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.
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
JULY 2, 2024
The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.
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 1, 2024
ASCO 2024 conference highlights the latest advancements in oncology, emphasising the art and science behind enhanced cancer care. Stay updated on the latest research, treatments, and innovations in the field of oncology.
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.
Advertisement
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.
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).
Fierce Pharma
JULY 2, 2024
In recent months, frequent pharma critic Sen. | As the November U.S. elections near, it's clear that drug pricing will remain an important topic for voters and politicians. In a Tuesday op-ed, President Joe Biden and Sen. Bernie Sanders placed a spotlight on Novo Nordisk and Eli Lilly's drug pricing.
pharmaphorum
JULY 2, 2024
The field of muscle stem cell research has been tangibly developing over the decades and in today’s pharmaphorum podcast wed editor Nicole Raleigh speaks with Dr Michael Rudnicki, co-founder and CSO of Satellos Biosciences, a company dedicated to developing novel therapeutics based on this science for those who live with Duchenne muscular dystrophy (DMD) and other degenerative muscle diseases.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
Advertisement
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.
Let's personalize your content