BioSpace
JUNE 16, 2024
The use of artificial intelligence in the development of cancer vaccines allows for individualized therapy, but the prospect of an ever-changing product poses new challenges for drug developers and regulators.
Bio Pharma Dive
JUNE 27, 2024
A growing cohort of biotechs, from Biohaven to Neurocrine to Jazz, hope research on ion channels will bring them new drugs and big business — much like it has done for Vertex.
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Pharmaceutical Technology
JUNE 17, 2024
Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.
Fierce Pharma
JUNE 20, 2024
For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.
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
Fierce Pharma
JUNE 26, 2024
In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate (ADC) patritumab deruxtecan. | In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate patritumab deruxtecan.
Antidote
JUNE 10, 2024
Also known as endometrial carcinoma or uterine cancer, endometrial cancer occurs when the cells that line the uterus begin growing uncontrollably. Though the mortality rates are relatively low due to the high rate of early detection, it is a cancer that impacts nearly 70,000 people every year.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
JUNE 17, 2024
One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.
Pharmaceutical Technology
JUNE 26, 2024
AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).
pharmaphorum
JUNE 28, 2024
Progress on ovarian cancer treatments has been slow, despite promising drugs like Keytruda and Lynparza. Learn about the obstacles and challenges in developing effective treatments for this deadly disease.
Fierce Pharma
JUNE 7, 2024
Once hailed as an anti-aging magic bullet, telomerase has failed to live up to the hype as it was profiled in a | The FDA has approved Geron Corporation's Rytelo (imetelstat) to treat a group of bone marrow disorders called myelodysplastic syndrome (MDS). The approval is the first for the 33-year-old California biotech.
FDA Law Blog
JUNE 13, 2024
By Sara W. Koblitz — As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. The FTC has put out policy statements, challenged patent listings, tapped Congress, appeared on talk shows, and filed amicus briefs all in the span of the last 8 months. It seems like all that work is paying off.
BioSpace
JUNE 19, 2024
PTC Therapeutics said Thursday the FDA has lifted a partial clinical hold on its Huntington’s disease candidate PTC518 after displaying favorable clinical trends in a mid-stage study.
Bio Pharma Dive
JUNE 21, 2024
Peter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could have a “lasting impact” on gene therapy as well as the FDA, one analyst wrote.
Pharmaceutical Technology
JUNE 24, 2024
The osteoporosis market is expected to grow at a compound annual growth rate of 5.4% from 2023 to 2032, reaching $17.9bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) by the end of this forecast period, according to leading data and analytics company GlobalData’s recent report: Osteoporosis: Seven-Market Drug Forecast and Market Analysis.
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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
JUNE 3, 2024
Understanding the challenges and opportunities in transitioning to IVDR for pharmacogenomics can be complex. Learn more about how to overcome these challenges effectively.
Fierce Pharma
JUNE 11, 2024
Right after signing on to help with bird flu pandemic preparedness efforts in the U.S., CSL Seqirus has agreed to do the same in Europe through a vaccine supply pact. | The vaccine maker will deliver 665,000 doses of its avian flu-matched pre-pandemic vaccine. Under a 4-year contract, authorities can purchase up to 40 million doses.
FDA Law Blog
JUNE 12, 2024
By Sara W. Koblitz & Jeffrey N. Gibbs — It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated. (FDA once estimated that OTC hearing aids would save patients over $3000.) A recent GAO Report hasn’t found that OTC hearing aids have had much impact.
BioPharma Reporter
JUNE 18, 2024
New data from a phase 1 clinical trial shows complete remission in 92% of lupus patients treated with a compound CAR (cCAR) T cell therapy
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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.
Bio Pharma Dive
JUNE 6, 2024
The agency is seeking input from an advisory panel on whether donanemab is effective across different groups of Alzheimer's patients, and on an unusual dosing strategy used by Lilly.
Pharmaceutical Technology
JUNE 25, 2024
Novavax has sought EMA approval for its updated JN.1 Covid-19 vaccine, NVX-CoV2705, for people aged 12 years and above.
pharmaphorum
JUNE 19, 2024
An AI-powered blood test that may be able to predict Parkinson’s years before symptoms develop could allow earlier treatment and guide trials of new treatments
Fierce Pharma
JUNE 12, 2024
As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target | As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target comes along.
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.
FDA Law Blog
JUNE 10, 2024
By Sarah Wicks & Anne K. Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program.
Pharma Times
JUNE 10, 2024
Hypertrophic cardiomyopathy is a rare condition that affects up to 1,000 children in the UK
Bio Pharma Dive
JUNE 7, 2024
A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.
Pharmaceutical Technology
JUNE 18, 2024
Johnson & Johnson has filed a BLA with the US FDA seeking approval for SC amivantamab for the treatment of non-small cell lung cancer.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
pharmaphorum
JUNE 24, 2024
Explore how digital twins are transforming healthcare and drug discovery, with success stories showcasing their impact in the biopharma industry. Learn about their journey from concept to real-world applications.
Fierce Pharma
JUNE 18, 2024
Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.
BioPharma Reporter
JUNE 10, 2024
AbbVie has announced that the Scottish Medicines Consortium (SMC) has approved Tepkinly (epcoritamab) for adults with diffuse large B-cell lymphoma (DLBCL) who have not responded to or have relapsed after at least two prior treatments.
JAMA Internal Medicine
JUNE 6, 2024
This randomized clinical trial evaluates the efficacy of oral nirmatrelvir-ritonavir for treatment of moderate to severe postacute sequelae of SARS-CoV-2 infection of 3 months or longer duration.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
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