KCL’s mini liver model promises more effective drug testing method
Pharma Times
JUNE 21, 2024
The method provides a more accurate and ethical approach to drug testing for medicines
Fri.Jun 21, 2024
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Duchenne approval exposes FDA rift over Sarepta gene therapy
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.
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WHO warns of “harmful” fake Ozempic in circulation in Americas and Europe
Pharmaceutical Technology
JUNE 21, 2024
Both Novo Nordisk and Eli Lilly have filed lawsuits against unapproved sellers of their diabetes and weight loss drugs.
Jazz drug for tremor fails study; Radiopharma drug developer ITM swaps CEOs
Bio Pharma Dive
JUNE 21, 2024
A medicine Jazz acquired in 2019 missed the goal of a Phase 2 study. Elsewhere, Vanda rejected two takeover bids and Ashibio emerged from stealth with an antibody licensed from Gilead.
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
EHA 2024: Monoclonal antibodies continue to dominate multiple myeloma treatments
Pharmaceutical Technology
JUNE 21, 2024
Trial investigators anticipate that the FDA will decide on approval for linvoseltamab in relapsed/refractory multiple myeloma by the end of 2024.
Exploring the Future of Oncology with ADCs and TILs: Key Insights From ASCO
Worldwide Clinical Trials
JUNE 21, 2024
The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Worldwide Clinical Trials attends each year to hear from the research community, connect with our sponsors and sites, and explore potential partnerships to drive forward novel treatments.
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New ‘space hairdryer’ to regenerate heart tissue after bypass surgery
Pharma Times
JUNE 21, 2024
According to WHO, cardiovascular diseases are responsible for 17.
Sarepta’s Elevidys secures US label expansion for DMD
Pharmaceutical Technology
JUNE 21, 2024
Sarepta’s stock rose by over 36% following the positive news of the FDA expanding the gene therapy’s US label.
African vaccine manufacturing initiative aims to provide $1B to local firms over next decade
Fierce Pharma
JUNE 21, 2024
Amid an influx of efforts to help the African continent claim vaccine sovereignty, a new financing mechanism devised by Gavi, the Vaccine Alliance, the African Union and the Africa Centres for Dise | Amid an influx of efforts to help the African continent claim vaccine sovereignty, a new financing mechanism devised by Gavi, the Vaccine Alliance, the African Union and the Africa Centres for Disease Control and Prevention (Africa CDC) has taken flight.
Will WHO’s new guidance spur hepatitis B immunisation?
Pharmaceutical Technology
JUNE 21, 2024
Based on the updated guidelines, over 50% of individuals with chronic hepatitis B infections may require treatment.
Vertex clinches Trikafta and other cystic fibrosis drug reimbursement deal in England
Fierce Pharma
JUNE 21, 2024
Cystic fibrosis (CF) patients and their families in England can rest a little easier this week, thanks to an extended long-term reimbursement deal inked by Vertex Pharmaceuticals and the country’s | Cystic fibrosis (CF) patients and their families in England can rest a little easier this week, thanks to an extended long-term reimbursement deal inked by Vertex Pharmaceuticals and the country’s National Health Service (NHS).
AstraZeneca’s Truqap and Faslodex combo receives approval in EU
Pharmaceutical Technology
JUNE 21, 2024
AstraZeneca has received approval for Truqap in combination with Faslodex in the EU to treat certain advanced breast cancer cases in adults.
The new genomic frontier: Next-generation data management takes flight
pharmaphorum
JUNE 21, 2024
Explore the latest advancements in genomics and sequencing technologies, and learn how next-generation data management tools are transforming genomic research and applications in this new genomic frontier.
Sanofi and Biovac partner to produce polio vaccines in Africa
Pharmaceutical Technology
JUNE 21, 2024
Sanofi and Biovac have announced a partnership to establish the first African-based manufacturing capabilities for polio vaccines.
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
A closer look at 'friend-shoring' and the drug shortage challenge
Fierce Pharma
JUNE 21, 2024
In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals, to discuss the concept of “friend-shoring” in drug manufacturing.< | In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals, to discuss the concept of “friend-shoring” in drug manufacturing.
Johnson & Johnson seeks FDA approval for Tremfya for Crohn’s disease
Pharmaceutical Technology
JUNE 21, 2024
Johnson & Johnson (J&J) has submitted an sBLA seeking approval from the US FDA for Tremfya (guselkumab) to treat Crohn’s disease.
Gilead’s twice-yearly HIV PrEP 100% effective, says study
pharmaphorum
JUNE 21, 2024
Twice-yearly lenacapavir injection provides 100% protection from HIV when used as PrEP in cisgender women, says Gilead.
Emergent to sell US sterile manufacturing facility to Bora
Pharmaceutical Technology
JUNE 21, 2024
Emergent BioSolutions has agreed to divest its sterile manufacturing facility in Baltimore-Camden, Maryland, to Bora Pharmaceuticals.
Merck’s Capvaxive Wins FDA Approval as First Pneumonia Vaccine Designed for Adults
XTalks
JUNE 21, 2024
The US Food and Drug Administration (FDA) has green-lighted the first pneumonia vaccine specifically designed for adults 50 years of age and older. The approval was granted to Merck’s 21-valent pneumococcal conjugate vaccine Capvaxive (formerly V116) for the prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia in adults. While Merck says the vaccine is specifically designed for adults and covers serotypes that cause about 84 percent of IPD in adults 50 years of age and ol
South Korea seeks to accelerate drug reimbursement administration process
Pharmaceutical Technology
JUNE 21, 2024
South Korea is moving forward with reforming its national health insurance system to improve patients' access to healthcare support under the Second Stage Comprehensive Insurance Plan, for the period 2024-28.
Chimps’ self-medication with plants could aid drug discovery
pharmaphorum
JUNE 21, 2024
Chimps’ self-medication with plants could aid drug discovery Phil.
Pharma Pulse 6/21/24: Global Mortality and Disability from Type 1 Diabetes Have Decreased, What Leaders of Effective Teams Know & more
Pharmaceutical Commerce
JUNE 21, 2024
Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.
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.
NWEH says module cuts side effect reporting burden in trials
pharmaphorum
JUNE 21, 2024
NWEH launches software that takes legwork out of serious adverse event reporting in clinical trials and could reduce costs.
Argenx's Vyvgart Hytrulo snares 2nd US nod as FDA gives green light in autoimmune disease CIDP
Fierce Pharma
JUNE 21, 2024
For more than a decade, argenx has sought to apply its novel antibody fragment treat | Argenx's Vyvgart has won approval to treat its second indication in the U.S. and its third globally after the U.S. FDA cleared the med to treat the rare and debilitating peripheral nervous system disease chronic inflammatory demyelinating polyneuropathy (CIDP).
Sustainable innovation for patients, people, and planet
pharmaphorum
JUNE 21, 2024
Sustainability is all important for the planet and its people, and in today’s podcast web editor Nicole Raleigh speaks with Harriet Lewis, director of public affairs and communications at Chiesi UK & Ireland, about how partnerships between the NHS and pharma industry can support the journey to more sustainable practices, from R&D and drug reimbursement to medicines and recycling.
Mark Cuban: Five Ways that Big PBMs Hurt U.S. Healthcare–And How We Can Fix It (rerun)
Drug Channels
JUNE 21, 2024
This week, I’m rerunning some popular posts while I prepare for today's live video webinar: The 340B Drug Pricing Program: Trends, Controversies, and Outlook. The webinar begins at 12:00 PM ET. Click here to see the original post from March 2024. Today’s guest post comes from Mark Cuban, co-founder of the Mark Cuban Cost Plus Drug Company A few weeks ago, Mark participated in the White House Roundtable on Lowering Healthcare Costs and Bringing Transparency to Prescription Drug Middlemen.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
ASCO 2024 - Scot Ebbinghaus
pharmaphorum
JUNE 21, 2024
Watch the exclusive video interview with Scot Ebbinghaus at ASCO 2024 as he shares insights and updates on the latest developments in cancer research.
New tentative approval for Alembic drug dabigatran etexilate mesylate
Drug Patent Watch
JUNE 21, 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. There are three patents protecting this compound. Drug patent litigation for DABIGATRAN ETEXILATE MESYLATE. Nine suppliers are listed for this compound.
Market Access and the Inflation Reduction Act
Intouch Solutions
JUNE 21, 2024
The Inflation Reduction Act of 2022 (IRA) institutes Medicare changes that include the ability to negotiate drug prices, limit price increases and cap out-of-pocket costs for beneficiaries. Understanding the far-reaching implications of these provisions is crucial for market access professionals to successfully navigate the new dynamics and plan for success in the future.
Ethical Review & AI in Clinical Trials
WCG Clinical
JUNE 21, 2024
This content is password protected. To view it please enter your password below: Password: The post Ethical Review & AI in Clinical Trials appeared first on WCG.
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.
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