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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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.
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.
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.
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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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.
Tectonic bets on GPCR heart failure drug following reverse merger with Avrobio
Pharmaceutical Technology
JUNE 21, 2024
The company has also raised $130.7m in a private placement, which along with Tectonics' previous cash reserves.
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 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
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
New ‘space hairdryer’ to regenerate heart tissue after bypass surgery
Pharma Times
JUNE 21, 2024
According to WHO, cardiovascular diseases are responsible for 17.
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
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.
Chimps’ self-medication with plants could aid drug discovery
pharmaphorum
JUNE 21, 2024
Chimps’ self-medication with plants could aid drug discovery Phil.
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.
Leriglitazone halts progression of fatal neurodegenerative disorder
Drug Discovery World
JUNE 21, 2024
Leriglitazone has been shown to halt disease progression in adult patients with early cerebral adrenoleukodystrophy (cALD) in a compassionate-use study. cALD is a fatal neurodegenerative disorder that is characterised by growing, demyelinating brain lesions, with death occurring typically within three to four years of onset. The study was led by Fanny Mochel, Professor at the Hôspital Universitaire La Pitié-Salpêtrière (Paris, France), as part of an early-access programme through the French nati
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.
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.
Phase II trial investigates allogeneic CAR-T for large B-cell lymphoma
Drug Discovery World
JUNE 21, 2024
Allogene Therapeutics and Foresight Diagnostics have announced the initiation of a Phase II trial evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line treatment regimen for newly diagnosed large B-cell lymphoma (LBCL) patients who are likely to relapse. The ALPHA3 trial will screen patients who are likely to relapse after first line treatment for enrolment in the trial by using the Foresight Clarity Investigational Use Only (IUO) measurable residual disease (MRD
New patent for Fennec Pharms drug PEDMARK
Drug Patent Watch
JUNE 21, 2024
Annual Drug Patent Expirations for PEDMARK Pedmark is a drug marketed by Fennec Pharms Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. This drug has thirty-six patent family members in thirteen countries. The generic ingredient in PEDMARK is sodium thiosulfate.
ENaC blocker enhances mucus clearance in cystic fibrosis models
Drug Discovery World
JUNE 21, 2024
A preclinical study in cystic fibrosis sheep models has demonstrated that low doses of the ENaC blocker ETD001 can enhance airway mucus clearance with a long duration of action. The study indicates that ETD001, at a dose level that was well tolerated in healthy volunteers, provides an opportunity to test whether a long-acting ENaC blocker can deliver benefit to people with cystic fibrosis (pwCF).
Roles and Responsibilities of Specialized Clinical Supply Experts
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
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