Acorda files for bankruptcy, reveals asset sale plan
Bio Pharma Dive
APRIL 2, 2024
Stalking horse bidder Merz Therapeutics could get rights to Acorda’s three marketed drugs if its $185 million proposal holds.
Tue.Apr 02, 2024
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IPC’s Pharmacovigilance Programmes complements CDSCO & Pharmexcil initiatives to fortify patient safety
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 2, 2024
In a concerted effort to bolster patient safety measures within the healthcare landscape, the Indian Pharmacopoeia Commission (IPC) is set to roll out its Skill Development Programmes on Pharmacovigilance.
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Verve pauses base editing study after treatment side effect
Bio Pharma Dive
APRIL 2, 2024
Lab test abnormalities in one study participant led the company to halt enrollment and prioritize a different version of its gene editing therapy for heart disease.
The Hidden Cause of Alzheimer’s May Have Been Identified a Century Ago
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 2, 2024
Alzheimer’s disease is commonly associated with clumps and tangles of proteins building up in brain cells. Yet for more than a century, accumulations of a completely different material have also been linked with the neurodegenerative condition.
Ginkgo, in search of more cell therapy tools, buys another startup
Bio Pharma Dive
APRIL 2, 2024
An acquisition of Modulus Therapeutics is the latest move by Ginkgo to accumulate technologies that can help other companies develop cellular medicines.
Magazine: What’s next for AAV gene therapies in 2024?
Pharmaceutical Technology
APRIL 2, 2024
In this issue: High-profile gene therapies that use AAV vectors, new research into HIV-TB coinfection treatments, traceability technologies for the supply chain, and more.
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Edenbridge selects PANTHERx to distribute Yargesa capsules
Pharmaceutical Technology
APRIL 2, 2024
Edenbridge Pharmaceuticals has selected PANTHERx Rare to distribute Yargesa (miglustat) capsules for the treatment of Type 1 Gaucher disease.
Gritstone shares fall on shaky study results for colorectal cancer vaccine
Bio Pharma Dive
APRIL 2, 2024
While the company claimed its shot showed signs of working in a Phase 2 trial, the data weren’t strong enough to prove a treatment benefit.
Cellenkos links with Mount Sinai to explore CK0804 for myelofibrosis
Pharmaceutical Technology
APRIL 2, 2024
Cellenkos has signed a sponsored research agreement with the Icahn School of Medicine at Mount Sinai, New York, to investigate CK0804.
A dementia-focused VC digs past amyloid for new kinds of brain drugs
Bio Pharma Dive
APRIL 2, 2024
The Dementia Discovery Fund set out to spark research into new approaches for diseases like Alzheimer’s, even as anti-amyloid therapies reach patients.
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
FDA settles ivermectin lawsuit, removes contentious COVID-19 posts
BioPharma Reporter
APRIL 2, 2024
The FDA has agreed to permanently remove several social media posts urging people not to take ivermectin for the treatment of COVID-19, after a lawsuit brought by three doctors accused the regulatory body of interfering with their ability to practice medicine.
Merz makes a $185m bid for assets from bankrupt Acorda
Pharmaceutical Technology
APRIL 2, 2024
Merz placed a “stalking horse bid” for Acorda’s Parkinson’s disease and multiple sclerosis treatments.
ICR collaboration forms national NHS patient database registry for Lynch syndrome patients
Pharma Times
APRIL 2, 2024
The genetic condition affects one in 279 people in England and significantly increases cancer risk
Xilio fires 21% of its workforce and reprioritises pipeline
Pharmaceutical Technology
APRIL 2, 2024
Xilio will focus its resources on clinical development plans for two Phase I candidates, including an asset licenced to Gilead.
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
Eli Lilly's popular diabetes drug Mounjaro to face continued supply squeeze through April, FDA says
Fierce Pharma
APRIL 2, 2024
Amid steadily increasing demand for Eli Lilly’s popular diabetes med Mounjaro, it appears patients on multiple dose strengths may have to wait even longer than anticipated to re-up on supply. | Four dose strengths are now expected to be in short supply through April, according to the FDA. The agency previously expected the squeeze to let up at the end of March.
Overcoming the added patient burden in DCTs
Pharmaceutical Technology
APRIL 2, 2024
Using the right translation and accessibility tools can facilitate patient comprehension and avoid costly delays in DCTs.
Ending the silence: Why the menopause matters in the workplace
pharmaphorum
APRIL 2, 2024
Discover the importance of addressing menopause in the workplace and the benefits of hormone replacement therapy (HRT) through this insightful and informative article on breaking the stigma.
Eisai agrees to divest rights for two therapies to Kaken
Pharmaceutical Technology
APRIL 2, 2024
Eisai to sell rights for two of its long-standing products in Japan, Merislon and Myonal, to Kaken Pharmaceutical.
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.
Acorda inks $185M asset sale to Merz, files for bankruptcy after years of disappointing sales
Fierce Pharma
APRIL 2, 2024
After years of struggling with hurdles such as generic competition and significantly lower-than-expected sales of its top meds, Acorda Therapeutics is hanging up the gloves with a $185 million deal | Merz Therapeutics, in a "stalking horse bid," agreed to pick up Acorda's Parkinson's disease med Inbrija and multiple sclerosis drug Amprya ahead of a court auction.
Alexion’s Voydeya gains FDA approval for extravascular haemolysis
Pharmaceutical Technology
APRIL 2, 2024
Alexion has received the approval of the US Food and Drug Administration (FDA) for Voydeya as an add-on therapy.
How Food Tech Startups Are Navigating Funding Challenges
XTalks
APRIL 2, 2024
The landscape for food tech startups in the past year has been marked by a distinct tightening of investment belts, reflecting broader economic pressures and a shift in investor sentiment. According to data from Pitchbook , investments in early-stage food technology companies have been on a downward trajectory through the third fiscal quarter of 2023.
FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah)
FDA Law Blog
APRIL 2, 2024
By Sara W. Koblitz — Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress. This year is no different , and in fact some of the requests on this year’s list are repeat offenders from last year’s. And though FDA may not have gotten everything that it wanted last year, reviewing and reflecting on these lists of legislative proposals provides im
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.
‘Cliff’ Countdown: Balancing Internal and External Growth
Pharmaceutical Commerce
APRIL 2, 2024
In this Pharmaceutical Commerce video interview, Joerg Tritschler, a partner in Simon-Kucher’s life sciences division, explores the two major strategies big pharma companies are employing amid current macro challenges and efforts to offset looming patent losses to blockbuster brands.
Top 10 Most Environmentally Sustainable Pharma Companies in 2023/2024
XTalks
APRIL 2, 2024
While individuals are encouraged to do their part to safeguard the planet, big corporations have perhaps a more significant role to play given their large carbon footprints. The pharmaceutical industry is a large contributor to greenhouse gas (GHG) emissions. According to a 2019 study , the pharmaceutical industry produced 48.55 tonnes of CO 2 equivalent (CO 2 e) for every $1 million it earned.
Bora Pharmaceuticals completes Upsher-Smith acquisition, expanding North American footprint
Outsourcing Pharma
APRIL 2, 2024
Bora Pharmaceuticals Co., Ltd. yesterday (April 1) finalized the acquisition of Upsher-Smith Laboratories, Inc., a leading generics manufacturer based in Minnesota, U.S., from its previous owners, Sawai Group Holdings and Sumitomo Corporation of Americas.
Securing the future: Innovating pharmaceutical supply chain for resilience and safety
pharmaphorum
APRIL 2, 2024
Explore the innovative use of artificial intelligence (AI) and machine learning (ML) in securing the pharmaceutical supply chain for resilience and safety. Learn how cutting-edge technology is shaping the future of pharmaceutical logistics.
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.
Data integration - has an influx of solution providers led to a litany of false starts and wasted effort?
Outsourcing Pharma
APRIL 2, 2024
OSP was lucky enough to talk to David Menzies (pictured), executive director, technology solutions at ICON to find out how he thinks the pharma industry needs to overcome the real-world data challenges.
Researchers reveal people with Parkinson’s more likely to experience delirium in hospital
Pharma Times
APRIL 2, 2024
Two out of three people with the neurodegenerative condition experienced delirium in hospital
Advancements in endometrial treatment - HUTCHMED & Innovent's cancer combo NDA accepted with Priority Review
Outsourcing Pharma
APRIL 2, 2024
In an important announcement today (April 2), HUTCHMED and Innovent jointly revealed the acceptance of their New Drug Application (NDA) in China for the combination of Fruquintinib with Sintilimab.
Ipsen licenses Sutro ADC in $900m deal
pharmaphorum
APRIL 2, 2024
Ipsen has expanded its oncology pipeline by licensing rights to an antibody-drug conjugate (ADC) for solid tumours from Sutro Biopharma, its first drug in the category. The deal, which has a top-end value of $900 million including $90 million in near-term payments, focuses on STRO-003, a preclinical-stage ADC targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1).
Accelerating Clinical Supply Through Integrated Drug Development
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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