FDA warns of rare hypersensitivity reaction due to antiseizure drugs
Pharmaceutical Technology
DECEMBER 29, 2023
FDA warns that levetiracetam and clobazam can cause DRESS, a rare hypersensitivity reaction which can be life threatening.
Fri.Dec 29, 2023
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Amgen’s Tarlatamab Gets FDA Priority Review for Small Cell Lung Cancer
XTalks
DECEMBER 29, 2023
Amgen recently reported that the US Food and Drug Administration (FDA) has given priority review status to its drug candidate, tarlatamab, intended for the treatment of small-cell lung cancer (SCLC). If approved, tarlatamab could bring about significant improvements compared to existing options or potentially offer a treatment alternative in cases where no adequate therapy currently exists. “The FDA’s Priority Review designation for this application underscores the urgency to provide
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Enveric’s EB-003 selected as lead candidate for mental health disorders
Pharmaceutical Technology
DECEMBER 29, 2023
Enveric Biosciences has selected EB-003 as its lead drug candidate from its EVM301 series for difficult-to-treat mental health disorders.
Navigating transplant networks: Ensuring equitable access and improving outcomes for highly sensitised kidney transplant patients
pharmaphorum
DECEMBER 29, 2023
Navigating transplant networks: Ensuring equitable access and improving outcomes for highly sensitised kidney transplant patients Mike.
Regeneron fends off Viatris' Eylea biosimilar with patent win
Fierce Pharma
DECEMBER 29, 2023
Armed with a new victory over Viatris in a patent dispute, Regeneron can knock off one contender in the Eylea biosimilar race. | A West Virginia judge found that Viatris' proposed biosimilar stepped on one of the three patents that Regeneron sued over. Shortly after, the company expanded its suit against another biosimilar contender, setting the stage for Regeneron's defense in Eylea's last few months of exclusivity.
Eisai working on wristband sensor for brain amyloid
pharmaphorum
DECEMBER 29, 2023
Eisai and Oita University have developed a machine learning-powered wearable that can predict whether someone is at risk of developing Alzheimer’s disease
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The smart-design evolution of the laboratory space
pharmaphorum
DECEMBER 29, 2023
In this penultimate instalment of the five-part, festive series of the pharmaphorum podcast, host Nicole Raleigh speaks with Bobby Savarese, senior principal and business development director at Unispace Life Sciences, exploring how laboratory space requirements have changed since the pandemic.
New patent expiration for Becton Dickinson drug CHLORAPREP WITH TINT
Drug Patent Watch
DECEMBER 29, 2023
Annual Drug Patent Expirations for CHLORAPREP+WITH+TINT Chloraprep With Tint is a drug marketed by Becton Dickinson Co and is included in one NDA. It is available from two suppliers. There… The post New patent expiration for Becton Dickinson drug CHLORAPREP WITH TINT appeared first on DrugPatentWatch - Make Better Decisions.
Novel technique opens up new possibilities in synthetic genomics
Drug Discovery World
DECEMBER 29, 2023
A new technique to clone and reassemble DNA could simplify and lower the cost of making synthetic chromosomes, according to its creators at University of Southern California (USC) Dornsife. Known as ‘CReATiNG’ (Cloning Reprogramming and Assembling Tiled Natural Genomic DNA), the method offers a simpler and more cost-effective approach to constructing synthetic chromosomes.
New patent expiration for Becton Dickinson drug CHLORAPREP ONE-STEP
Drug Patent Watch
DECEMBER 29, 2023
Annual Drug Patent Expirations for CHLORAPREP+ONE-STEP Chloraprep One-step is a drug marketed by Becton Dickinson Co and is included in two NDAs. It is available from two suppliers. There are… The post New patent expiration for Becton Dickinson drug CHLORAPREP ONE-STEP appeared first on DrugPatentWatch - Make Better Decisions.
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
Calculus’s Liz Klein: Investing in a changing landscape
pharmaphorum
DECEMBER 29, 2023
To learn more, Deep Dive editor Eloise McLennan sat down with Calculus Capital’s investment director, Liz Klein, to discuss the dynamic world where capital meets compassion.
New patent expiration for Novo Nordisk drug VICTOZA
Drug Patent Watch
DECEMBER 29, 2023
Annual Drug Patent Expirations for VICTOZA Victoza is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from two suppliers. There are six… The post New patent expiration for Novo Nordisk drug VICTOZA appeared first on DrugPatentWatch - Make Better Decisions.
Top 3 Manufacturing and Packaging Articles of 2023
Pharmaceutical Commerce
DECEMBER 29, 2023
Popular works in the category explore 340B guidelines, ‘smart pharma’ capabilities, and commercialization trends.
Which pharmaceutical companies have the most gel dosed drugs?
Drug Patent Watch
DECEMBER 29, 2023
This chart shows the pharmaceutical companies with the most gel dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most gel dosed drugs… The post Which pharmaceutical companies have the most gel dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.
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
Virtual Clinical Trial Companies: Bringing Revolution in Medical Research
Roots Analysis
DECEMBER 29, 2023
Clinical trials are prospective biomedical research studies designed to evaluate medical, surgical or behavioral interventions in people and investigate novel approaches for the diagnosis and prevention / treatment of diseases. In order to gain marketing approval from regulatory authorities for a novel therapeutic intervention, highly accurate and elaborate clinical trial data is required to validate the drug’s safety and effectiveness towards a specific target indication.
Analytical method to simplify the characterization of membrane proteins
Drug Discovery World
DECEMBER 29, 2023
Dr Sofia Ferreira, Director of Applications at Refeyn, discusses how various technologies can address the main challenges in membrane protein characterization, describing how novel technologies, such as mass photometry, can streamline and support analytical processes. Dissecting the structure of membrane proteins Membrane proteins play a crucial role in cellular functions, serving as essential components for intercellular communication, catalysing vital energy transformations, and facilitatin
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