Fri.Dec 15, 2023

article thumbnail

FDA widens use of cancer drug Merck acquired for $1B

Bio Pharma Dive

Welireg, which Merck got through its purchase of Peloton Therapeutics, can now be used to treat an advanced form of kidney cancer, adding to an earlier clearance in a rare genetic disease.

article thumbnail

Sanofi and AstraZeneca to supply additional RSV doses to US

Pharmaceutical Technology

The US government is set to receive an additional 230,000 doses of RSV injection Beyfortus from Sanofi and AstraZeneca in January 2024.

147
147
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

European regulators push Biogen, CRISPR drugs toward approval

Bio Pharma Dive

While a positive recommendation for the gene editing treatment Casgevy was expected, a clearance for Biogen’s Skyclaris, acquired through a recent acquisition, was no sure bet.

article thumbnail

FDA approves US WorldMeds’s iwilfin for neuroblastoma

Pharmaceutical Technology

The US FDA granted approval for US WorldMeds’ iwilfin for use as an oral maintenance treatment for high-risk neuroblastoma.

article thumbnail

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

article thumbnail

Amgen finds a new top scientist in Novartis veteran Bradner

Bio Pharma Dive

Jay Bradner, a well-known physician-scientist who left Novartis last year amid an organizational shakeup, will now serve a Amgen’s chief scientific officer and head of R&D.

Scientist 173
article thumbnail

New filtering system to combat spread of infections in hospitals

Pharma Times

The combined system works to detect and eliminate airborne pathogens - News - PharmaTimes

139
139

More Trending

article thumbnail

AstriVax awarded €3m to develop therapeutic vaccine for hepatitis B

Pharma Times

The funding builds on AstriVax’s €30m in seed funding for its vaccine platform - News - PharmaTimes

article thumbnail

Reneo cuts 70% of staff following Phase III trial failure

Pharmaceutical Technology

Reneo’s mavodelpar failed to meet its endpoints in the Phase III trial in primary mitochondrial myopathies, a rare genetic disorder.

Trials 130
article thumbnail

With new FDA approval, Merck's Welireg takes another step toward blockbuster goal

Fierce Pharma

Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. | Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. With a second FDA nod for a much larger patient population, the company can anticipate a more pronounced upswing in revenue from the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor.

article thumbnail

MSD’s Welireg secures FDA approval for renal cell carcinoma

Pharmaceutical Technology

This is the second FDA approval for MSD’s HIF-2α inhibitor following a 2021 approval to treat von Hippel-Lindau disease.

article thumbnail

Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

article thumbnail

MSD, Moderna cancer vaccine aces melanoma study

pharmaphorum

MSD and Moderna’s individualised cancer vaccine mRNA-4157 has shown impressive efficacy in a phase 2b trial in skin cancer melanoma, leaving the partners speculating about a possible regulatory filing.

article thumbnail

Biovac receives IFC loan for vaccine manufacturing in Africa

Pharmaceutical Technology

Biovac has received an investment and advisory package from the IFC to support vaccine manufacturing and pandemic preparedness in Africa.

article thumbnail

Threats impacting the pharmaceutical industry in 2024

pharmaphorum

Threats impacting the pharmaceutical industry in 2024 Mike.

118
118
article thumbnail

Teva and Biolojic enter therapeutic antibody development deal

Pharmaceutical Technology

Teva Pharmaceutical has signed a licence agreement with Biolojic Design for the development of BD9 to treat atopic dermatitis and asthma.

article thumbnail

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

article thumbnail

MSD claims 2nd FDA approval for Welireg, in kidney cancer

pharmaphorum

MSD claims 2nd FDA approval for Welireg, in kidney cancer Phil.

article thumbnail

New patent expiration for Biocryst drug RAPIVAB

Drug Patent Watch

Annual Drug Patent Expirations for RAPIVAB Rapivab is a drug marketed by Biocryst and is included in one NDA. It is available from one supplier. There are three patents protecting… The post New patent expiration for Biocryst drug RAPIVAB appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 104
article thumbnail

Enrolment starts in trial of AI-powered Parkinson’s therapy

pharmaphorum

Enrolment starts in trial of AI-powered Parkinson’s therapy Phil.

Trials 109
article thumbnail

AstriVax awarded €3m to develop therapeutic vaccine for hepatitis B

Pharma Times

The funding builds on AstriVax’s €30m in seed funding for its vaccine platform AstriVax has announced that it has been awarded a total of €3m in funding from Flanders Innovation & Entrepreneurship (VLAIO) for its therapeutic vaccine targeting chronic hepatitis B. The new funding will bring the company closer to revolutionising therapeutic vaccine development and creating a long-lasting impact in the hepatitis B field.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

NICE’s new cholesterol guidance looks beyond statins

pharmaphorum

NICE’s new cholesterol guidance looks beyond statins Phil.

107
107
article thumbnail

EXCLUSIVE: The 340B Program Reached $54 Billion in 2022—Up 22% vs. 2021 (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for today’s Drug Channels Outlook 2024 live video webinar. My topic #9 for 2024: The Battle Over 340B Gets Even Messier. Click here to see the original post from September 2023. Drug Channels has just obtained new details on the size of the 340B Drug Pricing Program. I couldn’t wait to share the news, hence this special Sunday post.

article thumbnail

Activist shareholders urge drugmakers to re-evaluate patent strategies, human rights policies

Fierce Pharma

Over the years, shareholders at the Interfaith Center on Corporate Responsibility (ICCR) have repeatedly voiced concerns on a variety of subjects to top pharma companies. | Once again, shareholders with the Interfaith Center on Corporate Responsibility are raising access concerns in proposals to several top drugmakers.

article thumbnail

New tentative approval for Teva Pharms drug dasatinib

Drug Patent Watch

Dasatinib is the generic ingredient in two branded drugs marketed by Apotex and Bristol Myers Squibb and is included in three NDAs. There are two patents protecting this compound. Drug… The post New tentative approval for Teva Pharms drug dasatinib appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 78
article thumbnail

The New Age of Decentralized Clinical Trials

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.

article thumbnail

New filtering system to combat spread of infections in hospitals

Pharma Times

The combined system works to detect and eliminate airborne pathogens A new air-filtering system developed by the University of Glasgow and Pinpoint Medical aims to detect and eliminate airborne pathogens to combat the spread of infections in hospitals. Funded by the UK Research and Innovations’ (UKRI) Engineering and Physical Sciences Research Council (EPSRC), the platform will decontaminate the air of pathogens and measure air quality to ensure a safer and healthier environment.

article thumbnail

New tentative approval for Ascent Pharms drug icosapent ethyl

Drug Patent Watch

Icosapent ethyl is the generic ingredient in two branded drugs marketed by Apotex, Dr Reddys, Hikma, Strides Pharma, Teva Pharms Usa, Zydus, and Amarin Pharms and, and is included in… The post New tentative approval for Ascent Pharms drug icosapent ethyl appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 75
article thumbnail

How large language models can help prevent the next pandemic

pharmaphorum

How large language models can help prevent the next pandemic Mike.

69
article thumbnail

Comparative Perspectives: Unveiling the Nuances Between Veterinary and Human Clinical Trials

Cloudbyz

Veterinary clinical trials and human clinical trials share some similarities, but there are key differences owing to the distinct nature of the subjects involved—animals versus humans. Here are several factors that differentiate veterinary clinical trials from human clinical trials: Purpose and Objectives: Veterinary Trials: Primarily focus on testing and developing treatments, drugs, or medical devices for animal health.

article thumbnail

Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

article thumbnail

New patent for SALIX drug TRULANCE

Drug Patent Watch

Annual Drug Patent Expirations for TRULANCE Trulance is a drug marketed by Salix and is included in one NDA. It is available from two suppliers. There are eight patents protecting… The post New patent for SALIX drug TRULANCE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
article thumbnail

Congratulations and Best Wishes to CTTI Executive Director Sally Okun on Her Retirement

CTTI (Clinical Trials Transformation Initiative)

T oday, Sally Okun, who has served as CTTI’s Executive Director since October 2021, is retiring after five decades in healthcare. “On behalf of the entire CTTI community, we congratulate Sally on her exceptional career and on her retirement,” said CTTI’s incoming executive director, Morgan Hanger. “Sally’s tenacity and gift for storytelling have had a remarkable impact on bringing person-centered research and care into the mainstream.

Nurses 59
article thumbnail

New patent for Genentech Inc drug EVRYSDI

Drug Patent Watch

Annual Drug Patent Expirations for EVRYSDI Evrysdi is a drug marketed by Genentech Inc and is included in one NDA. It is available from one supplier. There are three patents… The post New patent for Genentech Inc drug EVRYSDI appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
article thumbnail

Trade & Channel Strategies 2023: IRA—All the Things Beyond Price Negotiations That Will Impact Your Business

Pharmaceutical Commerce

Breakout session summarizes key areas that will affect all aspects of the industry.

52
article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

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.