Wed.Mar 13, 2024

article thumbnail

Biotech trade group pledges support for BIOSECURE Act, plans to boot member WuXi AppTec

Fierce Pharma

As CDMO giants Wuxi AppTec and WuXi Biologics come under mounting scrutiny for their alleged ties to Chinese government officials, they are losing a key ally in Washington, D.C. | As CDMO giants Wuxi AppTec and WuXi Biologics come under mounting scrutiny for their alleged ties to Chinese government officials, they are losing a key ally in Washington, D.C.

article thumbnail

Novartis Pays $90M for Molecules That Could Take STING Out of Inflammation

MedCity News

Placing research in the hands of a large pharmaceutical company is a goal of many biotech companies. IFM Therapeutics has now done it three times and its latest deal is the second time Novartis is the acquirer.

Insiders

Sign Up for our Newsletter

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

Trending Sources

article thumbnail

J&J's Duato nets major raise to $28.4M, jumps to top of pharma CEO pay rankings

Fierce Pharma

It didn’t take long for Johnson & Johnson CEO Joaquin Duato to catch up to his predecessor. | It didn’t take long for Johnson & Johnson CEO Joaquin Duato to catch up to his predecessor. After paying Duato $13.1 million in his first year as CEO, the pharma giant more than doubled his compensation to $28.4 million last year, according to a regulatory filing.

Pharma 254
article thumbnail

Lilly adds Amazon Pharmacy to LillyDirect DTC channel

pharmaphorum

Amazon Pharmacy will provide dispensing for Eli Lilly’s recently launched direct-to-consumer LillyDirect channel, covering obesity, diabetes, and migraine drugs.

Marketing 101
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

FDA flags early deaths in CAR-T myeloma trials for J&J and Legend’s Carvykti, Bristol Myers’ Abecma

Fierce Pharma

The FDA has raised concerns about early clinical trial deaths as part of two applications that aim to move the CAR-T therapies Carvykti and Abecma into earlier lines of treatment for multiple myelo | Ahead of an important advisory committee meeting, the FDA has raised concerns about early trial deaths for multiple myeloma cell therapies. At the meeting, experts will discuss applications that aim to move the CAR-T therapies Carvykti and Abecma into earlier lines of treatment.

FDA 248
article thumbnail

Rapid pseudomonas aeruginosa detection method developed

European Pharmaceutical Review

Findings from an experimental study report the development of a rapid method for the detection of pseudomonas aeruginosa bacteria in medications. The corresponding research paper stated the key benefits of the method include its high selectivity and specificity, cost-effectiveness as well as simplicity for application. For example, the author shared that the procedure can be used in microbiological laboratories of various levels.

Media 94

More Trending

article thumbnail

Five Ways Hospitals Can Reduce Industry Waste (While Recovering Dollars)

MedCity News

Between the environment and your healthcare organization’s balance sheet, waste is a big deal. These promising strategies can help solve that problem.

article thumbnail

Skincare products maker Galderma gears up for long-awaited $2.6B IPO

Fierce Pharma

After a few holdups, Swiss skincare company Galderma is finally going public in a highly anticipated market debut that could make for one of Europe’s largest listings this year. | The Swiss skincare company set its price range for a public offering after years of delays, with its listing now expected on March 22. The IPO could be one of Europe's largest this year.

Marketing 228
article thumbnail

Lilly Taps Amazon Pharmacy for Medication Home Delivery Services

MedCity News

Amazon Pharmacy will now provide home delivery services for certain medications through LillyDirect, the companies announced Wednesday.

Medical 105
article thumbnail

Merck takes Keytruda patent dispute with Johns Hopkins University from the court to the patent office

Fierce Pharma

Merck is kicking its Keytruda-related clash with Johns Hopkins University (JHU) up a notch by asking the U.S. Patent and Trademark Office (PTO) to weigh in following a 2022 complaint. | The company in 2022 claimed the research university breached its contracts relating to a joint trial the two ran in 2013 and wrongly secured patents for itself from the study.

180
180
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.

article thumbnail

FDA warning letters highlight data integrity issues

European Pharmaceutical Review

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. Specifically, these recent warning letters describe microbiology and environmental monitoring related data integrity issues.

FDA 91
article thumbnail

Coherus again axes staff, with 30% of roles on chopping block amid ‘sharpened focus’ on cancer drugs

Fierce Pharma

About a year after launching a prior round of layoffs, Coherus BioSciences is again reducing its head count, this time by 30%. | About a year after launching a prior round of layoffs, Coherus BioSciences is again reducing its head count, this time by 30%.

174
174
article thumbnail

Boutique Healthcare Investment Event MedCity INVEST Is Two Months Away. Register Today!

MedCity News

Join MedCity News and nearly 300 healthcare investors, startups, and innovative-minded executives in Chicago at the Ritz Carlton on May 21-22. Space is limited. Secure your spot today to attend!

article thumbnail

Mirum scores second FDA nod for rare liver disease drug Livmarli, this one to treat PFIC

Fierce Pharma

FDA has OKed Mirum’s Livmarli to treat the rare liver disease PFIC.

FDA 237
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

Prilenia eyes 2025 launch for Huntington’s drug pridopidine

pharmaphorum

Prilenia Therapeutics is planning to file its Huntington’s disease drug pridopidine in the EU shortly, after mixed results in a phase 3 trial.

101
101
article thumbnail

SXSW 2024 Insights: Why the Greatest Risk a Brand Can Take Is Being Ordinary, Part 1

Eversana Intouch

Our team is on the ground at SXSW 2024, and as we navigate through the bustling streets of downtown Austin, Texas — where the magic of immersive brand experiences dress the streets — we can’t help but feel the pulse of innovation surrounding us. In this blog, Hattie Stearns, Senior Director, Experience Design & Innovation, delves into several key trends and insights from Day 1 of the conference, including the importance of building authentic immersive experiences that enable human connection

article thumbnail

BaseCamp unveils improved protein structure prediction model

pharmaphorum

Basecamp Research launches BaseFold, a deep learning model that it says surpasses benchmark tool AlphaFold2 and should accelerate AI-based drug discovery

93
article thumbnail

Quantum Health Dips into Medicare Advantage Market

MedCity News

Quantum Health is now offering a navigation service for Medicare Advantage plans. The company has traditionally served employers.

Marketing 101
article thumbnail

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

article thumbnail

Bright Green invests $250m to expand facility in New Mexico, US

Pharmaceutical Technology

Bright Green has announced plans to expand its controlled substances drug production facility in New Mexico, US with an investment of $250m.

97
article thumbnail

Basecamp Research unveils improved protein structure model

pharmaphorum

Basecamp Research launches BaseFold, a deep learning model that it says surpasses benchmark tool AlphaFold2 and should accelerate AI-based drug discovery.

89
article thumbnail

J&J reveal long-term data for novel oral peptide

European Pharmaceutical Review

The first and only investigational targeted oral peptide has been shown to maintain high rates of skin clearance in adults with moderate-to-severe plaque psoriasis through 52 weeks, new data shows. In the long-term extension FRONTIER 2 study , JNJ-2113 demonstrated sustained efficacy from Week 16 to Week 52, based on data presented at the American Academy of Dermatology (AAD) 2024 Annual Meeting.

Safety 81
article thumbnail

A Changing of the Guard: Robert P. Mauch to Become CEO in October 2024

Pharmaceutical Commerce

Steven H. Collis, who currently holds the position, will transition to executive chair of the board.

105
105
article thumbnail

Roles and Responsibilities of Specialized Clinical Supply Experts

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.

article thumbnail

Philips, AWS Deepen Collaboration to Scale Digital Pathology in the Cloud

MedCity News

At HIMSS, Philips and AWS announced that they are expanding their collaboration with the goal of scaling digitized pathology slides in the cloud. The partners seek to help pathology labs better store and analyze vast volumes of data, as well as adopt more streamlined, cloud-based workflows to reduce clinician burnout.

70
article thumbnail

AbbVie’s Produodopa approved by SMC to treat Parkinson’s disease patients in Scotland

PharmaTimes

The progressive neurological disorder affects approximately 12,400 people in Scotland

Patients 102
article thumbnail

FDA reviewer pokes holes in Geron’s MDS drug data

pharmaphorum

FDA reviewers seem unconvinced by Geron's data on myelodysplastic syndrome therapy imetelstat ahead of FDA adcomm meeting.

FDA 83
article thumbnail

US study reveals age-related skin changes could contribute to melanoma metastases

PharmaTimes

Around 200,000 people in the US are expected to be diagnosed with the skin cancer this year

93
article thumbnail

Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

article thumbnail

Risk adjusted net present value: What is the current valuation of Novo Nordisk’s Belcesiran?

Pharmaceutical Technology

Belcesiran is an antisense rnai oligonucleotide commercialized by Novo Nordisk, with a leading Phase II program in Alpha-1 Antitrypsin Deficiency (A1AD).

Leads 72
article thumbnail

Clarivate awarded USPTO award for Designs Image Search AI (DesignVision)

Clarivate

Clarivate Plc , a leading global provider of transformative intelligence, has been awarded a contract from the USPTO which will transform capabilities for US examiners working on Design Patent applications. Using DesignVision from Clarivate, an Intellectual Property AI & Image Search Platform for Government, examiners will be able to easily expedite patent examinations by using reverse image search AI to quickly identify relevant prior art.

article thumbnail

Advanco Opens New Office in Singapore

Pharmaceutical Commerce

The Asia-Pacific location is expected to provide serialization solutions for counterfeit medication entering the pharma supply chain.

Pharma 64
article thumbnail

These biotech hotspots are ripe for IPOs

PharmaVoice

Biotech IPOs are off to the races in 2024, and investors are betting on horses that are derisked in targeted areas.

69
article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

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.