Fri.Dec 01, 2023

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European regulators want to know more about the risks of GLP-1 drugs

Bio Pharma Dive

The EMA's safety committee has more questions for makers of the in-demand therapies as it reviews whether the drugs are linked to the risk of suicidal thoughts.

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Orchard secures FDA fast track designation for Hurler syndrome gene therapy

Pharmaceutical Technology

Hot on the heels of the designation, Orchard Therapeutics is pressing ahead with a multi-centre trial for the candidate with a start date in December.

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Pfizer plans for oral obesity drug hit new trial setback

Bio Pharma Dive

The company won’t continue development of a twice-daily dose of its experimental weight loss medicine danuglipron after study data showed high rates of side effects.

Trials 164
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AstraZeneca’s durvalumab recommended for bile duct cancers

Pharmaceutical Technology

The SMC and NICE have recommended the use of AstraZeneca’s durvalumab to treat advanced biliary tract cancers in England and Scotland.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Concentra, on the hunt for deals, bids for LianBio

Bio Pharma Dive

The Tang Capital-controlled company is bidding for LianBio shortly after making takeover offers for Rain Oncology and Theseus Pharmaceuticals.

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Biocon integrates Viatris biosimilars in 31 European countries

Pharmaceutical Technology

Biocon subsidiary Biocon Biologics has successfully integrated Viatris' biosimilars business in 31 countries in Europe.

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More Trending

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Partnership deals for psychedelic drugs take a trip with 500% surge in 2023

Pharmaceutical Technology

Partnership deals involving psychedelic drugs saw a 500% growth in total deal volume from 2019 to 2023 year-to-date (YTD).

Drugs 246
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Prostate cancer focal therapy could improve costs and patient outcomes

Pharma Times

Every year, over 44,000 men are diagnosed with prostate cancer in England - News - PharmaTimes

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FDA accepts Merck’s Keytruda plus Padcev sBLA to treat urothelial cancer

Pharmaceutical Technology

The US FDA has accepted Merck’s new sBLA for Keytruda plus Padcev to treat adults with urothelial carcinoma (la/mUC) for review.

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Cannes Lions, Ad Forum Spotlight The Chrysalis Initiative & EVERSANA Intouch in New Webinar, Article

Intouch Solutions

Recently, Ad Forum published an article highlighting five campaigns it found to be “ Raising the Bar for Health Equity in Advertising.” One was our ongoing work with The Chrysalis Initiative, a nonprofit working to eliminate racial disparities in breast cancer treatment. This alliance dates back to 2021, but in 2023, as Fierce Pharma put it, we “ roared back from rejection to craft a Cannes-winning campaign hospitals couldn’t ignore.

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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

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Teva and Sanofi conclude collaboration deal for anti-TL1A therapy

Pharmaceutical Technology

Teva and Sanofi have concluded a collaboration deal for co-developing anti-tumour necrosis factor-like ligand 1A (TL1A) therapy, TEV’574.

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NotCo and Kraft Heinz Unveil Plant-Based NotMac&Cheese

XTalks

Since its debut in 1937, Kraft Mac & Cheese has become a beloved fixture in American homes. Known for its easy-to-prepare blue box meals, Kraft Mac & Cheese sells over one million boxes daily. This culinary icon is so ingrained in North American culture that it’s even dubbed Canada’s unofficial national dish. Now, in an era where dairy alternatives are soaring in popularity, Kraft Mac & Cheese is getting a plant-based makeover.

Branding 103
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Signal: Novo Nordisk sues more Florida pharmacies in battle against fake semaglutide

Pharmaceutical Technology

Novo Nordisk is continuing legal action against compounding pharmacies selling off-brand Ozempic which it claims are adulterated.

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Radiotherapy boost shown to reduce treatment times for breast cancer patients

Pharma Times

Every year, around 55,000 women in the UK are diagnosed with the condition - News - PharmaTimes

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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

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FDA clears IND for Biora Therapeutics’s ulcerative colitis drug

Pharmaceutical Technology

Biora Therapeutics announced FDA clearance for a Phase I trial for its ulcerative colitis therapy, BT-600.

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J&J, AbbVie, Sanofi and many other companies face competition probe in Turkey

Fierce Pharma

Turkish authorities have launched an investigation into 19 pharmaceutical companies to probe whether their operations violated the country’s competition law, the Turkish Competition Authority discl | The companies, which include Pfizer, J&J, Sanofi, AbbVie, AstraZeneca, Merck and others are being probed for potentially violating Turkish competition law, according to a release from the country's government.

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Navigating affordable approaches to cell therapy clinical trials

Pharmaceutical Technology

By Luisa Sterkel & Joana Loureiro, Tenthpin Consultants and Dr.

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Six company cohort joins BII's new accelerator start-up program to unlock potential of quantum science

Outsourcing Pharma

The first six companies enter the Deep Tech Lab - Quantum start-up accelerator at BioInnovation Institute (BII) to unlock the potential in quantum science

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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.

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AZ drops two trials aimed at expanding Lokelma’s label

pharmaphorum

AstraZeneca has decided to abandon two phase 3 trials of its drug to reduce high levels of potassium in the blood (hyperkalaemia) – Lokelma – in patients with kidney disease. The STABILIZE-CKD and DIALIZE-Outcomes studies – part of AZ’s CRYSTALIZE programme for the drug – have been shelved because patients were being enrolled into them more slowly than hoped for, and clinical events were occurring at a lower rate than expected.

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AstraZeneca calls it quits on pair of trials for hyperkalemia drug it scored in buyout of ZS Pharma

Fierce Pharma

After a hard-fought battle for FDA approval, AstraZeneca has hit another setback on its quest to turn its potassium-reduction drug Lokelma into a blockbuster. | AstraZeneca has put the kibosh on two late-stage Lokelma trials testing the hyperkalemia drug in patients with heart and kidney diseases. The studies were called off due to “substantially increased enrollment times and low event rates,” AZ said Friday.

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How to advance more late-stage neuroscience drugs to regulatory approval

pharmaphorum

How to advance more late-stage neuroscience drugs to regulatory approval Mike.

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Texas AG Paxton fires off another lawsuit at Pfizer, this one over the company's COVID-19 vaccine

Fierce Pharma

Texas attorney general Ken Paxton is going after Pfizer—again. | Texas attorney general Ken Paxton is going after Pfizer—again. Less than two weeks after documents were unsealed showing that Texas has accused Pfizer and manufacturer Tris Pharma of providing a compromised ADHD medicine to the state, Paxton has sued Pfizer for “unlawfully misrepresenting the effectiveness” of the company’s COVID-19 vaccine.

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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.

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AbbVie buys ImmunoGen for $10.1 billion, expanding cancer drug portfolio

BioPharma Reporter

AbbVie is acquiring rival biotech firm ImmunoGen for $10.1 billion, giving it access to ImmunoGen's flagship ovarian cancer treatment Elahere, which was granted accelerated approval from the FDA last year.

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'The Top Line': Fiercest Women in Life Sciences, meet the Fierce 50

Fierce Pharma

In this episode of "The Top Line," we're highlighting the remarkable women featured in our annual Fiercest Women in Life Sciences special report. | In this episode of "The Top Line," we're highlighting the remarkable women featured in our annual Fiercest Women in Life Sciences special report. The list comprises 10 trailblazers changing the leadership landscape in pharma, biotech and medtech.

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FDA starts review of Padcev/Keytruda for bladder cancer

pharmaphorum

FDA starts review of Padcev/Keytruda for bladder cancer Phil.

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New patent for Glaxosmithkline drug ANORO ELLIPTA

Drug Patent Watch

Annual Drug Patent Expirations for ANORO+ELLIPTA Anoro Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are fourteen patents… The post New patent for Glaxosmithkline drug ANORO ELLIPTA appeared first on DrugPatentWatch - Make Better Decisions.

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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.

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In a Time of Uncertainty for Clinical Researchers, Reliable Partners are Vital

Crucial Data Soutions

The clinical research industry is currently dealing with a great deal of uncertainty, with various solutions providers announcing layoffs often. The post In a Time of Uncertainty for Clinical Researchers, Reliable Partners are Vital appeared first on Crucial Data Solutions.

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New patent for Glaxosmithkline drug TRELEGY ELLIPTA

Drug Patent Watch

Annual Drug Patent Expirations for TRELEGY+ELLIPTA Trelegy Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are fourteen patents… The post New patent for Glaxosmithkline drug TRELEGY ELLIPTA appeared first on DrugPatentWatch - Make Better Decisions.

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MSD, Amgen back patient data specialist Culmination Bio

pharmaphorum

MSD, Amgen back patient data specialist Culmination Bio Phil.

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New patent for Glaxo Grp drug BREO ELLIPTA

Drug Patent Watch

Annual Drug Patent Expirations for BREO+ELLIPTA Breo Ellipta is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from two suppliers. There are… The post New patent for Glaxo Grp drug BREO ELLIPTA appeared first on DrugPatentWatch - Make Better Decisions.

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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.