Fri.Oct 20, 2023

article thumbnail

Merck cancer drug deal caps pharma investment influx into ‘ADC’ field

Bio Pharma Dive

With the alliance, Merck joins Pfizer, AstraZeneca and Gilead in staking major bets on the potential for antibody-drug conjugates to reshape cancer treatment.

Drugs 264
article thumbnail

NVIDIA banks on generative AI to pursue partnerships with biotechs

Pharmaceutical Technology

NVIDIA’s vice-president of healthcare, Kimberly Powell, discussed GenAI in pharma and the importance of partnerships.

264
264
Insiders

Sign Up for our Newsletter

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

article thumbnail

Merck allies with Daiichi Sankyo in major bet on antibody cancer drugs

Bio Pharma Dive

The deal is worth up to $22 billion in total, making it one of the largest pharmaceutical licensing agreements by value.

Antibody 148
article thumbnail

Health Canada grants NOC to Sumitomo and Pfizer’s MYFEMBREE

Pharmaceutical Technology

Health Canada has granted a Notice of Compliance (NOC) to Sumitomo Pharma Canada and Pfizer Canada’s MYFEMBREE.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

How Do You Design Trials That Are Fit for Purpose?

Rethinking Clinical Trials

How Do You Design Trials That Are Fit for Purpose? Description Dr. Lesley Curtis discusses how to design trials that are fit for purpose. Speaker Lesley Curtis, PhD Professor of Population Health Sciences and Medicine, Duke University Duke Clinical Research Institute Collaboratory Steering Committee Chair The post How Do You Design Trials That Are Fit for Purpose?

Trials 130
article thumbnail

MSD signs up Daiichi Sankyo in multibillion dollar deal to develop ADCs

Pharmaceutical Technology

Daiichi Sankyo will receive an upfront payment of $4bn and will be eligible for additional milestone payments of up to $22bn.

More Trending

article thumbnail

Tourmaline shifts focus to developing anti-IL6 antibody following merger

Pharmaceutical Technology

The company plans to initiate the Phase II trial of anti-IL-6 antibody in atherosclerotic cardiovascular disease in 2024.

Antibody 147
article thumbnail

Amylyx Pharmaceuticals hopes to launch largest PSP trial to date by the end of 2023

Outsourcing Pharma

The treatment of rare brain disease, progressive supranuclear palsy (PSP), that has no disease modifying therapies, has been given a glimmer of hope by Amylyx Pharmaceuticals.

Trials 114
article thumbnail

Endeavor acquires global rights to Hummingbird’s ADC

Pharmaceutical Technology

Endeavor BioMedicines has acquired exclusive global rights to the HER3-targeted antibody-drug conjugate (ADC) of Hummingbird Bio, HMBD-501.

Antibody 130
article thumbnail

Deep brain stimulation could improve memory loss in Alzheimer’s disease

Pharma Times

The new technology was safely trialled on 20 healthy volunteers for the first time ever - News - PharmaTimes

134
134
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

Lipella gets go-ahead for trial studying chronic oral condition

Pharmaceutical Technology

The company has said that it is ready to launch a Phase IIa trial with the drug being intended to treat an often painful condition.

Trials 130
article thumbnail

ESMO: Lilly's Retevmo drives major benefits in lung, thyroid cancers as Roche bows out of competition

Fierce Pharma

Eli Lilly is on a roll with its RET inhibitor Retevmo, with new trial results showing the drug can offer dramatic benefits in the treatment of certain lung and thyroid cancers. | Eli Lilly is on a roll with its RET inhibitor Retevmo, with new trial results showing the drug can offer dramatic benefits in the treatment of certain lung and thyroid cancers.

Trials 106
article thumbnail

EC grants approval to Pfizer for $43bn Seagen acquisition 

Pharmaceutical Technology

The European Commission (EC) has granted unconditional approval to Pfizer for the prospective takeover of Seagen for $43bn in cash.

130
130
article thumbnail

“In AI We Trust”: What Salesforce 2023 Offered Life Sciences Marketers

Intouch Solutions

This year’s Dreamforce conference – the annual gathering for Salesforce, one of the main providers in commercial marketing and sales technology for the Health & Life Science (HLS) industry – was bigger and more innovative than ever. But what news will matter most for health & life sciences companies? An EVERSANA INTOUCH team attends each year to get the latest on the technologies coming to market and to get inspired on the best ways to use them for our clients.

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

Over 20,000 UK businesses at risk of Chinese espionage, warns MI5 chief

Pharmaceutical Technology

Over 20,000 people and businesses in the UK have already been approached by Chinese spies, warned MI5 head Ken McCallum.

130
130
article thumbnail

New £30m initiative launched to support innovation against antimicrobial resistance

Pharma Times

Global innovators can apply to PACE to receive up to £1m per project - News - PharmaTimes

139
139
article thumbnail

Meilleur partners with ADNI4 for next-generation Alzheimer’s biomarker

Pharmaceutical Technology

Meilleur’s [F-18]NAV-4694 will be used as a biomarker in ADNI4’s Alzheimer’s disease research.

Research 147
article thumbnail

Interview: CRO Emmes on the unique challenges of clinical trials using psychedlics and the FDA guidance

Outsourcing Pharma

Feedback has been submitted to the US Food and Drug Administration (FDA) with guidelines intended for sponsors of clinical trials related to psychedelic compounds.

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

FDA clears UCB’s Bimzelx for psoriasis treatment

Pharmaceutical Technology

UCB’s drug is the first IL-17A and IL-17F inhibitor approved for patients with moderate to severe plaque psoriasis.

Drugs 130
article thumbnail

Pfizer beats out GSK with FDA nod for first 5-in-1 meningitis shot

Fierce Pharma

In the race to secure U.S. approval for the first five-pronged meningitis vaccine, Pfizer has eked out a regulatory win well ahead of its immunization rival GSK. | The U.S. FDA gave a thumbs-up to Penbraya, the commercial moniker for Pfizer’s pentavalent vaccine defending against the most common serogroups behind meningococcal disease. The shot is approved for adolescents and adults between the ages of 10 and 25.

article thumbnail

Roche posts 7% rise in Q3 2023 group sales

Pharmaceutical Technology

Roche has posted a 7% rise in group sales to SFr14.27bn ($15.91bn) at constant exchange rates (CER) in Q3 2023.

Sales 130
article thumbnail

CAR-TCR 2023 – Tim McGuire

pharmaphorum

At CAR-TCR last month in Boston, pharmaphorum Editor in Chief Jonah Comstock grabbed some time with Tim McGuire, director of business development at biomanufacturer Resilience.

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

New deep brain stimulation could improve memory loss in Alzheimer’s patients

BioPharma Reporter

Researchers at the UK Dementia Research Institute have developed a new form of deep brain stimulation that does not require surgery and could provide an alternative treatment option for debilitating brain diseases such as Alzheimerâs.

article thumbnail

Greenphire's Dave Hine's reflections on DPharm 2023 - and how 'rising tides lift all boats'

Outsourcing Pharma

Dave Hine is the senior director of sales and engineering at Greenphire. He has been reflecting on his time at DPharm and the collaborative approach to life sciences.

article thumbnail

Eli Lilly goes after 11 online pharmacies for allegedly selling unauthorized versions of Mounjaro

Fierce Pharma

In September, Eli Lilly filed lawsuits against eight com | Eli Lilly is going after 11 online pharmacies—including several overseas—that are allegedly importing, selling or distributing unauthorized versions of its diabetes drug Mounjaro. In a complaint filed with the U.S. International Trade Commission, Lilly has named three companies in China, three in Europe and five in the U.S. that it claims are selling “low-grade” versions of the drug.

article thumbnail

Empatica and the importance of wearable devices in getting the full patient profile

Outsourcing Pharma

Matteo Lai was part of a panel at DPharm in Boston this year, it was called working together to accelerate the adoption of digital biomarkers in clinical trials.

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

How Centralized Prescription Fulfillment Allows Pharmacists to Better Help Patients

Drug Channels

Today’s guest post comes from Melanie Christie, VP of Product Management at CoverMyMeds. Melanie discusses how the nationwide shortage of pharmacy technicians affects pharmacists. She argues that centralized prescription fulfillment can provide pharmacists with more time to care for patients while also reducing medication errors and accelerating time-to-treatment.

article thumbnail

Center focused on finding cure for glioblastoma reveals AstraZeneca drug may be a success

Outsourcing Pharma

A small molecule kinase inhibitor has been trialed in humans for the first time as part of a glioblastoma treatment study.

Trials 111
article thumbnail

ESMO: Merck exec sees signs of 'prolonged benefit' from Welireg in kidney cancer

Fierce Pharma

At ESMO, Merck is encouraged by Welireg's potential to treat clear cell renal cell carcinoma (ccRCC), a common type of kidney cancer.

99
article thumbnail

New tentative approval for Sandoz drug sugammadex sodium

Drug Patent Watch

Sugammadex sodium is the generic ingredient in two branded drugs marketed by Msd Sub Merck, Aspiro, Mylan, and Sandoz and, and is included in four NDAs. There is one patent… The post New tentative approval for Sandoz drug sugammadex sodium appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 78
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.