Mon.Oct 14, 2024

article thumbnail

Innovation in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

Worldwide Clinical Trials

Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.

Research 147
article thumbnail

Lundbeck to buy brain drug developer Longboard for $2.6B

Bio Pharma Dive

The deal would hand Lundbeck a treatment for a series of rare brain disorders that could, by the company's estimates, become a blockbuster product.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Innovating in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

Worldwide Clinical Trials

Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.

Research 130
article thumbnail

FDA, facing pressure, to review position on Zepbound, Mounjaro shortage

Bio Pharma Dive

The agency agreed in court to allow compounding companies to continue producing copycat versions of Lilly’s fast-selling medicines while it reevaluates its recent decision to declare the drugs back in supply.

Medicine 284
article thumbnail

Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

article thumbnail

Cell and gene therapy approvals drive paradigm change in manufacturing

Pharmaceutical Technology

Trends in gene therapy approvals in recent years are rapidly shaping the future of manufacturing capabilities in the pharmaceutical industry.

article thumbnail

Pfizer drug for hemophilia approved by FDA

Bio Pharma Dive

The approval of Hympavzi Friday was a dose of good news for Pfizer, which is dealing with research setbacks and a challenge from an activist investor.

Drugs 261

More Trending

article thumbnail

From maximizing recruitment to promoting diversity: How to deploy NGS technologies to achieve clinical trial success

Bio Pharma Dive

Learn how the right NGS technology can enhance clinical research while supporting downstream efforts toward global commercialization.

article thumbnail

Can a Supplement Really Help Control Your Pesky Eye Floaters?

AuroBlog - Aurous Healthcare Clinical Trials blog

(Filipp Romanovski/Unsplash) If you look up at the sky on a clear day, you might notice little cobweb-like structures drifting across your field of vision.

article thumbnail

Lilly pledges £279m to UK for biotech hub and obesity plan

pharmaphorum

Eli Lilly may invest $364m in the UK and work with the government to tackle serious public health challenges including obesity.

145
145
article thumbnail

GSK says antibody drug succeeds in testing for chronic nasal condition

Bio Pharma Dive

The company has set high expectations for depemokimab, which it is also advancing in three other inflammatory diseases, including asthma.

Antibody 144
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

Lundbeck to acquire Longboard Pharmaceuticals in strategic deal

Pharma Times

Acquisition to enhance Lundbeck’s neuroscience pipeline

144
144
article thumbnail

Optimising outcome measures in cognitive drug trials for schizophrenia

Pharmaceutical Technology

Digital assessment technologies continue to hold the potential to revolutionise pro-cognitive trials in schizophrenia.

article thumbnail

Transgene’s cancer vaccine trial shows mixed results

Pharma Times

Phase 2 study of TG4001 shows promise in cervical cancer patients

Vaccine 142
article thumbnail

Genentech’s Evrysdi helped babies with SMA reach rare milestones in Phase II trial 

Pharmaceutical Technology

Data from the Rainbowfish trial was presented at the World Muscle Society (WMS) Congress 2024 in Prague, Czech Republic.

Trials 130
article thumbnail

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

article thumbnail

Choosing the right hub partner: A blueprint for decision-makers

Bio Pharma Dive

An effective drug launch requires a hub partner with key capabilities, as outlined in the 2024 Patient Services Report by CareMetx.

Drugs 130
article thumbnail

Capricor touts long-term efficacy of DMD therapy ahead of FDA application

Pharmaceutical Technology

Capricor Therapeutics plans to apply for FDA approval for its DMD cell therapy, deramiocel, by the end of 2024.

article thumbnail

Successful COA selection paves the path to drug development

Bio Pharma Dive

Choosing the right clinical outcome assessments (COAs) is an important part of successfully advancing drug development and securing regulatory approval.

article thumbnail

Inventiva secures up to $380m for MASH treatment lanifibranor

Pharmaceutical Technology

Inventiva will gain a new chairman following the deal as it presses ahead with a Phase III trial for its lead asset.

Trials 130
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

In win for compounders, FDA will review its decision to put Eli Lilly's tirzepatide on shortage list

Fierce Pharma

Four days after a compounding industry group filed a lawsuit against the FDA | Four days after a compounding industry group filed a lawsuit against the FDA for removing Eli Lilly’s tirzepatide products from its shortage list, the U.S. regulator is taking a second look at its decision.

article thumbnail

ENHERTU gains conditional approval in China to treat NSCLC

Pharmaceutical Technology

Daiichi Sankyo and AstraZeneca's ENHERTU has been conditionally approved by China's NMPA for a specific type of NSCLC.

130
130
article thumbnail

GSK asthma hope depemokimab works in second indication

pharmaphorum

GSK's six-monthly IL-5 inhibitor depemokimab clears two phase 3 trials in chronic rhinosinusitis with nasal polyps (CRSwNP), its second indication

Trials 111
article thumbnail

Leading Cybersecurity Companies for the Pharmaceutical Industry

Pharmaceutical Technology

Discover the leading Cybersecurity Companies for the Pharmaceutical Industry. Download the free Buyer's Guide today for full contact details.

130
130
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

CEPI-backed trial of Rift Valley fever jab starts in Kenya

pharmaphorum

For the first time, a vaccine candidate for Rift Valley fever, developed by Oxford University, has been advanced into a phase 2 trial backed by CEPI.

Trials 111
article thumbnail

FDA approves Pfizer’s HYMPAVZI to treat haemophilia

Pharmaceutical Technology

Pfizer has announced the approval of HYMPAVZI by the US Food and Drug Administration (FDA) for patients with haemophilia A and B.

article thumbnail

The Role of Risk Assessment in Generic Drug Development

Drug Patent Watch

Risk assessment plays a crucial role in the development of generic drugs, ensuring that these products meet the required standards of safety and efficacy. The Food and Drug Administration (FDA) and other regulatory bodies have implemented various measures to ensure that generic drugs are equivalent to their brand-name counterparts in terms of quality, safety, and efficacy.

article thumbnail

FDA rethinking block on compounding of Lilly's obesity drug

pharmaphorum

Faced with lawsuit, FDA rethinks block on compounding pharmacies making Eli Lilly's diabetes and obesity drug tirzepatide

Pharmacy 110
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

On road to crowded Crohn's disease market, Lilly's Omvoh bests J&J's Stelara in head-to-head study

Fierce Pharma

On a mission to collect a key Crohn’s disease approval and build out its inflammatory bowel disease (IBD) profile, Eli Lilly has notched a trial win over a major rival in a head-to-head study.&nbsp | Eli Lilly's drug outperformed Johnson & Johnson's established Stelara in a phase 3 study that looked at histologic disease responses over 52 weeks.

Marketing 101
article thumbnail

Revitalising life sciences hiring: The case for creative recruitment

pharmaphorum

Revitalising life sciences hiring through creative recruitment strategies can make a significant impact on R&D, manufacturing, and medtech industries. Learn more about how innovative hiring practices can enhance talent acquisition in the life sciences sector.

article thumbnail

Women in STEM: Gitte Barknowitz’s journey to leading global initiatives

BioPharma Reporter

From exploring the wonders of plants as a curious teen to leading global initiatives at SCIEX, Gitte Barknowitz has carved out an exciting and unconventional career in science.

article thumbnail

Keeping stigma out of it: Personalising the mental health conversation

pharmaphorum

Personalising mental health treatment and doing away with stigma are crucial steps in meeting the unmet needs of the mental health space.

98
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