Fri.Jan 12, 2024

article thumbnail

Backed by billionaires, a new biomedical institute tests an unorthodox approach

Bio Pharma Dive

Arena BioWorks, which will be led by Harvard University scientist Stuart Schreiber, seeks to blend academic and venture capital drug research models.

Scientist 328
article thumbnail

Cereno partners with CordenPharma to scale up CS1 drug production

Pharmaceutical Technology

Cereno Scientific has announced a partnership with CordenPharma to scale up manufacture of its drug candidate CS1.

Insiders

Sign Up for our Newsletter

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

article thumbnail

FDA says no ‘clear relationship’ between GLP-1 drugs and suicide risk

Bio Pharma Dive

Regulators will continue to evaluate suicide ideation as the data don't "definitively rule out" an association.

article thumbnail

Emergent wins $235.8m US defence contract for Anthrax vaccine

Pharmaceutical Technology

The US Department of Defense procurement contract for Emergent’s BioThrax is comprised of an initial five-year base agreement.

Vaccine 162
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

Recursion’s Chris Gibson on AI in biotech, competition and ‘virtuous cycles’

Bio Pharma Dive

Showing reporters and industry veterans a demonstration of its new drug development software, Recursion said at J.P. Morgan it is now licensing its work to buyers.

Licensing 173
article thumbnail

Study reveals antibiotic use is not the only driver of antibiotic resistance

Pharma Times

Researchers compared 20 years of antibiotic use on E.

Research 138

More Trending

article thumbnail

Cambridge researchers begin new trial for oesophageal cancer screening

Pharma Times

If successful, the new test could see routine screening introduced in the NHS

Research 133
article thumbnail

Obesity disease management needs to be revolutionised

Pharmaceutical Technology

Obesity has only recently been recognised as a disease as opposed to a behavioural/lifestyle issue.

130
130
article thumbnail

Living with PSC: What to know about primary sclerosing cholangitis

Antidote

An estimated 1 in 10,000 people have primary sclerosing cholangitis (PSC) , a condition that impacts the bile ducts that run between the liver, the gallbladder, and the small intestine. The liver produces bile to transport to the gallbladder for storage, or to the small intestine where it aids in the digestion of fats. In the case of PSC, there is inflammation in the bile ducts (cholangitis) which leads to scarring (sclerosis) that narrows the ducts.

122
122
article thumbnail

FDA yet to find link between suicidal risk and GLP-1RA use

Pharmaceutical Technology

In an update, the FDA reported that it is yet to find a definitive association between GLP-1RA use and suicidal thoughts.

130
130
article thumbnail

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

article thumbnail

FDA's early review finds no evidence linking Novo, Lilly weight-loss drugs to suicidal thoughts

Fierce Pharma

A preliminary evaluation by the FDA found no evidence that use of popular diabetes and weight-loss drugs from Novo Nordisk and Eli Lilly can cause suicidal thoughts, the U.S. | A preliminary evaluation by the FDA found no evidence that use of popular diabetes and weight-loss drugs from Novo Nordisk and Eli Lilly can cause suicidal thoughts, the U.S. regulator said.

Drugs 117
article thumbnail

Ji Xing acquires Biogen’s BIIB131 for acute ischemic stroke

Pharmaceutical Technology

Ji Xing Pharmaceuticals acquired Biogen’s BIIB131 for advancing worldwide clinical developments in treating acute ischemic stroke (AIS).

article thumbnail

Nine for 2024, Pt 2: Phase change and the challenges of scale

pharmaphorum

Explore the trends and challenges in the pharmaceutical and healthcare markets, specifically focusing on phase change and the complexities of scaling up operations. Gain insights into the evolving landscape of the industry as we look ahead to 2024.

Marketing 115
article thumbnail

Santhera’s Agamree becomes first approved treatment in UK for all DMD patients

Pharmaceutical Technology

The UK nod for Agamree, which comes after previous approvals in Europe and the US, provides access to a corticosteroid with less severe side effects.

130
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

Appeals court allows unique argument in Gilead's legal battle over HIV meds

Fierce Pharma

When a plaintiff raises allegations of negligence against a company, the claims typically center on defective products that can cause harm. | A group of 24,000 users of Gilead's TDF-based HIV meds argue that the company knowingly shelved a safer HIV med to increase its profits. Now, Gilead will have to prove that a manufacturer can't be held liable for its development timeline of an upgraded product.

article thumbnail

ClinChoice enhances global reach with CSI Medical acquisition

Pharmaceutical Technology

Contract research organisation ClinChoice has acquired CSI Medical Research, marking a significant expansion of its international operations.

Research 130
article thumbnail

Bayer unit takes heart failure gene therapy into phase 2

pharmaphorum

Bayer’s AskBio gene therapy unit has started recruiting patients into a phase 2 trial of its AB-1002 candidate for congestive heart failure.

article thumbnail

SyntheticGestalt and Enamine partner on AI drug discovery models

Pharmaceutical Technology

SyntheticGestalt and Enamine have announced a collaboration to develop a suite of AI models to aid in the discovery of drugs.

Drugs 130
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

How AI is supercharging clinical trials

pharmaphorum

AI technology is revolutionising the field of clinical trials by enhancing patient identification, accelerating drug development and design, and improving monitoring processes. Discover how AI is supercharging clinical trials for better healthcare outcomes.

article thumbnail

Reimbursement-Related Analytics and Reporting

Pharmaceutical Commerce

An overview of a structural approach that guides development of the analytics and related reporting that may assist brands in gaining or maintaining reimbursement positions and maximizing sales.

Branding 104
article thumbnail

FDA finds no link between GLP-1 drugs and suicide

pharmaphorum

The FDA says it can find no evidence of increased risk of suicidal thoughts and self-harm with GLP-1 drugs like Novo Nordisk's Ozempic and Wegovy

Drugs 108
article thumbnail

Repairing the Patient Journey: How Pharma Can Fix the Obvious–and Not So Obvious–Breaking Points of Nonadherence

Drug Channels

Today’s guest post comes from Maria Kirsch, President, Patient Services, Krista Pinto, President, Deployment Solutions, and Mike Scott, Senior Vice President, Specialty Consulting at EVERSANA. Maria, Krista, and Mike discuss the key reasons why patients abandon drug therapy. They then describe EVERSANA’s approach for helping manufacturers and healthcare providers improve adherence and health outcomes.

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

Clinical to medical: Closed loop marketing and connectivity with Veeva

pharmaphorum

Discover how Veeva Systems is revolutionising closed loop marketing and connectivity in biopharma, from clinical to medical. Learn more about innovative solutions and insights from the Veeva Commercial Summit, featuring industry expert Chris Moore and the power of data-driven strategies.

Marketing 105
article thumbnail

Zelsuvmi Gets FDA Nod to Become Second Approved Treatment After Ycanth for Molluscum Contagiosum

XTalks

The US Food and Drug Administration (FDA) has given the nod to Ligand Pharmaceuticals’ topical antiviral Zelsuvmi (berdazimer gel 10.3%) for the treatment of molluscum contagiosum in adult and pediatric patients one year of age and older. The topical gel is the first approved treatment that can be used outside of a medical setting. It can be applied by patients, parents, caregivers or others at home, outside of a physician’s office, to treat the highly contagious viral skin infection, according

article thumbnail

FDA starts review of Lantheus’ generic Lutathera

pharmaphorum

Lantheus has filed what it says is the first generic version of Novartis’ big-selling cancer radionuclide therapy Lutathera in the US, used to treat rare neuroendocrine tumours (NETs). The FDA has started a review of the generic and – if approved – Lantheus could be in line for 180 days of market exclusivity as the first company to bring a copycat version of Lutathera (lutetium Lu 177 dotatate) to the US market.

Marketing 105
article thumbnail

Which pharmaceutical companies have the most drug patents in Luxembourg?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Luxembourg. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is… The post Which pharmaceutical companies have the most drug patents in Luxembourg? appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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

Study finds hundreds of overlooked cancer drug targets

pharmaphorum

Researchers from the Wellcome Sanger Institute and partners have carried out a comprehensive analysis of cancer cells, identifying 370 ‘priority’ targets that could be used to develop new drug therapies.

Drugs 105
article thumbnail

New patent expiration for Gilead Sciences drug STRIBILD

Drug Patent Watch

Annual Drug Patent Expirations for STRIBILD Stribild is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are eleven… The post New patent expiration for Gilead Sciences drug STRIBILD appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
article thumbnail

Six takeaways from JP Morgan 2024

pharmaphorum

Discover the top six key takeaways from JP Morgan's 2024 conference, focusing on dealmaking trends in big tech, life science, AI, and advancements in cell and gene therapies, as well as the future of Antibody-drug conjugates (ADCs). Stay informed with the latest industry insights.

article thumbnail

New patent expiration for Gilead drug TRUVADA

Drug Patent Watch

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

Drugs 59
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.