Bio Pharma Dive

JANUARY 5, 2024

The clearance is a major shift for the agency, which described its decision as a “first step” in allowing Florida to bulk purchase lower-cost Canadian medicines.

Drugs 300

Drugs Medicine 300

Pharmaceutical Technology

JANUARY 5, 2024

AbbVie and Umoja Biopharma partnered for the development of in-situ CAR-T cell therapy candidates for oncology targets.

Development 306

Development 306

Bio Pharma Dive

JANUARY 5, 2024

Lykos Therapeutics, formerly known as MAPS Public Benefit Corp., recently submitted its MDMA capsules for FDA approval, following two positive studies.

FDA Approval 281

FDA Approval 281

Pharma Mirror

JANUARY 5, 2024

New Delhi, India – FD-AID, LLC, a distinguished leader in pharmaceutical quality and compliance solutions, proudly announces its entry into the Indian pharmaceutical market. Spearheaded by a former US FDA Investigator and seasoned pharmaceutical executive, FD-AID is uniquely positioned to bring a wealth of expertise and insight to India’s rapidly growing pharmaceutical industry.

Compliance 130

Compliance FDA Compliance Marketing Drugs 130

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Clinical Supply

Pharmaceutical Technology

JANUARY 5, 2024

Intellia Therapeutics announced its clinical goals for the next few years, pushing development for its late-stage ATTR asset.

Development 162

Development 162

Antidote

JANUARY 5, 2024

Though clinical trial patient recruitment is an integral part of the medical research process, it is often one of the most difficult aspects of conducting a study. There are various reasons for this challenge, and among them is the widespread existence of misconceptions about participating in research that many patients may see as a barrier to entry.

Clinical Trials 124

Clinical Trials Clinical Trials Trials Research 124

Drug Discovery World

JANUARY 5, 2024

Kyverna Therapeutics has revealed plans to progress to Phase II trials of KYV-101 for multiple sclerosis (MS) following a green light from the US Food and Drug Administration (FDA). KYV-101 is an autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate for use in B cell-driven autoimmune diseases. “This approval is a critically necessary step that paves the way to enrol patients with treatment-refractory progressive MS for whom there are no currently available

Trials 124

Trials Protein Clinical Research Drugs 124

Pharmaceutical Technology

JANUARY 5, 2024

KAI, a technology company based in the UK, is a Category Award Winner for Innovation in the 2023 Pharmaceutical Technology Excellence Awards

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130

Fierce Pharma

JANUARY 5, 2024

Three days after the FDA included Novo Nordisk’s semaglutide treatments Ozempic and Wegovy on a list of medicines that it would monitor for side effects—one of them suicide ideation—a study of medi | Three days after the FDA included Novo Nordisk’s semaglutide treatments Ozempic and Wegovy on a list of medicines that it would monitor for side effects—one of them suicide ideation—a study of medical records of patients shows no link between use of the GLP-1 drugs and an increase in suicidal though

Drugs 116

Drugs Medicine Research 116

Pharmaceutical Technology

JANUARY 5, 2024

Avistone has closed its Series B financing round, raising 1bn yuan ($140m), to support clinical research and development of its drug pipeline.

Development 130

Development Research Drugs Clinical Research 130

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Pharmaceutical Commerce

JANUARY 5, 2024

LillyDirect will facilitate access to medications by connecting patients with independent telehealth providers, bypassing the need to obtain a prescription from a physician and then going to a pharmacy to fill it.

Pharmacy 105

Pharmacy Drugs 105

Pharmaceutical Technology

JANUARY 5, 2024

Menarini subsidiary Stemline will receive upfront and milestone payments, potentially worth more than $500m, along with royalties from sales.

Sales 130

Sales 130

pharmaphorum

JANUARY 5, 2024

Explore the highlights of the 2023 Benchling biotech press roundtable before Benchtalk London, showcasing cutting-edge software and innovations in the field of biotechnology.

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105

Pharmaceutical Technology

JANUARY 5, 2024

Boehringer Ingelheim has signed a deal with 3T Biosciences for the discovery and development of next-generation cancer immunotherapies.

Development 130

Development 130

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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

Clinical Research

pharmaphorum

JANUARY 5, 2024

Gain insights from sustainability leaders in the life sciences industry on navigating the path to sustainable pharma. Learn about their efforts in addressing environmental issues, social impact, governance practices, and enhancing patient outcomes.

Life Science 93

Life Science 93

Pharmaceutical Technology

JANUARY 5, 2024

MOMA Therapeutics and Roche have signed a strategic partnership and licensing agreement for discovering drug targets for cancer.

Drugs 130

Drugs Licensing Licensing 130

Fierce Pharma

JANUARY 5, 2024

When Theravance called it quits on a phase 2 JAK inhibitor program last February, the South San Francisco and Dublin-based biopharma company put the majority of its chips on a head-to-head trial pi | In the phase 4 study, Theravance and Viatris’ Yupelri failed to demonstrate greater lung function improvement in adults with COPD versus Spiriva delivered by a dry powder inhaler, Theravance said Friday.

Trials 80

Trials 80

Pharmaceutical Technology

JANUARY 5, 2024

Rhythm to acquire global rights for South Korean LG Chem’s oral obesity drug LB54640 for $100m in cash and equity.

Drugs 130

Drugs 130

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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.

Clinical Trials

Pharma Times

JANUARY 5, 2024

The companies will aim to select targets, discover and develop new therapeutics

Development 112

Development 112

Pharmaceutical Technology

JANUARY 5, 2024

The company aims to drive a small molecule resurgence with its lead Alzheimer’s symptom relief agent AD-101.

Trials 130

Trials Drugs Development 130

Pharma Times

JANUARY 5, 2024

Vd1-gd T cells were effective in predicting positive responses to ICI therapy

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pharmaphorum

JANUARY 5, 2024

Beckley Psytech has announced that is has received substantial strategic investment from atai Life Sciences, totalling $50 million, to accelerate the clinical development of short-duration psychedelics.

Life Science 78

Life Science Clinical Development Development 78

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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.

Clinical Supply

Fierce Pharma

JANUARY 5, 2024

The last few days of 2023 and the beginning of 2024 featured a flurry of dealmaking by the likes of AstraZeneca, Johnson & Johnson, Roche and Boehringer Ingelheim with Asian companies | A flurry of deals were inked by the likes of AstraZeneca, Johnson & Johnson, Roche and Boehringer Ingelheim with Asian companies. Big Pharma companies are also increasingly entrusting commercialization of some products in China to domestic firms.

Pharma Companies 71

Pharma Companies Production 71

XTalks

JANUARY 5, 2024

OAKBERRY, a leading Brazilian global açaí brand, has successfully raised $67 million in Series C funding. This significant financial milestone was led by the Brazilian investment bank, BTG Pactual. The capital raised will be set aside to accelerate OAKBERRY’s global expansion strategy, with a keen focus on the US market. The funds are strategically intended to bolster OAKBERRY’s revenue to an impressive $200 million.

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Branding Marketing Protein 64

Fierce Pharma

JANUARY 5, 2024

UCB is heading into 2024 with several new approvals under its belt, but it’s leaving its membership in the Biotechnology Innovation Organization (BIO) behind. | Both companies opted not to renew their 2024 memberships with the Biotechnology Innovation Organization (BIO). UCB will still retain its membership in other top trade groups, including the Pharmaceutical Research and Manufacturers Association of America (PhRMA).

Manufacturing 64

Manufacturing Research 64

Drug Patent Watch

JANUARY 5, 2024

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

Drugs 59

Drugs Marketing 59

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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.

Clinical Trials

XTalks

JANUARY 5, 2024

Eli Lilly launched LillyDirect this week, an online service that provides access to the company’s medicines, including its newly approved weight loss drug Zepbound (tirzepatide). The website, according to the announcement from Lilly , offers an end-to-end digital healthcare experience and will provide patients access to its diabetes, weight loss and migraine medications, among others.

Drugs 59

Drugs Pharmacy Cosmetics Insulin 59

Drug Discovery World

JANUARY 5, 2024

Massachusetts Institute of Technology (MIT) researchers have used deep learning to identify a new class of antibiotic candidates that can kill methicillin-resistant Staphylococcus aureus (MRSA). The study represents more good news in the battle against antimicrobial resistance, as researchers from Harvard University and Roche also recently announced the discovery of a novel class of antibiotics.

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Engineer Bacteria Research Drugs 59

Pharmaceutical Commerce

JANUARY 5, 2024

Trials will evaluate four novel agents for cancers that include essential thrombocythemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, non-small cell lung cancer, endometrial carcinoma, and metastatic castration-resistant prostate cancer.

Trials 52

Trials 52

Drug Discovery World

JANUARY 5, 2024

Techbio SimBioSys and the Mayo Clinic have entered into a strategic collaboration to develop novel digital precision medicine solutions for breast cancer. The aim of the collaboration is to develop cloud-based clinical software tools that will support the end-to-end decision-making process for early-stage breast cancer patients, including drug selection and risk stratification.

Genome 59

Genome Genomics Clinical Trials Clinical Trials 59

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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.

Clinical Supply