Fierce Pharma

DECEMBER 4, 2023

Last year, roughly 250 products that contain the decongestant phenylephrine—including popular brands such as Sudafed, NyQuil, Benadryl and Tylenol—rang up sales of nearly $1.8 billion. | House Republicans want to know why it has taken so long for the FDA to act on the decongestant phenylephrine. Rep. Lisa McClain (Mich.), who chairs the House oversight subcommittee on health care and financial services, has sent a letter to FDA commissioner Robert Califf, requesting a briefing on the effectivene

Containment 104

Containment Branding Sales Production 104

Bio Pharma Dive

DECEMBER 4, 2023

The biotech said Phase 2 study results showed its experimental medicine for age-related macular degeneration was "non-inferior" to Regeneron's Eylea.

Drug Trials 259

Drug Trials Trials Medicine Drugs 259

Pharmaceutical Technology

DECEMBER 4, 2023

Eli Lilly has received approval from the US FDA for Jaypirca to treat chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL)

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Bio Pharma Dive

DECEMBER 4, 2023

The acquisition of Carmot, which had been planning an IPO, will hand Roche three weight loss medicines in early clinical testing.

Medicine 288

Medicine Drugs 288

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Pharmaceutical Technology

DECEMBER 4, 2023

Roche has signed an agreement for the acquisition of US-based company Carmot Therapeutics in a deal valued at $2.7bn, to be paid in cash.

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Bio Pharma Dive

DECEMBER 4, 2023

Accurate and timely processing of data is imperative to create robust analytical datasets that can be used in the RWE setting.

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Bio Pharma Dive

DECEMBER 4, 2023

With clinical trials becoming more complex, finding ways to streamline and automate laboratory processes is vital when analyzing bioanalytical samples.

Clinical Trials 256

Clinical Trials Clinical Trials Trials 256

Pharmaceutical Technology

DECEMBER 4, 2023

The agreement allows Guardant Health to leverage Cancer Research UK’s network to validate its technologies.

Drugs 243

Drugs Research 243

Bio Pharma Dive

DECEMBER 4, 2023

Jaypirca, which has been on the market for less than a year, can now be used for more types of blood cancer but not as early as rival drugs from AbbVie and AstraZeneca.

Drugs 148

Drugs Marketing 148

Pharmaceutical Technology

DECEMBER 4, 2023

The $247m deal will focus on the use of generative artificial intelligence to develop an antibody therapy for an unnamed cancer.

Antibody 162

Antibody Drugs Development 162

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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

BioSpace

DECEMBER 4, 2023

The regulator placed a partial clinical hold on Roche’s fenebrutinib—being developed for relapsing MS—after two patients experienced elevated hepatic transaminase and bilirubin levels indicative of liver injury.

Regulation 112

Regulation Development 112

Pharmaceutical Technology

DECEMBER 4, 2023

GlobalData tracks 4 drugs in development for Cat Allergy by four companies/universities/institutes. The top development phase for Cat Allergy is preclinical, with two drugs in that stage.

Allergies 130

Allergies Development Drugs 130

XTalks

DECEMBER 4, 2023

Most oncology products approved in the past few decades are known for being highly toxic, non-specific and fraught with severe side effects for cancer patients. This was because higher doses often correlated with a better reduction in tumor size, so trial designs were predicated on obtaining the maximum tolerated dose (MTD). But today, with a rise in molecularly targeted therapies, oncology development has shifted to identifying an optimal biologic dose that balances toxicity with efficacy.

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Development Drugs Clinical Trials Clinical Trials 111

Pharmaceutical Technology

DECEMBER 4, 2023

A statement issued by leading industry bodies emphasises climate change as an urgent health challenge at COP28, as the president defends fossil fuel use.

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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

DECEMBER 4, 2023

Roche has agreed a deal to acquire US biotech Carmot Therapeutics that if consummated will thrust it into the increasingly competitive market for incretin-based therapies for diabetes and obesity. The Swiss pharma group has agreed to pay $2.7 billion upfront in cash when the deal closes, with shareholders in the US company also in line for up to $400 million if the drug programmes covered by the agreement meet various milestones.

Marketing 108

Marketing Drugs 108

Pharmaceutical Technology

DECEMBER 4, 2023

Blarcamesine hydrochloride is under clinical development by Anavex Life Sciences and currently in Phase I for Infantile Spasm (West Syndrome).

Life Science 130

Life Science Clinical Development Development 130

Pharma Times

DECEMBER 4, 2023

In England, an estimated 4,500 people are living with undiagnosed HIV - News - PharmaTimes

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Pharmaceutical Technology

DECEMBER 4, 2023

Dan Herron, of digital offerings at RWS Life Sciences, details how AI and algorithms can be used to optimise these administrative processes.

Clinical Trials 130

Clinical Trials Clinical Trials Life Science Trials 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

Fierce Pharma

DECEMBER 4, 2023

Fujifilm Corporation is spreading the wealth across two production units as the contract development and manufacturing organization (CDMO) juggernaut works through a cell therapy expansion. | Fujifilm is dividing $200 million between a pair of subsidiaries. Those are: Fujifilm Cellular Dynamics, which specializes in development and manufacturing of human induced pluripotent stem cells (iPSC), and the organization’s CDMO for biologics and advanced therapies, Fujifilm Diosynth Biotechnologies.

Manufacturing 104

Manufacturing Production Development 104

Pharmaceutical Technology

DECEMBER 4, 2023

Palvella will receive $5m as an upfront payment, with Ligand getting 8%-9.8% in tiered royalties on worldwide sales of Qtorin rapamycin.

Sales 130

Sales Trials 130

BioSpace

DECEMBER 4, 2023

The gene editing company is dropping two programs and favoring its next-generation assets CTX112 and CTX131, which it will continue to develop in oncology but will also test in autoimmune diseases.

Gene Editing 106

Gene Editing Gene Development 106

Pharmaceutical Technology

DECEMBER 4, 2023

GC Biopharma has concluded the construction activities at an mRNA manufacturing plant at its vaccine production site in South Korea.

Manufacturing 130

Manufacturing Vaccination Vaccine Production 130

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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

XTalks

DECEMBER 4, 2023

Ripple pea milk, a leading US plant-based milk brand, recently raised a substantial $49.2 million in its latest funding round, elevating the company’s total investments to a staggering $274 million. This financial boost coincides with a growing interest in the pea milk category, which has recently overshadowed the broader alt-dairy sector in year-on-year growth.

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Protein Branding Production Marketing 105

Pharmaceutical Technology

DECEMBER 4, 2023

BMS-986360 is under clinical development by Bristol-Myers Squibb and currently in Phase I for Triple-Negative Breast Cancer (TNBC).

Clinical Development 130

Clinical Development Development 130

Fierce Pharma

DECEMBER 4, 2023

A challenging year for the biotech industry has taken a heavy toll on Chinese manufacturer WuXi Biologics, sending the company’s stock plummeting nearly 24% Monday. | WuXi Biologics expects to miss its original sales target for the year by around $400 million, thanks to reductions across its development and manufacturing services. WuXi blamed the projected miss largely on a COVID-related revenue slowdown and a decline in projects.

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Contract Manufacturing Manufacturing Sales Development 97

Pharmaceutical Technology

DECEMBER 4, 2023

AZ-3102 is under clinical development by Azafaros and currently in Phase I for Sandhoff Disease (Jatzkewitz-Pilz Syndrome).

Clinical Development 130

Clinical Development Development 130

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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

BioSpace

DECEMBER 4, 2023

A combination of Roche’s investigational treatment with Ibrance and fulvestrant met its primary endpoint of progression-free survival in the first-line setting in treating PIK3CA-mutated breast cancer.

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Pharmaceutical Technology

DECEMBER 4, 2023

R-209 is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Inflammatory Bowel Disease.

Clinical Development 130

Clinical Development Development 130

Pharma Times

DECEMBER 4, 2023

The neurological condition affects around 50 million people worldwide - News - PharmaTimes

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Pharmaceutical Technology

DECEMBER 4, 2023

Everest’s clinical trial in China will contribute to Kezar’s global PALIZADE study of zetomipzomib for lupus nephritis.

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Clinical Trials Clinical Trials Drugs Trials 130

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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