Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The FDA will make an approval decision by the new Prescription Drug User Fee Act (PDUFA) target action date of 16 September 2023. The reason for this review extension was undisclosed in the announcement.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 19, 2023

In a major scientific first, synthetic human embryo models have been grown in the lab, without any need for the usual natural ingredients of eggs and sperm. The research – first brought to wider attention by The Guardian – has prompted excitement about the potential for new breakthroughs in health, genetics, and treating disease.

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Pharmaceutical Technology

JUNE 19, 2023

Indian pharmaceutical company Laurus Labs has signed a memorandum of agreement (MoA) with the Indian Institute of Technology, Kanpur (IIT Kanpur) to bring new gene therapy products to the market. The pharma company will in-license a small number of gene therapy products and offer research grants to advance them through pre-clinical development. Laurus Labs will be responsible for launching these products in India and emerging markets.

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Pharma Times

JUNE 19, 2023

Partnership will help NHS to prepare for fundamental change, including reducing carbon emissions - News - PharmaTimes

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Clinical Supply

Pharmaceutical Technology

JUNE 19, 2023

Although only a small number of gene therapies have reached the market thus far, the industry is poised to grow quickly over the next few years. Pharmaceutical companies are putting their trust in the immense potential this new generation of medicine has for treating individuals with rare genetic diseases, which currently affect an estimated 280 million patients worldwide.

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BioPharma Reporter

JUNE 19, 2023

SCTbio, a contract development and manufacturing organization (CDMO) specializing in cell-based therapy and viral vectors, has partnered with cell and regenerative medicine specialist Cyto-care.

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Manufacturing Medicine Development 97

Pharma Times

JUNE 19, 2023

Vital financing will be used to develop novel therapies for condition with high unmet medical need - News - PharmaTimes

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Development 107

Pharmaceutical Technology

JUNE 19, 2023

Coherus BioSciences has signed a definitive merger agreement to buy clinical-stage immuno-oncology (I-O) company Surface Oncology, in a deal valued at $65m. The company will buy all outstanding Surface Oncology shares at a price of $5.2831 per share, totalling approximately $40m, along with anticipated net cash of between $20 and $25m. Coherus BioSciences will gain access to Surface Oncology’s two differentiated clinical stage assets, SRF388 and SFR114.

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BioPharma Reporter

JUNE 19, 2023

CStone Pharmaceuticals' shares have risen after academic journal Nature Cancer published the clinical study results of its lung-cancer treatment sugemalimab.

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Development 97

Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. Biomm will gain exclusive rights for the distribution and marketing in Brazil of the proposed biosimilar to Janssen’s Stelara. Bio-Thera will handle BAT2206’s global development and commercial supply out of its manufacturing plants in Guangzhou, China.

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Licensing Licensing Clinical Trials Clinical Trials 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

BioSpace

JUNE 19, 2023

Eli Lilly stands to gain access to DICE Therapeutics’ DELSCAPE platform, which enables the design of orally available molecules for autoimmune and inflammatory diseases.

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BioPharma Reporter

JUNE 19, 2023

Abu Dhabi’s Department of Health has collaborated with Mass General Brigham's International Center for Genetic Disease (iCGD).

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BioSpace

JUNE 19, 2023

While the German biotech that partnered with Pfizer on a COVID vaccine sees its first lawsuit, legal experts don’t expect similar cases in the U.S.

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Vaccination Vaccine 92

Cloudbyz

JUNE 19, 2023

In recent years, the field of pharmacovigilance and drug/device safety has witnessed remarkable advancements in the use of artificial intelligence (AI). Specifically, the emergence of generative AI and large language models has revolutionized the way safety information is collected, analyzed, and utilized. This blog explores the transformative potential of generative AI and large language models in the realm of drug and device safety, highlighting their key applications, benefits, and future pro

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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

BioSpace

JUNE 19, 2023

As geopolitical tensions rise in the region, AstraZeneca is looking at potentially spinning off its China unit into its own independent business.

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JAMA Internal Medicine

JUNE 19, 2023

This cohort study measures the associated long-term effects of COVID-19 that are distinct from the risks associated with hospitalization for acute illnesses in general.

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BioSpace

JUNE 19, 2023

The International Chamber of Commerce arbitration tribunal has dismissed Boehringer’s attempt to seek indemnification from Sanofi for the ongoing Zantac lawsuits faced by the companies.

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pharmaphorum

JUNE 19, 2023

Weight-loss drugs ‘will be a $60bn market in 10 years’ Phil.

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Marketing Drugs 97

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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

BioSpace

JUNE 19, 2023

Arcellx contends that limitations on the bridging therapy are a contributing factor and is working with the regulator to amend the protocol, the company announced Monday.

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pharmaphorum

JUNE 19, 2023

Can forecasting help identify market opportunities for pharmaceutical companies? Mike.

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Marketing 79

BioSpace

JUNE 19, 2023

Following the FDA’s approval in March, India-based Lupin is launching its generic thiamine hydrochloride injection USP in the U.S. for treating vitamin B1 deficiency.

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Outsourcing Pharma

JUNE 19, 2023

Positive phase 3 results from a trial studying fruquintinib, in patients with previously treated colorectal cancer (CRC) were announced by Hutchmed and Takeda on Friday (June 16).

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Trials Drugs Clinical Development Development 52

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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

BioSpace

JUNE 19, 2023

The latest round of layoffs comes just two months after Thermo Fisher announced plans to close three sites in San Diego, bringing the total to nearly 600 jobs cut in 2023.

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Drug Patent Watch

JUNE 19, 2023

Annual Drug Patent Expirations for ORAVERSE Oraverse is a drug marketed by Septodont Holding and is included in one NDA. It is available from one supplier. There are three patents… The post New patent expiration for Septodont Holding drug ORAVERSE appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

Drug Discovery World

JUNE 19, 2023

Anoat Therapeutics, a preclinical stage biotechnology company specialised in Cystic Fibrosis (CF), has raised €2m ($2.17m) in seed funding from AdBio partners, a venture capital company specialised in seed investments in life sciences startups. This investment from the AFB FII fund stems from the AdBio-Inserm Transfert partnership announced in May 2022 to finance, support and grow Europe’s most innovative life science startups.

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Outsourcing Pharma

JUNE 19, 2023

A soft mist inhaler made by Resyca BV, a joint venture of Medspray Pharma BV and Recipharm AB, is being brought to patients with pulmonary arterial hypertension (PAH).

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Clinical Development Development 52

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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

Drug Discovery World

JUNE 19, 2023

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. Regulatory approvals and industry guidelines are key to the continued development and discovery of drugs, which is a common theme throughout this week’s news highlights, including an FDA approval for Pfizer, a NICE recommendation for AstraZeneca UK, and an update to the HER2 Breast Canc

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FDA Approval Drugs Development 52

FDA Law Blog

JUNE 19, 2023

By Jeffrey N. Gibbs & Allyson B. Mullen & Gail H. Javitt & McKenzie E. Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. In the most recent Unified Agenda, which is a list of planned regulatory actions published semi-annually by the Office of Management and Budget (OMB), FDA announced its intent to issue a proposed rule “to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug,

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Regulation Cosmetics In-Vitro Development 56

Drug Discovery World

JUNE 19, 2023

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. Regulatory approvals and industry guidelines are key to the continued development and discovery of drugs, which is a common theme throughout this week’s news highlights, including an FDA approval for Pfizer, a NICE recommendation for AstraZeneca UK, and an update to the HER2 Breast Canc

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FDA Approval Drugs Development 52

pharmaphorum

JUNE 19, 2023

BMS joins Merck in challenge to Medicare price negotiation Phil.

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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