Pharmaceutical Technology

JUNE 7, 2023

Eli Lilly has achieved significant gains in the past quarter, leading to it becoming the most valuable pharmaceutical company in the world, with a market cap of $420bn, surpassing Johnson & Johnson. The recent rallying of Lilly’s market value has come as the result of two major announcements: its blockbuster type 2 diabetes (T2D) drug Mounjaro (tirzepatide) successfully completed its second final-stage trial for obesity, and its experimental treatment for Alzheimer’s disease completed its Ph

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Bio Pharma Dive

JUNE 7, 2023

Co-founded by Stanford University professor Irv Weissman, the company debuted with $145 million and plans to use CD47 antibodies, best known as potential cancer immunotherapies, to reduce the risk of heart attacks.

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Antibody 238

Pharmaceutical Technology

JUNE 7, 2023

ZyVersa Therapeutics has received a notice of intention to grant from the European Patent Office for its patent application for the cholesterol efflux mediator VAR 200 (2-hydroxypropyl-beta-cyclodextrin). The application was filed for the treatment of diabetic nephropathy/diabetic kidney disease. The Phase IIa-ready VAR 200 is being developed to reduce renal cholesterol and the lipid accumulation that damages the filtration system of kidneys in glomerular diseases patients.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 7, 2023

Dr K Sujith Kumar, the senior deputy drugs controller (DDC) at the department of drugs control administration (DCA) in Kerala has been appointed as the drug controller-in-charge of the state from Thursday, June, 1. A Ph D holder in Pharmaceutical Regulatory Affairs (PRA) from the JSS University in Mysore, Dr.

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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

Pharmaceutical Technology

JUNE 7, 2023

Shanghai Fosun Pharmaceutical (Group) is to collaborate with the International Finance Corporation (IFC) to construct a new pharmaceutical production facility and distribution hub near Abidjan, Côte d’Ivoire. The IFC will provide two loans totalling $53.49m (€50m) to Fosun Pharma’s subsidiaries. The funding will support the new production plant and distribution hub, which is aimed at enhancing access to high-quality medicines in Africa.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 7, 2023

Researchers have recently shown that separate mechanisms drive the hallucinogenic and antidepressant effects of psychedelics like LSD and psilocin, potentially paving the way to use these ‘party drugs’ as treatments that don’t trigger psychedelic trips.

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Pharmaceutical Technology

JUNE 7, 2023

Clinical-stage biotechnology company Acepodia has raised $100m in a Series D financing round to advance the first-in-class cell therapies being developed using the antibody-cell conjugation (ACC) platform. The financing round, led by Digital Mobile Venture, has also seen participation from other existing investors. The latest funding brings the total venture capital financing secured by the company so far to $259m.

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Gene Therapy Gene Development Antibody 147

Rethinking Clinical Trials

JUNE 7, 2023

Dr. Shirley Wang In this Friday’s PCT Grand Rounds, Shirley Wang of Harvard Medical School will present “Emulating Randomized Clinical Trials With Non-randomized Real-World Evidence Studies: Results From the RCT DUPLICATE Initiative.” The Grand Rounds session will be held on Friday, June 9, 2023, at 1:00 pm eastern. The DUPLICATE initiative is building an empirical evidence base for using longitudinal insurance claims prospectively to achieve large-scale replication of randomiz

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Clinical Trials Clinical Trials Trials Medicine 130

Pharmaceutical Technology

JUNE 7, 2023

Baudax Bio revealed has additional results from a Phase II trial investigating its neuromuscular blockade (NMD) agent BX1000 in patients undergoing elective surgery demonstrating favourability to rocuronium. The company now plans to combine it with its pipeline reversal blocking agent. Shares in the US-based company previously surged after the topline data reveal in April.

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Bio Pharma Dive

JUNE 7, 2023

Despite the setback, FibroGen could still rebound later this year if a study in earlier-stage Duchenne patients, who can still walk, is successful.

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Trials Drugs 139

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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 Technology

JUNE 7, 2023

Covid-19 vaccine compositions should be updated to provide protection against XBB Omicron variant strains in preparation for the autumn vaccination campaign, say EU agencies in a joint 6 June statement. This reflects decisions made at past meetings by members of the International Coalition of Medicines Regulatory Authorities on 8 May and elsewhere. There, organisations determined that the compositions of Covid-19 vaccines need to be updated to reflect the evolution of the virus.

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Bio Pharma Dive

JUNE 7, 2023

Companies have had 10 years to comply with the Drug Supply Chain Security Act, but some fear the industry is not ready for a Nov. 27 deadline.

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Drugs 130

Pharmaceutical Technology

JUNE 7, 2023

The US Food and Drug Administration (FDA) has accepted GSK’s supplemental biologics licence application (sBLA) for its Jemperli (dostarlimab) plus chemotherapy for priority review. The company is seeking approval for the combination therapy to treat mismatch repair deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer in adult patients.

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Fierce Pharma

JUNE 7, 2023

Merck has taken the lead, filing a lawsuit seeking to overturn drug pricing measures in the Inflation Reduction Act (IRA). | Merck has filed a lawsuit seeking to overturn drug-pricing measures in the Inflation Reduction Act (IRA). Now, emboldened by the New Jersey drugmaker, other biopharma CEOs are making their concerns known. At the BIO International Convention, Biogen CEO Chris Viehbacher registered severe criticism of the IRA and said his company was considering filing its own lawsuit.

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Drugs 127

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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

Pharmaceutical Technology

JUNE 7, 2023

The European Commission (EC) has granted marketing authorisation for Fennec Pharmaceuticals’ Pedmarqsi (sodium thiosulfate) to reduce the risk of hearing loss in paediatric oncology patients. Known as Pedmark in the US, Pedmarqsi is the first and only therapy to receive approval in the European Union to prevent cisplatin chemotherapy-induced hearing loss (ototoxicity) in patients aged between one month and 18 years with localised, non-metastatic solid tumours.

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Rethinking Clinical Trials

JUNE 7, 2023

                                            Speaker John Alexander, MD, MHS Professor of Medicine/Cardiology DCRI/Duke University Slides Keywords PROACT Xa, Aortic Valve Replacement, Warfarin, Apixaban, Pragmatic Clinical Trial Key Points In the PROACT Xa trial, researchers wanted to learn if patients with an On-X mech valve implanted in the aortic position can be maintained on a factor Xa inhibitor (Apixaban) with a safe level of thromboembolic events

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Pharmaceutical Technology

JUNE 7, 2023

The US Food and Drug Administration (FDA) has granted approval for a new indication for Merck’s PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients. The latest move follows a priority review of a supplemental new drug application (sNDA) for the therapy. In 2017, the therapy received FDA approval for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.

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Fierce Pharma

JUNE 7, 2023

As Alzheimer's disease partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. | As Alzheimer's partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. On Wednesday, that vision came into better focus as the FDA released a document showing how the agency views the drug.

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FDA Approval Drugs 108

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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

Pharmaceutical Technology

JUNE 7, 2023

Rituximab biosimilar is under clinical development by Celltrion and currently in Phase II for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma).

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Clinical Development Development 130

Fierce Pharma

JUNE 7, 2023

The rush to provide revolutionary weight-loss drugs to obese patients has reached the U.K. | The rush to provide revolutionary weight-loss drugs to obese patients has reached the U.K. On Wednesday, the government unveiled a two-year pilot program that will allow Novo Nordisk’s Wegovy to be given to more overweight participants, even though the treatment has yet to be launched there.

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Drugs 102

Pharmaceutical Technology

JUNE 7, 2023

Gebasaxturevis under clinical development by Merck and currently in Phase II for Oral Cavity (Mouth) Cancer.

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Clinical Development Development 130

Fierce Pharma

JUNE 7, 2023

As pharma supply chain problems drag on, a shortage of key cancer drugs has afflicted a large number of treatment centers and many patients. | The National Comprehensive Cancer Network's recent survey shows that nearly all of the treatment centers it polled are facing a carboplatin shortage. Meanwhile, 70% of them reported a cisplatin shortage.

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Drugs 101

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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

XTalks

JUNE 7, 2023

In the dynamic and ever-evolving food and beverage industry, growth is not just about size; it’s about speed, too. The fastest growing beverage brands are those that have tapped into the consumer’s evolving demands, bringing to the table innovative products that combine taste, convenience, affordability and sustainability. The following list is based on the Financial Times’ ranking of The Americas’ Fastest-Growing Companies 2023 , a list of the 500 companies in the Americas that hav

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Antidote

JUNE 7, 2023

Before any new medical treatment, therapy, or device is approved, it must first be tested through clinical research studies. While some research studies seek participants with illnesses or conditions to be studied in the clinical trial, it is not always necessary to have a specific illness or condition to participate. In fact, there are many trials that need healthy volunteers.

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BioPharma Reporter

JUNE 7, 2023

Adede is a seasoned computer scientist and data professional known for providing high quality service whilst employing her multi talents which include efficiency, analytical thinking, and fast learning.

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Cloudbyz

JUNE 7, 2023

The medical technology (MedTech) industry has been witness to revolutionary changes over the last few years. These transformations have been fueled by a mix of technological innovation, policy changes, and shifts in healthcare delivery. One such significant development shaping the future of the MedTech sector is the adoption of Real-World Evidence (RWE).

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Clinical Trials Clinical Trials Trials Marketing 96

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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

Fierce Pharma

JUNE 7, 2023

Legend Biotech and Johnson & Johnson are moving fast in their efforts to forward their CAR-T standout Carvykti. | Legend Biotech and Johnson & Johnson have filed with the FDA for expanded use of Carvykti. After gaining approval 16 months ago for the CAR-T to treat multiple myeloma patients following four or more lines of therapy, the companies hope to get the U.S. regulator to sign off on its use at an earlier stage of treatment.

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BioSpace

JUNE 7, 2023

In a late-stage study of non-ambulatory patients with DMD on background corticosteroids, pamrevlumab failed to meet the primary endpoint for upper limb performance.

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Trials Drugs 87

Fierce Pharma

JUNE 7, 2023

After GSK nabbed a coveted world-first approval for its adult respiratory syncytial virus (RSV) vaccine in the U.S., it has scored the same title in Europe with Arexvy. | After scoring its world-first approval in May, GSK's RSV vaccine for older adults bagged a nod in Europe. The company and its rivals are gearing up to launch their products ahead of the fall RSV season.

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Pharma Times

JUNE 7, 2023

Therapy treats patients with specific types of ovarian, fallopian tube or primary peritoneal cancer - News - PharmaTimes

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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Clinical Trials