Wed.Jun 07, 2023

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Eli Lilly achieving significant gains in obesity results

Pharmaceutical Technology

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

Marketing 246
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With new startup Bitterroot, Forty Seven founder takes aim at heart disease

Bio Pharma Dive

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.

Antibody 241
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ZyVersa Therapeutics inches closer to European patent approval for VAR 200

Pharmaceutical Technology

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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Dr K Sujith Kumar appointed as new drug controller-in-charge in Kerala

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Drugs 210
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Fosun Pharma and IFC to build new drug manufacturing plant in Africa

Pharmaceutical Technology

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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Antidepressant Psychedelics With No Hallucinations May Finally Be Possibl

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Research 189

More Trending

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Acepodia raises funds to advance pipeline of cell therapies

Pharmaceutical Technology

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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June 7, 2023: This Week’s PCT Grand Rounds Will Feature the DUPLICATE Initiative

Rethinking Clinical Trials

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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Baudax Bio reports promising additional data for neuromuscular blockade agent

Pharmaceutical Technology

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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FibroGen’s Duchenne drug misses mark in first large trial

Bio Pharma Dive

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

Trials 141
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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

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EU agencies back Covid-19 vaccine update ahead of autumn campaign

Pharmaceutical Technology

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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Pharmaceutical supply chains raise data concerns as traceability law nears final step

Bio Pharma Dive

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.

Drugs 130
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FDA accepts GSK’s sBLA for Jemperli to treat endometrial cancer

Pharmaceutical Technology

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.

Trials 130
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After Merck's flashpoint IRA lawsuit, Biogen CEO and others register their own complaints

Fierce Pharma

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.

Drugs 129
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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

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EC grants marketing authorisation for Fennec’s Pedmarqsi

Pharmaceutical Technology

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.

Marketing 130
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Grand Rounds June 2, 2023: PROACT Xa and The Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial (John Alexander, MD, MHS)

Rethinking Clinical Trials

                                            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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US FDA expands approval for Merck’s PREVYMIS (letermovir)

Pharmaceutical Technology

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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FDA document outlines apparent agency support for full approval of Biogen, Eisai's Leqembi

Fierce Pharma

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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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.

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Rituximab biosimilar by Celltrion for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma): Likelihood of Approval

Pharmaceutical Technology

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

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Novo Nordisk's obesity drug Wegovy to be provided to more patients under UK pilot program

Fierce Pharma

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.

Drugs 114
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Gebasaxturev by Merck for Oral Cavity (Mouth) Cancer: Likelihood of Approval

Pharmaceutical Technology

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

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National cancer group reports widespread chemo shortages, calls on government and industry to help resolve them

Fierce Pharma

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.

Drugs 107
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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Top 3 Fastest Growing Beverage Brands in 2023

XTalks

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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Johnson & Johnson, Legend file for expanded use of Carvykti after key trial win

Fierce Pharma

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.

Trials 99
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Why volunteer for research studies?

Antidote

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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Interview: Women in Science - Pamela Adede and her hope for future generations of women to thrive in science

BioPharma Reporter

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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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.

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ASCO 2023 – Arun Krishna

pharmaphorum

With a 51% reduction in deaths, AstraZeneca’s ADAURA trial was one of the breakout stories of this year’s ASCO. In Chicago, Editor in Chief Jonah Comstock was able to sit down with AstraZeneca Head of Lung Cancer Commercial Arun Krishna to dive in a little bit on this practice-changing study.

Trials 96
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GSK's adult RSV shot Arexvy nabs European approval weeks after US endorsement

Fierce Pharma

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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FibroGen’s Duchenne Muscular Dystrophy Drug Fails Phase III Trial

BioSpace

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.

Trials 98
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NICE nod for AstraZeneca’s Lynparza

Pharma Times

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

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Accelerating Clinical Supply Through Integrated Drug Development

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.