Thu.May 25, 2023

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J&J antibody drug combination shows promise in multiple myeloma

Bio Pharma Dive

A pair of dual-acting antibodies displayed early potential to become a new type of drug regimen for the blood cancer, but led to a high rate of side effects as well.

Antibody 357
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Appili Therapeutics receives US patent for ATI-1501

Pharmaceutical Technology

Appili Therapeutics has received a US patent for ATI-1501 , a liquid oral reformulation of metronidazole. The patent claims for ATI-1501 were published by the US patent and trademark office under US application no. 18/072,154, filed on 30 November 2022. It covers the composition and preparation methods for ATI-1501 until 2039. Metronidazole is a widely used frontline oral treatment for parasitic and anaerobic bacterial infections.

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ASCO puts spotlight on advancing antibody-drug conjugate pipeline

Bio Pharma Dive

Study abstracts released Thursday give investors and analysts a better look at cancer treatments recently licensed by Merck and BioNTech as well as fresh details on other closely watched ADC candidates.

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Clover collaborates with Kyuan Trade to launch AdimFlu-S (QIS) in China

Pharmaceutical Technology

Clover Biopharmaceuticals has established a commercial collaboration with Keyuan Xinhai (Beijing) Medical Products Trading (Kyuan Trade) for the launch of its quadrivalent seasonal influenza vaccine, AdimFlu-S (QIS), in China. The China National Medical Products Administration approved AdimFlu-S (QIS) in January 2022 for individuals aged three years and above.

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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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Bristol Myers data make case for earlier use of bone marrow disease drug

Bio Pharma Dive

Data released ahead of next month’s ASCO meeting detail how well Bristol Myers’ Reblozyl outperformed the decades-old standard Epogen in treating anemia from myelodysplastic syndromes.

Drugs 312
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ElevateBio raises funds to advance cell and gene therapies

Pharmaceutical Technology

ElevateBio has raised $401m in a Series D financing round for advancing its technology platforms to expedite the design, production and development of cell and gene therapies. The technology platforms include the Life Edit gene editing platform, an RNA, cell, protein, vector engineering and induced pluripotent stem cells (iPSCs) platform. ElevateBio intends to use the funds to advance its genetic medicine current good manufacturing practice (cGMP) and process development business, BaseCamp.

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Meningitis vaccine comes to the forefront with impressive study results

Pharmaceutical Technology

A new vaccine developed by the Serum Institute of India to fight meningococcal disease could help eliminate meningitis across Africa. The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile. The trial, conducted in 1,800 healthy individuals ranging from ages 2-29 years in Mali and The Gambia in 2021, found NmCV-5 induced a strong immune response across five strains of meningococcal bacteri

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A Popular Sweetener Had A Worrying Impact on Generations Of Mice

AuroBlog - Aurous Healthcare Clinical Trials blog

Could the sweetened drinks we knock back make us feel a little more anxious? A 2022 study that looked at the effects of the artificial sweetener aspartame on mice suggested that it’s a possibility that’s worth investigating further.

Drugs 185
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BenevolentAI CFO resigns as company lays off staff, restructures

Bio Pharma Dive

The biotech, one of several AI drug discovery specialists to go public in recent years, is cutting up to 180 jobs and reorganizing its pipeline to conserve cash.

Drugs 195
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UK agency pilots biobank to study links between genetics and drug side effects

Pharmaceutical Technology

The Medicines and Healthcare products Regulatory Agency (MHRA) aims to launch a pilot genetic biobank that will gather patient data to associate drug-related adverse events to their genetic makeup. The Yellow Card biobank will launch as a joint venture with the UK-government funded entity Genomics England on June 1. The biobank will work in parallel with the MHRA’s Yellow Card website, which is used for reporting adverse events and side effects caused by medicines and medical devices, per the 25

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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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Annexon claims a silver lining in failed eye drug study

Bio Pharma Dive

The company’s geographic atrophy drug didn’t slow the growth of eye lesions, as similar medicines have in clinical testing. But executives said it may have helped preserve some patients’ vision.

Drugs 183
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Pyxis Oncology signs agreement to buy Apexigen

Pharmaceutical Technology

Pyxis Oncology has made a definitive agreement to buy biopharmaceutical company Apexigen, in a deal valued at nearly $16m. Pyxis Oncology will issue 0.1725 shares of its common stock, with par value of $0.001 per share, for each Apexigen share. Apexigen discovers and develops a new generation of antibody therapeutics to treat cancer, along with new immuno-oncology products to harness the immune system to combat and eradicate cancer.

Antibody 130
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Apellis abandons ALS drug after study miss

Bio Pharma Dive

The trial failure is the second for an ALS medicine this week, adding to a lengthy list of study setbacks that have thinned the pipeline of experimental medicines for the disease in recent years.

Medicine 161
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Adalvo signs licence deal with EQL Pharma for Mellozzan

Pharmaceutical Technology

Adalvo has entered a strategic licensing agreement with Swiss pharmaceutical company EQL Pharma for Mellozzan (melatonin) outside Europe and the US. Adalvo will gain exclusive rights to register, commercialise and distribute Mellozzan across 89 countries including Canada, Egypt, Japan, China and Brazil. If the company chooses not to pursue these in some countries, the rights to the product there will be returned to the Swiss company in a pre-defined reasonable timeframe.

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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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Digital health funding holds steady in Q1 after year of decline

Bio Pharma Dive

The sector defied trends seen in the larger venture capital environment, where funding continues to fall. But investment is still at years-low levels.

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FDA delays Sarepta’s DMD gene therapy decision until June

Pharmaceutical Technology

Pushing back an initial deadline, the US Food and Drug Administration (FDA) has proposed a new regulatory action date of 22 June, by which time the agency will assess the logistics of a possible approval for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy. In a press release, Sarepta said that ongoing discussions with the FDA, are weighing the therapy’s potential accelerated approval for DMD patients of ages four to five years old, possibly later expanding to a non-age-restr

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Illumina, Icahn prepare for proxy showdown

Bio Pharma Dive

Can Carl Icahn bend Illumina to his will? Shareholders will vote Thursday on removing the company’s CEO and chairman from the board and replacing them with nominees from the activist investor.

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Celltrion’s Yuflyma receives US FDA approval for multiple conditions

Pharmaceutical Technology

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma is indicated to treat juvenile idiopathic arthritis, hidradenitis suppurativa, Crohn’s disease, plaque psoriasis, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.

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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.

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House lawmakers, PBM lobby spar over committee hearing

Bio Pharma Dive

At the latest congressional inquiry into pharmacy benefit managers, lawmakers argued the middlemen profit at the expense of patients and taxpayers.

Pharmacy 130
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Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD)

Rethinking Clinical Trials

                                            Speaker Robert O’Toole, MD Chief of Orthopaedics, R Adams Cowley Shock Trauma Center Head, Division of Orthopaedic Trauma Department of Orthopaedics Director, Clinical Research, Department of Orthopaedics University of Maryland School of Medicine Slides Keywords Pragmatic trials, orthopedic surgery, orthopedic trauma, Venous thromboembolism Key Points Venous thromboembolism (VTE) is a potentially fatal compli

Trials 130
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Lupus Awareness Month: A Q&A with Lupus Foundation of America

Antidote

Lupus is a chronic, autoimmune disease that can be extremely difficult to identify and treat. Lupus can occur in anyone , and symptoms can range from mild to life threatening. Consequently, raising awareness and promoting early diagnosis is so important to identify and manage this condition.

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World Hunger Day 2023: A Call for Sustainable Solutions

XTalks

World Hunger Day, commemorated every year on May 28, provides a platform to raise awareness about global hunger issues and celebrate the tangible solutions that can end hunger. Founded by The Hunger Project in 2011, the day is dedicated to recognizing the efforts of local communities worldwide who strive towards ending hunger and poverty​​. Read on to learn about the history of world hunger and the theme of World Hunger Day 2023.

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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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Johnson & Johnson takes another step in CAR-T race with Bristol Myers in multiple myeloma

Fierce Pharma

Johnson & Johnson takes another step in CAR-T race with Bristol Myers in multiple myeloma kdunleavy Thu, 05/25/2023 - 10:52

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Centre for Genomic Regulation and Almirall join forces on skin cancer treatments

Pharma Times

The collaboration aims to develop novel preclinical models with a view to identifying new treatments

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Apellis scraps pegcetacoplan development in ALS after phase 2 trial flop

Fierce Pharma

Apellis scraps pegcetacoplan development in ALS after phase 2 trial flop zbecker Thu, 05/25/2023 - 10:42

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BioInvent and Transgene and report positive BT-001 data

Pharma Times

Tumour treatment among all phase 1a cohorts in were concluded with no safety concerns

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.

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ASCO preview: Merck's Keytruda, Novartis' Kisqali face their moment of truth in early-stage cancers

Fierce Pharma

ASCO preview: Merck's Keytruda, Novartis' Kisqali face their moment of truth in early-stage cancers aliu Thu, 05/25/2023 - 14:31

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ASCO: Regeneron Touts New Data in Bid to Become Next Big LAG-3 Player

BioSpace

ASCO: Regeneron Touts New Data in Bid to Become Next Big LAG-3 Player 5/26/2023

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After breakup with Otsuka, Akebia finds new partner for oral anemia drug in Europe

Fierce Pharma

After breakup with Otsuka, Akebia finds new partner for oral anemia drug in Europe aliu Thu, 05/25/2023 - 09:32

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Virtual ward firm Doccla starts atrial fibrillation project

pharmaphorum

Virtual ward firm Doccla starts atrial fibrillation project Phil.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.