Bio Pharma Dive
MAY 25, 2023
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.
Pharmaceutical Technology
MAY 25, 2023
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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Bio Pharma Dive
MAY 25, 2023
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.
Pharmaceutical Technology
MAY 25, 2023
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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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
Bio Pharma Dive
MAY 25, 2023
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.
Pharmaceutical Technology
MAY 25, 2023
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 25, 2023
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.
Bio Pharma Dive
MAY 25, 2023
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 25, 2023
The Indian Council of Medical Research (ICMR) has invited Expression of Interest (EoI) through email from experienced Indian agencies for undertaking Transfer of Technology for commercialization and marketing of multiplex single tube real time RT PCR assay for detection of Influenza A , B and SARS CoV2.
Bio Pharma Dive
MAY 25, 2023
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.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Pharmaceutical Technology
MAY 25, 2023
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
Bio Pharma Dive
MAY 25, 2023
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.
Pharmaceutical Technology
MAY 25, 2023
BioInvent International and Transgene ’s partnership is looking optimistic following positive Phase 1a data on its oncolytic virus BT-001 for the treatment of solid tumours. BT-001 encodes a differentiated regulatory T-cell depleting human recombinant anti-CTLA4 antibody as well as granulocyte-macrophage colony-stimulating factor (GM-CSF). The drug is currently in a Phase I/IIa clinical trial as a single agent and in combination with the PD-1 checkpoint inhibitor Keytruda (pembrolizumab) against
Bio Pharma Dive
MAY 25, 2023
The sector defied trends seen in the larger venture capital environment, where funding continues to fall. But investment is still at years-low levels.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Pharmaceutical Technology
MAY 25, 2023
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
Bio Pharma Dive
MAY 25, 2023
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.
Pharmaceutical Technology
MAY 25, 2023
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.
Bio Pharma Dive
MAY 25, 2023
At the latest congressional inquiry into pharmacy benefit managers, lawmakers argued the middlemen profit at the expense of patients and taxpayers.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
Pharmaceutical Technology
MAY 25, 2023
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.
Rethinking Clinical Trials
MAY 25, 2023
                                            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
Pharmaceutical Technology
MAY 25, 2023
Adherence to medications – defined as the extent to which patients take medications as prescribed by their healthcare providers – can be a significant clinical challenge. Lower levels of medication adherence are associated with increased rates of hospital admissions and can lead to poorer health outcomes and increased health system costs. Patients are often prescribed complex medication regimens and are simultaneously tasked with understanding and taking these products appropriately, sometimes f
Fierce Pharma
MAY 25, 2023
Johnson & Johnson takes another step in CAR-T race with Bristol Myers in multiple myeloma kdunleavy Thu, 05/25/2023 - 10:52
Advertiser: Aggregage
New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!
Pharmaceutical Technology
MAY 25, 2023
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
Antidote
MAY 25, 2023
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.
Pharmaceutical Technology
MAY 25, 2023
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.
XTalks
MAY 25, 2023
The US Food and Drug Administration (FDA) has granted approval to AbbVie and Genmab’s Epkinly (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two or more lines of systemic therapy. This includes DLBCL arising from indolent lymphoma and high-grade B-cell lymphoma (HGBL).
Outsourcing Pharma
MAY 25, 2023
H1, a US data healthcare data technology company has been selected by non-profit funder of Parkinsonâs Disease (PD) research, The Michael J Fox Foundation (MJFF), for its Trial Landscape solution.
XTalks
MAY 25, 2023
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.
Fierce Pharma
MAY 25, 2023
Apellis scraps pegcetacoplan development in ALS after phase 2 trial flop zbecker Thu, 05/25/2023 - 10:42
Pharma Times
MAY 25, 2023
The collaboration aims to develop novel preclinical models with a view to identifying new treatments
Fierce Pharma
MAY 25, 2023
ASCO preview: Merck's Keytruda, Novartis' Kisqali face their moment of truth in early-stage cancers aliu Thu, 05/25/2023 - 14:31
Pharma Times
MAY 25, 2023
Tumour treatment among all phase 1a cohorts in were concluded with no safety concerns
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