Can supermarket pharmacies plug urgent healthcare gaps?
Pharmaceutical Technology
JUNE 18, 2024
As Asda sets up a nationwide retail pharmacy in the UK and US grocer pharmacies expand, scaling up this model will be the next frontier.
Tue.Jun 18, 2024
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The Blood of Exceptionally Long-Lived People Reveals Crucial Differences
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 18, 2024
(Bloomberg Creative/Getty Images) Centenarians, once considered rare, have become commonplace. Indeed, they are the fastest-growing demographic group of the world’s population, with numbers roughly doubling every ten years since the 1970s. [link] How long humans can live, and what determines a long and healthy life, have been of interest for as long as we know.
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Johnson & Johnson submits BLA to FDA for lung cancer drug
Pharmaceutical Technology
JUNE 18, 2024
Johnson & Johnson has filed a BLA with the US FDA seeking approval for SC amivantamab for the treatment of non-small cell lung cancer.
Sanofi taps Belharra for immune drug research; AstraZeneca’s new cancer drug falls short
Bio Pharma Dive
JUNE 18, 2024
Belharra will use its chemoproteomics technology to identify immune drugs for Sanofi. Elsewhere, Regenxbio mapped a regulatory path and Taysha shared updated results for its Rett treatment.
SPH-4336 by Shanghai Pharmaceutical Group for Well Differentiated Liposarcoma: Likelihood of Approval
Pharmaceutical Technology
JUNE 18, 2024
SPH-4336 is under clinical development by Shanghai Pharmaceutical Group and currently in Phase II for Well Differentiated Liposarcoma.
Roche partners with RNA editing biotech Ascidian
Bio Pharma Dive
JUNE 18, 2024
While the Swiss pharma recently pruned its neurology drug pipeline, it has shown interest in the possibilities of RNA-focused approaches like what Ascidian is exploring.
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Lingering cholesterol can keep heart risk high. Marea Therapeutics has $190M to target it.
Bio Pharma Dive
JUNE 18, 2024
With a drug licensed from Novartis, the new biotech startup aims to reduce the ‘remnant’ cholesterol it says existing medicines can’t address.
FDA approves MSD’s KEYTRUDA for advanced endometrial cancer
Pharmaceutical Technology
JUNE 18, 2024
The US FDA has granted approval for MSD’s KEYTRUDA regimen to treat primary advanced or recurrent endometrial carcinoma in adults.
Intra-Cellular depression drug succeeds in second late-stage study
Bio Pharma Dive
JUNE 18, 2024
The results position the company to unlock what’s believed to be a multibillion-dollar sales opportunity for Caplyta, which is already used to treat schizophrenia and bipolar disorder.
CRTE-7A2 by Beijing Corregene Biotechnology for Anal Cancer: Likelihood of Approval
Pharmaceutical Technology
JUNE 18, 2024
CRTE-7A2 is under clinical development by Beijing Corregene Biotechnology and currently in Phase I for Anal Cancer.
The New Age of Decentralized Clinical Trials
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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
ICMR-NIREH to host online training on ethical research practices
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 18, 2024
The Indian Council for Medical Research (ICMR)-National Institute for Research in Environmental Health (NIREH) will conduct an online training programme titled “Ethical Principles and Practices for Research Involving Human Participants with Environmental-Associated Ailments.
Ability Biologics closes extended $18m seed funding round
Pharmaceutical Technology
JUNE 18, 2024
Since emerging from stealth in December 2023, the company has begun establishing its laboratories in Montreal.
Merck wins FDA OK for vaccine rival to Pfizer’s pneumococcal shot
Bio Pharma Dive
JUNE 18, 2024
The new vaccine, which Merck will sell as Capvaxive, will compete with Pfizer’s blockbuster Prevnar franchise.
Muvalaplin by Eli Lilly and Co for Atherosclerosis: Likelihood of Approval
Pharmaceutical Technology
JUNE 18, 2024
Muvalaplin is under clinical development by Eli Lilly and Co and currently in Phase II for Atherosclerosis.
June 18, 2024: NIH Pragmatic Trials Collaboratory to Hold Virtual Workshop July 15-16 Featuring NIH Director as Keynote
Rethinking Clinical Trials
JUNE 18, 2024
The NIH Pragmatic Trials Collaboratory will hold a virtual workshop July 15-16, 2024, on “Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues.” Dr. Monica Bertagnolli, director of the NIH, will deliver the keynote presentation exploring how to identify high-priority healthcare issues that require the effort, time, and funding of a trial.
Human papillomavirus [serotypes 6, 11, 16, 18] (quadrivalent) vaccine by Nanolek for Human Papillomavirus Infections: Likelihood of Approval
Pharmaceutical Technology
JUNE 18, 2024
Human papillomavirus [serotypes 6, 11, 16, 18] (quadrivalent) vaccine is under clinical development by Nanolek and currently in Phase III for Human Papillomavirus Infections.
Kansas AG accuses Pfizer of misrepresenting COVID vaccine, hiding safety risks in lawsuit
Fierce Pharma
JUNE 18, 2024
Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.
Q&A with Springer Nature’s Leslie Lansman: Ethical content sharing and the benefits of the CLA Pharmaceutical Licence
Pharmaceutical Technology
JUNE 18, 2024
The pharmaceutical and medical communications industry relies heavily on the use and dissemination of scientific journals, research papers, medical reports,…
The New Age of Decentralized Clinical Trials
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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.
AstraZeneca's Truqap misses the mark in late-stage triple-negative breast cancer trial
Fierce Pharma
JUNE 18, 2024
While AstraZeneca’s Truqap bears the distinction of being the first AKT inhibitor to pass muster with the U.S. | In the late-stage CAPItello-290 study, Truqap plus the chemotherapy paclitaxel failed to help extend the lives of patients with locally advanced or metastatic triple-negative breast cancer (TNBC) over paclitaxel and placebo alone, AstraZeneca said Tuesday.
CAR-T Cell Therapy by Shanghai Unicar-Therapy Bio-Medicine Technology for Diffuse Large B-Cell Lymphoma: Likelihood of Approval
Pharmaceutical Technology
JUNE 18, 2024
CAR-T Cell Therapy is under clinical development by Shanghai Unicar-Therapy Bio-Medicine Technology and currently in Phase II for Diffuse Large B-Cell Lymphoma.
Antibiotic kills gram-negative bacteria, spares gut microbiome
Drug Discovery World
JUNE 18, 2024
Researchers have developed a new antibiotic that reduced or eliminated drug-resistant bacterial infections in mouse models of acute pneumonia and sepsis while sparing healthy microbes in the gut. The drug, called lolamicin, also warded off secondary infections with Clostridioides difficile, and was effective against more than 130 multidrug-resistant bacterial strains in cell culture.
Pharmaceutical cleaning equipment, agents and services
Pharmaceutical Technology
JUNE 18, 2024
Discover key factors in selecting cleaning solutions for the pharmaceutical industry. Ensure compliance with our guide to pharmaceutical cleaning equipment.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
NIH awards Cellibre $2M to advance sustainable cannabinoid ingredient production
Outsourcing Pharma
JUNE 18, 2024
Cellibre, a pioneer in sustainable biochemical manufacturing, has received a $2 million grant from the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH).
KP-201 by Korea Pharma for Reflux Esophagitis (Gastroesophageal Reflux Disease): Likelihood of Approval
Pharmaceutical Technology
JUNE 18, 2024
KP-201 is under clinical development by Korea Pharma and currently in Phase I for Reflux Esophagitis (Gastroesophageal Reflux Disease).
CAR-T therapy achieves lupus remission breakthrough
BioPharma Reporter
JUNE 18, 2024
New data from a phase 1 clinical trial shows complete remission in 92% of lupus patients treated with a compound CAR (cCAR) T cell therapy
RevOpsis and Kemwell partner to boost biologic development
Pharmaceutical Technology
JUNE 18, 2024
RevOpsis Therapeutics has entered into a manufacturing collaboration with Kemwell Biopharma to develop new multispecific biologics.
How Machine Learning Drives Clinical Trial Efficiency
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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.
12 Questions with Caroline Phillips
pharmaphorum
JUNE 18, 2024
Dive into an exclusive Medscape interview with HCP Caroline Phillips as she shares her insights, experiences, and advice. Discover the key takeaways that can benefit your medical practice.
BBI-355 by Boundless Bio for Head And Neck Squamous Cell Carcinoma (HNSC): Likelihood of Approval
Pharmaceutical Technology
JUNE 18, 2024
BBI-355 is under clinical development by Boundless Bio and currently in Phase II for Head And Neck Squamous Cell Carcinoma (HNSC).
Maximizing ROI with Branded Generics: A Comprehensive Guide
Drug Patent Watch
JUNE 18, 2024
Branded generics are generic drugs that are marketed under a brand name by the manufacturer. These products contain the same active ingredients as their brand-name counterparts but are typically sold at a lower price point. Branded generics can be an attractive option for both consumers and pharmaceutical companies, offering cost savings while leveraging brand recognition.
Charles River and Captain T Cell sign vector production agreement
Pharmaceutical Technology
JUNE 18, 2024
Charles River and Captain T Cell have signed a deal to produce plasmid DNA and retrovirus vectors for gene-modified cell therapy.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
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