Bio Pharma Dive
SEPTEMBER 11, 2023
The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Kroger's settlement, alongside the review of the Purdue Pharma bankruptcy case, is proof that the opioid reckoning isn't over yet.
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Fierce Pharma
SEPTEMBER 11, 2023
Out with the old and in with the new: Monday, the U.S. | The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.
ACRP blog
SEPTEMBER 13, 2023
With observations of National Hispanic Heritage Month kicking off on September 15, this year’s events will have special resonance for a team of Oregon Health & Science University (OHSU) researchers who are working to bring the benefits of clinical trials to more persons in underserved communities. Eneida R. Nemecek, MD, MS, MBA, an endowed professor of pediatrics and medical oncology and Medical Director of Clinical Research at the Knight Cancer Institute of OHSU, recently received a $625,00
Bio Pharma Dive
SEPTEMBER 11, 2023
Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming days.
Pharmaceutical Technology
SEPTEMBER 12, 2023
The US FDA has approved Pfizer and BioNTech’s sBLA for Omicron XBB.1.5-adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
SEPTEMBER 14, 2023
The two biotech companies announced initial public offering pricing Thursday, respectively, with shares beginning trading Friday and valued at more than $560 million cumulatively.
Bio Pharma Dive
SEPTEMBER 12, 2023
Arialys Therapeutics launched Tuesday with $58 million in funding from a group of life sciences investors that includes Johnson & Johnson’s venture arm.
Pharmaceutical Technology
SEPTEMBER 15, 2023
The company is also planning to expand its Phase I/II PRODYGY lead candidate trial in retinitis pigmentosa to three more US sites.
Antidote
SEPTEMBER 14, 2023
Alzheimer’s disease, the most prevalent type of dementia , is diagnosed in more than 6 million Americans. Estimates project that by 2050, 13 million individuals will be diagnosed with Alzheimer’s disease. This condition ranks among the top 10 causes of death in the United States, profoundly impacting those diagnosed, their loved ones, and their caregivers.
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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
Drug Discovery World
SEPTEMBER 15, 2023
Advanced Therapies Europe took place from 9-12 September 2023 in Portugal. DDW’s Megan Thomas asked attendees: What is most important to scale from discovery to commercialisation of cell and gene therapies (CGTs)? Joel Eichmann, Co-Founder, Green Elephant Biotech It always comes down to time-to-market and risk minimisation. To cover these, it is critical to choose [.
Bio Pharma Dive
SEPTEMBER 13, 2023
The biotech is telling investors it expects to launch as many as 15 new products in five years, a bold goal that will require a lot to go right to pull off.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Pharmaceutical supply chain partners are trying to create an efficient cold chain system to transport cell and gene therapies.
Fierce Pharma
SEPTEMBER 15, 2023
Questions first circulated about decongestant pills containing phenylephrine in 2007. | Several companies, including Johnson & Johnson, GSK, Procter & Gamble and Walgreens, face class-action lawsuits that claim the drugmakers knew that over-the-counter cold and flu pills containing phenylephrine did not work as advertised.
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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.
Pharma Times
SEPTEMBER 15, 2023
The site will contribute to the development and commercialisation of antibody drugs - News - PharmaTimes
Bio Pharma Dive
SEPTEMBER 14, 2023
Since 2019, Generate has raised nearly $700 million in private financing and has now brought a monoclonal antibody into Phase 1 testing.
Pharmaceutical Technology
SEPTEMBER 15, 2023
Cure Genetics has entered a partnership and licensing deal with Frametact to develop gene therapy for familial neurological ailments.
Fierce Pharma
SEPTEMBER 12, 2023
The CDC wants to reset expectations for flu vaccines to correct falling uptake. | The CDC wants to reset expectations for flu vaccines to correct falling uptake. After tracking declines in vaccine use in pregnant people and children, the health body has initiated its “Wild to Mild” campaign to raise awareness of the benefits of vaccination and encourage more people to get their shots.
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.
Drug Discovery World
SEPTEMBER 14, 2023
Ernesto Staroswiecki, Senior Manager, R&D, at Beckman Coulter Life Sciences takes readers through common lab automation myths. Many clinical and research laboratories today are having to do more with less: faced with ongoing staffing shortages, increased workloads, and budgetary constraints, many laboratory managers are feeling the stress, which is where the benefits of automation can be truly realised for labs in both academia and industry.
Bio Pharma Dive
SEPTEMBER 14, 2023
The company is working on a treatment of alpha-1 antitrypsin deficiency, which it claims it can deliver direct to lung cells via a nebulizer.
Pharmaceutical Technology
SEPTEMBER 12, 2023
BioLineRx has received the US Food and Drug Administration approval for Aphexda plus filgrastim to mobilise haematopoietic stem cells.
Drug Patent Watch
SEPTEMBER 12, 2023
In the world of patents, the right to exclude others from using or selling an invention is granted only during the patent’s validity. Once a patent expires, this exclusivity vanishes.… The post Understanding Patent Term Extensions: An Overview appeared first on DrugPatentWatch - Make Better Decisions.
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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
XTalks
SEPTEMBER 13, 2023
This episode features an interview with Ram Mukunda and Claudia Grimaldi from IGC Pharma , a clinical-stage pharmaceutical company focused on improving the health and well-being of patients affected by Alzheimer’s disease and bringing therapies for it to market. The company is currently conducting a Phase II study with IGC-AD1, an investigational low-dose tetrahydrocannabinol-(THC) based formulation that reduces neuropsychiatric symptoms such as agitation in dementia due to Alzheimer’s.
Bio Pharma Dive
SEPTEMBER 12, 2023
Citing “near-term headwinds,” the cancer cell therapy developer will lay off 176 employees and pare back some of its research spending.
Pharmaceutical Technology
SEPTEMBER 12, 2023
CancerVAX plans to adapt its universal cancer vaccine platform to develop a universal CAR-T cell platform.
Drug Patent Watch
SEPTEMBER 12, 2023
In a recent STAT article Sanofi CEO Paul Hudson discusses the potential of artificial intelligence (AI) in the pharmaceutical industry. While some in the industry have been hesitant to embrace… The post From Expert AI to Snackable AI: A New Era in Pharma, as Seen by Sanofi’s CEO appeared first on DrugPatentWatch - Make Better Decisions.
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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.
Outsourcing Pharma
SEPTEMBER 12, 2023
The increasing prevalence of chronic diseases could see the market for active pharmaceutical ingredients (APIs) growing by 7.5% per year, says a report by Prophecy Market Insights.
Bio Pharma Dive
SEPTEMBER 12, 2023
The two-year-old San Diego biotech is allied with The Jackson Laboratory to engineer better mouse models of the rare diseases it plans to target.
Pharmaceutical Technology
SEPTEMBER 13, 2023
The FDA is also reviewing a subcutaneous formulation of Takeda’s blockbuster drug for ulcerative colitis.
Pharma Times
SEPTEMBER 11, 2023
Both companies will work to advance the development of novel radiopharmaceuticals - News - PharmaTimes
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