Bio Pharma Dive
SEPTEMBER 20, 2021
The results position Pfizer and BioNTech to seek clearance in children as young as five years old. But the companies haven't yet shared data on a rare heart inflammation associated with their shot that's a concern for regulators.
BioPharma Reporter
SEPTEMBER 20, 2021
Synthetic DNA vector producer, Touchlight, has announced the extension of its fundraising round to a current aggregate total of US$125m (Â92m). The financing was led by Bridford Investments Limited and Novator Partners.
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Bio Pharma Dive
SEPTEMBER 20, 2021
Mirati's KRAS-blocking drug looks to have an edge over Amgen's, while AstraZeneca and Daiichi reported impressive data for their drug Enhertu.
BioSpace
SEPTEMBER 20, 2021
In September 20, 2021, the United States marked a grisly milestone, recording more American deaths from COVID-19 than died from the 1918-1919 Spanish flu pandemic.
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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
Bio Pharma Dive
SEPTEMBER 20, 2021
Calibration is too important to do on spreadsheets or paper. See how you can improve your calibration activities with a cloud-based solution.
Drug Patent Watch
SEPTEMBER 20, 2021
I’ll be leading a workshop on generic portfolio management, and also giving a talk, at the 14th annual Marcus Evans event on Portfolio Planning and Partnerships for Generics. The event…. The post Workshop and lecture on generic portfolio management appeared first on DrugPatentWatch - Make Better Decisions.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
SEPTEMBER 20, 2021
Building modern commercialisation strategies requires pharma to find the right balance of old ways and new approaches, says Cardinal Health’s Jennifer Baughman. COVID-19 has fundamentally changed much of our lives – from how we interact with people to how we work. For the pharma industry, the pandemic’s changes were both abrupt and industry-altering, requiring companies to rapidly adapt their approaches to drug development and commercialisation.
Bio Pharma Dive
SEPTEMBER 20, 2021
The approval of Byooviz, developed by Samsung Bioepis and set to be sold by Biogen, comes amid a slowdown in biosimilar clearances from the agency.
BioPharma Reporter
SEPTEMBER 20, 2021
Gritstone bio, Inc., has dosed the first volunteer in a Phase 1 trial for a self-amplifying mRNA second-generation COVID-19 vaccine booster.
BioSpace
SEPTEMBER 20, 2021
It earned the FDA's green light after its Phase II innovaTV 204 clinical trial delivered stellar results in terms of tumor response and durability of the response.
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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
Pharma Times
SEPTEMBER 20, 2021
'Groundbreaking results' for the treatment of HER2-positive metastatic breast cancer
BioSpace
SEPTEMBER 20, 2021
?The Phase III COSMIC-311 trial for CABOMETYX delivered favorable final results in terms of objective response rate, progression-free survival, median overall survival, and safety.
Scienmag
SEPTEMBER 20, 2021
A new meteorological satellite, called Fengyun-3E (FY-3E), is crossing the early morning sky, observing and collecting data about the weather, climate and more. Launched by China on July 5, the satellite joined those operated by Europe and the United States orbiting the Earth’s poles. FY-3E is roughly the size of a pick-up truck and will […].
BioSpace
SEPTEMBER 20, 2021
On the tailcoat of Tuesday’s United Nations General Assembly, President Biden is hosting a virtual COVID-19 summit Wednesday, calling for the end of the pandemic globally.
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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.
pharmaphorum
SEPTEMBER 20, 2021
Danish drugmaker Lundbeck has teamed up with Inscopix – the developer of a technology that can film neurons in the brain in real time – to try to find new drugs for central nervous system diseases. The two partners will use the nVista wearable microscope technology to develop a map of the brain and brain circuit-based preclinical assays that could be used to identify drug candidates for diseases like Alzheimer’s, depression, and schizophrenia.
BioSpace
SEPTEMBER 20, 2021
Novartis expands its optogenetics portfolio with the acquisition of Arctos Medical, cementing its commitment to optogenetics-based therapies to restore vision to patients with advanced blindness.
Pharma Times
SEPTEMBER 20, 2021
Drug combination could offer a new option for treatment-resistant advanced ovarian cancer
BioSpace
SEPTEMBER 20, 2021
French artificial heart maker Carmat announced Tuesday that it had successfully implanted its Aeson artificial heart into the chest cavity of a 57-year-old woman.
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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.
Delveinsight
SEPTEMBER 20, 2021
Onychomycosis is the most commonly prevalent nail infection in adults. It is a fungal infection that leads to discoloration and thickening of the nail plate. It is four to seven times more frequent in toenails, where it often involves several nails. It is a progressive disease and may become widely spread to other nails, body sites such as groin, skin, scalp, and even to other people. .
BioSpace
SEPTEMBER 20, 2021
As the COVID-19 pandemic hit a grim milestone, marking more U.S. deaths than were reported in the 1918–19 Spanish flu pandemic, research and breakthroughs continue.
pharmaphorum
SEPTEMBER 20, 2021
Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. The US green light for Byooviz (formerly SB11) covers the treatment of wet age-related macular degeneration (AMD) and two other eye conditions, and is the first ophthalmology biosimilar to be registered by the FDA.
BioSpace
SEPTEMBER 20, 2021
Nektar collaborates with Pfizer and Merck KGaA, Darmstadt, Germany, to assess NKTR-255 in combination with Bavencio in patients with bladder cancer.
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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.
BioPharma Reporter
SEPTEMBER 20, 2021
Dutch group, Intravacc, has launched a hybrid business model that it believes will fuel growth and innovation.
BioSpace
SEPTEMBER 20, 2021
MiroBio’s pipeline involves checkpoint receptor pathways, not for immuno-oncology indications, but for the treatment of autoimmune diseases.
Drug Channels
SEPTEMBER 20, 2021
Informa Connect's Pharma/Biotech GTN Summit. Hybrid Event In-Person: November 17-19, 2021 in Philadelphia Virtual: November 22-23, 2021 www.informaconnect.com/gtn. Join the life sciences community this fall at Informa Connect’s GTN Summit , now in the 11th year. Whether you register with an All-Access Pass (attending in-person on November 17-19, 2021 with access to Virtual content) or register with a Virtual Pass (attending from your home or office on November 22-23, 2021 with access to the In-P
BioSpace
SEPTEMBER 20, 2021
During the past two years, fundraising and investment in biotechnology have reached record levels.
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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.
Outsourcing Pharma
SEPTEMBER 20, 2021
Two experts from the contract research organization offer advice on planning and executing clinical studies with the unique needs of such patients in mind.
pharmaphorum
SEPTEMBER 20, 2021
There’s no shortage of cancer immunotherapies trying to knock Merck & Co’s Keytruda off the top of the tree in previously-untreated non-small cell lung cancer (NSCLC). Sanofi and Regeneron have reported new data for Libtayo that suggests the drug could be a contender. Libtayo (cemiplimab) given in combination with chemotherapy looks broadly to have matched Keytruda (pembrolizumab) plus chemo in newly-diagnosed people with metastatic NSCLC , reducing the risk of death by 29% versu
BioSpace
SEPTEMBER 20, 2021
On Tuesday, 858 Therapeutics launched with a $60 million Series A financing round under its belt.
Pharma Times
SEPTEMBER 20, 2021
Positive data presented at the 2021 ESMO virtual congress
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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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