Bio Pharma Dive
NOVEMBER 30, 2021
While agency advisers raised concerns over molnupiravir's modest benefits and potential risks, a majority felt the antiviral drug is a needed option for COVID-19 patients at high risk of severe disease.
Pharma Times
NOVEMBER 30, 2021
Following its recent approval of an injectable HIV-1 treatment from the National institute for Health and Care Excellence (NICE), GlaxoSmithKline (GSK) has high hopes in developing a cure for the virus in the future.
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Bio Pharma Dive
NOVEMBER 30, 2021
Philip Dormitzer, who helped Pfizer develop shots for COVID-19, RSV and influenza, will become the British pharma's head of vaccine R&D next month.
BioPharma Reporter
NOVEMBER 30, 2021
Australian biotech EnGeneIC, which is developing its nanocell tech for use in infectious diseases (including a COVID-19 vaccine) as well as a cancer treatment, has announced a deal with US biotech ImmunityBio to develop, manufacture and commercialize the tech.
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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
NOVEMBER 30, 2021
While Regeneron is still testing its treatment against the new variant, the biotech is readying contingency plans, including second-generation versions of its drug.
pharmaphorum
NOVEMBER 30, 2021
The FDA will deliver a verdict on AstraZeneca’s PARP inhibitor Lynparza as an adjuvant treatment for breast cancer in the first quarter of next year, after granting the application a priority review. AZ and partner Merck & Co have filed Lynparza (olaparib) for use in BRCA-mutated, HER2-negative early breast cancer in patients who have already been treated with chemotherapy either before or after surgery and are at high risk of the disease coming back.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
NOVEMBER 30, 2021
In the most recent of the Health Innovators video series, pharmaphorum’s founder, Dr Paul Tunnah, chats with the chief medical officer of Senseonics. Francine Kaufman discusses how Senseonics is helping patients monitor their diabetes with the first fully implantable long-term continuous glucose monitoring (CGM) system. Monitoring glucose values is necessary for diabetes patients, and technologically advanced systems make it much easier for patients to self-manage the disease, according to
BioSpace
NOVEMBER 30, 2021
Genoskin’s solution is to develop the technologies to replace animals and humans in clinical studies with virtual models, steadily pushing living creatures further and further from testing.
pharmaphorum
NOVEMBER 30, 2021
Targeted cancer drug specialist Blueprint Medicines has agreed to pay $250 million upfront to acquire Lengo Therapeutics and its lead drug for lung cancer, a rival to already-approved therapies from Johnson & Johnson and Takeda. There’s another $215 million tied to the achievement of regulatory and sales-based milestones with LNG-451, a compound that targets tumours with EGFR exon 20 mutations.
BioSpace
NOVEMBER 30, 2021
Deciphera Pharmaceuticals announced it is restructuring with the intention of prioritizing clinical development of specific programs and streamlining its commercial operations.
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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
XTalks
NOVEMBER 30, 2021
Despite being one of the most well-known holiday drinks, eggnog has gained a controversial reputation among skeptics. This is why two prominent food and beverage brands launched their own limited-edition eggnog alternatives. Here’s what Chobani and Hidden Valley Ranch are offering to eggnog skeptics this holiday season. Chobani’s Oat Nog. Chobani — known for it’s Greek-style dairy yogurt — launched an oat-based eggnog alternative, aptly called Oat Nog.
BioSpace
NOVEMBER 30, 2021
Early tests of Regeneron’s antibody cocktail show it isn’t as effective against Omicron while a separate tests of Eli Lilly’s antibody cocktail also demonstrated the same.
Drug Patent Watch
NOVEMBER 30, 2021
Annual Drug Patent Expirations for FLOVENT+HFA Flovent Hfa is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from four suppliers. There are…. The post New patent expiration for Glaxo Grp drug FLOVENT HFA appeared first on DrugPatentWatch - Make Better Decisions.
BioPharma Reporter
NOVEMBER 30, 2021
The EMA has validated Atara Biotherapeutics' Marketing Authorization Application (MAA) for tabelecleucel (tab-cel), the first time an off-the-shelf allogeneic T-cell therapy will be evaluated by any regulatory agency in the world.
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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.
BioSpace
NOVEMBER 30, 2021
Elizabeth Holmes blames the allegations of investor fraud perpetrated by her blood-testing company Theranos at the feet of her former business partner Ramesh “Sunny” Balwani.
pharmaphorum
NOVEMBER 30, 2021
GlaxoSmithKline has found a replacement for head of vaccines R&D Emmanuel Hanon, who left the company for a US biotech earlier this year, hiring Phil Dormitzer from Pfizer. Phil Dormitzer. Dormitzer is due to take up his new role at GSK on Friday, and will report to chief scientific officer and group president of R&D Hal Barron. His most recent role at Pfizer was chief scientific officer for RNA and viral vaccines, a position he held for more than six years.
BioSpace
NOVEMBER 30, 2021
The takeover is part of the French biotech giant's "Play to Win" strategy of growing its global vaccines pipeline through the acquisition of promising projects and companies.
Scienmag
NOVEMBER 30, 2021
EL PASO, Texas (Nov. 30, 2021) – UTEP President Heather Wilson and El Paso Electric President and CEO Kelly A. Tomblin signed a memorandum of understanding today to establish a partnership that will enhance energy research and improve education in the El Paso region. Credit: UTEP Marketing and Communications EL PASO, Texas (Nov. 30, 2021) […].
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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.
BioSpace
NOVEMBER 30, 2021
The approval was based on Phase II data from the PLEIADES study that showed patients treated with the combination therapy generated an overall response rate of 84.8%.
Scienmag
NOVEMBER 30, 2021
CHICAGO – COVID-19 of mild to moderate severity in pregnant women appears to have no effect on the brain of the developing fetus, according to a study being presented today at the annual meeting of the Radiological Society of North America (RSNA). Credit: RSNA and Sophia Stöcklein, M.D. CHICAGO – COVID-19 of mild to moderate […].
BioSpace
NOVEMBER 30, 2021
It may take two to four weeks before experts have enough data to know whether Omicron is a bigger threat than Delta. Much of what is known is based on lab tests and models of the virus’ spike protein mutations.
Scienmag
NOVEMBER 30, 2021
Irvine, Calif., Nov. 30, 2021 — A new study led by University of California, Irvine researchers has confirmed a link between altered DNA repair and increased DNA damage associated with spinocerebellar ataxia type 7 (SCA7), a debilitating, sometimes deadly neurodegenerative condition causing movement disorders. Their work also revealed a potential therapeutic target for the currently […].
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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.
BioSpace
NOVEMBER 30, 2021
ImmunoGen shares positive results from its Phase III SORAYA trial, which is evaluating the use of mirvetuximab soravtansine in treating patients diagnosed with a certain type of ovarian cancer.
Scienmag
NOVEMBER 30, 2021
For quantum computers to surpass their classical counterparts in speed and capacity, their qubits—which are superconducting circuits that can exist in an infinite combination of binary states—need to be on the same wavelength. Achieving this, however, has come at the cost of size. Whereas the transistors used in classical computers have been shrunk down to […].
BioSpace
NOVEMBER 30, 2021
The radiopharmaceuticals being developed by Curie are composed of rationally designed conjugates in contrast to delicately chosen biological targets.
Scienmag
NOVEMBER 30, 2021
Restoration efforts hold unique potential for improving environmental outcomes and human wellbeing. They are the focus of the recently launched UN Decade on Ecosystem Restoration. Yet, ignoring the social dimensions of environmental initiatives is likely to fail to achieve ecological and other objectives. Neglecting social and people-centered restoration models can result in land grabs, conflict, […].
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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.
BioSpace
NOVEMBER 30, 2021
The company plans to move it into Phase III studies in APOL1-mediated kidney disease, including FSGS, in the first quarter of 2022.
Scienmag
NOVEMBER 30, 2021
SEATTLE, November 30, 2021 — About one in 20 people go through a period of stuttering during childhood. Until the latter half of the 20th century, stuttering was believed to be a psychological problem stemming from lack of effort or from trauma. Credit: Frank Guenther SEATTLE, November 30, 2021 — About one in 20 people […].
BioSpace
NOVEMBER 30, 2021
As the late-stage trials continue to progress, Talaris is rapidly ramping up its resources and investments.
Scienmag
NOVEMBER 30, 2021
Nanoengineers at the University of California San Diego have developed a new and potentially more effective way to deliver messenger RNA (mRNA) into cells. Their approach involves packing mRNA inside nanoparticles that mimic the flu virus—a naturally efficient vehicle for delivering genetic material such as RNA inside cells. Credit: Angewandte Chemie International Edition Nanoengineers at […].
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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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