Bio Pharma Dive
DECEMBER 22, 2021
Leqvio, which Novartis acquired for nearly $10 billion two years ago, arrives with high sales expectations. But uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness.
World of DTC Marketing
DECEMBER 22, 2021
With days to go before Christmas, Americans are sick and tired of being sick and tired. Of reworking plans to adapt to the latest virus risks. Of searching for at-home tests and not finding them. Of wondering whether, after two years of avoiding Covid-19, or surviving it, or getting vaccinated and maybe even boosted, Omicron is the variant they inevitably catch.
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Bio Pharma Dive
DECEMBER 22, 2021
Paxlovid is the first oral treatment for COVID-19, a potentially valuable new tool as the fast-spreading omicron variant fuels a sharp surge in cases across the U.S.
Camargo
DECEMBER 22, 2021
One of Camargo’s differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio. Informed by today’s competitive drug development landscape, as well as by the sponsor’s strategic goals and capabilities, a portfolio analysis involves assessing product concept and differentiation, strategic planning, factoring in unmet patient needs, and estimating timelines and e
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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
DECEMBER 22, 2021
The deal for Gyroscope Therapeutics, worth up to $1.5 billion, gives the Swiss pharma access to a treatment for a type of age-related blindness as well as new means of delivering drugs into the eye.
Pharma Times
DECEMBER 22, 2021
Calls for booster vaccinations in order to combat the rising cases brought about by winter and the recent Omicron variant have intensified, in the midst of record case rates.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
DECEMBER 22, 2021
A group of 15 digital health startups have joined a programme set up by the US federal government to address health inequality and mitigate the effects if the COVID-19 pandemic. The PandemicX accelerator, launched by the Department of Health and Human Services, is focused on “using digital tools and publicly accessible data to eliminate disparities and tackle drivers of inequity exacerbated by COVID-19.” Companies that have been invited to take part will get “curriculum, mentor
Bio Pharma Dive
DECEMBER 22, 2021
The FDA has halted all clinical trials testing the injectable form of Gilead's lenacapavir, for fear that incompatibility between the drug and the vials it's held in could cause contamination.
Outsourcing Pharma
DECEMBER 22, 2021
It has been a pleasure for the OSP team to connect with a long list of fascinating industry minds and share the stories; here are a few of our favorites.
Pharma Times
DECEMBER 22, 2021
With authorisation, Pfizer’s oral antiviral candidate Paxlovid is an investigational SARS-CoV-2 protease inhibitor could be prescribed at the first sign of COVID-19 infection.
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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
pharmaphorum
DECEMBER 22, 2021
Patient centricity and patient engagement have been hot topics in pharma for some time – but buzz words do not always translate into concrete action. However, we have seen a framework of guidelines and recommendations during the last year on everything from increasing diversity to producing lay summaries, start to take shape. As part of our 2021 in Review series, we look back over some of these developments.
BioPharma Reporter
DECEMBER 22, 2021
Live biotherapeutic product (LBP) developer, 4D Pharma, which has been NASDAQ listed since March this year, has announced positive topline results for the first part of its Phase I/II trial of an LBP strain for the treatment of asthma.
pharmaphorum
DECEMBER 22, 2021
Gyroscope Therapeutics and its gene therapy for the sight-robbing disease geographic atrophy (GA) has been acquired by a big pharma company – but likely not the one you would expect. Just a few weeks France’s Sanofi made a $40 million investment in Gyroscope for first refusal rights on the gene therapy – called GT005 – but it is Novartis that has swooped on the company and its main asset.
BioPharma Reporter
DECEMBER 22, 2021
As 2021 draws to a close, we take a look at the COVID-19 vaccine development landscape and some of the candidates progressing through clinical trials.
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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.
Drug Patent Watch
DECEMBER 22, 2021
Annual Drug Patent Expirations for CORLANOR Corlanor is a drug marketed by Amgen Inc and is included in two NDAs. It is available from one supplier. There are eight patents…. The post New patent for Amgen Inc drug CORLANOR appeared first on DrugPatentWatch - Make Better Decisions.
BioPharma Reporter
DECEMBER 22, 2021
The pandemic has focused biopharma industry minds on digital innovation, finds a Deloitte report.
Drug Patent Watch
DECEMBER 22, 2021
Annual Drug Patent Expirations for VIBERZI Viberzi is a drug marketed by Allergan Holdings and is included in one NDA. It is available from one supplier. There are sixteen patents…. The post New patent for Allergan Holdings drug VIBERZI appeared first on DrugPatentWatch - Make Better Decisions.
BioPharma Reporter
DECEMBER 22, 2021
There is a healthy appetite for continued investment in gene therapy, in new modalities and more indications, says an industry insider as he reflected on the prospects for the US gene therapy sector next year.
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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.
pharmaphorum
DECEMBER 22, 2021
The Japanese regulator looks like it could follow the European Commission and reject approval of Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, leaving the FDA an outlier in its stance on the drug. An advisory committee to the Ministry of Health, Labour and Welfare (MHLW) has declined to approve Aduhelm (aducanumab), saying the data from its two main clinical trials is hard to interpret, and is seeking additional data.
Scienmag
DECEMBER 22, 2021
There have been many research efforts describing the nature and progression of dog allergies, but there have been very few applied studies that use this information to try to cure people of dog allergies entirely by artificially inducing immune tolerance. But researchers have now for the first time identified candidates for those parts of the […].
BioPharma Reporter
DECEMBER 22, 2021
Novartis will acquire UK-based Gyroscope Therapeutics, the company behind a one-time investigational gene therapy for geographic atrophy (GA).
Scienmag
DECEMBER 22, 2021
Patients hospitalized with COVID-19 who had a combination of high blood pressure, obesity, diabetes, or other conditions associated with metabolic syndrome were at much higher risk of acute respiratory distress syndrome (ARDS) and death, according to an international study published in the medical journal JAMA Network Open. Credit: Tulane University Patients hospitalized with COVID-19 who had a combination of high […].
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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.
Outsourcing Pharma
DECEMBER 22, 2021
OSPâs list of the yearâs most-read stories shows readers are interested in M&A activities, new drug candidates, COVID-19 developments, and other hot news.
Scienmag
DECEMBER 22, 2021
Using observations and archival data from several of NSF’s NOIRLab’s observatories, together with observations from telescopes around the world and in orbit, astronomers have discovered at least 70 new free-floating planets — planets that wander through space without a parent star — in a nearby region of the Milky Way. This is the largest sample […].
NY Times
DECEMBER 22, 2021
The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.
Scienmag
DECEMBER 22, 2021
Quantum effects in superconductors could give semiconductor technology a new twist. Researchers at the Paul Scherrer Institute PSI and Cornell University in New York State have identified a composite material that could integrate quantum devices into semiconductor technology, making electronic components significantly more powerful. They publish their findings today in the journal Science Advances.
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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.
NY Times
DECEMBER 22, 2021
The caps come as the rapid spread of the Omicron variant has customers flocking to testing sites and pharmacies, which are struggling to keep up.
Scienmag
DECEMBER 22, 2021
The Matterhorn appears as an immovable, massive mountain that has towered over the landscape near Zermatt for thousands of years. A study just published in the journal Earth and Planetary Science Letters ([link] now shows that this impression is wrong. An international research team has proven that the Matterhorn is instead constantly in motion, swaying gently […].
pharmaphorum
DECEMBER 22, 2021
Amgen has won FDA approval for a stronger label for its oral plaque psoriasis therapy Otezla, as it prepares for competition from Bristol-Myers Squibb’s much-touted rival deucravacitinib, which could make its debut next year. The agency has cleared Otezla (apremilast) for the treatment of adult patients with plaque psoriasis, regardless of the severity of their symptoms, making it an option for an estimated eight million people with the skin disorder in the US.
Scienmag
DECEMBER 22, 2021
Snakes, some lizards and even a few mammals can have a venomous bite. Although these lineages split more than 300 million years ago, their venoms have evolved from the same ancestral salivary protein, reported scientists today in BMC Biology. Credit: Pixabay A new study has found that venoms found in snakes and mammals share a […].
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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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