Bio Pharma Dive
JANUARY 7, 2021
Company executives, however, blamed "improbably bad luck" for study enrollment that resulted in more older patients with milder disease receiving placebo, and pledged to press on.
World of DTC Marketing
JANUARY 7, 2021
MINUTE READ: Big pharma should take a good, hard look at small biotech companies and try to better understand how they succeed and are able to make strategic decisions faster without multi-levels of bureaucracy. This week a person with whom I have the highest level of respect because of her emotional and marketing intelligence landed a position with a small biotech company as Global Marketing Director.
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Bio Pharma Dive
JANUARY 7, 2021
The first patient enrolled in a Phase 3 trial of Pfizer's treatment was given the experimental one-time therapy on Dec. 29.
BioPharma Reporter
JANUARY 7, 2021
The World Health Organizationâs vaccine advisory group recommends the two doses of the Pfizer/BioNTech vaccine should be delivered 21 to 28 days apart: although it adds that the maximum time period between doses could be up to six weeks in some situations.
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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
JANUARY 7, 2021
Late-stage results for vutrisiran look as though they'll help Alnylam deliver on the promise that RNAi technology can be a repeatable drug platform.
pharmaphorum
JANUARY 7, 2021
The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules. With the UK reeling from one of the worst outbreaks of the disease, it’s a worrying situation for one of the countries worst hit by the pandemic that is relying on vaccines to bring the virus under control.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JANUARY 7, 2021
Biotech growth in China continued at a rapid pace in 2020, despite COVID-19, which emerged from that country to become a global pandemic. Opportunities in China remain good and are expected to continue.
pharmaphorum
JANUARY 7, 2021
Shortly after launching large-scale trials of its COVID-19 vaccine candidate, CureVac has the partner it will need to roll the shot out at scale if it works as hoped. Bayer has joined forces with the German biotech to support the development and supply of CVnCoV, an mRNA candidate using a similar technology to the Pfizer/BioNTech and Moderna jabs, with the drugmaker saying it will help CureVac produce “several hundred million doses” CureVac has been working steadily on CVnCoV over the last
Drug Patent Watch
JANUARY 7, 2021
Annual Drug Patent Expirations for ENVARSUS+XR Envarsus Xr is a drug marketed by Veloxis Pharms Inc and is included in one NDA. There are seventeen patents protecting this drug. Drug…. The post New patent for Veloxis Pharms drug ENVARSUS XR appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
JANUARY 7, 2021
Gilead Sciences’ Kite unit has teamed up with the UK’s Oxford BioTherapeutics (OBT) to develop a new clutch of cell therapy products for solid tumours and blood cancers. The partnership covers up to five oncology targets identified by OBT using its discovery platform, and the UK firm will try to develop antibodies against them. Kite and Gilead will then develop and commercialise therapies based on these targets or antibodies.
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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
Scienmag
JANUARY 7, 2021
Chemicals used for vaping break down zipper-like junctions between cells in the gut, leading to chronic inflammation and potential for other health concerns Credit: HUMANOID Center of Research Excellence Touted by makers as a “healthy” alternative to traditional nicotine cigarettes, new research indicates the chemicals found in e-cigarettes disrupt the gut barrier and trigger inflammation […].
BioSpace
JANUARY 7, 2021
BioSpace spoke to executives from four companies about their expectations for the conference and the coming year.
pharmaphorum
JANUARY 7, 2021
AbbVie is in a race against time as US patent expiry of its Humira inflammatory diseases blockbuster looms in 2023 – but it just scored two crucial phase 3 trial victories that could help rebuild sales when cheaper biosimilars flood the market in two years’ time. The company’s follow-up drug Skyrizi is a key plank in AbbVie’s strategy to negotiate the $20 billion patent cliff from Humira, which has already seen sales decline outside of the US where it has already lost protection from cheaper com
Scienmag
JANUARY 7, 2021
CABBI study shows the annual crop behaves more like the perennial grass miscanthus in its efficient use of water and light to produce abundant biomass Credit: – Center for Advanced Bioenergy and Biofuels Innovation (CABBI) Large perennial grasses like miscanthus are a primary target for use as bioenergy crops because of their sustainability advantages, but […].
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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
JANUARY 7, 2021
Although yesterday’s media focus was on the riots at the U.S. Capitol, there was a fair amount of ongoing COVID-19 news. Here’s a look.
Scienmag
JANUARY 7, 2021
Like many of today’s millennials, adolescent Sabre-Toothed Cats stayed with family longer than expected Credit: Illustration by Danielle Dufault © Royal Ontario Museum New research indicates adolescent offspring of the menacing sabre-toothed predator, Smilodon fatalis, were more momma’s cubs than independent warriors. A new study by scientists at the Royal Ontario Museum (ROM) and University […].
BioPharma Reporter
JANUARY 7, 2021
Tokyo headquartered, Fujifilm Corporation, has announced a new US$2bn (Â1.4bn/â1.5bn) investment to establish a new large-scale biopharma site in the US.
Scienmag
JANUARY 7, 2021
Rice, Baylor device mimics intestines to show how invading bacteria cause disease Credit: Rice University/Baylor College of Medicine HOUSTON – (Jan. 7, 2021) – Rice University and Baylor College of Medicine researchers have found a way to mimic conditions in intestines, giving them a mechanical model for the real-time growth of bacterial infections.
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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
JANUARY 7, 2021
Mana Therapeutics takes aim at solid tumors with allogenic cell therapies and Aulos Bioscience sees a new path for IL-2 monoclonal antibodies.
BioPharma Reporter
JANUARY 7, 2021
Pharmaceutical giant Bayer will support development of CureVacâs mRNA COVID-19 vaccine candidate across numerous areas: helping facilitate the global supply of several hundred million doses.
BioSpace
JANUARY 7, 2021
If you are certain that attending graduate school is the right move for you, it’s time to look into the specifics of various programs.
Pharma Times
JANUARY 7, 2021
The prestigious PharmaTimes INTCR competition has amassed a strong following since its introduction over two decades ago, with many of the fantastic finalists eager to show their support.
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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
JANUARY 7, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Scienmag
JANUARY 7, 2021
Grant establishes network of bee researchers at four UC campuses Credit: Boris Baer/UCR The University of California, Riverside, is leading a new effort to stop and reverse a worldwide decline in honeybees, which threatens food security and prices. Honeybees pollinate more than 80 agricultural crops, which account for about a third of what we eat. […].
BioSpace
JANUARY 7, 2021
Sarepta Therapeutics announced topline results from Part 1 of Study SRP-9001-102 for its gene therapy SRP-9001 for Duchenne muscular dystrophy.
Scienmag
JANUARY 7, 2021
Radboud university medical center and TNO show that cooling vests reduce heat stress Credit: Radboudumc Wearing cooling vests during a COVID-19 shift ensures that nurses experience less heat during their work. During their shifts, nurses wear protective clothing for three hours in a row, during which the temperature can rise to as much as 36 […].
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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
JANUARY 7, 2021
Frank Nestle, Sanofi’s chief scientific officer and Global Head of Research, and Dietmar Berger, Sanofi’s chief medical officer and Global Head of Development, provided an overview of the company’s clinical activities and highlighted some assets that will be key revenue drives for the company.
Scienmag
JANUARY 7, 2021
UTA students have earned 40-plus Eisenhower Transportation Fellowships in recent years Credit: UT Arlington Ten students from The University of Texas at Arlington have received coveted Dwight David Eisenhower Transportation Fellowships from the U.S. Department of Transportation. The students come from three UTA colleges: College of Engineering College of Liberal Arts (COLA) College of Architecture, […].
Pharma Times
JANUARY 7, 2021
Service will accelerate the ethics review stage of clinical trials approval
Scienmag
JANUARY 7, 2021
Credit: MBI Femtosecond hard X-ray pulses are an important tool for unraveling structure changes of condensed matter on atomic length and time scales. A novel laser-driven X-ray source provides femtosecond copper K? pulses at a 1 kHz repetition rate with an unprecedented flux of some 10^12 X-ray photons per second. Elementary processes in physics, chemistry, […].
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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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