Bio Pharma Dive
NOVEMBER 30, 2020
New results confirm the shot's strong efficacy against COVID-19, and should raise confidence vaccination can prevent against severe symptoms as well.
Pharma Mirror
NOVEMBER 30, 2020
The new report looks ahead to a post-pandemic 2021 with pharma manufacturing capacity and payment structures shifting as new sourcing strategies emerge Amsterdam: A new report from CPhI explores the potential implications in 2021 of impending vaccine approvals, a new administration in the White House and a return to dual supply chain strategies. The report – which summarises expert analysis into 12 key findings – foresees a particularly positive outlook for the pharma manufacturing supply chain
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Bio Pharma Dive
NOVEMBER 30, 2020
With two experimental shots now undergoing FDA review, airports and shipping companies are readying for the mass shipment of vaccine doses.
Pharma Mirror
NOVEMBER 30, 2020
Chippenham, UK: Vectura Group plc, an industry leading inhalation CDMO, today announces that it has signed a global out licence and development agreement with Kinaset Therapeutics Inc. for the development and commercialisation of VR588, a preclinical novel inhaled pan-JAK inhibitor for the prevention and treatment of severe asthma. Pan-JAK inhibitors have been developed and tested in clinical trials, approved and commercialised for many different indications but mainly for the treatment of chron
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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, 2020
Freight forwarders, the linchpins of the supply chain, face the daunting task of ensuring hundreds of millions of doses make the journey from factory to clinic.
Pharma Mirror
NOVEMBER 30, 2020
The Hague — The digital era is radically changing how technology is used, and new technologies are set to have major impacts on how people live and work. How pharmacists and pharmacy organisations can rise to the challenge of these technologies and embrace them is set out in a new Position Statement on emerging technologies and pharmacy practice released by the International Pharmaceutical Federation (FIP) today.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
NOVEMBER 30, 2020
Another clinical study could confirm the 90% efficacy data that stemmed from accidental use of a half-dose in an arm of its Phase III trial.
NY Times
NOVEMBER 30, 2020
Researchers at DeepMind say they have solved “the protein folding problem,” a task that has bedeviled scientists for more than 50 years.
pharmaphorum
NOVEMBER 30, 2020
Cure Rare Disease’s Rich Horgan discusses the importance of preclinical NAbs screening and helping rare disease patients better understand their eligibility for gene therapies. Neutralising antibodies (NAbs) present a unique challenge to researchers looking to treat patients with AAV treatment. As AAV is a virus derived from the common cold, the immune system can easily have levels of pre-existing NAbs that will recognise and neutralise AAV, rendering it ineffective.
BioSpace
NOVEMBER 30, 2020
The Federal Aviation Administration indicated that charter flights began flying Pfizer-BioNTech’s COVID-19 vaccine from Belgium to the U.S. on November 27 in the first “mass air shipment.
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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
NY Times
NOVEMBER 30, 2020
The first shots could be given as early as Dec. 21, if authorization is granted.
VirTrial
NOVEMBER 30, 2020
VirTrial software offers trial-tested solutions for remote-based patient and site visits . BLUE BELL, PA – November 30, 2020 – Signant Health , the leading enabler of evidence generation for modern clinical trials, announced today the acquisition of VirTrial , a leading provider of software solutions for remote site startup and decentralized clinical trial conduct.
BioSpace
NOVEMBER 30, 2020
Sage and Biogen forged the deal to jointly develop and commercialize zuranolone (SAGE-217) for major depressive disorder, postpartum depression and other psychiatric disorders and SAGE-324 for essential tremor and other neurological disorders.
BioPharma Reporter
NOVEMBER 30, 2020
Moderna has announced it will submit an Emergency Use Authorization request to the US FDA today for its COVID-19 vaccine candidate. It has also released the Phase 3 primary efficacy analysis, showing 94.1% efficacy.
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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.
The Pharma Data
NOVEMBER 30, 2020
TDR, in partnership with the WHO Global Tuberculosis Programme, has developed an interactive web-based toolkit that supports national TB programmes and other partners to conduct implementation research designed to evaluate digital technologies for TB care. This will be launched today at a workshop taking place in Beijing, China. THE CHALLENGE: Implementing and scaling up digital tools for TB care.
BioSpace
NOVEMBER 30, 2020
California-based Grail aims to alter the devastating trajectory of cancer mortality with the addition of one simple blood test.
NY Times
NOVEMBER 30, 2020
Multiple inoculations for the coronavirus are making their way through the approval process. Here’s what we know about the plan for their distribution.
BioSpace
NOVEMBER 30, 2020
The end of November and beginning of December is marked by several PDUFA dates at the U.S. Food and Drug Administration (FDA). Here’s a look.
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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.
NY Times
NOVEMBER 30, 2020
For the 80,000 children who die of H.I.V. each year, drugs are often bitter or hard to swallow. Dolutegravir will soon come in a tasty dissolving tablet.
BioSpace
NOVEMBER 30, 2020
The FDA approval was based on results from the largest studies conducted to date in obesity associated with POMC, PCSK1 or LEPR deficiency.
Scienmag
NOVEMBER 30, 2020
Credit: Marine and Environmental Research Lab Non-indigenous or alien species need to be appreciated for their potential benefits and not just the negative impacts they can have on the environment, according to new research. In recent decades, there have been numerous examples of non-indigenous species (NIS) establishing a foothold and then causing harm in new […].
BioSpace
NOVEMBER 30, 2020
Although biopharma executives leave for many reasons and at any time, there is a tendency to make shifts toward the end of the year. Today there were two high-profile announcements to start off the month of December.
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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.
pharmaphorum
NOVEMBER 30, 2020
We speak to finalists from the Greater Manchester Future of Health accelerator to find out how digital start-ups can overcome the challenges small companies face in bringing their technologies into the NHS. Right now the NHS is embracing digital to an extent no one could have foreseen a year ago – but that doesn’t mean it’s a smooth journey for digital health start-ups looking to gain traction in the health service.
BioSpace
NOVEMBER 30, 2020
Moderna announced that it plans to submit its request to the U.S. Food and Drug Administration for an Emergency Use Authorization for its COVID-19 vaccine, mRNA-1273.
pharmaphorum
NOVEMBER 30, 2020
The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine. According to press reports, the UK’s drug regulator, the Medicines and Healthcare products Regulatory Authority (MHRA) could become one of the first bodies to approve the vaccine. According to the Financial Times, the MHRA could approve the vaccine by 7 th December after the companies announced supportive data from a phase 3 trial
BioSpace
NOVEMBER 30, 2020
Without the ability to see as many people in person, how can you thank someone for their ongoing help and perpetual cheerleading? Here are a few ways to virtually thank your broader network.
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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.
Scienmag
NOVEMBER 30, 2020
Credit: NAOJ Earth just got 7 km/s faster and about 2000 light-years closer to the supermassive black hole in the center of the Milky Way Galaxy. But don’t worry, this doesn’t mean that our planet is plunging towards the black hole. Instead the changes are results of a better model of the Milky Way Galaxy […].
BioSpace
NOVEMBER 30, 2020
Venture capital investment firm GV, formerly Google Ventures, led the Series A financing round for the company. Other investors contributed to the round but have decided to remain anonymous.
Outsourcing Pharma
NOVEMBER 30, 2020
A recent survey conducted by Oracle reveals trial professionalsâ thoughts, feelings and behavior around decentralized research in the face of the pandemic.
BioPharma Reporter
NOVEMBER 30, 2020
From operational uncertainty and outdated manual processes to new cell lines and a potential shift towards allogeneic cell therapy, CRBâs new report - Horizons: Cell and Gene Therapy - finds the biopharma industry at the critical intersection of obstacle and opportunity.
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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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