Bio Pharma Dive
DECEMBER 21, 2020
Servier will pay Agios $1.8 billion upfront to acquire the biotech's approved leukemia treatment Tibsovo as well as the rest of its pipeline in cancer and early-stage research work.
World of DTC Marketing
DECEMBER 21, 2020
It’s hard to believe that 2020 is almost over but goodbye and good riddance. I’m hoping a new leader can restore the CDC and FDA’s trust and that the nationwide vaccination problem can proceed, but there are bigger issues. Long after COVID is a bad memory, the pharma industry will still be making more and more mistakes in the name of profits.
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Bio Pharma Dive
DECEMBER 21, 2020
The FDA halted the AMT-061 program, which could be the first approved gene therapy for hemophilia B, because a patient who received the treatment appears to have developed liver cancer.
pharmaphorum
DECEMBER 21, 2020
2020’s M&A activity hasn’t quite reached the heights of last year’s, where two pharma mega-mergers – BMS’ buyout of Celegne and AbbVie’s acquisition of Allergan – accounted for almost 40% of total M&A deal values. That said, there were still some interesting moves indicating new directions of travel for big pharma players – with most deals focused on specific drugs from biotechs, particularly in cancer (though we did get rumours of an AstraZeneca-Gilead merger , which would have been the
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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 21, 2020
The regulator declined to approve inclisiran, which Novartis acquired in its buyout of The Medicines Co., after agency staff weren't able to inspect a production facility in Europe.
BioSpace
DECEMBER 21, 2020
At the moment, eight clinical trials are currently being carried out to determine if the link between melatonin and the novel coronavirus is legitimate.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
DECEMBER 21, 2020
In a December 8, 2020 meeting with U.K. scientists and public health experts, it was announced that there was a growing new strain of the SARS-CoV-2 virus that causes COVID-19.
BioPharma Reporter
DECEMBER 21, 2020
It is known and expected that viruses constantly change through mutation leading to the emergence of new variants, but preliminary analysis in the UK suggests the new SARS-CoV-2 variant is significantly more transmissible than previous ones.
BioSpace
DECEMBER 21, 2020
Rhythm Pharmaceuticals announced on Tuesday that its hunger and severe obesity drug, setmelanotide, significantly reduced weight and hunger scores in people with Bardet-Biedl syndrome and Alström syndrome.
Scienmag
DECEMBER 21, 2020
UC Riverside study examines molecular pathways that may instigate seizures in some multiple sclerosis patients Credit: Tiwari-Woodruff lab, UC Riverside. RIVERSIDE, Calif. — A research team at the University of California, Riverside School of Medicine has identified a pathway involving astrocytes, a class of central nervous system support cells, that could shed light on why […].
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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
BioSpace
DECEMBER 21, 2020
A new Series B financing round sees Peter Thiel, co-founder of PayPal and Palantir Technologies, joining entrepreneur Christian Angermayer in investing $35 million in Pittsburgh, Penn.-based biotech Peptilogics.
Scienmag
DECEMBER 21, 2020
The article by Dr. Gustavo R. Zubieta-Calleja and colleagues in published as open access in Reviews on Recent Clinical Trials, 2020 Credit: Dr. Gustavo R. Zubieta-Calleja and colleagues, Bentham Science Publishers The current COVID-19 pandemic has caused over 1 million deaths which can be attributed to its severe progressive pulmonary compromise. The necessity to understand […].
BioSpace
DECEMBER 21, 2020
It has been thought that llamas may hold the key to developing an effective therapeutic against COVID-19, as well as the flu. This morning, scientists from the National Institutes of Health made additional headway in llama research, isolating promising antibodies from the South American animal.
BioPharma Reporter
DECEMBER 21, 2020
A US advisory panel has recommended the next two US priority population groups to receive the COVID-19 vaccine should be those 75 and older and essential workers.
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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
DECEMBER 21, 2020
Skyhawk Therapeutics and Vertex Pharmaceuticals inked a strategic research collaboration and licensing deal focused on developing novel small molecules that modulate RNA splicing.
pharmaphorum
DECEMBER 21, 2020
Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. Just who are these companies and who is behind them, asks Richard Staines. A year ago, the names Moderna and BioNTech were known mainly to those who followed biotech and pharma dealings. But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against t
BioSpace
DECEMBER 21, 2020
An investigational asthma treatment under development by Amgen and AstraZeneca failed to reduce asthma patients’ dependence on corticosteroids in a Phase III study.
Pharma Times
DECEMBER 21, 2020
EGFR-TKI approved in the US for early non-small cell lung cancer
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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
DECEMBER 21, 2020
Myovant's oral Orgovyx beat out Abbvie's injectable Lupron in achieving medical castration levels in patients.
Outsourcing Pharma
DECEMBER 21, 2020
A partnership between Immunai and 10x Genomics will use artificial intelligence to create a map of the immune system to help accelerate drug development.
Pharma Times
DECEMBER 21, 2020
Treatment demonstrated non-inferior visual acuity gains compared to Regeneron's Eylea
BioSpace
DECEMBER 21, 2020
The U.S. Food and Drug Administration has approved several drugs and medical devices in the last week. Here’s a look.
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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.
Pharma Times
DECEMBER 21, 2020
Drug becomes first treatment for peanut allergy in the EU
pharmaphorum
DECEMBER 21, 2020
More than 1,000 NHS patients have booked flu vaccinations using a virtual assistant as part of a pilot project in the south east of England. The pilot project, run in collaboration with GP practices in Buckinghamshire, Brent, and Greenwich, involved patients using the Ask NHS app, which is already used by more than 375,000 patients. Patients in the pilot used the app developed by Sensely to self-check eligibility and quickly make appointments for flu jabs.
NY Times
DECEMBER 21, 2020
Christie Smythe helped break the story of Mr. Shkreli’s arrest in 2015. Then she “started to fall for him,” she said, and quit her job at Bloomberg News.
JAMA Internal Medicine
DECEMBER 21, 2020
After a hard year, good news related to coronavirus disease 2019 (COVID-19) is welcome. In this issue of JAMA Internal Medicine, Asch and colleagues provide a reason for optimism that our health care system has improved in our ability to care for persons with COVID-19. The authors performed a national analysis of COVID-19–associated mortality that spanned 955 US hospitals, representing nearly 40?
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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.
pharmaphorum
DECEMBER 21, 2020
As expected, the FDA has moved swiftly ahead with emergency approval of Moderna’s COVID-19 vaccine after a positive assessment at its vaccines advisory committee. The authorisation means that around six million more vaccine doses can now be rolled out in the US coronavirus immunisation programme, adding to the almost three million doses of Pfizer/BioNTech’s already-approved shot which started to be administered a few days ago.
Outsourcing Pharma
DECEMBER 21, 2020
The pharma firm will lend support to Aqemiaâs high-tech drug discovery tools in order to work on discovery and development of therapies for the virus.
pharmaphorum
DECEMBER 21, 2020
Two weeks ago, Vicore reported mid-stage data showing that its lead drug C21 could boost the benefit of steroid therapy in treating COVID-19. Now, it has new data from the trial to back up that promise, and says the drug could act as a “complement” to coronavirus vaccines. Carl-Johan Dalsgaarl. The Swedish biotech’s chief executive Carl-Johan Dalsgaarl said on a conference call that the extended analysis from the ATTRACT trial reinforced earlier data showing that C21 reduced the need for supplem
Scienmag
DECEMBER 21, 2020
Two novel discoveries led by Singapore team; sets pace for targeted therapy development among those diagnosed Credit: A*STAR’s Genome Institute of Singapore (GIS) 22 December 2020, Singapore – For over 20 years, the Genetics Service at the KK Women’s and Children’s Hospital (KKH) has been providing clinical care to patients with genetic disorders.
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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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