Bio Pharma Dive
DECEMBER 14, 2020
A New York nurse was among the first to get the shot after FDA authorization late Friday. Many other health systems are either preparing to receive supplies or are already beginning immunizations.
Pharma Mirror
DECEMBER 14, 2020
The future of pharmaceutical manufacturing is mobile. Advances in cloud computing and the onset of Industry 4.0 has led to the proliferation of mobile IT solutions for manufacturing, including pharmaceuticals. Particularly, mobile workstations and tablets are becoming staples of the pharmaceutical manufacturing workflow due to their cost-effectiveness, particularly in demanding environments like cleanrooms, where even modular fixed human-machine interfaces (HMIs) can be exorbitantly priced and c
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Bio Pharma Dive
DECEMBER 14, 2020
Roche's interest backs up Relay's bet that understanding how proteins move will help it design better drugs.
Pharma Mirror
DECEMBER 14, 2020
Manufacturers seeking CDMOs that can quickly develop complex formulations offering both body and mind benefits SIRIO Europe (Ayanda) – the European nutraceutical and pharmaceutical contract development and manufacturing organisation (CDMO) and member of SIRIO Group – forecasts a winter surge in requests from nutra brands for new ‘dual benefit’ mood enhancing formulations as a result of COVID-19 measures.
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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 14, 2020
In-home phlebotomy services support therapy initiation and maintenance throughout the patient journey.
BioPharma Reporter
DECEMBER 14, 2020
The US has started COVID-19 vaccinations this morning: after the Pfizer/BioNTech vaccine was granted Emergency Use Authorization (EUA) by the FDA on Friday.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
DECEMBER 14, 2020
Shares of Prevail Therapeutics have skyrocketed more than 84% in premarket trading after Eli Lilly announced it was acquiring the gene therapy company in a deal valued at approximately $1.04 billion.
Pharma Times
DECEMBER 14, 2020
The triple combination therapy Trixeo Aerosphere cut the rate of moderate or severe exacerbations compared with dual-combination therapies in clinical trials
pharmaphorum
DECEMBER 14, 2020
Daiichi Sankyo and AstraZeneca could be just weeks away from an EU approval for their antibody-drug conjugate (ADC) for breast cancer – Enhertu – which is tipped to become a multibillion-dollar blockbuster. At its meeting last week, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Enhertu (trastuzumab deruxtecan) for patients with unresectable or metastatic HER2-positive breast cancer, who have been previously treated with other anti-HER2 drugs.
BioSpace
DECEMBER 14, 2020
Regeneron Pharmaceuticals reported that it is pausing enrollment in two of its clinical trials for odronextamab for lymphoma. The U.S. Food and Drug Administration (FDA) placed a partial clinical hold on the trials.
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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 14, 2020
The roll-out of the biggest vaccination programme in the history of the UK’s NHS is gathering pace, as family doctors and their teams begin taking delivery of Pfizer/BioNTech’s COVID-19 shot. In a statement the NHS said that GP practices in more than 100 parts of the country are taking delivery of the vaccine today. Some clinics will begin immunisations this afternoon and the majority will start tomorrow (Tuesday), the NHS said.
BioSpace
DECEMBER 14, 2020
Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie.
XTalks
DECEMBER 14, 2020
AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility. The identity of the facility was not disclosed.
BioSpace
DECEMBER 14, 2020
Westlake Village BioPartners launched two new funds totaling $500 million that will be used to build and invest in promising life sciences companies, with a particular focus on bolstering companies in the Los Angeles area.
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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.
Scienmag
DECEMBER 14, 2020
Advance could pave the way for early warning system on COVID-19 and flu using wearables Credit: Oura Ring Temperature data collected by wearable devices worn on the finger can be reliably used to detect the onset of fevers, a leading symptom of both COVID-19 and the flu, according to a team of researchers from the […].
BioSpace
DECEMBER 14, 2020
One of the key projections is that for the second consecutive year, biotech and pharma VC deal activity will probably exceed $20 billion.
Scienmag
DECEMBER 14, 2020
Credit: ©ICFO/L.Maidment, U. Elu & J. Biegert. Analytical optical methods are vital to our modern society as they permit the fast and secure identification of substances within solids, liquids or gases. These methods rely on light interacting with each of these substances differently at different parts of the optical spectrum. For instance, the ultraviolet range […].
BioSpace
DECEMBER 14, 2020
Mergers and acquisitions are a well-known fact in the life sciences industry, and anyone working within the sector knows to expect them at any time.
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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.
Scienmag
DECEMBER 14, 2020
Meier-Gorlin syndrome is a rare genetic developmental disorder that causes dwarfism, small ears, a small brain, missing patella and other skeletal abnormalities Credit: UAB BIRMINGHAM, Ala. – Meier-Gorlin syndrome, or MGS, is a rare genetic developmental disorder that causes dwarfism, small ears, a small brain, missing patella and other skeletal abnormalities.
BioSpace
DECEMBER 14, 2020
vTv Therapeutics has provided worldwide rights for its novel clinical-stage Nrf2 activator compound, HPP971, to newly formed Anteris Bio.
Scienmag
DECEMBER 14, 2020
Credit: Photo by L. Brian Stauffer CHAMPAIGN, Ill. — According to new research, people tend to moralize COVID-19-control efforts and are more willing to endorse human costs emerging from COVID-19-related restrictions than to accept costs resulting from other restraints meant to prevent injury or death. The level of support – and resulting outrage in response […].
BioSpace
DECEMBER 14, 2020
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 15, 2020.
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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.
Scienmag
DECEMBER 14, 2020
Early memory abilities predict future brain connections; early connections predict future memory abilities Credit: Geng et al., JNeurosci 2020 In early childhood, memory skills predict the strength of future brain connections, and conversely, the strength of early brain connections predict future memory acuity. New research published in JNeurosci highlights the complex, bidirectional relationship between brain […].
Pharma Times
DECEMBER 14, 2020
Drug approved to help reduce cholesterol levels
Scienmag
DECEMBER 14, 2020
Credit: Marsh et al. After Julia had a minor stroke, she was thankful for receiving rapid treatment and recovering well. But she did notice an unexpected aftereffect as she returned to normal activities. In meetings at work, she was unable to follow the back and forth among attendees. And when she was asked for her […].
Pharma Times
DECEMBER 14, 2020
New analyses submitted by Novartis has helped to secure a NICE recommendation for NHS funding
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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
DECEMBER 14, 2020
Findings debunk dozens of prominent published papers claiming to read minds with EEG Credit: Chris Adam/Purdue University WEST LAFAYETTE, Ind. – Is it possible to read a person’s mind by analyzing the electric signals from the brain? The answer may be much more complex than most people think. Purdue University researchers – working at the […].
Outsourcing Pharma
DECEMBER 14, 2020
The research (conducted by trial tech provider Litmus Health) shows an indepth picture of wearable device use, top devices, data capture and other factors.
Scienmag
DECEMBER 14, 2020
Credit: RUDN University Chemists from RUDN University synthesized soluble biopolymers based on chitin from crab shells. Together with palladium, they form effective catalysts for organic reactions, and their nanoparticles can be re-used over ten times. The results of the study were published in the Carbohydrate Polymers journal. Palladium-based catalysts are used to speed up cross-coupling […].
pharmaphorum
DECEMBER 14, 2020
As this issue’s title suggests, patient centricity is about more than just talking points and marketing strategies – it requires companies to truly listen to, engage with and partner with the patients they serve, and in putting this month’s Deep Dive together it’s been great to see that so many pharma firms are now taking this to heart. Not only that, but we are seeing patient insights being considered at every stage of a product’s lifecycle, from product design to clinical trials and even post-
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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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