Scienmag
DECEMBER 20, 2020
Credit: CEM Ivory Coast has announced the creation of its first Marine Protected Area (MPA). The MPA will cover 2,600km2 (1,000 square miles) of pristine ocean off the coast of Grand-Béréby, protecting marine biodiversity including threatened shark and turtle species. The announcement is the culmination of years of work by the Ivorian government, the Abidjan […].
BioSpace
DECEMBER 20, 2020
The company and Operation Warp Speed began distribution of the vaccine through McKesson, along with United Parcel Services and FedEx, over the weekend. The first vaccinations are expected today.
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Scienmag
DECEMBER 20, 2020
National poll: Cyberbullying, depression and unhealthy habits on parents’ top 10 list of worries; Black families rank racism as No.1 concern and COVID-19 as No.2 Credit: C.S. Mott Children’s Hospital National Poll on Children’s Health at Michigan Medicine. ANN ARBOR, Mich. — Parenting in a pandemic is not for the faint of heart.
BioSpace
DECEMBER 20, 2020
Shares of NantKwest were up more than 27% in premarket trading after the company announced a stock-for-stock reverse merger with privately-held ImmunityBio.
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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
Scienmag
DECEMBER 20, 2020
A study of more than 1,400 protein-coding genes of fleas has resolved one of the longest standing mysteries in the evolution of insects, reordering their placement in the tree of life and pinpointing who their closest relatives are. The University of Bristol study, published in the journal Palaeoentomology, drew on the largest insect molecular dataset […].
BioSpace
DECEMBER 20, 2020
Many companies appear to be getting their clinical trial news updated ahead of the holidays. Here’s a look.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
DECEMBER 20, 2020
Genentech, a Roche company, announced positive topline data from two identical Phase III trials of faricimab in diabetic macular edema (DME).
The Pharma Data
DECEMBER 20, 2020
The U.S. Food and Drug Administration (FDA) is plenty busy with COVID-19 vaccine Emergency Use Authorizations (EUAs) this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. Here’s a look. Urovant Sciences’ Vibegron for Overactive Bladder. Urovant Sciences has a target action date of December 26, 2020, for its New Drug Application for once-daily 75 mg vibegron for patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and
BioSpace
DECEMBER 20, 2020
The FDA put a clinical hold on UniQure's Phase III trial after a high-risk participant developed liver cancer.
The Pharma Data
DECEMBER 20, 2020
VANCOUVER, Dec. 20, 2020 (GLOBE NEWSWIRE) — BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU) is pleased to announce that further to its press release of December 8, 2020 , the Company has completed its acquisition to acquire 100% of the assets in Transcend Biodynamics LLC (“Transcend”) in an all-stock transaction, for a total of 13,333,333 common shares at $0.75 per share, with the transaction valued at $10 million.
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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 20, 2020
The company bolstered its presence in oncology with the acquisition of the clinical and research-stage oncology business of Agios in a deal worth up to $2 billion.
The Pharma Data
DECEMBER 20, 2020
Dec. 21, 2020 11:00 UTC. ACTON, Mass.–( BUSINESS WIRE )– Insulet Corporation (NASDAQ: PODD) (Insulet), the global leader in tubeless insulin pump technology with its Omnipod ® Insulin Management System, today announced that management will present at the 39 th Annual J.P. Morgan Virtual Healthcare Conference on January 12, 2021 at 9:10 a.m.
BioSpace
DECEMBER 20, 2020
The U.S. FDA is plenty busy with COVID-19 vaccine Emergency Use Authorizations this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. Here’s a look.
Scienmag
DECEMBER 20, 2020
Group’s report addresses surgery backlog, conditions created by pandemic Credit: TTUHSC In 2013, the National Institute for Health Research (NIHR) established the GlobalSurg Collaborative, a network that has since grown to include more than 5,000 practicing surgeons from all corners of the planet. Through GlobalSurg, networks of local, state, national and international researchers have formed […].
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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
DECEMBER 20, 2020
Oxford University released new trial data last week that raises further questions about the most effective dosing regimen for Oxford’s COVID-19 vaccine candidate, AZD1222, that is being co-developed with AstraZeneca and how it came to pass that two different dosing regimens were pursued. In a study published in the journal Nature Medicine , the Oxford researchers revealed that results from phase 1/2 trials showed that two full doses of the vaccine induced a stronger antibody response than one fu
Scienmag
DECEMBER 20, 2020
Credit: European Heart Journal Hospital in-patients from lower socioeconomic backgrounds are less likely to receive prompt cardiopulmonary resuscitation (CPR) after their hearts stop beating and less likely to survive than patients from higher socioeconomic backgrounds. These are the findings of a new study in over 24,000 patients in Sweden, published in the European Heart Journal […].
The Pharma Data
DECEMBER 20, 2020
UK drug developer Scancell said it has chosen a COVID-19 vaccine candidate, SN14, from more than a dozen potential products to advance to a clinical trial. . SN14 works by targeting the coronavirus’ nucleocapsid and spike proteins to prevent viral replication using the company’s ImmunoBody DNA vaccine technology. In October, Scancell signed a manufacturing deal for SN14 with Cobra Biologics, a Cognate BioServices subsidiary, ahead of a planned phase 1 trial in 2021.
BioSpace
DECEMBER 20, 2020
A new and more easily transmissible strain of COVID-19, dubbed VUI-202012/01, has now been reported in at least six different countries and global territories since it first appeared in the U.K. a few weeks ago.
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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.
The Pharma Data
DECEMBER 20, 2020
SUNDAY, Dec. 20, 2020 – Chronic pain can be excruciating, debilitating and hard to describe. Yet the best way to get the right treatment for the exact pain you’re experiencing is to put those symptoms into words, so your doctor can pinpoint a diagnosis and help you find relief. The Arthritis Foundation created a guide with suggestions for communicating your discomfort.
BioTech 365
DECEMBER 20, 2020
European Commission Approves Aimmune’s PALFORZIA® as First-Ever Treatment for Peanut Allergy in the EU European Commission Approves Aimmune’s PALFORZIA® as First-Ever Treatment for Peanut Allergy in the EU — Peanut Allergy is One of the Most Common Food Allergies in … Continue reading →
The Pharma Data
DECEMBER 20, 2020
Dec. 21, 2020 07:00 UTC. OSAKA, Japan–( BUSINESS WIRE )– Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it has entered into an agreement to divest a portfolio of non-core prescription pharmaceutical products sold in China to Hasten Biopharmaceutic Co., Ltd. (China) (“Hasten”), a company funded by Feidong County of Hefei City, China and established by Ray Capital Management Limited (“Ray Capital”) 1 Takeda will receive $322 million USD, sub
BioTech 365
DECEMBER 20, 2020
Inotrem announces Data Monitoring Committee (DMC) recommends continuation of Phase IIa study of nangibotide for the treatment of severe forms of COVID-19 Inotrem announces Data Monitoring Committee (DMC) recommends continuation of Phase IIa study of nangibotide for the treatment of … Continue reading →
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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.
The Pharma Data
DECEMBER 20, 2020
NEW YORK, Dec. 21, 2020 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced initial data from two clinical studies of galinpepimut-S (GPS), the Company’s Wilms Tumor-1 (WT1)-targeting peptide immunotherapeutic, in combination with checkpoint inhibitor therapies in patients with two diff
BioTech 365
DECEMBER 20, 2020
Takeda Furthers Innovation-Focused Strategy in China with Sale of Select Non-Core Assets to Hasten for $322 million USD Takeda Furthers Innovation-Focused Strategy in China with Sale of Select Non-Core Assets to Hasten for $322 million USD ?
The Pharma Data
DECEMBER 20, 2020
Collaboration Strengthens Peijia’s Position for Competing in a Largely Untapped Market and Supports Global Expansion of HighLife’s Technology. SUZHOU, China and PARIS , Dec. 20, 2020 /PRNewswire/ — Peijia Medical Ltd (HK Stock Code: 09996) and HighLife SAS , a Paris -based medical device company, focused on the development of a unique transeptal mitral valve replacement (“TMVR”) system to treat patients suffering from mitral regurgitation, announced that they have e
BioTech 365
DECEMBER 20, 2020
Janssen Announces European Commission Authorisation of the First Complete Long-Acting Injectable HIV Treatment in Europe Janssen Announces European Commission Authorisation of the First Complete Long-Acting Injectable HIV Treatment in Europe Marketing Authorisation granted by European Commission for Janssen’s REKAMBYS® (rilpivirine … Continue reading →
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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.
The Pharma Data
DECEMBER 20, 2020
Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties. Shanghai Haini gains exclusive manufacturing, development and commercial rights for the licensed territory. SAINT-LOUIS, France and WEIL AM RHEIN, Germany and SHANGHAI, China, Dec
Scienmag
DECEMBER 20, 2020
Credit: Ville Vähä Salmon from upstream reaches of the two northernmost Baltic rivers are different from downstream salmon. A recent study found that upstream salmon from the large Tornio and Kalix Rivers in Finland and Sweden are genetically distinct and migrate at different times and ages than their downstream counterparts. However, there seems to be […].
The Pharma Data
DECEMBER 20, 2020
Dec. 21, 2020 11:00 UTC. TUSTIN, Calif.–( BUSINESS WIRE )– Hospitals and institutions are continually looking for ways to improve diagnostic imaging throughput, especially in today’s environment where disinfection of systems and rooms in between patients is crucial. Now, Compressed SPEEDER technology has been FDA-cleared for 3D sequences on Canon Medical Systems USA, Inc. ’s Vantage Orian 1.5T MR system, so clinicians can easily expect to scan at least twice as fast, and even faster
Scienmag
DECEMBER 20, 2020
An international team of researchers from the Chinese Academy of Sciences, Zhejiang A & F University and the University of Eastern Finland have found that regardless of whether flowering or leaf unfolding occurred first in a species, the first event advanced more than the second over the last seven decades. In the four European tree […].
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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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