Bio Pharma Dive
DECEMBER 22, 2020
In a landmark study, fewer people given Ebanga died from Ebola virus infection than did those who received a control drug. Results from the trial also led to an OK for Regeneron's drug Inmazeb.
World of DTC Marketing
DECEMBER 22, 2020
Consumers downloaded 204 billion apps in 2019, and mobile use has been increasing during the pandemic. Apple, with its new privacy requirements, is challenging app developers and brands while Facebook cries fowl. It will have little effect on app use, though, for consumers. In 2020, there should be over 592 million daily app downloads, and a survey by Gallup revealed that nearly half (45%) of Americans have at least tried digital health products such as fitness trackers or mobile health apps.
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Bio Pharma Dive
DECEMBER 22, 2020
Following a string of deals in edgy, unproven fields of scientific research, Vertex's latest diversification push involves chemical-based drugs that target RNA — an approach that's already attracted several large pharmas.
BioPharma Reporter
DECEMBER 22, 2020
BioNTech's CEO says it is highly likely that the Pfizer/BioNTech vaccine will be able to deal with the new variant that has emerged in the UK. And a new vaccine could be developed within six weeks if needed.
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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 22, 2020
Just a month after finding success in a Phase 3 trial, Amgen's tezepelumab has come up short in a different study that some analysts think will give an upper hand to Regeneron's Dupixent.
Pharma Times
DECEMBER 22, 2020
Rekambys plus Vocabria authorised to treat HIV-1 infections in adults who are virologically suppressed
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
DECEMBER 22, 2020
It is already a very Merry Christmas for brand new San Diego-based biotech Neomorph, Inc., which found $109 million under the tree in a Series A financing to advance its proprietary protein degradation platform and programs.
Pharma Times
DECEMBER 22, 2020
Murepavadin is being developed to treat Pseudomonas aeruginosa infections in people with cystic fibrosis
Outsourcing Pharma
DECEMBER 22, 2020
A leader from the IQVIA company explains how the boom in the volume and quality of data, and advanced analysis, can speed and streamline drug development.
Scienmag
DECEMBER 22, 2020
Blocking gene expression in mitochondria in mice stops cancer cells from growing Credit: Hauke S. Hillen A newly developed compound starves cancer cells by attacking their “power plants” – the so-called mitochondria. The new compound prevents the genetic information within mitochondria from being read. Researchers from the Max Planck Institute for Biology of Ageing in […].
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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 22, 2020
The new state-of-the-art facility, dubbed the “Factory of the Future,” will span 110,000 square feet and will be located in the city of Wilsonville, Oregon.
NY Times
DECEMBER 22, 2020
The 160-page civil complaint alleges that the retail giant knew that its system for detecting illegitimate prescriptions was inadequate.
BioSpace
DECEMBER 22, 2020
Yesterday it was reported that the two companies were working to make more of their vaccine than the 1.3 billion it promised to manufacture in 2021.
Outsourcing Pharma
DECEMBER 22, 2020
A new survey from the supply-chain analysis company revals inefficiencies, inaccurate data and other flaws can be costly in terms of revenue, reputation and patient lives.
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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.
Pharma Times
DECEMBER 22, 2020
Follows positive opinion issued by EMA's CHMP
pharmaphorum
DECEMBER 22, 2020
BioNTech CEO Ugur Sahin has said that it is “highly likely” the company’s COVID-19 vaccine will work against the more infectious strain circulating in the south east of England, although further studies will be needed. Sahin was addressing a news conference after the vaccine was approved by the European Union, three weeks after the shot was independently backed by the UK’s regulator.
BioSpace
DECEMBER 22, 2020
A roundup of the latest biopharma companies scooping up cash through IPOs and financing rounds.
BioTech 365
DECEMBER 22, 2020
Illumina to Webcast Upcoming Investor Conference Presentations Illumina to Webcast Upcoming Investor Conference Presentations SAN DIEGO–(BUSINESS WIRE)–$ILMN #ILMN–Illumina, Inc. (NASDAQ:ILMN) today announced that its executives will be speaking at the following investor conference and invited investors to participate via webcast.
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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.
pharmaphorum
DECEMBER 22, 2020
The trials and tribulations of 2020 have brought the vital role of research, pharma, and biotech into sharp focus. But how has the push to develop treatments and vaccines for SARS-CoV-2 affected the industry’s commitment to patient centricity? This time last year, researchers and industry players were working hard to embed patient centricity and engagement into their everyday work.
BioSpace
DECEMBER 22, 2020
In October, the FDA placed a clinical hold on the company’s Huntington’s disease gene therapy before that asset could make its way into the clinic.
pharmaphorum
DECEMBER 22, 2020
The UK government is funding a network of three centres that will use digital technology to train the next generation of scientists specialising in advanced therapies. The National Horizons Centre, RoslinCT and the University of Birmingham have been selected as preferred bidders to deliver high impact physical and digitally-delivered training courses as part of the growing Advanced Therapies Skills Training Network (ATSTN) programme.
The Pharma Data
DECEMBER 22, 2020
Dec. 23, 2020 15:07 UTC. Deal enables A2 to build allogeneic capability. AGOURA HILLS, Calif.–( BUSINESS WIRE )– A2 Biotherapeutics ( www.a2bio.com ), a biotechnology company developing innovative cell therapies for cancer patients with solid tumors, today announced that it has entered into an agreement with Merck, known as MSD outside the United States and Canada, in which A2 will continue research and preclinical development of its undisclosed Tmod cell therapy candidate (its third
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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 22, 2020
$4.67 million helps put new fruits to the test Credit: Chandrika Ramadugu/UCR UC Riverside scientists are betting an ancient solution will solve citrus growers’ biggest problem by breeding new fruits with natural resistance to a deadly tree disease. The hybrid fruits will ideally share the best of their parents’ attributes: the tastiness of the best […].
The Pharma Data
DECEMBER 22, 2020
SAN MATEO, Calif. , Dec. 23, 2020 /PRNewswire/ — Rakuten Medical, Inc. (Rakuten Medical) today announced that their Phase 1b /2 clinical trial, an Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors (ClinicalTrials.gov Identifier: NCT04305795) has enrolled and treated its first patient in the United States , at The University of Texas MD Anderson Cancer Center, Houston, Texas.
Drug Patent Watch
DECEMBER 22, 2020
Annual Drug Patent Expirations for INGREZZA Ingrezza is a drug marketed by Neurocrine and is included in one NDA. It is available from one supplier. There are three patents protecting…. The post New patent for Neurocrine drug INGREZZA appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
DECEMBER 22, 2020
News. Professional. Tagrisso Approved as Adjuvant Therapy for NSCLC With EGFR Mutations. TUESDAY, Dec. 22, 2020 — Tagrisso ( osimertinib ) received approval as an adjuvant treatment for patients with non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, the U.S. Food and Drug Administration announced Friday.
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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.
Drug Patent Watch
DECEMBER 22, 2020
Annual Drug Patent Expirations for FLUORESCEIN+SODIUM+AND+BENOXINATE+HYDROCHLORIDE Fluorescein Sodium And Benoxinate Hydrochloride is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There…. The post New patent for Bausch drug FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
DECEMBER 22, 2020
The National Institutes of Health (NIH) has paused enrollment of critically ill COVID-19 patients in a phase 3 trial of various blood thinners, one of three international trials evaluating whether a full or lower dose of anticoagulants in hospitalized COVID-19 patients is more effective. Source link.
Drug Patent Watch
DECEMBER 22, 2020
Annual Drug Patent Expirations for GAVRETO Gavreto is a drug marketed by Blueprint Medicines and is included in one NDA. There is one patent protecting this drug. This drug has…. The post New patent for Blueprint Medicines drug GAVRETO appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
DECEMBER 22, 2020
AstraZeneca (AZ) and Amgen disclosed that their investigational asthma drug tezepelumab failed to achieve its primary endpoint of reducing dependence on oral corticosteroids while keeping asthma symptoms stable. Source link.
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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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