Bio Pharma Dive
JANUARY 12, 2021
Moderna and Gilead reported billions in sales for their coronavirus treatments, but Regeneron's antibody drug cocktail hasn't gained traction. BioNTech, meanwhile, could report critical new vaccine results in days.
World of DTC Marketing
JANUARY 12, 2021
SUMMARY: TV doesn’t make sense for smaller and older patient populations. DTC marketers should be thinking digital and aligning execution with their needs. BMS has been advertising Opdivo via DTC TV ads but does TV really make sense? It’s estimated that 228,820 adults (116,300 men and 112,520 women) in the United States will be diagnosed with lung cancer.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Bio Pharma Dive
JANUARY 12, 2021
Verve, a buzzy gene editing startup, unveiled its first drug candidate on Tuesday, while Eli Lilly's and Pfizer's CEO gave updates on Alzheimer's and dealmaking.
Camargo
JANUARY 12, 2021
In the first half of 2020 and as a direct consequence of the ongoing pandemic, China issued a ban on the export of non-human primates (NHPs) , including those used for pharmaceutical research. As this affected COVID-19 research, the NIH later issued a Notice of Limited Availability in an effort to prioritize studies requiring NHPs and minimize the impact of the resulting shortage.
Advertisement
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
NY Times
JANUARY 12, 2021
In their first abortion case since Justice Amy Coney Barrett joined the court, the justices reinstated a requirement that women seeking medication abortions pick up a pill in person.
BioSpace
JANUARY 12, 2021
Publicly-traded companies that have been heavily involved in developing therapies and vaccines for COVID-19 have seen significant spikes in their stock prices over the past 10 months, including Germany’s BioNTech, which has surged 187% in one year.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JANUARY 12, 2021
Merck announced the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for V114, its 15-valent pneumococcal conjugate vaccine, for Priority Review.
XTalks
JANUARY 12, 2021
The US Food and Drug Administration (FDA) has sent a warning letter to Coco’s Holistic Specialties & Apothecary , an online holistic and Eastern medicine company, for falsely advertising its products’ ability to prevent, treat, cure and even diagnose people with COVID-19. The letter , which was sent on January 4, 2021, stated that several of the company’s products violated section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a) which prohibits the introd
pharmaphorum
JANUARY 12, 2021
US biotech Atalanta Therapeutics has come out of stealth mode backed with $110m from Biogen and Roche, who have also signed separate partnerships to develop new therapies for neurological diseases using RNA interference (RNAi) technology. While there are RNAi products on the marketplace, with Alnylam becoming the first company to get a product approved in 2018, it is difficult to get this class of drug distributed through the brain and spinal cord.
BioPharma Reporter
JANUARY 12, 2021
Swissmedic, the Swiss Agency for Therapeutic Products, has authorized Modernaâs COVID-19 vaccine for adults aged 18+.
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
BioSpace
JANUARY 12, 2021
As an immigrant, female, mid-30’s CEO in the biotech world, Leen Kawas is used to being told no. She’s familiar with doubts being cast on her ideas, eyebrows raised at her push for innovation and some flat out telling her it won’t work. And she’s comfortable with all of that. It’s that grit that’.
pharmaphorum
JANUARY 12, 2021
Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes. The US regulator is looking at data from the EMPEROR-Reduced trial of Jardiance (empagliflozin), which found that the drug achieved a 25% reduction in the combined primary endpoint of cardiovascular death or hospitalisation compared to placebo.
Outsourcing Pharma
JANUARY 12, 2021
A Miami physician has owned up to falsifying research data and patient participation figures for a pediatric asthma trial conducted from 2013 to 2016.
Scienmag
JANUARY 12, 2021
Credit: TAMEST (The Academy of Medicine, Engineering, and Science of Texas) DALLAS – UT Southwestern Biochemist Benjamin Tu, Ph.D., is the recipient of the 2021 Edith and Peter O’Donnell Award in Science from TAMEST (The Academy of Medicine, Engineering and Science of Texas). He was chosen for his pioneering research on cellular roles of small […].
Advertisement
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.
Outsourcing Pharma
JANUARY 12, 2021
Sosei Heptares and PharmEnable will harness artificial intelligence-enabled technology and advanced chemistry to explore neurological disease solutions.
JAMA Internal Medicine
JANUARY 12, 2021
This Viewpoint discusses ways in which state medical licensing regulations can be modified to allow wider adoption of telemedicine by practitioners and to increase access for patients.
Outsourcing Pharma
JANUARY 12, 2021
Exploring alternative uses for drugs tapped for other indications, can save considerable time and money in discovery, according to an expert from the CRO.
BioSpace
JANUARY 12, 2021
Pfizer anticipates the initiative to invest up to half-a-billion dollars in small- to medium-sized companies developing clinical-stage assets aligned with Pfizer’s core areas of focus.
Advertisement
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
JANUARY 12, 2021
Credit: Are college campuses superspreaders? A data-driven modeling study – Lu et al, Computer Methods in Biomechanics and Biomedical Engineering College campuses are at risk of becoming COVID-19 superspreaders for their entire county, according to a new vast study which shows the striking danger of the first two weeks of school in particular.
BioSpace
JANUARY 12, 2021
As is typical, the second day of the JP Morgan Annual Healthcare Conference—conducted virtually this year because of the pandemic—had plenty of news from the largest biopharma companies globally.
Pharma Times
JANUARY 12, 2021
CCS1477 has a novel mechanism of action compared to existing treatments
pharmaphorum
JANUARY 12, 2021
European telehealth firm HealthHero has bought MyClinic.ie, a rival based in the Republic of Ireland. Already a major telehealth player in Europe, HealthHero’s services cover 20 million people and 1,000 businesses across Europe. The acquisition means HealthHero has a direct-to-consumer offer in Ireland, where it was previously providing services through insurance companies and through businesses to their employees.
Advertisement
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.
BioPharma Reporter
JANUARY 12, 2021
The European Commission had held discussions with French pharma company, Valneva, with a view to securing up to 60 million doses of its inactivated virus COVID-19 vaccine, VLA2001.
pharmaphorum
JANUARY 12, 2021
Boehringer Ingelheim has signed a strategic collaboration with UK biotech Enara Bio, focused on finding ways to fight cancer using “dark antigens” in a deal worth up to €876 million ($1.07bn). Dark Antigens represent a new class of cancer-associated antigens that derive from the genomic “dark matter” – the portion of the human genome that is normally not expressed as protein.
Scienmag
JANUARY 12, 2021
Credit: MU College of Veterinary Medicine COLUMBIA, Mo. – As a former school nurse in the Columbia Public Schools, Gretchen Carlisle would often interact with students with disabilities who took various medications or had seizures throughout the day. At some schools, the special education teacher would bring in dogs, guinea pigs and fish as a […].
BioPharma Reporter
JANUARY 12, 2021
UK biotech, OXGENE, says its SLIM platform for discovery of antibodies against membrane proteins in their native configuration in mammalian cells could support CAR-T therapeutics.
Advertisement
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
JANUARY 12, 2021
Credit: Bindu Paul and Johns Hopkins Medicine Typically characterized as poisonous, corrosive and smelling of rotten eggs, hydrogen sulfide’s reputation may soon get a face-lift thanks to Johns Hopkins Medicine researchers. In experiments in mice, researchers have shown the foul-smelling gas may help protect aging brain cells against Alzheimer’s disease.
The Pharma Data
JANUARY 12, 2021
– INNATE is a robust Phase 1 study designed to dose escalate quickly and demonstrate proof of concept for JTX-8064 monotherapy and PD-1i combinations – – Tumor-specific expansion cohorts to include PD-(L)1i resistant and sensitive tumors and PD-(L)1i naïve and experienced patients – CAMBRIDGE, Mass., Jan. 13, 2021 (GLOBE NEWSWIRE) — Jounce Therapeutics , Inc.
Scienmag
JANUARY 12, 2021
Development of flexible thermoelectric devices with maximized flexibility and high efficiency; enabling mass production with high yield by automated process, commercialization of self-powered wearable devices Credit: Korea Institute of Science and Technology(KIST) A thermoelectric device is an energy conversion device that utilizes the voltage generated by the temperature difference between both ends of a material; […].
The Pharma Data
JANUARY 12, 2021
Ann Arbor, Michigan–(Newsfile Corp. – January 13, 2021) – Akadeum Life Sciences, today announced that it is participating in Biotech Showcase. Akadeum has achieved a series of recent scientific advancements and commercial successes through strategic collaborations and aggressive applications discovery. Addressing the needs of the ongoing pandemic, newly developed capabilities include nucleic acid extraction from pooled patient samples to improve sensitivity and throughput of ex
Advertisement
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.
Expert insights. Personalized for you.
298 
Let's personalize your content