Bio Pharma Dive
FEBRUARY 5, 2021
Delays tied to factory inspections had pushed an FDA decision on Breyanzi past a key deadline, allowing Bristol Myers to avoid paying billions of dollars in payouts to investors.
BioPharma Reporter
FEBRUARY 22, 2021
Pfizer and BioNTech have dosed the first participants in a Phase 2/3 study for their COVID-19 vaccine in pregnant women; and plan to trial the vaccine in children later this year.
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BioSpace
FEBRUARY 23, 2021
Pfizer has been accused of bullying governments in Latin America over coronavirus disease 2019 (COVID-19) vaccine negotiations, a recent investigative article revealed.
pharmaphorum
FEBRUARY 4, 2021
A white paper has outlined a pathway that could allow Italy to realise the potential of digital therapeutics (DTx). The official journal of the Smith Kline Foundation, Tendenze Nuove, has published the paper entitled “Digital Therapeutics, an Opportunity for Italy” earlier this month. The book features insights and recommendations from 40 leading experts in the field, who hope that Italy will begin to follow in the footsteps of early adopters of digital therapeutics such as Germany, France and
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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
Pharma Times
FEBRUARY 3, 2021
The data show 100% protection against severe disease, hospitalisation and death, greater vaccine efficacy with an inter-dose interval of 12 weeks or more, and the potential for reduced asymptomatic transmission
Scienmag
FEBRUARY 23, 2021
Western forests may be less able to regenerate following large-scale diebacks Credit: USGS DURHAM, N.C. — Younger, smaller trees that comprise much of North America’s eastern forests have increased their seed production under climate change, but older, larger trees that dominate forests in much of the West have been less responsive, a new Duke University-led […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
FEBRUARY 10, 2021
BioNTech announced this morning it has started the production of mRNA at its new facility in Marburg, Germany: which will become one of the largest mRNA manufacturing sites in Europe.
BioSpace
FEBRUARY 10, 2021
The company’s head of drug development, Samit Hirawat, told analysts in a conference call last week that the decision was about working with the best drugs, particularly in a crowded field like BCMA.
pharmaphorum
FEBRUARY 5, 2021
Over the last year, we’ve noticed that “connectivity” doesn’t always equate to “connected” – and that’s just as true in the realm of clinical trials as it is in our personal lives. Amanda Barrell reports from a panel at the Patients as Partners Europe conference on remote clinical trials. Decentralised trials have been growing in popularity in recent years, and the COVID-19 pandemic has served to accelerate that progress.
XTalks
FEBRUARY 5, 2021
As COVID-19 vaccines continue to be in short supply around the world, pharma giants such as Bayer (Nasdaq: BAYRY ) are stepping up to help fulfill the need. Bayer has agreed to assist in the manufacturing of an mRNA-based coronavirus vaccine, CVnCOV, developed by fellow German biopharma company CureVac (Nasdaq: CVAC ). In early January, Bayer also struck an agreement with the company to support the further development, supply and key territory operations of CureVac’s COVID-19 vaccine candidate.
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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
NY Times
FEBRUARY 3, 2021
The consulting firm has reached the agreement with 47 states because of its advice to drugmakers, including Purdue Pharma, the manufacturer of OxyContin.
Bio Pharma Dive
FEBRUARY 1, 2021
Gritstone Oncology, known for its cancer research, is drawing attention in infectious disease, signing a deal with Gilead two weeks after announcing plans to develop a coronavirus vaccine.
BioPharma Reporter
FEBRUARY 9, 2021
Health officials in Azerbaijan have granted approval for a clinical trial to take place in that country combining Russiaâs Sputnik V vaccine with the Oxford-AstraZeneca COVID-19 shot in adults 18 years and older.
BioSpace
FEBRUARY 14, 2021
A new biotech hotspot could be on the horizon in Oregon thanks to a $500 million gift to the University of Oregon from Nike co-founder Phil Knight, an alumnus of the university.
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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
FEBRUARY 4, 2021
For World Cancer Day, David Long, business unit director of Oncology at MSD UK tells pharmaphorum about the company’s ‘Do It Yourself’ campaign launched in the North East to raise awareness of lung cancer symptoms. As COVID cases surged last year, lung cancer referrals dropped in the UK, causing alarm to the UK Lung Cancer Coalition (UKLCC), an alliance of the UK’s leading lung cancer experts, senior NHS professionals, charities, and healthcare companies.
Outsourcing Pharma
FEBRUARY 4, 2021
The founder of Andaman7âs leukemia diagnosis, and his sonâs experience with bone cancer, have helped inform the firm's tech and patient-centric approach.
NY Times
FEBRUARY 28, 2021
The company’s coming trials will also involve pregnant women and people whose immune systems are compromised.
Bio Pharma Dive
FEBRUARY 18, 2021
For $125 million up front, Lilly secures rights to a drug about to enter mid-stage testing for autoimmune and inflammatory diseases, as well as preclinical assets targeting the central nervous system.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
BioPharma Reporter
FEBRUARY 23, 2021
Real-world data from England shows that the Pfizer/BioNTech vaccine offers 'clear protection from first dose' and may help interrupt transmission; while Scottish data shows the first doses of vaccines led to a substantial fall in hospital admissions.
Pharma Times
FEBRUARY 10, 2021
Trial is sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID)
pharmaphorum
FEBRUARY 19, 2021
Psychedelic medicine biotech MindMed is to acquire digital medicine and therapeutics startup HealthMode for around $32.2 million, which uses artificial intelligence (AI) technology to speed up drug development. The move will also see ex-Pfizer digital medicine executive Dr Daniel Karlin join the MindMed executive team, along with former Google AI guru Bradford Cross.
Drug Patent Watch
FEBRUARY 11, 2021
Are you tired of having to naviagate complicated contracts to access the information you need? Let DrugPatentWatch free you from weeks of negotiating complex contracts and let you focus on…. The post Say ‘NO’ to bad contracts appeared first on DrugPatentWatch - Make Better Decisions.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
BioSpace
FEBRUARY 8, 2021
While the space is just beginning to emerge, therapies for long-haul COVID-19 patients are still very much an unmet need.
Bio Pharma Dive
FEBRUARY 24, 2021
Agency scientists noted the shot's strong protection against severe COVID-19, even for the virus variant first detected in South Africa and known to weaken vaccine potency.
BioPharma Reporter
FEBRUARY 8, 2021
CureVac aims to bring together expertise from both its own company and other stakeholders to provide âbroader and faster protection against current and future viral threatsâ: through collaborations with the UK Government, Bayer and GSK all announced this month.
Pharma Times
FEBRUARY 8, 2021
Jazz will add GW's plant-derived cannabinoid treatment Epidiolex to its roster
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
pharmaphorum
FEBRUARY 10, 2021
Improving the Safety, Efficacy & Predictability of Monotherapy & Combinatorial Therapies to Fast-track the Discovery & Development of TNBC Treatments to Reach Patients in Need. This is the primary industry platform specifically dedicated to providing you insight into the latest developments of safe and efficacious blockbuster therapies to treat triple negative breast cancer.
Clinical Trial Podcast
FEBRUARY 23, 2021
Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”. That’s when this post comes handy. Clinical Research is sometimes also referred to as Medical Affairs or Clinical Affairs.
BioSpace
FEBRUARY 7, 2021
South Africa has delayed the distribution of the AstraZeneca-University of Oxford COVID-19 vaccine after data suggested it “provides minimal protection” against mild disease from the South African variant.
Bio Pharma Dive
FEBRUARY 27, 2021
The agency's emergency clearance makes J&J's vaccine the third available in the U.S., adding much-needed reinforcements at a critical time.
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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.
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