Bio Pharma Dive
JANUARY 5, 2021
By March, the FDA expects to conclude reviews of key drugs for heart failure, Duchenne's and multiple myeloma, as well as decide on whether to clear Biogen's controversial Alzheimer's treatment.
World of DTC Marketing
JANUARY 4, 2021
KEY TAKEAWAY: Consumer behavior has changed due to the pandemic, and DTC marketers should be aware of how consumers will evaluate and choose prescription drugs. Many organizations have postponed market research due to the pandemic but knowledgeable DTC marketers should be aware of the progressive trends in healthcare. Here’s my list: 1ne: DTC should focus more on providing health information about advertised medications and less on “selling.” The overwhelming majority of consum
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
BioPharma Reporter
JANUARY 7, 2021
The World Health Organizationâs vaccine advisory group recommends the two doses of the Pfizer/BioNTech vaccine should be delivered 21 to 28 days apart: although it adds that the maximum time period between doses could be up to six weeks in some situations.
pharmaphorum
JANUARY 7, 2021
The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules. With the UK reeling from one of the worst outbreaks of the disease, it’s a worrying situation for one of the countries worst hit by the pandemic that is relying on vaccines to bring the virus under control.
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
Bio Pharma Dive
JANUARY 4, 2021
With no decision from the FDA on approval of an experimental cancer cell therapy, an agreement by Bristol Myers to pay out more money as part of its Celgene acquisition fell apart.
World of DTC Marketing
JANUARY 8, 2021
SUMMARY: Pfizer and Moderna will sell $28 billion of Covid-19 vaccines this year. Pharma companies will make an estimated $40 billion on the global COVID-19 vaccine market this year, which will be split between Johnson & Johnson, AstraZeneca, Novavax, and others. Wall Street has been speculating for a long time on which pharma company is going to make the most from the development of a Covid-19 vaccine.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JANUARY 8, 2021
The Pfizer/BioNTech vaccine appears to work against an important mutation in the new coronavirus variants causing havoc in the UK and South Africa, according to research from the drugs giant. Findings of the lab study posted online have not yet been peer reviewed but provide some reassurance for countries like the UK, which are relying on vaccines to bring the pandemic under control.
Bio Pharma Dive
JANUARY 5, 2021
Founded by industry veteran Arie Belldegrun's venture capital firm, IconOVir Bio raised $77 million to push its lead drug — derived from the common cold — into clinical testing.
World of DTC Marketing
JANUARY 7, 2021
MINUTE READ: Big pharma should take a good, hard look at small biotech companies and try to better understand how they succeed and are able to make strategic decisions faster without multi-levels of bureaucracy. This week a person with whom I have the highest level of respect because of her emotional and marketing intelligence landed a position with a small biotech company as Global Marketing Director.
BioSpace
JANUARY 5, 2021
BioSpace is proud to present its NextGen Bio “Class of 2021,” a list of up-and-coming life sciences companies in North America that recently launched.
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
pharmaphorum
JANUARY 6, 2021
Louis van de Wiel, Vice President, Site Head EU Manufacturing, Kite, a Gilead Company, reveals the complexity that sits behind the process of individualised cell therapy – and why team culture makes it work. This thought leadership series has been paid and developed by Kite, a Gilead Company. In 2018, we were preparing to build a European facility to produce individualised cell therapies for the treatment of cancer.
Bio Pharma Dive
JANUARY 8, 2021
With additional financing, Celularity will have $372 million to back development of experimental off-the-shelf treatments for cancer and autoimmune diseases.
BioPharma Reporter
JANUARY 6, 2021
AstraZeneca officially announced today the Serum Institute of India, had obtained emergency use authorization in India for its COVID-19 vaccine. It also confirmed the vaccine has been granted emergency use authorization in Argentina, Dominican Republic, El Salvador, Mexico and Morocco.
BioSpace
JANUARY 3, 2021
As the sun rose on a new year, approximately 70 companies raised the price of hundreds of prescription drugs by an average of 3.3%.
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.
pharmaphorum
JANUARY 6, 2021
Pharma companies are always talking about moving ‘beyond the pill’, and Pfizer’s new brand identity embodies that – it’s decades old pill-like logo has been replaced with a DNA double helix that it says reflects its commitment to breakthrough science. The logo – which retains the company’s traditional blue colour scheme – has been more than 18 months in the making and according to the company it is “unlocking the pill to reveal Pfizer’s DNA: the power of science.”.
Bio Pharma Dive
JANUARY 7, 2021
Company executives, however, blamed "improbably bad luck" for study enrollment that resulted in more older patients with milder disease receiving placebo, and pledged to press on.
BioPharma Reporter
JANUARY 5, 2021
The US FDA has emphasized it will not make any changes to the recommended dosing of authorized COVID-19 vaccines: saying any modifications would create a âsignificant riskâ of undermining vaccination efforts.
BioSpace
JANUARY 3, 2021
As Operation Warp Speed struggles to ramp up vaccinations, one of the approaches under consideration is cutting the doses of the Moderna vaccine.
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.
Scienmag
JANUARY 4, 2021
Welcome to the World of Hyperautomation Credit: World Scientific Two centuries ago, the Industrial Revolution began to automate “blue-collar” work, allowing higher profits and wider societal improvements like the reduction of famine and the increase in living standards. Today, Intelligent Automation has the ability to automate “white-collar” work, also called office work, in a shift […].
Bio Pharma Dive
JANUARY 6, 2021
Partnering with German biotech ViGeneron bolsters Biogen's pipeline of drugs for eye diseases, which includes assets acquired through its buyout of Nightstar Therapeutics.
pharmaphorum
JANUARY 7, 2021
Gilead Sciences’ Kite unit has teamed up with the UK’s Oxford BioTherapeutics (OBT) to develop a new clutch of cell therapy products for solid tumours and blood cancers. The partnership covers up to five oncology targets identified by OBT using its discovery platform, and the UK firm will try to develop antibodies against them. Kite and Gilead will then develop and commercialise therapies based on these targets or antibodies.
BioSpace
JANUARY 3, 2021
This news, published in the American Journal of Human Genetics, enables researchers to develop early screening methods before the most serious symptoms arise, and thus intervene.
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.
XTalks
JANUARY 6, 2021
Researchers at the National Institutes of Health (NIH) in the US have isolated small antibodies called “nanobodies” from a llama named Cormac that can block the SARS-CoV-2 coronavirus. One nanobody in particular, called NIH-CoVnb-112, was shown to be able to prevent COVID-19 infection from the novel coronavirus by targeting both the spike protein on SARS-CoV-2, as well as the angiotensin converting enzyme 2 (ACE2) receptor that it binds to on human cells.
Bio Pharma Dive
JANUARY 7, 2021
The first patient enrolled in a Phase 3 trial of Pfizer's treatment was given the experimental one-time therapy on Dec. 29.
pharmaphorum
JANUARY 8, 2021
How can pharma improve the patient-centricity of its trials during COVID-19 and beyond? Experts from across the sector give their thoughts on the key approaches and technologies that are driving patient engagement forward. With COVID-19 presenting new barriers to running and recruiting for clinical trials, making studies patient-centric is more important now than ever before.
BioSpace
JANUARY 5, 2021
SARS-CoV-2 has mutated into several strains. Most of them are not particularly different than the primary strains, but two, B.1.1.7, which was first observed in the U.K., and now 501.V2, which originated in South Africa, have virologists watching closely.
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.
Pharma Times
JANUARY 4, 2021
KRAS mutations are found in several hard-to-treat cancers
Bio Pharma Dive
JANUARY 8, 2021
Gene therapy developers will need to address a series of setbacks that have shaded optimism in the sector's fast growth.
pharmaphorum
JANUARY 8, 2021
Six months after rebranding from BHE, Panalgo has won a contract to supply the European Medicines Agency (EMA) with its IHD data analytics platform, pledging to streamline its public health efforts. IHD – or Instant Health Data – will be used by the EMA to carry out data analyses and examine medicinal product utilisation, answer questions about safety and efficacy, and understand how treatments perform in real-world settings, said the Boston, US-based company.
BioSpace
JANUARY 3, 2021
It’s not particularly surprising that there wasn’t a lot of clinical trial news between Christmas and New Year’s, although there was some. Here’s a look.
Advertisement
Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
Expert insights. Personalized for you.
359 
Let's personalize your content