Bio Pharma Dive
DECEMBER 12, 2021
Study results presented at ASH suggest Gilead's Yescarta and Bristol Myers Squibb's Breyanzi could become replacements for stem cell transplants in treating the blood cancer.
World of DTC Marketing
DECEMBER 17, 2021
The public has been told that pharma needs money to develop new drugs, but unfortunately, that’s a huge lie. As biopharmadive recently, “some of the biggest pharmaceutical companies, sitting on large and growing sums of cash, are funneling those funds into major share buyback programs and acquisitions of smaller biotech companies. On Thursday, Swiss drug-making giant Novartis announced plans to buy back up to $15 billion worth of its shares by end of 2023, a program it will fund wi
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Camargo
DECEMBER 13, 2021
The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. When developing biologics, sponsors must manage several scientific considerations specific to large molecule products, including biochemical characterization studies to confirm structural identity, biological activity studies to confirm potency, and mechanism of action maintenance.
BioPharma Reporter
DECEMBER 13, 2021
Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.
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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 16, 2021
Days after the FDA strengthened safety warnings for the company's shot, a CDC panel recommended Pfizer's and Moderna's vaccines be "preferred" over J&J's.
pharmaphorum
DECEMBER 15, 2021
Words matter. In the pharma industry, “patient engagement” and “patient centricity” might seem like interchangeable bits of corporate jargon. But the difference between them is not like the choice between “agreeing” and “aligning” or “getting together later” and “taking this offline.” Going from the vital activity of patient engagement to the more encompassing state of patient centricity requires big steps in the evolution of new-drug discovery, development, and delivery.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Outsourcing Pharma
DECEMBER 13, 2021
The pharmaceutical company currently has several promising treatments in development for gastroenterological, dermatological, and cardiological conditions.
Bio Pharma Dive
DECEMBER 14, 2021
Fitusiran, which Sanofi licensed from Alnylam, could finally get to market after trial delays and safety concerns slowed its progress. But gene therapies and other new medicines might provide competition.
Scienmag
DECEMBER 15, 2021
Key takeaways: Credit: USC Dornsife/Yekaterina Kadyshevskaya Key takeaways: New technology called “V-SYNTHES” uncovers more effective drug candidates in a fraction of the time other algorithms need. The method screens virtual chemical components that can be “clicked” together to build a drug. Scientists tested V-SYNTHES on the protein receptors affected by the active ingredient in marijuana, […].
pharmaphorum
DECEMBER 13, 2021
UCB has the positive result it was hoping for in its phase 3 trial of anti-neonatal FC receptor (FcRn) antibody rozanolixizumab for autoimmune disease generalised myasthenia gravis (gMG), setting up regulatory filings next year. The MycarinG study met its primary endpoint, demonstrating a “statistically significant and clinically meaningful” improvement from baseline in the myasthenia gravis-activities of daily living (MG-ADL) score, said the Belgian drugmaker.
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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
Outsourcing Pharma
DECEMBER 15, 2021
The artificial intelligence-driven drug discovery company has dosed its first healthy volunteer in a trial for a candidate to treat idiopathic pulmonary fibrosis.
Bio Pharma Dive
DECEMBER 14, 2021
Novartis' CAR-T drug Kymriah didn't appear better than standard of care in earlier lymphoma treatment. Its two similar rivals, Gilead's Yescarta and Bristol Myers' Breyanzi, did, raising questions about potential differences.
BioPharma Reporter
DECEMBER 14, 2021
Moderna and the Australian Government have announced an agreement in principle to build a mRNA vaccine manufacturing facility in Victoria, Australia: providing up to 100 million doses a year.
NY Times
DECEMBER 14, 2021
Two drugmakers have been mired for years in the pre-application phase of getting F.D.A. approval for over-the-counter use.
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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
DECEMBER 17, 2021
The EMA’s human medicines committee has said it cannot approve Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, saying it was unconvinced by the data submitted for the drug. The companies had already indicated that the CHMP looked likely to turn down their marketing application for Aduhelm (aducanumab), but the decision nevertheless is a heavy blow, coming as take-up of the drug has pretty much stalled in the US.
Bio Pharma Dive
DECEMBER 14, 2021
The pharma has expanded an alliance with a German biotech by paying $150 million for a drug candidate that executives hope can have "cell therapy-like efficacy" for solid tumors.
BioPharma Reporter
DECEMBER 15, 2021
The Parkinsonâs Progression Markers Initiative, built using Evidation Healthâs research platform, aims to triple enrollment and recruit online participants.
Pharma Times
DECEMBER 13, 2021
A team at The Institute of Cancer Research (ICR), London and the Clinical Trials Research Unit (CTRU) at the University of Leeds adopted a new high-speed trial methodology.
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.
NY Times
DECEMBER 13, 2021
Some laboratory studies suggest that molnupiravir can insert errors in DNA, which could in theory harm a developing fetus, sperm cells or children.
Bio Pharma Dive
DECEMBER 14, 2021
Full study results show Paxlovid cut the risk of COVID-19 hospitalization or death by about 90% among high-risk adults, matching the interim findings Pfizer disclosed last month.
pharmaphorum
DECEMBER 15, 2021
Incyte could be a few month away from a second FDA approval for its Opzelura cream that would make it the first medical treatment to re-pigment the skin of people with vitiligo. The FDA has kicked off a priority review of Opzelura (ruxolitinib), a JAK1/JAK2 inhibitor it approved to treat atopic dermatitis in September, and aims to decide on the vitiligo indication by 18 April next year.
Pharma Times
DECEMBER 14, 2021
Nivolumab plus ipilmumab has been accepted as a treatment option for adult patients by NHS Scotland for patients who have previously failed fluoropyrimidine-based chemotherapy.
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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.
NY Times
DECEMBER 14, 2021
Vuity, a once-a-day treatment that can help users see up close without affecting their long-range vision, went on the market Thursday after being approved by the F.D.A. in October.
Bio Pharma Dive
DECEMBER 16, 2021
Novartis is using funds gained from the recent sale of its stake in Roche to buy back $15 billion worth of its own shares, while Pfizer is signaling more dealmaking could follow its buyout of Arena.
Scienmag
DECEMBER 14, 2021
For the first time ever, scientists have been able to measure the speed of a bacterium that causes the incurable citrus greening disease. Citrus greening disease (also known as Huanglongbing) is the most devastating citrus disease in the world. Afflicted trees grow yellow leaves and low-quality fruit and eventually stop producing altogether, resulting in enormous […].
Pharma Times
DECEMBER 16, 2021
Venetoclax is an oral once-daily treatment, which blocks the action of the B-cell lymphoma-2 protein, the presence of which helps cancer cells survive.
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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.
BioPharma Reporter
DECEMBER 13, 2021
Moderna released what it deemed to be positive interim data from the phase 1 study of its quadrivalent flu vaccine, mRNA-1010, on Friday. But the markets were left underwhelmed.
Bio Pharma Dive
DECEMBER 16, 2021
The European Medicines Agency is still reviewing Paxlovid but, citing fast increasing cases and deaths from COVID-19, offered flexibility to EU countries which may authorize emergency use.
Pharma Marketing Network
DECEMBER 17, 2021
The pharma industry has been slower to embrace digital technologies than other less-regulated sectors but the COVID-19 pandemic has greatly changed this long-standing mindset. In 2020 and 2021, we saw pharma forced to become more flexible and open-minded than ever before. In this article, R.J. Lewis, Founder & CEO of eHealthcare Solutions and Tap Native, offers his top ten predictions for what’s ahead for pharma in 2022.
XTalks
DECEMBER 13, 2021
The ongoing COVID-19 pandemic, which began in early 2020, has led to irreversible changes in consumer behavior , especially when it comes to their food and beverage purchasing habits. As stay-at-home orders and lockdowns were enforced in many cities and countries around the world, consumers formed new preferences, habits and expectations. Many of those new habits, however, were formed out of necessity rather than choice.
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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.
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