Bio Pharma Dive
DECEMBER 23, 2021
The decision follows worrisome results in lab studies that indicated omicron can evade both drugs and leaves the U.S. with fewer treatments to respond to the variant's spread.
World of DTC Marketing
DECEMBER 3, 2021
LEAD-IN: Yesterday I had a long talk with someone who has been in the industry for over 25 years. She has decided to leave the pharma industry because she said, “patients have been reduced to numbers on an excel spreadsheet” and “I am tired of trying to get coworkers to see them as people with real needs.” According to my WordPress stats, I have over 100 readers a day.
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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.
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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NY Times
DECEMBER 16, 2021
The ruling said the company’s owners, members of the Sackler family, could not receive protection from civil lawsuits in return for a $4.5 billion contribution.
Outsourcing Pharma
DECEMBER 13, 2021
The pharmaceutical company currently has several promising treatments in development for gastroenterological, dermatological, and cardiological conditions.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
World of DTC Marketing
DECEMBER 22, 2021
With days to go before Christmas, Americans are sick and tired of being sick and tired. Of reworking plans to adapt to the latest virus risks. Of searching for at-home tests and not finding them. Of wondering whether, after two years of avoiding Covid-19, or surviving it, or getting vaccinated and maybe even boosted, Omicron is the variant they inevitably catch.
pharmaphorum
DECEMBER 6, 2021
Pear Therapeutics has completed its merger with blank cheque company Thimble Point Acquisition Corp, claiming a Nasdaq listing and raising $175 million in gross proceeds for the digital health specialist. Pear will make its debut on the exchange today after combining with Thimble Point – a special purpose acquisition company (SPAC) – in a deal that sidestepped the conventional initial public offering (IPO) route and has propelled its valuation to around $1.6 billion.
BioSpace
DECEMBER 9, 2021
?A U.S. Congress subcommittee unanimously approved the ACT for ALS bill in a decision that could soon pour massive funding into the search for treatment for this debilitating and deadly disease.
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, […].
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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 22, 2021
Leqvio, which Novartis acquired for nearly $10 billion two years ago, arrives with high sales expectations. But uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness.
Pharma Times
DECEMBER 9, 2021
In a new report from The Institute of Cancer Research (ICR), data from cancer trials alongside assessments from clinicians and patients aims to provide guidance on how to improve services
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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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.
NY Times
DECEMBER 2, 2021
Spain surpassed others in Europe by avoiding politicized debate about Covid shots. Citizens also largely heeded the health guidance from their leaders.
XTalks
DECEMBER 8, 2021
B.T. Sweet, an Israeli food tech startup, recently unveiled a plant-based, one-to-one drop-in sugar substitute called Cambya. It can replace sugar in a multitude of applications in the chocolate and confectionary space, boasting the same levels of sweetness and body as real sugar. So, what is Cambya and what differentiates it from other sugar substitutes?
Outsourcing Pharma
DECEMBER 7, 2021
According to a leader from Cytoreason, AI isnât necessarily the best or only tool suited to discover new and novel therapiesâit might take a human touch.
Bio Pharma Dive
DECEMBER 20, 2021
As a result of new laboratory data, the biotech company is deemphasizing more complex "multivalent" booster shots in favor of further study of its existing formulation and an omicron-specific version.
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.
Pharma Times
DECEMBER 2, 2021
Researchers have identified in those patients experiencing blood clots after vaccination a subsequent condition referred to as vaccine-induced immune thrombotic thrombocytopenia (VITT).
pharmaphorum
DECEMBER 21, 2021
Sanofi has bolstered its immuno-oncology pipeline with a $1 billion agreement to acquire Amunix Pharma of the US – its fourth bolt-on deal of 2021. South San Francisco-based Amunix specialises in T-cell engager and cytokine-based treatments for solid tumours, and is planning to advance its lead programme AMX-818 – a cell-based therapy which targets HER2-expressing cancers – into the clinic next year.
BioSpace
DECEMBER 8, 2021
Researchers published a study proving that SARS-CoV-2 infects human adipose or fat tissue to multiply and elicit an inflammatory response corresponding with severe COVID-19.
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.
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.
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.
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.
Outsourcing Pharma
DECEMBER 20, 2021
According to an expert from the clinical insights company, prejudice in AI can impact patient outcomes as well as the ability to develop effective treatments.
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.
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
BioSpace
DECEMBER 2, 2021
Researchers from Harvard University and the U.S. Department of Veterans Affairs (VA) found that the Moderna mRNA vaccine was slightly better than the Pfizer-BioNTech vaccine.
BioPharma Reporter
DECEMBER 15, 2021
The Parkinsonâs Progression Markers Initiative, built using Evidation Healthâs research platform, aims to triple enrollment and recruit online participants.
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 7, 2021
Founded and led by Gary Glick, Odyssey Therapeutics has raised $218 million in an initial fundraising round for its cancer and inflammatory disease drug research.
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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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