Bio Pharma Dive
MARCH 15, 2022
Stung by a stock market downturn, a number of biotechs are trimming spending and reprioritizing research to save cash. Passage's layoffs will reduce its workforce by 13%.
World of DTC Marketing
MARCH 14, 2022
It’s not only getting harder for small biotechs to find funding; too many have scaled up operations by adding employees too quickly, forcing them to lay off people as the path to new drug approvals gets more complicated. With two of its prized gene therapies on clinical hold, Bluebird, a small biotech company in Cambridge, is going through some hard times.
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Pharma Mirror
MARCH 18, 2022
HONG KONG, Sisram Medical Ltd (the “Company” or “Sisram”, stock code: 1696.HK; together with its subsidiaries referred as the “Group”), a global consumer wellness group, featuring a never-before-seen synergistic ecosystem of business building blocks and consumer-focused branding, ranging from medical aesthetics capital equipment, via injectables therapy, aesthetic dentistry, personal care and more, today announced its audited consolidated annual results for th
pharmaphorum
MARCH 17, 2022
The uptake of digital health tools during the pandemic has been enormous due to improved access they provide to healthcare. In this article, Ben Hargreaves asks whether there are gaps in those utilising these solutions and what action is being taken to address this. Digital health has a tremendous capacity to transform the healthcare industry, with the ability to provide easy access to a multitude of services and new types of therapies.
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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
MARCH 16, 2022
Draft recommendations from the agency were generally straightforward, analysts said, although the document emphasized the potential safety risks of gene editing.
World of DTC Marketing
MARCH 16, 2022
The pharma industry’s reputation continues to slip from a pandemic halo-high of 62% in February 2021 to now when fewer than half, just 47%, of people have a favorable view of the industry, according to the Harris Poll’s latest survey. (Source: Endpoints News ) Does anyone believe that pharma cares? Like it or not, the media has had pharma in their crosshair for a long time.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
MARCH 13, 2022
The FDA has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending its lead over pretenders to its PARP inhibitor crown. The new approval is for use in patients with BRCA-mutated, HER2-negative early-stage breast cancer who have already been treated with chemotherapy – either before or after surgery – and are at high risk of the disease coming back.
Bio Pharma Dive
MARCH 14, 2022
Lynparza is the first drug targeting BRCA mutations to be approved for use in early breast cancer, a decision that could lead to more genetic testing.
Pharma Times
MARCH 18, 2022
With the significant increase in entries this year, the competition to name the finalists proved incredibly tough. The International Clinical Researcher judging panel, however, have made their decisions and the finalists have now been announced.
BioPharma Reporter
MARCH 14, 2022
The first participant has been dosed in a Phase 1 clinical trial of HIV trimer mRNA vaccine candidate mRNA-1574.
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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
pharmaphorum
MARCH 14, 2022
AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic rhinosinusitis in people with nasal polyps, after the FDA rejected its marketing application. The US regulator has asked for additional clinical data, according to AZ, which said it remains committed to brining the drug to patients with the inflammatory condition, which results in the growth of nasal polyps in the nose that can sometimes require surgical intervention.
Bio Pharma Dive
MARCH 15, 2022
Rather than fund development of a more convenient version of its blood cancer drug Sarclisa on its own, Sanofi has instead turned to Blackstone, which has fast become one of the sector's more active investors.
Pharma Times
MARCH 15, 2022
COVID-19 has highlighted another significant widespread problem – the mental health pandemic
Outsourcing Pharma
MARCH 14, 2022
The pharma company and academic institution will explore the viability of a psychedelic treatment to help patients suffering from cancer-related distress.
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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.
BioPharma Reporter
MARCH 15, 2022
Sanofi and Blackstone today announced a strategic, risk-sharing collaboration under which funds managed by Blackstone Life Sciences will contribute up to â300m ($329m) to accelerate development for subcutaneous formulation and delivery of anti-CD38 antibody Sarclisa to treat patients with multiple myeloma (MM).
Bio Pharma Dive
MARCH 17, 2022
Biosimilar copies of Humira will arrive in the U.S. beginning early next year, testing both AbbVie and the market potential for knockoff biologic drugs.
Pharma Times
MARCH 17, 2022
The sub-variant combines mutations from both Omicron and Delta
pharmaphorum
MARCH 15, 2022
Japanese pharma Eisai has backed away from its 50:50 profit-sharing arrangement with Biogen for troubled Alzheimer’s therapy Aduhelm, handing over full responsibility to its US counterpart. The changes to the terms of their longstanding collaboration on Aduhelm (aducanumab) means that Eisai’s profit-share converts to a simple royalty rate on revenues from 1 January next year.
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
MARCH 14, 2022
Pfizer Inc says it will maintain its supply of medicines to Russia but it will not initiate new clinical trials in the country, while Bayer is suspending investment projects and new-business development in that market.
Bio Pharma Dive
MARCH 17, 2022
New study data add to evidence that checkpoint inhibitors can slow the return of lung tumors. But the results also leave some doubt over the best way to use the drugs.
Pharma Times
MARCH 14, 2022
In the coming months, an additional vaccine booster will be offered to those over 75, care home residents and to those over 12 who are most vulnerable
pharmaphorum
MARCH 15, 2022
A group of pharma companies and academic groups have joined forces with the Digital Medicine Society (DiMe) to develop standardised, digital clinical measures that can be used in the development of therapies for Alzheimer’s disease and related dementias. According to the consortium – which includes drugmakers Biogen, Eisai, Eli Lilly and Merck & Co – there is a lack of measures that can be used to determine whether new therapies for Alzheimer’s are actually working.
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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.
Scienmag
MARCH 16, 2022
A challenge in materials design is that in both natural and manmade materials, volume sometimes decreases, or increases, with increasing temperature. While there are mechanical explanations for this phenomenon for some specific materials, a general understanding of why this sometimes happens remains lacking. Credit: Elizabeth Flores-Gomez Murray/Jennifer M.
Bio Pharma Dive
MARCH 17, 2022
The biotech claims the lipid nanoparticles used by Pfizer and Moderna for delivery of their coronavirus shots infringe on a key patent it holds.
Pharma Times
MARCH 18, 2022
The hybrid of Delta and Omicron, known as ‘Deltacron’, has been identified in France, Denmark and the Netherlands
pharmaphorum
MARCH 15, 2022
The new normal is already here. Get used to it. The COVID-19 pandemic has radically disrupted traditional medical society conferences in a way that could scarcely have been imagined in 2019. The vast majority of societies were able to transition their planned physical events to virtual formats within remarkably short periods of time, and some delivered impressive attendee experiences.
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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.
XTalks
MARCH 18, 2022
The Anaheim Convention Center in California buzzed with an energy that hadn’t been felt since 2019, when the COVID-19 pandemic would soon end in-person events for the foreseeable future. But Natural Products Expo West 2022, a five-day event highlighting the latest natural and organic food and beverage products, saw more than 2,700 exhibitors nearly fill the 480,000 square-foot venue for the first time in over two years. .
Bio Pharma Dive
MARCH 14, 2022
Positive signs for the experimental treatment could help shore up investor confidence in BridgeBio after the December study failure of a drug for a rare heart condition.
Drug Patent Watch
MARCH 16, 2022
Annual Drug Patent Expirations for XYREM Xyrem is a drug marketed by Jazz Pharms and is included in one NDA. It is available from one supplier. There are seven patents…. The post New patent for Jazz Pharms drug XYREM appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
MARCH 17, 2022
Researchers in Germany are have found a possible link between mild COVID-19 infection and an increased risk of type 2 diabetes, although they caution the signal needs further investigation. The team from Heinrich Heine University in Dusseldorf and healthcare data science company IQVIA identified the possible correlation after analysing health records from 8.8 million patients registered at 1,171 health practices across Germany, including almost 36,000 who had been diagnosed with mild COVID-19.
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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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