Bio Pharma Dive
MARCH 10, 2022
Arena Pharmaceuticals expects its $7 billion sale to Pfizer to close Friday, ending a slightly protracted regulatory review that raised questions about whether the deal would be cleared as anticipated.
World of DTC Marketing
MARCH 10, 2022
AbbVie’s wall of patents protecting its top-selling drug Humira will keep another would-be competitor from entering the U.S. market until next year, with the pharmaceutical company announcing Tuesday a settlement with the Iceland-based Alvotech. Sales of Humira earned AbbVie $20.7 billion last year, the highest total for any pharmaceutical product and they will do anything to keep that money.
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Bio Pharma Dive
MARCH 10, 2022
In an unusual arrangement, the Swiss pharma will make Carisma Therapeutics' experimental cell therapy at its Morris Plains factory, part of its plans to build up a CMO business.
BioPharma Reporter
MARCH 10, 2022
Vibalogics, which was recently acquired by Swedish company, Recipharm, says the completion of its expansion project at its facility in Germany boosts capacity and further enhances its flexibility, minimizing time to clinic for customers.
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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 10, 2022
"We've proven that foundation and now it's time to run and scale," said CEO Eddie Martucci. The company is going public through a $1 billion SPAC, rather than a traditional IPO.
pharmaphorum
MARCH 10, 2022
Mallinckrodt’s liability problems in the US have been lightened slightly, after it agreed a $260 million deal to resolve allegations of Medicare rebate fraud and payment of illegal kickbacks. The Ireland-domiciled company was accused of illegally paying smaller drug rebates to Medicaid than were due, as well as using a charitable foundation to cover co-pays for its Acthar Gel (corticotropin) epilepsy treatment – which is not allowed under US law.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
MARCH 10, 2022
18 months after signing its first partnering deal with Genentech, Scenic Biotech has raised $31 million in first-round financing that it will use to take its own genetic modifier-targeted medicines into clinical trials. The Netherlands-based biotech, which is putting together a pipeline of genetic modifier drugs for cancer and rare diseases, said the new funding would also allow it to double its headcount to add clinical capabilities and move to a larger facility.
XTalks
MARCH 10, 2022
Johnson & Johnson’s baby powder woes do not look like they will be ending any time soon as newly unsealed court documents, first reported by Bloomberg , reveal that the company funded human experiments in 1971 that involved injecting almost a dozen prisoners in a Pennsylvania jail with asbestos. In one study, the investigators wanted to evaluate the possible cancer-causing effects of asbestos versus talc, one of the main ingredients in the baby powder, on the skin of the prisoners.
pharmaphorum
MARCH 10, 2022
In little over three decades, advances in biotechnology have noticeably disrupted the development landscape of small molecule drugs. Yet, despite the immense potential of the field, biologics have remained largely untapped. Now, amid a wave of innovation, investors and drugmakers are putting their weight behind the drug class. “Biologics have revolutionised treatments for several serious diseases, some of which had no therapeutic alternatives until now,” says Antonio Magnelli, head of the Chiesi
XTalks
MARCH 10, 2022
In the last decade, next generation sequencing (NGS) has gone from being solely a research tool to becoming routinely applied in many fields, including food safety testing. While legacy food safety testing methods — such binary pathogen detection tests — can be useful, companies can no longer rely on them alone. Xtalks spoke to Sasan Amini, founder and CEO of Clear Labs, to find out more about the evolving food safety standards. .
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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
Pharma Times
MARCH 10, 2022
Certain areas in the UK have been experiencing a significant increase in COVID-19 cases in recent days
Scienmag
MARCH 10, 2022
One of the fundamental questions in biology, and a centuries-old academic debate, is: How do new species form? And, how do species end up on mountaintops several kilometers high? Indeed, 85% of the world’s vertebrates – birds included – live in mountainous areas where lowland habitats isolate animal species and populations from one another. Credit: […].
pharmaphorum
MARCH 10, 2022
Is open, responsible research the key to translating quality science into clinical benefit as quickly as possible? We ask the AMRC’s new CEO, Nicola Perrin. Accelerating access to life changing treatments is every medical research charity’s aim – and open, responsible research is the key to doing just that. Nicola Perrin, the new CEO of AMRC, which is currently working to strengthen its focus on responsible funding, told pharmaphorum that supporting the charity sector to conduct better research
Scienmag
MARCH 10, 2022
For the first time, an international group of experts has issued recommendations to doctors about how to distinguish between true side effects caused by statins that have been prescribed in order to lower cholesterol levels and side effects arising due to patients’ expectations that they will occur. Credit: Please credit European Heart Journal and Journal […].
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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.
Drug Patent Watch
MARCH 10, 2022
DrugPatentWatch developed this course to help users better understand the complexities and common strategies around brand erosion and generic entry. The positive responses received made it apparent that the course…. The post Free Online Course on Drug Patents, Generic and Branded Drugs appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
MARCH 10, 2022
CHAMPAIGN, Ill. — A new study finds that some people routinely monitor the behavior of others and are eager to punish those who violate laws or societal norms, especially when they believe authorities have failed to do so. These self-appointed enforcers eagerly embrace the job of keeping order, aren’t particularly concerned about accidentally punishing innocent […].
pharmaphorum
MARCH 10, 2022
Bayer has filed for approval to extend the use of its prostate cancer therapy Nubeqa as it tries to achieve labelling parity with rival drugs from Pfizer/Astellas and Johnson & Jonson, and fulfil its aim of €3 billion in peak sales for the drug. Nubeqa is already making headway in the market as a treatment for non-metastatic, castration resistant prostate cancer (nmCRPC), with sales of €219 million last year, but will need to expand into new forms of the disease if it is to meet its commerc
Scienmag
MARCH 10, 2022
The breakthrough came on molecular biologist Christopher Garcia’s birthday. Credit: Eric Smith/Chris Garcia/Howard Hughes Medical Institute The breakthrough came on molecular biologist Christopher Garcia’s birthday. For more than 20 years, his team and others around the world had been chasing an elusive quarry – the 3D structure of a crucial signaling protein in cells.
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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.
Pharma Times
MARCH 10, 2022
The government’s planned ‘Road to Recovery’ will have a new focus on prevention
Scienmag
MARCH 10, 2022
Eye infections are common in rural farming communities. A scratch on the cornea caused during agricultural work can get infected and turn into a scar, then an ulcer. These corneal ulcers cause blindness and visual impairment in 4.3 million people worldwide every year, according to data published by The Lancet Global Health. Credit: Kris Hanning […].
Drug Patent Watch
MARCH 10, 2022
Annual Drug Patent Expirations for JORNAY+PM Jornay Pm is a drug marketed by Ironshore Pharms and is included in one NDA. There are thirteen patents protecting this drug. JORNAY PM…. The post New patent for Ironshore Pharms drug JORNAY PM appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
MARCH 10, 2022
Researchers from Brock University and McGill University published a new paper in the Journal of Marketing that shows how marketers can leverage strategic thinking to create advertising that increases sales and ultimately “moves the needle” in changing customer perceptions. The study, forthcoming in the Journal of Marketing, is titled “The Impact of Advertising Creative Strategy on Advertising Elasticity” and is authored by […].
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
Drug Patent Watch
MARCH 10, 2022
Annual Drug Patent Expirations for GILOTRIF Gilotrif is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are five patents…. The post New patent for Boehringer Ingelheim drug GILOTRIF appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
MARCH 10, 2022
Scientists have developed a powerful, inclusive new tool for genomic research that boosts efforts to develop more precise treatments for many diseases by leveraging a better representation of the genetic diversity of people around the world. Credit: Dan Addison | UVA Communications Scientists have developed a powerful, inclusive new tool for genomic research that boosts […].
Intouch Solutions
MARCH 10, 2022
Last fall, following Mark Zuckerberg’s announcement that “Meta” would now be the name of the company formerly known as Facebook, a group of Intouch experts asked, “What will make up the metaverse?” and further, “How does this impact marketers and their customers?” At the time, our experts noted that the question isn’t easy to answer yet, because the metaverse is still being created, and it will be unique for everyone. “According to Zuckerberg
Scienmag
MARCH 10, 2022
The consequences of crossing a tipping point might often be much more subtle and less severe than generally assumed. That is the conclusion of a mathematical analysis of tipping in large, spatially heterogeneous systems, which natural systems like ice sheets, lakes, and forests often are. The study by dr. Robbin Bastiaansen et al. from Utrecht […].
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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.
XTalks
MARCH 10, 2022
Each year, International Women’s Day falls on March 8 to celebrate the social, cultural, economic and political success of women. In this episode of the Xtalks Food Podcast, Sydney highlights six women-owned-and-operated food brands. From gluten-free beer and allergen-free beef jerky, to sustainably packaged healthy snacks and a better-for-you breakfast cereal, women-owned food brands have managed to fill a niche in the food industry to bring all sorts of unique, high-quality food products into
Scienmag
MARCH 10, 2022
A clinical trial at UC Davis Health and six other sites showed that a cellular therapy offers promise for patients with late-stage Duchenne muscular dystrophy (DMD), a rare genetic disorder causing muscle loss and physical impairments in young people. Credit: UC Regents A clinical trial at UC Davis Health and six other sites showed that […].
pharmaphorum
MARCH 10, 2022
Advance Combination Therapies, Outline Clinical Endpoints & Understand the Immunology Perspective to Achieve Functional Cures for Chronic Hepatitis B. With a tight lens on late translational through to phase II clinical progress; the 2nd Chronic HBV Drug Development Summit is dedicated to advancing direct antiviral and immunotherapy pipelines in combination therapy paradigms.
Scienmag
MARCH 10, 2022
TUCSON, Ariz., March 10, 2022 — Critical Path Institute (C-Path) and Tufts Medical Center have announced a collaboration to transfer electronic healthcare records (EHR) data to C-Path as part of the real-world data (RWD) effort to generate actionable real-world evidence (RWE) for neonatal drug development. This initiative, funded by a grant from the U.S.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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