Fierce Pharma
MAY 30, 2023
Alnylam sticks with aggressive litigation strategy against Pfizer and Moderna, filing yet another patent lawsuit zbecker Tue, 05/30/2023 - 10:24
Pharmaceutical Technology
MAY 30, 2023
SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. SKYCovion is intended for the prevention of Covid-19 resulting from SARS-CoV-2 infection in individuals aged 18 years and above. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.
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Fierce Pharma
MAY 30, 2023
Lexicon finally scores FDA nod for heart failure drug Inpefa kdunleavy Tue, 05/30/2023 - 05:46
Pharmaceutical Technology
MAY 30, 2023
According to GlobalData’s Looking Ahead to 2023 – the Future of Pharma report, five drugs set for approval in 2023 are projected to attain blockbuster status or near-blockbuster status by 2028 with US company dominance. Lecanemab by Eisai Co Ltd, a monoclonal antibody therapy marketed for Alzheimer’s disease, is predicted to achieve the most significant commercial debut.
Fierce Pharma
MAY 30, 2023
Persistent Sun Pharma ready to complete Taro buyout—16 years after initial offer kdunleavy Tue, 05/30/2023 - 09:57
MedCity News
MAY 30, 2023
Employers have a responsibility to support the food as medicine movement and help employees who are food insecure, said Jay Bhatt, managing director of Deloitte Services and managing director of the Center for Health Solutions and Health Equity Institute. He made these comments last week at the MedCity INVEST conference in Chicago.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Referral MD
MAY 30, 2023
Photo by Marek Studzinski on Unsplash The medical billing process can be a tedious, lengthy, and complex one. This can leave healthcare practitioners struggling to stay afloat financially. Can a healthcare practice increase revenue by improving its medical billing process? A reliable medical billing service or software can help reduce backlogs and increase revenue.
Fierce Pharma
MAY 30, 2023
After price cuts, Eli Lilly inks $13.
Pharmaceutical Technology
MAY 30, 2023
Amplo Biotechnology has received a fast track phase I/II STTR grant from the NIH-NIAMS [National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases] for its gene therapy AMP-201. The company will receive substantial funding to advance AAV-ColQ gene therapy. AMP-201 addresses the severe congenital myasthenic syndrome (CMS) caused by collagen Q (ColQ) deficiency.
MedCity News
MAY 30, 2023
In addition to reducing workload, NLP and ambient voice technology can also improve the quality of care that clinicians provide. By analyzing EHRs and other patient data, NLP algorithms can identify potential health risk factors and recommend preventative measures.
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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.
Clarify Health
MAY 30, 2023
Addressing the mental health crisis in the United States is a complex undertaking, due to multiple factors contributing to prevalence and severity of several conditions. Recent findings from the Clarify Health Institute highlight these growing problems and speak to a need for action to combat this crisis. According to its most recent research brief, “The Kids Are Not Alright: Mental Health Utilization Among Children and Young Adults, 2016-2022,” hospital admissions for mental illnes
MedCity News
MAY 30, 2023
Lexicon Pharmaceuticals drug Inpefa is now FDA-approved for heart failure. Inpefa is third in its class, but the biotech says its pill can reach a specific subset of patients, enabling it to stand apart from rival medicines from AstraZeneca and partners Eli Lilly and Boehringer Ingelheim.
Medgadget
MAY 30, 2023
Researchers at MIT have developed smart sutures with a hydrogel coating that contains sensing and drug delivery components, and could even be used to implant therapeutic cells. The sutures are made using pig tissues that have been decellularized with detergents to reduce the possibility that they could provoke an immune reaction. The surrounding hydrogel layer contains microparticles that can release peptides when enzymes involved in inflammation are present, and other microparticles that allow
MedCity News
MAY 30, 2023
A group of federal agencies recently released an updated set of guidelines to help healthcare organizations protect themselves from ransomware attacks and the data breaches that often follow. The guidance lays out best practices to prevent the six major ways that bad actors gain access to providers’ systems, which include compromised credentials and phishing.
Medgadget
MAY 30, 2023
Researchers at UMass Chan Medical School have developed a small interfering RNA (siRNA) technology that is stable enough for inhalation into the lungs, where it can potentially treat diseases as diverse as asthma, pulmonary fibrosis, and viral infections such as COVID-19. siRNA is not typically stable enough to survive for long in the lungs, but the researchers chemically modified the constituent nucleotides to stabilize the molecules and help them to evade immune destruction.
MedCity News
MAY 30, 2023
Marstacimab, a Pfizer drug for both hemophilia A and B, met the main goal of a Phase 3 study and the company now plans to discuss the data with regulators. The Pfizer drug could beat to the market a Novo Nordisk drug that addresses the same novel target.
PharmaTimes
MAY 30, 2023
The drug has already been approved for this indication in the EU, with regulatory reviews continuing elsewhere including in the US
MedCity News
MAY 30, 2023
Global funding for digital health companies finally stabilized in Q1 of this year. The sector raised $3.4 billion — this marks the first time the digital health world didn’t experience a quarter-over-quarter funding decline since Q4 of 2021. By holding steady, digital health startups defied the dwindling fundraising totals seen across the broader venture capital landscape, where funding dropped by 13% quarter-over-quarter.
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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.
MedReps
MAY 30, 2023
In order for teams to work together more effectively, each person involved needs to have respect for the others in the group. This is true in many different settings, including those who work in medical sales. For a medical sales team to become a high-performing one, they first need to make sure there’s a long-standing tradition of psychological safety involved for everyone in the group.
MedCity News
MAY 30, 2023
Carrum Health’s $45 million funding round was led by OMERS Growth Equity and included participation from Revelation Partners, Tiger Global, Wildcat Venture Partners, Cross Creek and SpringRock Ventures. It brings the company’s total financing to about $96 million.
PharmaTimes
MAY 30, 2023
The EMA's human medicines committee concluded that the benefits of Adakveo did not outweigh its risks
Clarivate
MAY 30, 2023
As the business value of intellectual property (IP) continues to grow, the need to manage IP as a strategic asset is greater than ever. As of 2018, intangible assets accounted for 84% of market capitalization for S&P 500 companies , compared to just 12% four decades ago. While 95% of senior corporate decision makers believe these intangible assets predict future strength , many organizations still fall short in their strategic IP management.
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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
PharmaTech
MAY 30, 2023
The $87.5 million purchase grants Novartis rights to an investigational gene therapy program intended for treatment of cystinosis.
PharmExec
MAY 30, 2023
Inpefa to support multiple cardiovascular issues.
Spotio
MAY 30, 2023
The solar industry continues to grow, as does the competition to acquire new customers. Of course, the only way to acquire new customers is to first generate quality solar leads. It’s not always easy, but it’s far from impossible. We’re about to teach you exactly how to get solar leads for your business in 2023 using 12 proven strategies.
Legacy MEDSearch
MAY 30, 2023
THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The TMINI system includes a wireless robotic handpiece that assists surgeons in performing total knee replacement. Following a CT based three-dimensional surgical plan, the TMINI robotic handpiece automatically compensates for surgeon hand movement to locate bone pins along precisely
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
Pharmaceutical Technology
MAY 30, 2023
The Italian pharmaceutical company Abiogen Pharma completed an acquisition of a 97.09% stake in the Swiss orphan conditions-focused EffRx Pharmaceuticals on May 29. This deal follows Abiogen’s recent acquisition of the Cologne, Germany-based Altamedics in December 2022. Altamedics specialises in pharmaceutical distribution in hospital settings. The €8 million ($8,559,480) deal was Abiogen’s first move in its global expansion plan and the deal with EffRx is a continuation of this.
Pharma Leaders
MAY 30, 2023
Italy-based Abiogen Pharma has announced the acquisition of a 97.09% stake in Switzerland-based EffRx Pharmaceuticals. Abiogen Pharma’s business spans across many integrated aspects : research and development, manufacturing of pharmaceuticals under its own brand or third-party contracts, and marketing of its own and licensed drugs. Among its target therapeutic areas include bone metabolism, pain treatment, as well as respiratory, metabolic (diabetes) and dermatological disorders.
Pharmaceutical Technology
MAY 30, 2023
Catalent’s (Somerset, NJ, US) CEO has admitted to the company’s “disappointing” and “poor performance” over the past quarter, and dropped expected annual revenue for FY2023 by $450m. The company plans to slash CapEx and other costs to recover and has replaced many of its executives. In an investor call on 19 May, Catalent reduced its annual net revenue forecast by approximately 10% compared to its February predictions.
PharmaTech
MAY 30, 2023
The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.
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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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