Pharmaceutical Technology
JUNE 6, 2023
Alkeus Pharmaceuticals has raised $150m in Series B financing to support the registration and launch of gildeuretinol (ALK-001) to treat Stargardt disease, a genetic cause of blindness in children and young adults. Led by Bain Capital Life Sciences, the financing round has also seen participation from Sofinnova Investments, TCGX and Wellington Management.
Bio Pharma Dive
JUNE 6, 2023
Having taken the rare step of filing for approval over protest, Brainstorm will get another chance to make a case for its drug NurOwn during a Sept. 27 meeting of cell, tissue and gene therapy experts.
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Pharmaceutical Technology
JUNE 6, 2023
Oragenics has secured funding from the Canadian bioresearch consortium CQDM to develop a variant-agnostic protein antigen for use in its Covid-19 intranasal vaccine. SynergiQC, the Quebec-based funding programme created by CQDM, has awarded the funding. The project is a partnership with Inspirevax and the National Research Council of Canada (NRC). In March 2023, Oragenics and Inspirevax entered an exclusive global licence deal to develop the former’s lead intranasal Covid-19 vaccine candidate, N
Bio Pharma Dive
JUNE 6, 2023
The biotech has raised about $65 million to test two ways to deliver larger genes into the body, each of which could help gene therapy treat more diseases.
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 6, 2023
A pill has been shown to halve the risk of death from a certain type of lung cancer when taken daily after surgery to remove the tumor, according to clinical trial results presented on Sunday.
Bio Pharma Dive
JUNE 6, 2023
Dramatically positive trial data for AstraZeneca’s Tagrisso capped an important conference for the British drugmaker, while Gilead built a stronger case for its cell therapy Yescarta.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
JUNE 6, 2023
Agency scientists raised no major red flags in their review of the antibody medicine in documents posted ahead of a Thursday meeting of FDA advisers.
Pharmaceutical Technology
JUNE 6, 2023
Chicago, Illinois-based Ellipses Pharma has announced its intention to accelerate the global clinical development of its selective RET inhibitor EP0031/A400. Following the publication of clinical data from its Phase I study of the inhibitor at the American Society of Clinical Oncology (ASCO) conference, Ellipses was motivated to accelerate clinical development due to what it believes are “very encouraging” results.
Bio Pharma Dive
JUNE 6, 2023
The drugmaker’s lawsuit claims the new pricing powers granted by the Inflation Reduction Act are unconstitutional and “tantamount to extortion.
Rethinking Clinical Trials
JUNE 6, 2023
In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting in Bethesda, Maryland, Richard Platt, MD, MS (co-principal investigator) and Shruti Gohil, MD, MPH (lead investigator) of the INSPIRE Demonstration Project , shared the status of the trials, discussed recent lessons learned, described the impact they hope their trials will have on the future of healthcare, and reflected on the impact the NIH Collaboratory has had on their trials thus far.
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
Pharmaceutical Technology
JUNE 6, 2023
The United States Patent and Trademark Office (USPTO) has issued a notice of allowance for Enveric Biosciences’ patent application for the EVM301 series of drug candidates to treat mental health disorders. The patent, which is expected to be issued shortly, will contain composition of matter claims for a family of tryptamine-based drug candidates. This family of new small molecules has been designed to promote neuroplasticity without inducing hallucinations.
Bio Pharma Dive
JUNE 6, 2023
Gurnet Point Capital and Novo Holdings aim to take Paratek private in a deal that highlights the challenges small biotechs face selling new antibiotics.
Pharmaceutical Technology
JUNE 6, 2023
Lotus Pharmaceuticals, NRx Pharmaceuticals and Alvogen have entered a global collaboration deal to develop and commercialise NRX-101 for suicidal treatment-resistant bipolar depression (S-TRBD). Lotus will purchase global rights for NRX-101 and handle the commercialisation activities of the product in markets outside the US. The company will collaborate with Alvogen to commercialise NRX-101 in the US through the Almatica label, the CNS-focused division of Alvogen.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 6, 2023
There is a growing concern about the lack of stringent norms on disposal of unused and expired medicines that pose a threat to health and the environment. The key issue is the lack of dedicated guidelines on the disposal under the Drugs & Cosmetics Act.
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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.
Pharmaceutical Technology
JUNE 6, 2023
American Regent and Daiichi Sankyo have announced that the INJECTAFER (ferric carboxymaltose injection) has received approval from the US Food and Drug Administration (FDA) to treat iron deficiency in adult patients with heart failure. The therapy is indicated to improve exercise capacity in heart failure patients, who are categorised as New York Heart Association class II/III based on the severity of their symptoms.
Fierce Pharma
JUNE 6, 2023
The pharma industry has voiced loud complaints about the Biden administration's Inflation Reduction Act, specifically focusing on a clause that will allow Medicare to negotiate the prices of top-se | The pharma industry has voiced loud complaints about the Biden administration's Inflation Reduction Act, specifically focusing on a clause that will allow Medicare to negotiate the prices of top-selling pharmaceuticals.
Pharmaceutical Technology
JUNE 6, 2023
In a 2022 annual report, the US Food and Drug Administration’s (FDA) Office of Generic Drugs stated it had approved 106 first generics— the introductory generic competitors of branded drugs. This month’s cover story investigates how the regulatory process for these first generics differs from other drugs, and whether the promise of significant cost savings to consumers has been fulfilled.
Fierce Pharma
JUNE 6, 2023
Eisai is the latest drugmaker to be hit with a ransomware attack. | Eisai was the victim of a ransomware attack late Saturday night and is now working on response efforts, including the creation of a company-wide task force.
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.
Pharmaceutical Technology
JUNE 6, 2023
XB-002 is a monoclonal antibody conjugated commercialized by Exelixis, with a leading Phase I program in Esophageal Squamous Cell Carcinoma (ESCC). According to Globaldata, it is involved in 1 clinical trial, which is ongoing. GlobalData uses proprietary data and analytics to provide a complete picture of XB-002’s valuation in its risk-adjusted NPV model (rNPV).
Fierce Pharma
JUNE 6, 2023
Novo Holdings and Gurnet Point have added antibiotics maker Paratek Pharma to their fold in a biopharma M&A deal worth approximately $462 million. | Paratek's key selling point is its antibiotic, Nuzyra, which was expected to garner $500 million in peak sales at the time of its 2018 approval.
Pharmaceutical Technology
JUNE 6, 2023
PF-06835375 is a biologic commercialized by Pfizer, with a leading Phase II program in Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura). According to Globaldata, it is involved in 2 clinical trials, of which 1 was completed, and 1 is ongoing. GlobalData uses proprietary data and analytics to provide a complete picture of PF-06835375’s valuation in its risk-adjusted NPV model (rNPV).
XTalks
JUNE 6, 2023
The digital age has brought us an array of novel concepts, trends and terminologies, adding a fresh zest to our everyday lexicon. One such recent phenomenon making waves on social media is water recipes. This term might initially baffle those unacquainted with the trend, but it’s relatively simple and straightforward. Water recipes refer to a variety of methods to enhance plain water by adding flavorings, typically sugar-free syrups, powdered flavorings or a combination of the two.
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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
JUNE 6, 2023
MRNA-0184 is an oligonucleotide commercialized by Moderna, with a leading Phase I program in Congestive Heart Failure (Heart Failure). According to Globaldata, it is involved in 1 clinical trial, which is ongoing. GlobalData uses proprietary data and analytics to provide a complete picture of MRNA-0184’s valuation in its risk-adjusted NPV model (rNPV).
XTalks
JUNE 6, 2023
Prostate cancer stands as the second leading cause of cancer death among American men. Its early detection enhances the likelihood of survival, and survival is greatly influenced by the type and localization of the cancer. As a result, there is a constant demand for highly specific molecular imaging technologies. Recently, Blue Earth Diagnostics announced that the US Food and Drug Administration (FDA) has granted approval to its novel, high-affinity radiohybrid prostate-specific membrane antigen
Pharmaceutical Technology
JUNE 6, 2023
Ecubectedin is a small molecule commercialized by Pharma Mar, with a leading Phase II program in Hormone Sensitive Breast Cancer. According to Globaldata, it is involved in 5 clinical trials, which are ongoing. GlobalData uses proprietary data and analytics to provide a complete picture of Ecubectedin’s valuation in its risk-adjusted NPV model (rNPV).
Fierce Pharma
JUNE 6, 2023
As GSK and Pfizer look to roll out their adult respiratory syncytial virus (RSV) vaccines later this year, Sanofi and AstraZeneca hope to join them on the market with an antibody designed to protec | As GSK and Pfizer look to roll out their adult RSV vaccines later this year, Sanofi and AstraZeneca hope to join them on the market with an antibody designed to protect infants.
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.
Pharmaceutical Technology
JUNE 6, 2023
The global pharma industry experienced a 21% rise in social media posts on virtual care in Q1 2023 compared with the previous quarter, with the highest share accounted for Bicycle Health, according to GlobalData’s analysis of social media posts. GlobalData’s Telehealth Market Size by Segments, Share, Trends, and Forecast, 2022-2030 report provides key insights into business strategies, trends driving the telehealth market and granular data on market segments forecast up to 2030.
Fierce Pharma
JUNE 6, 2023
Alkermes has bumped | Alkermes has bumped up its revenue forecast for 2023 by $425 million after winning a final award in its arbitration battle with Johnson & Johnson over the licensing of its NanoCrystal technology. The final award came last week from the arbitral tribunal.
Pharmaceutical Technology
JUNE 6, 2023
The global pharma industry experienced an 11% rise in social media posts on regenerative medicine in Q1 2023 compared with the previous quarter, with the highest share accounted for Pfizer, according to GlobalData’s analysis of social media posts. GlobalData’s Regenerative Medicine in Medical thematic intelligence report provides an overview of the current landscape, including healthcare, technology, regulatory, macroeconomic trends, and key players.
Outsourcing Pharma
JUNE 6, 2023
Jim Murphy is Greenphire's CEO and leads the company's strategy and he says he is committed to fostering a culture of growth, innovation, excellence and employee satisfaction. Under his leadership, the company has expanded exponentially - in product depth, client adoption and geographic coverage.
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
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