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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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.
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.
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.
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.
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.
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
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.
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.
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
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.
Advertisement
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
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.
Pharmaceutical Technology
JUNE 6, 2023
Bezuclastinibis under clinical development by Cogent Biosciences and currently in Phase II for Systemic Mastocytosis.
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
PRT-811is under clinical development by Prelude Therapeutics and currently in Phase I for CNS Lymphoma.
Advertisement
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.
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
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
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.
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).
Advertisement
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.
Outsourcing Pharma
JUNE 6, 2023
Research has reinforced the efficacy of Lumakras (sotorasib), a small molecule inhibitor in advanced non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC).
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).
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.
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).
Advertisement
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.
ProRelix Research
JUNE 6, 2023
Being the second most populous country in the world with skilled labor and good infrastructure, India is a favorable destination for clinical trials for a wide variety of diseases. However, […] The post Changes to CDSCO’s Rules for Clinical Trials in India: New Drugs & Clinical Trial Rules 2019 appeared first on ProRelix Research.
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.
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.
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.
Advertisement
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.
Expert insights. Personalized for you.
279 
Let's personalize your content