Bio Pharma Dive
JULY 24, 2023
Treatment with magrolimab proved ineffective in a Phase 3 study in myelodysplastic syndrome, adding to doubts about so-called CD47 inhibitors as well as Gilead’s deal strategy.
Pharmaceutical Technology
JULY 24, 2023
Verrica has received approval from the US FDA for its YCANTH to treat molluscum in adult and paediatric patients aged two years and above.
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Bio Pharma Dive
JULY 24, 2023
The Swiss pharma company is the latest large drugmaker to invest big in an experimental heart treatment, after years of prioritizing medicines for cancer and immune diseases.
Pharmaceutical Technology
JULY 24, 2023
Shares in the company dropped by 29% despite assurances the failure would not harm its 2023 financial outlook.
Bio Pharma Dive
JULY 24, 2023
The shot failed to meet a key goal of Bavarian Nordic’s Phase 3 study, a finding that separates it from marketed vaccines developed by Pfizer and GSK.
Pharmaceutical Technology
JULY 24, 2023
In the Middle East and Africa pharmaceutical industry, there were 4 private equity deals announced in Q2 2023, worth a total value of $49.6m, according to GlobalData's Deals Database.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 24, 2023
In the Middle East and Africa pharmaceutical industry, there were 4 private equity deals announced in Q2 2023, worth a total value of $49.6m, according to GlobalData's Deals Database.
Bio Pharma Dive
JULY 24, 2023
Outsourcing in the cell and gene therapy industry is booming and no longer considered just a “trend.
Pharmaceutical Technology
JULY 24, 2023
Artificial intelligence (AI) has the potential to expedite the discovery of new drugs. Using AI-powered platforms, biopharma companies can create research processes that are time and cost-efficient.
Bio Pharma Dive
JULY 24, 2023
Despite setbacks with a Humira biosimilar, the partners have expanded an existing alliance, with Teva agreeing to purchase bonds while Alvotech pursues a stock sale.
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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
Pharmaceutical Technology
JULY 24, 2023
RedHill Biopharma has received funds worth $1.7m from the US government to advance the development of opaganib as a medical countermeasure.
Bio Pharma Dive
JULY 24, 2023
The appointment of Linda Burkly follows the exit of CSO Mark Shearman, whose departure Editas announced alongside layoffs earlier this year.
Pharmaceutical Technology
JULY 24, 2023
Research and development into novel sterilisation methods using supercritical fluids is aiding pharmaceutical formulation techniques.
XTalks
JULY 24, 2023
El Niño, a powerful weather event known for causing both flooding and drought, poses significant threats to global food production. In June, scientists announced the arrival of an El Niño this year, anticipating record-breaking heat and precipitation. As the climate crisis intensifies, various crops are under strain, drawing the food industry’s attention to the looming effects of this weather event, which are anticipated to be felt deep into 2024.
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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
Pharmaceutical Technology
JULY 24, 2023
The EMA’s decision marks a further step in the biosimilar’s pathway to potential approval and launch amid an ongoing legal battle.
BioPharma Reporter
JULY 24, 2023
Janssen Pharmaceuticals has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorisation for Talvey (talquetamab).
Pharmaceutical Technology
JULY 24, 2023
Roche has announced a collaboration with Alnylam for the development and marketing of zilebesiran to treat hypertension.
XTalks
JULY 24, 2023
Concordance Healthcare Solutions LLC, one of the largest independent healthcare distributors in the US, has officially launched Surgence, a groundbreaking healthcare supply chain ecosystem. This innovative platform aims to revolutionize the industry by seamlessly connecting providers, distributors and suppliers, providing unprecedented visibility into supply and demand information.
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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.
Pharmaceutical Technology
JULY 24, 2023
When changing from helium to hydrogen as a GC carrier gas, there are several important considerations to bear in mind.
Outsourcing Pharma
JULY 24, 2023
Phesi, a global provider of patient-centric data analytics, has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.
Pharmaceutical Technology
JULY 24, 2023
AbbVie has received a positive opinion from the CHMP of EMA for epcoritamab to treat adults with R/R DLBCL.
BioSpace
JULY 24, 2023
The biotech’s “Fit for Growth” program, which includes the headcount reduction, is expected to generate a net savings of $700 million on operating expenses by 2025.
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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.
Outsourcing Pharma
JULY 24, 2023
Greenphire, provider of clinical trial financial solutions, has released its global 2023 State of Clinical Trial Patient Convenience Market Trends survey.
BioPharma Reporter
JULY 24, 2023
LinKinVax, a clinical-stage biotech company, has announced the manufacture and bottling of a GMP batch of its next generation pan-sarbecovirus vaccines, known as PanCov, designed to prevent COVID-19 and other known coronavirus diseases.
Fierce Pharma
JULY 24, 2023
SK Chemicals of Korea has signed a deal with AstraZeneca to manufacture diabetes drug Sidapvia through the rest of the deca | SK Chemicals of Korea has signed a deal with AstraZeneca to manufacture type 2 diabetes drug Sidapvia through the rest of the decade, according to a regulatory filing. Sidapvia was approved in Korea last month.
Pharma Times
JULY 24, 2023
The treatment is a monotherapy for treating adult patients with refractory or relapsed multiple myeloma - News - PharmaTimes
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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.
BioSpace
JULY 24, 2023
The license and option deal, for an undisclosed amount, seeks to develop potentially first-in-class antibody-drug conjugate candidates against different oncology targets.
Pharma Times
JULY 24, 2023
The drug is an injectable or tablet specifically developed for HIV prevention among certain individuals - News - PharmaTimes
BioSpace
JULY 24, 2023
Following two BLA rejections for its Humira biosimilar, Alvotech is expanding its partnership with Teva Pharmaceuticals, which will enable the latter to have greater involvement with quality and control.
Fierce Pharma
JULY 24, 2023
After Teva’s Alvotech-partnered Humira biosimilar suffered its second FDA rejection, the generics giant is stepping up its role in their long-term collaboration with increased manufacturing involve | After Teva and Alvotech's proposed Humira biosimilar suffered a second FDA rejection because of issues at Alvotech's manufacturing plant, Teva is pledging increased involvement at the plant.
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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.
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