Bio Pharma Dive
DECEMBER 14, 2023
According to Apellis executives, reviewers in Europe are skeptical of the benefits of its geographic atrophy medicine, Syfovre, and appear poised to recommend against approval at a meeting next month.
Pharmaceutical Technology
DECEMBER 14, 2023
Acadia received two patent rulings that strengthen Nuplazid’s patent position and protect the drug into 2038.
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Bio Pharma Dive
DECEMBER 14, 2023
Shares climbed by double digits after new evidence led to speculation among analysts that Moderna and partner Merck could seek an approval before completing Phase 3 testing.
Pharmaceutical Technology
DECEMBER 14, 2023
In this article, we’ll explore the patient communication risks that now confront life science organisations and provide insights into how to navigate them effectively.
Bio Pharma Dive
DECEMBER 14, 2023
The deal, struck after Editas was awarded ownership of a key patent for the landmark gene editing technology, could be the first of many like it.
Pharmaceutical Technology
DECEMBER 14, 2023
Abbisko Therapeutics has received fast track designation from the US FDA for pimicotinib to treat tenosynovial giant cell tumour (TGCT).
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
DECEMBER 14, 2023
Amgen has received US FDA priority review for its biologics licence application for tarlatamab to treat advanced small-cell lung cancer.
Fierce Pharma
DECEMBER 14, 2023
Pfizer’s $43 billion acquisition of Seagen is in the books, the company said on Thursda | It’s a done deal. Pfizer’s $43 billion acquisition of Seagen is in the books, as it becomes the largest M&A transaction in the biopharma industry since AbbVie snatched up Allergan for $63 billion in 2019. The buyout of the antibody-drug conjugate specialist has doubled Pfizer’s pipeline to 60 programs.
Pharmaceutical Technology
DECEMBER 14, 2023
The US FDA has granted fast track designation for Kyverna Therapeutics’ CAR T-cell therapy KYV-101 to treat myasthenia gravis (MG).
Pharma Times
DECEMBER 14, 2023
The collaboration aims to develop biomarker-based diagnostics for the condition - News - PharmaTimes
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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
DECEMBER 14, 2023
The payment, which encompasses newly approved Casgevy, is the latest deal in a long line of CRISPR licensing twists and turns.
BioSpace
DECEMBER 14, 2023
The regulator placed the clinical hold on the Chinese biotech’s trio of CAR-T cell therapy candidates after an inspection of its Durham, North Carolina manufacturing facility.
Pharmaceutical Technology
DECEMBER 14, 2023
Experts discussed the potential impacts of climate change on the pharma supply chain and how companies can prepare for them.
XTalks
DECEMBER 14, 2023
In a bold move, Canadian brand Daiya Foods recently unveiled its revamped vegan cheese lineup, showcasing a unique oat cream base and leveraging traditional fermentation methods to enhance dairy-like qualities. This launch comes nine months after Daiya announced a significant investment in fermentation technology. The reimagined cheese collection uses Daiya’s oat cream blend instead of the previous chickpea protein base, marking a significant shift in its product formulation.
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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
DECEMBER 14, 2023
At ISPOR 2023, where GlobalData had the opportunity to share some of our key insights across a variety of subject matters.
BioSpace
DECEMBER 14, 2023
Amid falling COVID-19 revenues, Pfizer continues to invest in antibody-drug conjugates in a deal with Nona Biosciences worth $1 billion as its $43 billion Seagen buy closed on Thursday.
Pharmaceutical Technology
DECEMBER 14, 2023
A Phase II clinical trial treating 160 acute kidney injury patients with MTX652 is expected to be initiated in Q1 2024.
Pharma Times
DECEMBER 14, 2023
The free programme will be offered to those who are affected by the condition - News - PharmaTimes
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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
DECEMBER 14, 2023
Accord Healthcare is a Category Award Winner in four areas in the 2023 Pharmaceutical Technology Excellence Awards
BioSpace
DECEMBER 14, 2023
Despite pricing concerns for bluebird bio’s FDA-approved sickle cell disease gene therapy, the biotech has inked a deal with an unnamed commercial payer “representing approximately 100 million covered lives” in the U.S.
Pharmaceutical Technology
DECEMBER 14, 2023
Novo Nordisk will pay $92.5m in one-time cash payment to Alkermes, and the deal is expected to close in mid-2024.
Outsourcing Pharma
DECEMBER 14, 2023
Celadon Pharmaceuticals has today (December 14) announced its first supply of it pharmaceutical-grade breakthrough cannabis-based medicine.
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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.
BioPharma Reporter
DECEMBER 14, 2023
UK-based Lindus Health and US-based Thirty Madison today (December 14) announced they have completed the enrolment of a trial to assess their personalized dermatology telemedicine platform, Facet.
Outsourcing Pharma
DECEMBER 14, 2023
Mission Therapeutics, a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with a phase 2 trial for its kidney treatment MTX652.
Fierce Pharma
DECEMBER 14, 2023
While existing neuroblastoma treatments can help patients achieve remission, sustaining that remission has proven tricky. But now, patients and doctors have a new oral option. | The U.S. FDA has approved US WorldMeds’ Iwilfin—also known as eflornithine—as a new oral maintenance therapy for high-risk neuroblastoma. The drug, cleared in 192 mg tablets, is indicated to cut the risk of relapse in kids and adults with high-risk neuroblastoma who’ve had at least a partial response to prior treatment.
Outsourcing Pharma
DECEMBER 14, 2023
Patient centric, healthcare data tech company, SEQESTER says it can now deliver real-time and real-world data layering in artificial intelligence (AI) to accelerate drug discovery, thanks to its partnership with Atropos Health.
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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.
Fierce Pharma
DECEMBER 14, 2023
Despite the high list price of Lyfgenia, bluebird has signed a large reimbursement deal for the sickle cell disease (SCD) gene therapy less than a week after its
Outsourcing Pharma
DECEMBER 14, 2023
Mission Therapeutics, a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with a phase 2 trial for its kidney treatment MTX652.
BioSpace
DECEMBER 14, 2023
Despite the lack of a randomized clinical trial to support eflornithine’s efficacy, the regulator approved US WorldMeds’ oral maintenance treatment for high-risk neuroblastoma in adults and children.
Outsourcing Pharma
DECEMBER 14, 2023
A portfolio company created and incubated by Apple Tree Partners (ATP) has raised $52 million in series A funding to enable it to rapidly discover novel small molecule therapeutics.
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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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