Bio Pharma Dive
JUNE 28, 2022
Positive results for the treatment, which was developed by U.K. biotech MeiraGTx, could rebuild expectations after another gene therapy from Biogen failed in the retinal disease.
Pharmaceutical Technology
JUNE 28, 2022
Astellas Pharma and Sutro Biopharma have entered a global, strategic partnership and licencing agreement to discover and develop new immunostimulatory antibody-drug conjugates (iADCs). An iADC merges an antibody with a small molecule compound that elicits immunogenic cell death, and an immune-activating molecule. It can potentially enhance the anti-cancer effect.
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Bio Pharma Dive
JUNE 28, 2022
The pharma licensed rights to two drugs, one of which is in late-stage testing for a rare autoimmune condition, to a new biotech jointly owned by Roivant.
Pharmaceutical Technology
JUNE 28, 2022
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting approval for AstraZeneca and Merck’s (MSD outside the US and Canada) Lynparza (olaparib) as adjuvant therapy for high-risk early breast cancer patients. The treatment is intended for breast cancer patients with germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative who have previously received neoadjuvant or adjuvant chemotherapy.
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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
Bio Pharma Dive
JUNE 28, 2022
The drug, part of Jazz’s $7 billion acquisition of GW Pharmaceuticals, didn’t perform significantly better than placebo in treating the muscle spasticity that’s tied to the disease.
Pharmaceutical Technology
JUNE 28, 2022
Researchers at the Rensselaer Polytechnic Institute in the US have received a five-year, $3.5m grant from the National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) for developing a Covid-19 oral antiviral drug. The antiviral will be a low-dose drug which can be taken in the at-home setting. The latest research is part of the consortium of a new antiviral drug development centre named Center for Antiviral Medicines and Pandemic Preparedness (CAMPP)
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 28, 2022
Mentions of robotics within the filings of companies in the pharmaceutical industry fell 22% between the final quarter of 2021 and the first quarter of 2022. In total, the frequency of sentences related to robotics between April 2021 and March 2022 was as frequent as in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings.
NY Times
JUNE 28, 2022
With Roe v. Wade overturned, states banning abortion are looking to prevent the distribution of abortion medication. Brazil shows the possible consequences.
pharmaphorum
JUNE 28, 2022
Astellas has agreed a $1.36 billion partnership with US biotech Sutro Biopharma for a series of antibody-drug conjugates for cancer, focusing on applications in patients who don’t respond to current immunotherapies. The alliance includes an upfront payment of $90 million, backed by $422.5 million in possible milestone payments apiece for up to three development programmes based on Sutro’s immunostimulatory antibody-drug conjugate (iADC) technology.
BioSpace
JUNE 28, 2022
Jazz's Phase III study on Sativex (JZP378) for people in the United States living with multiple sclerosis failed to achieve the primary endpoint of an improvement in muscle tone.
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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
XTalks
JUNE 28, 2022
Becton, Dickinson and Company (BD), a pioneer in medical technology, has issued a voluntary recall notice for a trio of their intraosseous access products. Intraosseous infusion of a drug is when a drug is administered into the bone marrow cavity which facilitates the delivery of the drug through a non-collapsible vein. The intraosseous infusion concept was created in 1922 by Dr.
BioPharma Reporter
JUNE 28, 2022
The European Commission (EC) has approved Kiteâs CAR T-cell therapy, Yescarta, (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.
FDA Law Blog
JUNE 28, 2022
By John A. Gilbert & Karla L. Palmer — On June 27, 2022, in one of the last opinions issued during its current term, a majority of the U.S. Supreme Court (six justices) issued a noteworthy opinion on criminal liability related to prescribers of controlled substances. This consolidated case has implications not only for prescribers of controlled substances but also for pharmacists and pharmacies who are subject to a “corresponding responsibility” to only fill prescriptions issued for a legiti
BioSpace
JUNE 28, 2022
BioNTech announced it is partnering with Pfizer to begin testing a next-generation universal vaccine against coronaviruses, including SARS-CoV-2, the coronavirus that causes COVID-19.
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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.
Drug Patent Watch
JUNE 28, 2022
Annual Drug Patent Expirations for NOCTIVA Noctiva is a drug marketed by Serenity Pharms Llc and is included in one NDA. There are four patents protecting this drug. Drug patent…. The post New patent for Serenity Pharms drug NOCTIVA appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Commerce
JUNE 28, 2022
Amy Shortman outlines some ways visibility technology is solving problems at a time when it’s needed most, and how digitization is the key to overcoming supply chain crises.
BioSpace
JUNE 28, 2022
Icosavax posted positive topline interim data from its Phase I/Ib trial of IVX-121, its candidate virus-like particle vaccine against the respiratory syncytial virus in young and older adults.
Drug Patent Watch
JUNE 28, 2022
Annual Drug Patent Expirations for AUSTEDO Austedo is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. There are seven…. The post New patent for Teva Branded drug AUSTEDO appeared first on DrugPatentWatch - Make Better Decisions.
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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.
BioSpace
JUNE 28, 2022
Generian and Mitobridge, a wholly-owned subsidiary of Astellas Pharma, announced a collaboration to discover and develop novel small molecules for undruggable therapeutic targets.
Scienmag
JUNE 28, 2022
AMHERST, Mass. — Lauren Andrews, University of Massachusetts Amherst assistant professor and the Marvin and Eva Schlanger Faculty Fellow in the department of chemical engineering, has received a three-year, $1.4 million grant from the National Science Foundation for a collaborative project to engineer synthetic bacteria to neutralize toxic contaminants found in drinking water.
Drug Patent Watch
JUNE 28, 2022
Annual Drug Patent Expirations for WINLEVI Winlevi is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are eight patents…. The post New patent for Sun Pharm drug WINLEVI appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
JUNE 28, 2022
New research by investigators at Columbia University and MIT describes how cancer cells often depend upon the importation of fat for continued growth and division.
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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.
Scienmag
JUNE 28, 2022
Most teachers focus on academic considerations when assigning seats. A new study by Florida Atlantic University psychology researchers is the first to show that these classroom seat assignments also have important implications for children’s friendships. Credit: Florida Atlantic University Most teachers focus on academic considerations when assigning seats.
BioSpace
JUNE 28, 2022
This article offers a template with examples of an effective cover letter for a research scientist job. Let's explore some tips to help you write your own.
Scienmag
JUNE 28, 2022
AMES, IA – Through CRISPR and other gene-editing technologies, researchers and developers are poised to bring dozens – if not hundreds – of new products to grocery stores: mushrooms with longer shelf lives, drought-resistant corn and bananas impervious to a fungus threatening the global supply. A few, including a soybean variety that produces a healthier […].
BioSpace
JUNE 28, 2022
BioSpace spoke with several Black individuals working within the life sciences to get their thoughts on the current representative disconnect and what they believe can be done to fix it.
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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.
Scienmag
JUNE 28, 2022
People who develop an abnormal heart rhythm after surgery have an increased risk of subsequently being admitted to hospital with heart failure, according to a study of over three million patients, which is published in the European Heart Journal [1], today (Wednesday). Credit: Please credit European Heart Journal People who develop an abnormal heart rhythm […].
BioSpace
JUNE 28, 2022
???????Voting 19-2, the Vaccines and Related Biological Products Advisory Committee favored redesigning booster shots to include the coronavirus’ Omicron variant.
Scienmag
JUNE 28, 2022
Researchers at Washington University School of Medicine in St. Louis are leading a national study aimed at identifying patients with early-stage lung cancer who are at high risk of having the cancer return, even after surgery and chemotherapy appear to have eliminated their tumors. The research is supported by a $5.3 million grant from the […].
BioPharma Reporter
JUNE 28, 2022
The pharmaceutical company is expanding its alliance with historically Black medical schools to bolster the battle against systemic health disparities.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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