Bio Pharma Dive
APRIL 4, 2022
The Swiss pharma said its plan to merge multiple business units and cut yearly costs by $1 billion is likely to impact jobs, but declined to specify which roles and how many.
pharmaphorum
APRIL 4, 2022
The National Institutes of Health (NIH) is funding a nationwide study in the US to support research on long-COVID, chronic COVID, or as it’s scientifically known, post-acute sequelae of SARS-CoV-2 (PASC) in children. An estimated 10% to 30% of adults who contract COVID-19 suffer from long COVID. Though speciality departments and independent institutions have opened to study chronic COVID in adults, little research has been done to evaluate the long-term effects of the virus on children.
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Bio Pharma Dive
APRIL 4, 2022
Yescarta, previously cleared only for use in treating late-stage lymphoma, can now be used after initial treatment has failed, a first for the cellular drugs.
BioPharma Reporter
APRIL 4, 2022
The US FDA has approved Yescarta, Kite's CAR-T cell therapy, for initial treatment in adults with large B-cell lymphoma (LBCL) that is refractory to one prior therapy or that relapses within 12 months of first-line chemoimmunotherapy.
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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
APRIL 4, 2022
The large quantity of digitized healthcare data in the U.S. presents an enormous opportunity to shift dramatically how post-marketing safety studies can and should be conducted.
Pharma Times
APRIL 4, 2022
Golden Ticket programme is open to early-stage life sciences companies and biotech start-ups which are focusing on cutting edge therapies
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
APRIL 4, 2022
Last week, Hormel Foods announced a voluntary food recall of 9,353 cases (or about 60,000 jars) of Skippy peanut butter over concerns that a “limited number” could contain stainless steel fragments from an errant piece of manufacturing equipment. The US Food and Drug Administration (FDA) subsequently issued a news release further detailing the recall.
Bio Pharma Dive
APRIL 4, 2022
The FDA has yet to sign off on a third-party packaging and labeling facility that Alnylam planned to help launch its drug, called vutrisiran, meaning an approval decision could come as late as mid-July.
BioPharma Reporter
APRIL 4, 2022
Biogen's Phase 4 trial for Aduhelm â required by the FDA as part of last year's accelerated approval of the Alzheimerâs drug â will start screening patients in May.
Pharma Times
APRIL 4, 2022
Investments will enhance the development of lipid systems manufacturing, while also boosting the development of gene therapies
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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
BioPharma Reporter
APRIL 4, 2022
The first patient has been dosed in the Phase 1/2 clinical trial of OCU400, a modifier gene therapy candidate for the treatment of retinitis pigmentosa (RP) resulting from mutations in the nuclear receptor subfamily 2 group E member 3 (NR2E3) and Rhodopsin (RHO) genes.
Drug Channels
APRIL 4, 2022
Rare Disease Innovation & Partnering Summit. Hybrid Event May 17-19, 2022 | Boston, MA www.informaconnect.com/rare. Don’t miss the Rare Disease Innovation & Partnering Summit, coming up May 17-19, 2022 in Boston, MA. Visit www.informaconnect.com/rare for further details and to register. Drug Channels readers will save 10% off when they use code 22DRCH10 and register prior to April 29, 2022.*.
BioPharma Reporter
APRIL 4, 2022
Vetter and Rentschler Biopharma are looking to boost the awareness and benefits of their strategic CDMO alliance.
pharmaphorum
APRIL 4, 2022
Gilead Sciences’ Kite Pharma has become the first drugmaker to get FDA approval to use a CAR-T therapy after just one earlier systemic therapy, moving the approach up the treatment pathway. The US regulator has cleared Kite’s CD19-targeted CAR-T Yescarta (axicabtagene ciloleucel) for people with large B-cell lymphoma (LBCL) refractory to one earlier therapy, or who have relapsed within 12 moths of first-line chemo-immunotherapy.
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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 Discovery World podcast
APRIL 4, 2022
This is the latest episode of the free DDW podcast, “What does gene-based medicine have to offer?”. It covers two narrated articles written for Volume 22, Issue 3 – Summer 2021 of DDW. The articles are called “Lipidomics in biomedical research: chance and challenges” and “Exploring gene-based medicine’s true potential”. In the first article, Afrisha Anderson, a Product Manager at Merck KGaA, discusses the opportunities and challenges in lipidomics.
pharmaphorum
APRIL 4, 2022
Two years after it was first proposed and a year after it officially launched, the pharma-backed AMR Action Fund has made its first investments in companies trying to tackle the pressing problem of antibiotic resistance. The Fund – set up as a public-private partnership by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) – started life with $1 billion earmarked to support companies trying to develop antibiotics that can be used to replace those that have star
Drug Patent Watch
APRIL 4, 2022
Annual Drug Patent Expirations for ORACEA Oracea is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from two suppliers. There are eleven…. The post New patent expiration for Galderma Labs drug ORACEA appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
APRIL 4, 2022
April 4, 2022 – Zaid Siddiqui has been appointed as AXON’s new Global Healthcare Insights and Strategy Lead, an exciting asset for the healthcare communications agency. Zaid brings a decade of experience in the medical sector, with seven years of experience in medical insights and strategy. Zaid is particularly renowned for discovering compelling and strategic stories within the deluge of data.
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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.
Pharma Marketing Network
APRIL 4, 2022
The American Academy of Dermatology (AAD) held its annual conference last weekend, and it was my privilege to be in attendance. As COVID-19 had put the brakes on the show for the past two years, that same sentiment was shared by most of the attendees and exhibitors this year. Admittedly, attendance was down slightly from previous years, but that just meant shorter lines and extra opportunity to learn at each booth, and I have no doubt that it will exceed its former glory once COVID goes the way
pharmaphorum
APRIL 4, 2022
Multinational insurance company AXA has launched a new €440 million ($500 million) drive to provide private equity investments in healthcare companies that deepens its interest in the life sciences sector. Until now, AXA Investment Managers has been focused more on the delivery end of health care – health centres and private hospitals, for example – but the new strategy is directed at four key areas, including biopharma, vaccines, medical devices and diagnostics companies.
FDA Law Blog
APRIL 4, 2022
With great sadness, we announce that our firm’s co-founder, leader, colleague and friend, Jim Phelps passed away on April 2, 2022, at the age of 83. Jim is survived by Sophia, his wife of 57 years, his three sons and their wives, Evan and Nicola, Morgan and Mijiko, Michael and Kimberley, and 9 grandchildren. Jim established the firm with Paul Hyman and Bob Dormer on March 17, 1980.
pharmaphorum
APRIL 4, 2022
The largest-ever study of genetics in Alzheimer’s disease patients has identified 42 new genes that appear to be linked to the neurodegenerative disorder. The new genes takes the total number associated with Alzheimer’s to 75, opening up new avenues for research of ways to diagnose and treat the conditions, and suggest that immunological dysfunction may have a greater role to play than previously thought.
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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.
The Pharma Data
APRIL 4, 2022
If approved, Actemra/RoActemra would be the first U.S. FDA-approved immunomodulator for the treatment of COVID-19 in hospitalised patients Since the beginning of the pandemic, more than one million people hospitalised with COVID-19 have been treated with Actemra/RoActemra worldwide 1 Actemra/RoActemra is approved for the treatment of COVID-19 in many territories including the European Union Roche has established a comprehensive access approach to improve availability of Actemra/RoActemra around
Outsourcing Pharma
APRIL 4, 2022
Working with numerous partners, DiMe has introduced the 3Ps of Digital Endpoint Value to help inclusion of digital endpoints in drug reimbursement decisions.
The Pharma Data
APRIL 4, 2022
If approved, Dupixent would be the first medicine available in the U.S. indicated to treat eosinophilic esophagitis There are approximately 160,000 patients in the U.S. living with eosinophilic esophagitis who are currently treated, of whom approximately 48,000 have failed multiple treatments. The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) 300 mg weekly to treat adult and pediatric pati
Drug Patent Watch
APRIL 4, 2022
This chart shows the pharmaceutical companies with the most patents in Argentina. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Argentina? appeared first on DrugPatentWatch - Make Better Decisions.
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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.
The Pharma Data
APRIL 4, 2022
Thrive for Change winning projects include work to eliminate food waste in Bolivia, put vegetable production tools into the hands of African farmers and use microalgae to eliminate nutrient pollution in the world’s water / Winners are delegates from Bayer’s Youth Ag Summit and YAS University / Awardees will receive a €5,000 bursary to execute their impact projects ein Stipendium in Höhe von 5.000 Euro für die Durchführung ihrer Projekte.
pharmaphorum
APRIL 4, 2022
Novartis chief executive Vas Narasimhan, already eyeing a possible divestment of generics business Sandoz, has now turned his attention to the rest of the company. The Swiss group will see major changes to its organisational structure, including the merger of its pharmaceuticals and oncology businesses into a single unit known as innovative medicines (IM) with separate US and international commercial operations, according to this morning’s announcement.
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