Fri.Aug 20, 2021

article thumbnail

Biden said to rule out Woodcock as permanent FDA chief

Bio Pharma Dive

A published report indicated the agency's longtime drug reviewer is no longer in consideration for the role, leaving the FDA's top job in flux as key decisions near on coronavirus booster shots and vaccinations for children.

article thumbnail

F.D.A. Aims for Full Approval of Pfizer Covid Vaccine on Monday

NY Times

Federal regulators are winding down the process of licensing Pfizer’s two-dose coronavirus vaccine, setting up an approval possibly by Monday and possibly kicking off a wave of new mandates.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

J&J chief Alex Gorsky to step down early next year

Bio Pharma Dive

Citing family health reasons, Gorsky will transition to the role of executive chairman and pass his torch to Joaquin Duato, currently vice chairman of J&J's executive committee.

300
300
article thumbnail

AAIC 2021: Best Practices for Remote Cognitive Assessments for Alzheimer’s Patients During COVID-19

XTalks

The COVID-19 pandemic has had wide-ranging health impacts outside of infection with the coronavirus itself. From remote medical visits and monitoring to adoption of decentralized clinical trials (DCT), both clinical care and research have been significantly impacted by the pandemic. Alzheimer’s and dementia patients are among some of the most vulnerable and high-risk patient populations not only with respect to contracting COVID-19, but also being burdened by adapting to remote health monitoring

article thumbnail

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

article thumbnail

With new Fate data, same promise, questions surround 'natural killer' cell therapy

Bio Pharma Dive

Though early results from two of the biotech's experimental lymphoma treatments have shown promise, it’s unclear whether they can match the potency and durability of T cell therapies.

183
183
article thumbnail

BMS buys into AI-designed immune drug from Exscientia

pharmaphorum

Bristol Myers Squibb has exercised an option on an immune-modulating drug candidate developed by UK artificial intelligence specialist Exscientia, paying $20 million for the buy-in as part of their $1.2 billion alliance. The unnamed drug candidate acts on an immunological kinase enzyme, which has proven hard to target using conventional drug discovery techniques because challenges relating to “potency, selectivity, and overall drug-like properties,” according to the partners.

Drugs 98

More Trending

article thumbnail

AstraZeneca to seek regulatory approval for COVID-19 prevention antibody

BioPharma Reporter

AZD7442, a combination of two long-acting antibodies (LAAB), reduced the risk of developing symptomatic COVID-19 by 77%, according to results from a Phase 3 trial.

article thumbnail

NICE recommends Novartis’ Rydapt for AdvSM treatment

Pharma Times

Treatment provides therapeutic benefits to adults with the disease

129
129
article thumbnail

First monoclonal antibody treatment for COVID-19 approved for use in UK

BioPharma Reporter

The UK health regulator has today given approval for the first monoclonal antibody treatment for the prevention and treatment of COVID-19 in the UK.

article thumbnail

EC nod for Astellas, FibroGen’s roxadustat for chronic kidney disease

Pharma Times

Phase III trial showed the drug achieved and maintained target Hb levels

Trials 123
article thumbnail

Roles and Responsibilities of Specialized Clinical Supply Experts

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.

article thumbnail

After FDA snub, EMA backs FibroGen, Astellas’ roxadustat

pharmaphorum

The EU regulator has approved FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug in the US. The decision makes Evrenzo (roxadustat) the first oral HIF-PH inhibitor to be cleared for use in the EU, ahead of rival candidates daprodustat from GlaxoSmithKline and Akebia Therapeutics’ vadadustat.

Sales 59
article thumbnail

UK approves monoclonal antibody treatment for COVID-19

Pharma Times

Regeneron/Roche's drug found to reduce hospitalisation

Antibody 129
article thumbnail

How Much Does it Cost to Start a Clinical Research Site?

ECRG Media's Clinical Research Podcast

How Much Does it Cost to Start a Clinical Research Site? Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite Clinical Research Group or ECRG for short is a

article thumbnail

Leveraging Mobile Patient Support to Boost Adherence

Drug Channels

Today’s guest post comes from Ian Ocilka, Senior Vice President of Client Solutions at ConnectiveRx. . Ian discusses how mobile platforms like mobileCare Manager can boost patient adherence to specialty therapies. To learn more, register for ConnectiveRx's free panel discussion on September 15, 2021, at 1:00 p.m. ET. Email inquiries@ConnectiveRx.com with any questions.

Drugs 56
article thumbnail

The New Age of Decentralized Clinical Trials

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.

article thumbnail

How Much Does it Cost to Start a Clinical Research Site?

ECRG Media's Clinical Research Podcast

How Much Does it Cost to Start a Clinical Research Site? Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link]. We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education.

article thumbnail

Important Site Initiation Visit To Do Items In Clinical Research In Under 2 Minutes

Clinical Trial Gurus

Site Initiation Visits in clinical research allow the research site to be ready to screen patients. These are what CRAs should ensure sites do at an SIV.

article thumbnail

That $56,000 Drug? Blame Medicare.

NY Times

For an increasingly important set of drugs, Medicare has been driving up prices. It knows how to do better.

Drugs 59
article thumbnail

ELRIG UK Announces Drug Discovery 2021 Event to Host SLAS’s Innovation AveNEW

Drug Discovery Today

• ELRIG Drug Discovery 2021, ACC Liverpool, UK, 19–20 October• Face-to-face event aims to re-connect, re-invent, and re-imagine drug discovery• SLAS’s Innovation AveNEW promotes start-ups by awarding free-of-charge exhibition space and access to a network of potential business partners

Drugs 45
article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

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.

article thumbnail

¿La vacuna Johnson & Johnson requerirá refuerzo?

NY Times

Tenemos una guía con las recomendaciones y opiniones de los expertos en salud para despejar tus dudas.

article thumbnail

Alex Gorsky will pass leadership of J&J to Joaquin Duato in January

pharmaphorum

Johnson & Johnson has appointed Joaquin Duato as chief executive officer to replace long-serving Alex Gorsky, who has been CEO since 2012. Joaquin Duato. Gorsky will stay on at the company as executive chairman, but Duato – currently vice chairman at J&J’s executive committee – will take the top job at the company on 3 January and also take a seat on the board.

Sales 59
article thumbnail

AGC Biologics starts construction at new Copenhagen facility

BioPharma Reporter

CDMO AGC Biologics has announced the groundbreaking of a new multipurpose facility in Copenhagen, Denmark.

52
article thumbnail

Pulmonx Announces Anthem Blue Cross Blue Shield Now Provides Coverage for Severe COPD/Emphysema Treatment

BioTech 365

Pulmonx Announces Anthem Blue Cross Blue Shield Now Provides Coverage for Severe COPD/Emphysema Treatment Pulmonx Announces Anthem Blue Cross Blue Shield Now Provides Coverage for Severe COPD/Emphysema Treatment Positive Coverage Policy Gives Additional 34 Million People Access to Treatment with … Continue reading →

52
article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

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.

article thumbnail

Which pharmaceutical companies have the most drug patents in Finland?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Finland. 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 Finland? appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
article thumbnail

XELJANZ® (tofacitinib citrate) Receives Marketing Authorization in the European Union for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis

BioTech 365

XELJANZ® (tofacitinib citrate) Receives Marketing Authorization in the European Union for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis XELJANZ® (tofacitinib citrate) Receives Marketing Authorization in the European Union for the Treatment of Active Polyarticular Juvenile … Continue reading →

article thumbnail

Organon Makes Women’s Health a Priority

pharmaphorum

Simon Nicholson tells us how Organon, a new women’s healthcare company, is working to effect positive change globally by listening to women about their health care needs and allowing that information to drive their business development strategy. As Merck looked to expand its portfolio, it was determined that there’s a huge problem and need, particularly in women’s health.

article thumbnail

Leslie A. Brun Resigns from Merck Board of Directors

BioTech 365

Leslie A. Brun Resigns from Merck Board of Directors Leslie A. Brun Resigns from Merck Board of Directors KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Leslie A.

52
article thumbnail

The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.

article thumbnail

PROVENT trial puts AZ COVID antibody combo back on track

pharmaphorum

AstraZeneca’s AZD7442 has shown that it can prevent COVID-19 infection when given to healthy patients – the first time this has been demonstrated by a long-acting antibody-based drug. The results of the almost 5,200-patient PROVENT study show that pre-exposure prophylaxis using the antibody combination reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo.

article thumbnail

Brooklyn ImmunoTherapeutics Announces Adjournment of Annual Meeting of Stockholders Due to Lack of Quorum

BioTech 365

Brooklyn ImmunoTherapeutics Announces Adjournment of Annual Meeting of Stockholders Due to Lack of Quorum Brooklyn ImmunoTherapeutics Announces Adjournment of Annual Meeting of Stockholders Due to Lack of Quorum BROOKLYN, N.Y., Aug. 20, 2021 (GLOBE NEWSWIRE) — Brooklyn ImmunoTherapeutics, Inc.

40
article thumbnail

Editas Medicine Presents Data on New SLEEK Gene Editing Technology at Cold Spring Harbor Laboratory’s Genome Engineering: CRISPR Frontiers Meeting

BioTech 365

Editas Medicine Presents Data on New SLEEK Gene Editing Technology at Cold Spring Harbor Laboratory’s Genome Engineering: CRISPR Frontiers Meeting Editas Medicine Presents Data on New SLEEK Gene Editing Technology at Cold Spring Harbor Laboratory’s Genome Engineering: CRISPR Frontiers Meeting … Continue reading →

article thumbnail

Precipio Reschedules Q2-2021 Shareholder Update Call

BioTech 365

Precipio Reschedules Q2-2021 Shareholder Update Call Precipio Reschedules Q2-2021 Shareholder Update Call Due to a schedule conflict, the call is moved to Thursday August 26th at 5:00PM EST NEW HAVEN, Conn., Aug.

40
article thumbnail

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.