Thu.Aug 19, 2021

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Cell, gene therapy company funding reaches new heights, despite setbacks

Bio Pharma Dive

Developers of the complex treatments raised $14 billion between January and June, nearly three-quarters of last year's record-setting total, according to numbers compiled by the Alliance for Regenerative Medicine.

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COVID Booster shots: Experts say it’s a mistake

World of DTC Marketing

SUMMARY: Not only do booster shots risk depriving millions throughout the world of the vaccine, but there is also is no evidence that additional shots meaningfully reduce death or hospitalization from covid-19 for healthy Americans. ( William F. Parker is an assistant professor of pulmonary and critical care medicine at the University of Chicago and assistant director of the MacLean Center for Clinical Medical Ethics via the Washington Post ).

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Coherus, known for biosimilars, nears an immunotherapy battle with big pharma

Bio Pharma Dive

New lung cancer results could make Coherus the next entrant in an ultra-competitive market dominated by pricey drugs like Merck's Keytruda.

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Although Rare, New Data Suggests Higher Rate of Myocarditis with Moderna Shot

BioSpace

As governments and now even businesses push citizens to get vaccinated against COVID-19, anti-vaxxers are loading up more ammo for their argument with this week's report.

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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

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FDA approves Lilly, Boehringer diabetes drug for heart failure

Bio Pharma Dive

The expanded clearance in heart failure with reduced ejection fraction is expected to boost sales of the drug, called Jardiance.

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Canada Gaining in the Global War for Biotech Talent

BioSpace

Toronto saw the biggest growth in technology jobs of any North American city between 2015 and 2020, while Vancouver, British Columbia also made the top five.

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NICE says yes to Novartis’ Rydapt for rare blood disorder

pharmaphorum

Novartis’ Rydapt has become the first and only licensed treatment for rare and life-threatening blood disorder systemic mastocytosis (SM) to be cleared for routine NHS use, after getting a green light from NICE. The decision means around 170 people with advanced SM in England and Wales will be eligible for treatment with oral, twice-daily drug, which since 2018 has also been cleared for NHS treatment of a form of acute myeloid leukaemia.

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NICE’s health technology assessment methods and processes to be evaluated

Pharma Times

Public consultation launches on proposed changes aiming to provide earlier access to new treatments

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Does draft RCT guide set the scene for future trials?

pharmaphorum

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. The Good Clinical Trials Collaborative (GCTC) has published a draft guidance document, and is asking for the life sciences sector to make its views known. The publication, which is out for public consultation until 15 September, said RCTs played a central role in generating the evidence needed to inform the de

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Runny Nose, Sneezing and Headache: Seasonal Allergies or Delta Variant?

BioSpace

As the delta variant continues to contribute to the majority of COVID-19 cases worldwide, many patients are reporting symptoms different than those reported with earlier strains.

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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.

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Latest COVID-19 updates from the FDA

Outsourcing Pharma

The US Food and Drug Administration continues to review potential preventatives and treatments for the virus, and to offer advice to life-sciences professionals and civilians alike.

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US approval for Boehringer Ingelheim, Lilly's heart failure drug Jardiance

Pharma Times

Jardiance reduced risk of death or hospitalisation by 25% for adults with heart failure with reduced ejection fraction

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Another ALS Hopeful Falls Short as Alexion Halts Phase III Trial

BioSpace

?The group said that the Phase III trial of Ultomiris (ravulizumab) lacked efficacy when it was used on adults diagnosed with amyotrophic lateral sclerosis.

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BMS advances AI-designed drug candidate into development

Pharma Times

Option is a collaboration between BMS and AI-driven pharmatech Exscientia

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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.

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Former Google Health Exec to Take the Helm at Cerner

BioSpace

?Cerner has appointed former Google Health boss David Feinberg as its new chief executive and president effective October 1, 2021.

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Paige, Perspectum forge AI-centered clinical trial alliance

Outsourcing Pharma

The digital pathology firm and image-analysis software developer will partner on artificial intelligence based solutions to improve trial decision making.

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Research Roundup: Preventing Type 1 Diabetes and More

BioSpace

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.

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Moderna secures extended vaccine supply with Canada, sees regulatory advances

BioPharma Reporter

The last week has seen a plethora of announcements linked to ModernaĂ¢s mRNA COVID-19 shot.

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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.

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Aduhelm Approval Could Imperil Woodcock's Future as FDA Commissioner

BioSpace

Woodcock faces heavy opposition from an evenly divided U.S. Senate, particularly from West Virginia Sen. Joe Manchin, who has been critical of the approval process for Biogen’s Aduhelm, formerly known as aducanumab.

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Xywav Narcolepsy Drug Scores FDA Approval for Rare Sleep Disorder

XTalks

The US Food and Drug Administration (FDA) has approved a new indication for Jazz Pharmaceuticals’ (Nasdaq: JAZZ ) Xywav for idiopathic hypersomnia (IH) in adults. IH is a rare chronic sleep disorder that causes people to be extra sleepy during the daytime despite getting eight or nine hours worth of a good night’s sleep. With the FDA green light, Xywav has become the first drug approved for IH.

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Moderna secures extended vaccine supply with Canada, sees regulatory advances

BioPharma Reporter

The last week has seen a plethora of announcements linked to ModernaĂ¢s mRNA COVID-19 shot.

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FDA Grants Public Hearing for Preterm Birth Drug Amidst Controversy

BioSpace

Makena currently remains on the market but is poised to be removed pending the outcome of the meeting.

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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.

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DePuy Synthes Introduces the INHANCEâ„¢ Shoulder System, a First-to-Market, Fully.

The Pharma Data

The INHANCEâ„¢ Shoulder System empowers surgeons to treat a broad range of cases with a streamlined, comprehensive implant offering that features common instrumentation and unique interoperative flexibility. Designed for hospitals as well as outpatient and ASC settings where economic value and operational efficiency are critical considerations. Today, The Johnson & Johnson Medical Devices Companies* announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson,** introduces

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New patent for Astrazeneca Ab drug BYDUREON PEN

Drug Patent Watch

Annual Drug Patent Expirations for BYDUREON+PEN Bydureon Pen is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are twenty-two…. The post New patent for Astrazeneca Ab drug BYDUREON PEN appeared first on DrugPatentWatch - Make Better Decisions.

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RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

The Pharma Data

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment

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New patent for Astrazeneca Ab drug BYDUREON BCISE

Drug Patent Watch

Annual Drug Patent Expirations for BYDUREON+BCISE Bydureon Bcise is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are fifteen…. The post New patent for Astrazeneca Ab drug BYDUREON BCISE appeared first on DrugPatentWatch - Make Better Decisions.

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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.

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AbbVie Kicks Off Two-Week Public Voting Open for the 2021.

The Pharma Data

– Voting is open to the public now through September 1 to help determine this year’s two Thriving Scholars – Forty students living with cystic fibrosis who have demonstrated academic excellence, creativity, and community involvement/extracurricular activities are in the running – Scholarships totaling $25,000 each – the Thriving Undergraduate Scholarship and the Thriving Graduate Scholarship – will be awarded to two deserving students.

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New patent for Novartis drug TAFINLAR

Drug Patent Watch

Annual Drug Patent Expirations for TAFINLAR Tafinlar is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are six patents protecting…. The post New patent for Novartis drug TAFINLAR appeared first on DrugPatentWatch - Make Better Decisions.

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New England Journal of Medicine Publishes 12-Week Results from Study.

The Pharma Data

– In the atogepant Phase 3 ADVANCE trial, participants experienced a significant reduction in migraine and headache days across 12 weeks of treatment¹ – Study also found the majority of atogepant-treated participants achieved at least a 50% reduction in mean monthly migraine days for all doses compared to placebo as a secondary endpoint¹. – Atogepant 30 mg and 60 mg doses demonstrated statistically significant improvements in all six prespecified, multiplicity-controlled second

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New patent for Novartis drug MEKINIST

Drug Patent Watch

Annual Drug Patent Expirations for MEKINIST Mekinist is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are eight patents protecting…. The post New patent for Novartis drug MEKINIST appeared first on DrugPatentWatch - Make Better Decisions.

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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.