Wed.Apr 07, 2021

article thumbnail

AstraZeneca's coronavirus vaccine possibly linked to rare blood clots, EMA says

Bio Pharma Dive

Europe's drug regulator affirmed the benefits of vaccination outweigh the risks, but recommended the shot's label be updated to warn of the newly established side effect.

article thumbnail

What do future healthcare CEOs look like?

World of DTC Marketing

QUICK READ: The compensation for pharma CEOs is starting to be reported and it’s off the charts. Bob Bradway of Amgen bagged a $20.1 million compensation package in 2020, a slight increase from his $19.6 million total the previous year. Pfizer CEO Bourla’s Pay Climbed 17% to $21 Million in 2020 and Gilead Sciences CEO Daniel O’Day earned a $19 million take home.

Insiders

Sign Up for our Newsletter

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

article thumbnail

FibroGen admits misleading safety data for anemia drug, dimming prospects

Bio Pharma Dive

In a surprising announcement, the company said data used to tout the safety of the anemia pill roxadustat included “post hoc changes” that executives became aware of during regulatory review.

Drugs 238
article thumbnail

Molecules from Probiotic-Rich Foods May Combat “Cytokine Storm” in COVID-19

BioSpace

A recent study from Ben-Gurion University of the Negev (BGU) found that isolated molecules from probiotic-rich dairy products could have potential as novel drug candidates for fighting against pathogenic bacteria and treating inflammatory diseases.

Bacteria 127
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

Bluebird executive joins Flagship startup Tessera as CMO

Bio Pharma Dive

David Davidson is leaving Bluebird bio after nearly a decade as the gene therapy developer's top doctor. His new home, Tessera, just raised $230 million to advance its "gene writing" research.

article thumbnail

Symbiotica and Quidel Score FDA Authorizations for COVID-19 Tests

XTalks

As the COVID-19 pandemic shifts with new case surges largely owing to new variants of SARS-CoV-2, the US Food and Drug Administration (FDA) continues to offer up emergency use authorizations (EUA) for tests for the detection of COVID-19 infection, with the latest being antibody and antigen tests from Symbiotic and Quidel, respectively. With the EUA, Symbiotica’s COVID-19 Self-Collected Antibody Test System becomes the first antibody test authorized for collection of dried blood spot samples at h

Antibody 102

More Trending

article thumbnail

Nationwide launch for pioneering fertility study

Pharma Times

The NIHR-funded trial will assess whether removing small fibroids and endometrial polyps improves fertility and live births

Trials 122
article thumbnail

Mission Bio Taps Thermo Fisher Scientific Veteran Yan Zhang as New CEO

BioSpace

She succeeds Mission Bio’s current chief executive officer Charlie Silver, who will shift into an advisory role with the company he co-founded.

98
article thumbnail

One in ten have long-term effects 8 months following mild COVID-19

Scienmag

Credit: Ludvig Kostyal Eight months after mild COVID-19, one in ten people still has at least one moderate to severe symptom that is perceived as having a negative impact on their work, social or home life. The most common long-term symptoms are a loss of smell and taste and fatigue. This is according to a […].

article thumbnail

The Ebola Vaccine: A Cautionary Tale

BioSpace

The first vaccine for Ebola, Merck’s rVSV-ZEBOV (Ervebo), was given the green light by the U.S. Food and Drug Administration in December 2019.

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

Stop paying your staff to make repetitive reports

Drug Patent Watch

How Much Time Are You Wasting on Manual, Repetitive Tasks? Stop wasting time on repetitive reports: Contact us Are your staff burdened with manual, repetitive tasks, like data collection, and…. The post Stop paying your staff to make repetitive reports appeared first on DrugPatentWatch - Make Better Decisions.

77
article thumbnail

Jan van de Winkel: Building Europe’s biotech powerhouse at Genmab

pharmaphorum

Jan van de Winkel has overseen one of biotech’s big success stories since he took over Genmab’s CEO in 2010. He spoke to pharmaphorum’s news editor Richard Staines to outline his plans to create a European biotech powerhouse. . The last ten years has seen Denmark’s Genmab become one of biotech’s big success stories. Under the leadership of CEO Jan van de Winkel it has gone from financially precarious position following the stock market crash in the late noughties, to the darling of the Nasdaq wi

article thumbnail

An amyloid link between Parkinson’s disease and melanoma

Scienmag

Credit: Dexter Dean, Ph.D. WASHINGTON, April 7, 2021 — On the surface, Parkinson’s disease — a neurodegenerative disorder — and melanoma — a type of skin cancer — do not appear to have much in common. However, for nearly 50 years, doctors have recognized that Parkinson’s disease patients are more likely to develop melanoma than […].

Doctors 75
article thumbnail

Genmab could spin out autoimmune disease unit, says CEO

pharmaphorum

Genmab’s CEO Jan van de Winkel has said he would consider spinning out a smaller autoimmune diseases biotech, while ruling out any interest in a merger with big pharma. . In an interview with pharmaphorum, van de Winkel noted that the company’s drugs could be used for diseases outside of cancer, where Copenhagen-based Genmab first made its mark. A drug it originally developed to treat leukaemia has been repurposed by Novartis as a treatment for multiple sclerosis.

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

Fund opens to boost UK life sciences manufacturing

Pharma Times

The £20 million fund will boost the UK's life sciences manufacturing capabilities, creating new economic opportunities and highly skilled jobs

article thumbnail

FDA May be Getting Tougher, but Gives Trodelvy Nod for Triple-Negative Breast Cancer

BioSpace

The agency granted full approval to Gilead Sciences’ Trodelvy (Sacituzumab govitecan-hziy) for adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more previous system therapies, at least one for metastatic disease.

98
article thumbnail

Patient-centric approach more important than ever: Deloitte

Outsourcing Pharma

Especially with the COVID-19 pandemic impacting studies, the company says, putting patients at the center of studies and trial tech must be top priority.

Trials 72
article thumbnail

Targeting Overseas Tax Shelters

NY Times

How one U.S. multinational used overseas shelters to slash its tax bill — and how the Biden administration plans to crack down on such practices.

Drugs 72
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

Patient centricity vital to advancing rare-disease treatments: ICON

Outsourcing Pharma

A leader from the global CRO discusses how putting the patient first in clinical research is essential to discovering new therapies for orphan diseases.

article thumbnail

Kite: New data offers transparency into CAR T cell therapy manufacturing in real world setting

BioPharma Reporter

Kite says a two-year retrospective analysis of the commercial manufacturing and supply of its CAR T therapy, called axicabtagene ciloleucel (Yescarta), shows a high manufacturing success rate and a reliable turnaround time.

article thumbnail

Social Media’s Disinformation Dozen + Pfizer’s Latest COVID-19 Vaccine Trial Results – Xtalks Life Science Podcast Ep. 5

XTalks

In this episode of the Xtalks Life Science Podcast, Ayesha discusses a report from the Center for Countering Digital Hate (CCDH) and Anti-Vax Watch that shows there are just 12 people behind 65 percent of all online anti-vaccine disinformation. While social media operators such as Facebook and Twitter had vowed to remove vaccine disinformation from their platforms, the disinformation dozen are still active and well on the sites.

article thumbnail

EMA finds possible link to AstraZeneca vaccine and very rare cases of unusual blood clots: Regulator not recommending age or gender restrictions

BioPharma Reporter

The European Medicines Agencyâs safety committee, PRAC, has concluded there is a possible link between the use of AstraZenecaâs COVID-19 vaccine and rare side effects of unusual blood clots and low blood platelets in individuals who received the shot.

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

Lilly and Incyte’s Olumiant Shows Mixed Results Against COVID-19

BioSpace

Eli Lilly and Company and Incyte announced today that their Phase III COV-BARRIER study of Olumiant (baricitinib) plus standard of care (SoC) compared to placebo plus SoC failed to hit statistical significance against COVID-19 for its primary endpoint.

89
article thumbnail

Cleaner solutions for marine and off-road transport

Scienmag

Finnish consortium aims for a breakthrough Credit: Riikka Kalmi, University of Vaasa The Clean Propulsion Technologies project consortium, led by the University of Vaasa, aims to develop radically new solutions for clean and efficient marine and off-road transport – a Finnish response to tightening emission legislation and growing global competition in these segments.

article thumbnail

ValenzaBio Closes Series A Financing Round Worth $70 Million

BioSpace

ValenzaBio plans to use the new financing to advance pipeline programs into autoantibody-mediated diseases, thyroid eye disease, inflammatory disorders and other therapeutic areas.

87
article thumbnail

Una vacuna de bajo costo contra la COVID-19 está en marcha

NY Times

Una nueva formulación que está entrando en ensayos clínicos en Brasil, México, Tailandia y Vietnam podría cambiar la forma en que el mundo combate la pandemia.

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

‘Our center will tackle major challenges in gene therapy development’: University of Sheffield to house new innovation and manufacturing hub

BioPharma Reporter

The UK has a strong genetics research base: but to date, academics have found it difficult to progress gene therapy research into clinical trials and beyond. The Sheffield Gene Therapy Innovation and Manufacturing Centre (GTIMC) is one of three new hubs, announced this month, that will tackle these challenges.

article thumbnail

Reneo Pharmaceuticals and VectivBio Prepare to Begin Trading on the Nasdaq

BioSpace

The wave of biopharma companies going public continues with two more companies setting sights on publicly trading on a stock exchange. Reneo Pharmaceuticals and VectivBio will both begin trading on the Nasdaq this week.

84
article thumbnail

Billboard and storefront ads for cannabis linked to problematic use in teens

Scienmag

Credit: adrienblanc (via Wikimedia Commons, Creative Commons Attribution 2.0) PISCATAWAY, NJ – Adolescents who frequently see billboard or storefront advertisements for recreational cannabis are more likely to use the drug weekly and to have symptoms of a cannabis use disorder, according to a new study in the Journal of Studies on Alcohol and Drugs.

Drugs 55
article thumbnail

Dedicated dad hopes to run down cure for a rare disease

Outsourcing Pharma

A father of two boys with Duchenne muscular dystrophy is running the Austin Marathon to raise funds toward pursuit of a cure for the rare, fatal disease.

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.