Thu.Dec 10, 2020

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FDA advisers back Pfizer, BioNTech vaccine, clearing way for emergency approval

Bio Pharma Dive

A panel of independent experts agreed the benefits of vaccination outweigh the risk, convinced by strong data showing the companies' shot to be 95% effective in preventing COVID-19.

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Telstar strengthens its activity in Bangladesh and relocates its office in Dhaka

Pharma Mirror

Terrassa (Barcelona) 2020. The Telstar subsidiary in Dhaka, Bangladesh, has relocated to a new installation reacting to the ongoing growth of demand for Life Sciences service & product solutions in the region. Under the leadership of Parvez Hashim, Country General Manager, Telstar’s office has consolidated a professional and specialized service in Asia’s pharmaceutical market in consultancy, engineering, construction and manufacturing processes for development of turnkey plants and installat

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Boehringer goes after antibody cancer drugs in latest acquisition

Bio Pharma Dive

For about $1.4 billion, Boehringer will take control of NBE-Therapeutics and its antibody drug conjugate technology, which has already produced one clinical-stage therapy.

Antibody 161
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COVID-19 Vaccine Shelved After False HIV Positives Affirms Need for Multiple Vaccines

BioSpace

A COVID-19 vaccine being developed by CSL Ltd., and the University of Queensland was scrapped this week after numerous vaccine recipients reported receiving false positives on certain HIV tests.

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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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Gilead inks a billion-dollar deal for a hepatitis drug

Bio Pharma Dive

Adding to a string of deals, the biotech has agreed to acquire Myr Pharmaceuticals and its marketed drug Hepcludex.

Drugs 177
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AstraZeneca Hopes COVID-19 Vaccine Will Take Off in Combination with Sputnik V

BioSpace

AstraZeneca, which is jointly developing a COVID-19 vaccine with the University of Oxford, plans to begin clinical trials testing its vaccine in combination with Russia’s Sputnik V vaccine by the end of the year.

More Trending

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Obstructive sleep apnoea puts a strain on the heart, too

Scienmag

Credit: UEF / Raija Törrönen Longer nocturnal respiratory events in patients with obstructive sleep apnoea (OSA) cause higher immediate heart rate variability, and greater changes in beat-to-beat intervals are associated with reduced daytime alertness, according to new research from the University of Eastern Finland. Obstructive sleep apnoea affects approximately 1 billion people worldwide.

Research 113
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Cyberattack targets EMA, hacks COVID-19 vaccine data

pharmaphorum

The European Medicines Agency (EMA) says it suffered a cyberattack, with documents relating to a Pfizer and BioNTech’s COVID-19 vaccine accessed. In a terse statement, the EU regulator confirmed its security had been breached and said it had launched an investigation with law enforcement, but would not be providing any additional information while that probe was underway.

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Biogen Corporate Event Was COVID Superspreader, Up to 300,000 Related Infections, Study Says

BioSpace

A Biogen corporate conference held in February at the Boston Marriott Long Wharf Hotel was initially traced to about 100 cases of COVID-19 that spread across the country. That number has grown exponentially.

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MHRA issues allergy warning for Pfizer/BioNTech COVID-19 jab

Pharma Times

Updated guidance warns people with a history of allergic reactions not to receive the shot

Allergies 143
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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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Pfizer COVID-19 vaccine should not be given to people with history of anaphylaxis: MHRA guidance update

BioPharma Reporter

The UKâs MHRA says anyone with a history of anaphylaxis should not receive the Pfizer/BioNTech COVID-19 vaccine: following two reports of anaphylaxis and one report of a possible allergic reaction in the first immunizations carried out this week.

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Sanofi-GSK COVID-19 Vaccine Hits Snag With Insufficient Immune Response in 50+ Population

BioSpace

The COVID-19 vaccine candidate developed by Sanofi and GlaxoSmithKline hit a snag that will delay the launch of a Phase III study due to an insufficient immune response in older trial patients.

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New Matchmaking Service Helps Food Producers Find Buyers for Unwanted Food

XTalks

A new service allows European food producers to be matched to other businesses looking to buy food that would otherwise go to waste. Funded by EIT Food , the Digital Marketplace for Side Streams will help food companies upcycle waste to produce by-products by matching them with businesses that have an overabundance of food. Conceptualized by a team at the University of Reading in England, the project brought on board several Europen food companies, including Givaudan , Döhler, Puratos and Pepsic

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Sanofi Genzyme to Resume Clinical Trials of Hemophilia Drug Fitusiran with Optimized Dosing Regimen

BioSpace

Sanofi announced yesterday that they will resume dosing in U.S. clinical trials. They noted that on October 30, they had “voluntarily paused dosing in all ongoing fitusiran clinical studies … to assess reports of non-fatal thrombotic events in patients participating in the Phase III program.

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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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Largest-ever study on children’s soft contact lens safety shows low complication rates

Scienmag

Extensive retrospective review offers real-world data for myopia management in children Credit: R Chalmers SAN RAMON, Calif., December 10, 2020–The largest-ever retrospective study of its kind has found very low complication rates in children who wear soft contact lenses, similar to rates in adults.(1) The newly-published outcomes offer eye care professionals (ECPs) valuable real-world information […].

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Sensyne launches fundraising, agrees patient data deal with Phesi

pharmaphorum

UK digital health firm Sensyne has secured access to millions more anonymised patent records via an alliance with US clinical trial data specialist Phesi. The new agreement comes after a string of access deals with NHS trusts for patient data, and coincides with a bid by Sensyne to raise £27.5 million (around $37 million) through a 90 pence per share placing.

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Self-collected saliva samples prove effective for diagnosing COVID-19

Scienmag

Use of self-collected saliva can minimize healthcare worker exposure and expand testing capabilities for symptomatic and asymptomatic patients, researchers report in The Journal of Molecular Diagnostics Credit: Memorial Sloan Kettering Cancer Center Philadelphia, December 10, 2020 – Researchers at Memorial Sloan Kettering Cancer Center (MSK) have found that SARS-CoV-2 genetic material can be reliably detected […].

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Coronavirus vaccine may have allergy warning in US, says expert

pharmaphorum

The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone to serious allergic reactions. Moncef Slaoui, co-head of the US government’s Operation Warp Speed COVID-19 vaccine programme, made the comments after the UK drugs regulator advised those with severe allergies to avoid the vaccine.

Allergies 103
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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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New serological assay provides rapid, accurate testing for SARS-CoV-2 antibodies

Scienmag

Using optical biosensor technology, the test provides quantitative measurements of antibodies in blood plasma in less than 20 minutes Credit: Carolyn Lagattuta Researchers at UC Santa Cruz have developed a novel serological assay for the detection of antibodies to SARS-CoV-2, the coronavirus that causes COVID-19. Rebecca DuBois, associate professor of biomolecular engineering at UC Santa […].

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Vaccine Development and Approval in a Time of Pandemic

Eye on FDA

Sometimes in the midst of events, perspective is elusive. Today the Food and Drug Administration will hold a meeting of the Vaccines and Related Biologics Advisory Committee (VRBAC) to consider the application for an Emergency Use Authorization (EUA) submitted by Pfizer/BioNTech for their investigative vaccine for COVID-19. Usually prior to an FDA Advisory Committee meeting where a product is being considered for approval, the posting of the FDA Reviewer comments is greatly anticipated for what

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Scientists look to meteorites for inspiration to achieve critical element-free magnet

Scienmag

Credit: photo credit: U.S. Department of Energy Ames Laboratory The U.S. Department of Energy’s (DOE’s) Critical Materials Institute has developed a low-cost, high performance permanent magnet by drawing inspiration from an out-of-this-world source: iron-nickel alloys in meteorites. The magnet rivals widely used “Alnico” magnets in magnetic strength and has the potential to fill a strong […].

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V2ACT Therapeutics on Track to Launch Phase I/IIa Pancreatic Cancer Trial, Following FDA Nod

BioSpace

The U.S. Food and Drug Administration (FDA) has given the greenlight for V2ACT Therapeutics to proceed with a Phase I/IIa clinical trial of its investigational treatment for newly diagnosed surgically resectable pancreatic cancer.

Trials 112
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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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Bosses need appreciation, too

Scienmag

Study shows supervisors who feel appreciated have better outlook at work Credit: University of Central Florida ‘Tis the season to be grateful, even for your boss, according to a recent University of Central Florida study that suggests when supervisors feel appreciated, it gives them a boost of energy and optimism. In the end, that’s good […].

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New patent for Alkermes Inc drug ARISTADA INITIO KIT

Drug Patent Watch

Annual Drug Patent Expirations for ARISTADA+INITIO+KIT Aristada Initio Kit is a drug marketed by Alkermes Inc and is included in one NDA. It is available from one supplier. There are…. The post New patent for Alkermes Inc drug ARISTADA INITIO KIT appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 93
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Why does exercise make some people healthier than others?

Scienmag

The answers may lie in how the power plants of your cells react to physical activity Credit: Pennington Biomedical Research Center BATON ROUGE, Louisiana – Why do some people benefit so much from exercise while others enjoy few health gains or even suffer harm? Does age matter when it comes to exercise’s health benefits? Are […].

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Evaluation of Cloth Masks and Modified Procedure Masks as Personal Protective Equipment

JAMA Internal Medicine

This comparative study examines the fitted filtration efficiency of 7 consumer-grade face masks and 5 medical procedure mask modifications.

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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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Young people embrace new model of teaching sexual consent, study finds

Scienmag

Sexual health charity Brook has adopted these latest research findings in its teaching methods Credit: Taylor & Francis: [link] Sexual health charity Brook has adopted these latest research findings in its teaching methods A new nuanced way of teaching young people about consent that is based on their real-life experiences helps them develop a better […].

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uniQure Phase III HOPE-B Trial Signals Hope for Hemophilia B Patients Everywhere

BioSpace

In a shining moment that signaled hope for hemophilia B patients, uniQure presented data on Tuesday showing that its gene therapy treatment, etranacogene dezaparvovec (AMT-061), substantially increased production of the blood-clotting protein factor IX in nearly all pivotal Phase III HOPE-B trial.

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Researchers identify the physical mechanism that can kill bacteria with gold nanoparticles

Scienmag

The research, involving URV researcher Vladimir Baulin, opens the door to the development of new bactericide materials as an alternative to antibiotics Credit: Vladimir Baulin Finding alternatives to antibiotics is one of the biggest challenges facing the research community. Bacteria are increasingly resistant to these drugs, and this resistance leads to the deaths of more […].

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White House Says to FDA Commissioner: Authorize the Vaccine or ‘You’re Fired,’ Report Says

BioSpace

If the U.S. Food and Drug Administration does not grant Emergency Use Authorization to the COVID-19 vaccine developed by Pfizer and BioNTech, the White House will demand the resignation of FDA Commissioner Stephen Hahn.

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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.