Mon.Jul 12, 2021

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FDA flags rare side effect in new warning on J&J's coronavirus vaccine

Bio Pharma Dive

The agency said the benefits of vaccination with J&J's shot still "clearly outweigh" the risks, which now include very rare cases of a immune-driven condition known as Guillain-Barré

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PHE study finds COVID-19 vaccines ‘highly effective’ in at-risk groups

Pharma Times

Vaccine effectiveness against symptomatic disease in at-risk groups is approximately 60% after one dose of either the AZ or Pfizer/BioNTech vaccines

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Alzheimer's Association, insurers press Medicare for coverage rules on Aduhelm

Bio Pharma Dive

Days after the FDA narrowed the target population for Biogen's drug, the patient advocacy group said it's urging Medicare to adopt a nationwide policy. Payers are seeking guidance, too.

Drugs 269
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NICE ‘no’ for Orchard Therapeutics’ gene therapy Libmeldy

Pharma Times

NICE concluded the cost-effectiveness estimates for Libmeldy are unlikely to be within the range that it would consider an effective use of NHS resources

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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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Medicare to weigh nationwide coverage rules for Biogen Alzheimer's drug

Bio Pharma Dive

CMS announced it would begin an official process to determine whether a national policy is necessary for Aduhelm and other drugs in development like it, responding to calls from insurers and patient advocates.

Drugs 248
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USC study shows dire impacts downstream of Nile River dam

Scienmag

The research forecasts water supply and economic risks as tensions mount over Grand Ethiopian Renaissance Dam Credit: (Photo/NASA-JPL) Rapid filling of a giant dam at the headwaters of the Nile River — the world’s biggest waterway that supports millions of people — could reduce water supplies to downstream Egypt by more than one-third, new USC […].

Research 119

More Trending

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4 New Hot Sauce Brands for Spice Enthusiasts

XTalks

In recent times, hot sauce has become increasingly popular as many consumers crave spicy foods. Companies have recognized this eagerness to try new hot sauces and have started to introduce consumers to a wide range of options to choose from. The growing popularity of hot sauce has largely been influenced by social media. First We Feast is a YouTube channel that has gained in viewership over the years.

Branding 105
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UK study raises hopes of long COVID test within months

pharmaphorum

A diagnostic test to detect long COVID could be available within six to 12 months, following the discovery that patients with the chronic condition have distinctive antibodies in their blood. . Researchers at Imperial College London (ICL) led by Professor Danny Altmann told the BBC’s Panorama programme that they have identified a pattern of antibodies in people with long COVID different from those who have fully recovered from COVID-19.

Antibody 105
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ReiThera’s COVID-19 vaccine looks to Phase 3 trial after preliminary Phase 2 data

BioPharma Reporter

Antibody responses against the SARS-CoV-2 spike protein were found in 99% of volunteers after the second dose of ReiTheraâs COVID-19 vaccine candidate, according to Phase 2 preliminary data.

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Almost 50,000 extra doctors needed in England, says BMA

Pharma Times

BMA research finds the number of doctors per 1,000 people in England is 25 years behind comparable EU nations

Doctors 129
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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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F.D.A. Attaches Warning of Guillain-Barré Syndrome to Johnson & Johnson Covid Vaccine

NY Times

Federal regulators concluded that the risk of developing the syndrome was low, and that the benefits of the vaccine still strongly outweigh it.

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Galapagos’ filgotinib leads to rapid symptom improvement for ulcerative colitis patients

Pharma Times

Data also suggested filgotinib 200mg reduced and eliminated corticosteroid use compared to placebo

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COVID-19 News: WHO Warns Against Mixing and Matching Vaccines and More

BioSpace

The U.S. appears to be beating back COVID-19 but it’s still raging in many parts of the world, and studies and trials are still ongoing. Here’s a look at some of today’s top COVID-19 stories.

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Why Pet Food Acquisitions Are On the Rise Among Meat and Poultry Brands

XTalks

The COVID-19 pandemic influenced 47 percent of new dog adoptions, so it’s only logical that big food brands would start making acquisitions of their own. Specifically, meat and poultry brands, along with some “human food” brands, are acquiring pet food businesses. In 2020 alone, there were 27 pet food industry mergers and acquisitions, but recently, one meat and poultry giant ventured into pet food.

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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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Bayer’s finerenone gets FDA nod for diabetic kidney disease

pharmaphorum

Bayer’s big investment in time and money on the development of finerenone for chronic kidney disease (CKD) in diabetics has paid off with an FDA approval, although it could face stiff competition in the market. . The oral, non-steroidal mineralocorticoid receptor (MR) antagonist has been approved as Kerendia in the US – its first world market – to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalisation for heart failure

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FDA Trims Broad Label for Biogen’s Alzheimer’s Drug Amidst Harsh Criticism

XTalks

The US Food and Drug Administration’s (FDA) recent approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) was met with a lot of backlash, prompting the health agency to narrow its recommendation of the drug for mild forms of the disease. The FDA based the decision on the fact that there is “no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”.

Drugs 98
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Brain injury lab receives additional federal funding to boost research

Scienmag

UC Riverside postdoc and graduate students are recipients of new awards Credit: Santhakumar lab, UC Riverside. RIVERSIDE, Calif. — Earlier this year, Viji Santhakumar, an associate professor of molecular, cell and systems biology at the University of California, Riverside, received funding from the National Institute of Neurological Disaster and Stroke of the National Institutes of […].

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Man vs. Machine – Which is Best at Predicting Clinical Trial Outcomes?

BioSpace

A recent Deny-Colton Virtual Salon pitted human intelligence against AI/ML to weigh not just the outcomes, but the process.

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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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Phasecraft reveals a more efficient method for modelling electrons in materials

Scienmag

UK quantum software startup Phasecraft, spun out of UCL and University of Bristol, releases peer-reviewed research that shows significant improvement beyond previous techniques for simulating fermions on quantum computers Credit: Phasecraft Ltd One of the most significant challenges in the global R&D effort towards better energy technologies — efficient and accurate material simulation — may […].

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Biogen Scoops Up Exclusive Rights to Chinese Molecule for MS

BioSpace

?The license and collaboration agreement center on orelabrutinib, an oral small molecule BTKi characterized by its high selectivity and the ability to cross the blood-brain barrier.

Licensing 102
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Artificial intelligence could be new blueprint for precision drug discovery

Scienmag

Mathematical approach could transform drug development by searching for disease targets, then predicting if a drug will be successful Credit: UC San Diego Health Sciences Writing in the July 12, 2021 online issue of Nature Communications, researchers at University of California San Diego School of Medicine describe a new approach that uses machine learning to […].

Drugs 97
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Ohio State Researchers Use Gene Therapy to Treat Children with Rare AADC Disease

BioSpace

A new study has found potential in a novel gene therapy method to help children born with the rare genetic and neurodegenerative disorder, AADC deficiency.

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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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Neutron-clustering effect in nuclear reactors demonstrated for first time

Scienmag

Long-theorized phenomenon observed in a working reactor could improve reactor safety, according to a new study Credit: Los Alamos National Laboratory Los Alamos, N.M., July 12, 2021–For the first time, the long-theorized neutron-clustering effect in nuclear reactors has been demonstrated, which could improve reactor safety and create more accurate simulations, according to a new study […].

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Pfizer Pushes Officials to Approve COVID-19 Vaccine Booster Shot

BioSpace

The data may show the need for one, but vaccine and immunologists are pushing back against Pfizer and BioNTech’s contention that one is necessary now.

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Naturally abundant venom peptide from ants can activate a pseudo allergic pathway unravelling a novel immunomodulatory pathway of MRGPRX2

Scienmag

Credit: The University of Hong Kong Ants are omnipresent, and we often get blisters after an ant bite. But do you know the molecular mechanism behind it? A research team led by Professor Billy K C CHOW from the Research Division for Molecular and Cell Biology, Faculty of Science, the University of Hong Kong (HKU), […].

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Pneumococcal Vaccine Snags Breakthrough Therapy Designation

BioSpace

The vaccine candidate ASP3772 generated an antibody response to each of the 24 polysaccharides in its makeup and antibody response to the two conserved pneumococcal proteins.

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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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Emotions and culture are most important for acceptance of carnivore management strategies

Scienmag

Credit: Photo: Oliver Höner/Leibniz-IZW Emotions towards and cultural importance of large carnivores are better predictors of the acceptance of management strategies by local communities than the extent of livestock depredation. This is the result of a new interdisciplinary investigation led by scientists from the Leibniz Institute for Zoo and Wildlife Research (Leibniz-IZW).

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Founder Shield: Navigating Biotech Risks from Discovery to Approval

BioSpace

Up and down the development pipeline, there are vulnerabilities. From shareholder expectations and IP protection to clinical trial risk and cyberattacks, it’s a minefield and enlisting a risk management partner is vital.

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Quantum phase transition discovered in a quasi-2D system consisting purely of spins

Scienmag

The study could have applications in spintronics and quantum computing; it was conducted by an international collaboration and published in Nature; its first author is a researcher at the University of São Paulo Credit: Julio Larrea/IF-USP) Pure quantum systems can undergo phase transitions analogous to the classical phase transition between the liquid and gaseous states […].

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U.S. Officials Push Back on Pfizer’s Request for Booster Shot Approval

NY Times

After meeting with company representatives, officials said the decision would depend partly on data on infections in vaccinated people that cause serious disease or hospitalization.

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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.