Tue.Jan 11, 2022

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JPM22: M&A anxiety, Roche's comeback plan and Vir's omicron moment

Bio Pharma Dive

Pharma executives fielded many questions about their dealmaking intentions on the conference's second day, while Roche outlined its plan to compete against Merck and Bristol Myers in cancer immunotherapy.

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HCPs are overwhelmed by promotional content in digital

World of DTC Marketing

As HCPs get more digitally savvy, pharma marketers should understand that engaging physicians through channels and time of their preference with content relevant to the individual customer. is no more an option but a critical factor to ensure success for any multichannel marketing initiatives. Key findings: 77% of HCPs use digital channels primarily for personal learning and development.

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5 questions facing the FDA in 2022

Bio Pharma Dive

If Robert Califf wins Senate confirmation as expected, he will face a lengthy agenda as well as questions on Aduhelm controversy, accelerated approval and agency funding.

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Oxford joins consortium to advance quantum drug discovery

Pharma Times

The partnership between Oxford University and SEEQC promises to accelerate the use of quantum computing within pharmaceutical research in order to reduce the development time required for drug production worldwide.

Drugs 148
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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 proposes to limit coverage of Biogen Alzheimer's drug

Bio Pharma Dive

The program will only cover Aduhelm, which the FDA controversially approved last June, for patients enrolled in rigorous clinical trials, likely forestalling broad adoption of the treatment.

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Pfizer, Moderna are prepping new vaccines for Omicron

pharmaphorum

With evidence growing that the current crop of COVID-19 vaccines are less protective against infection with Omicron, both Pfizer and Moderna have announced plans to develop new versions of their mRNA-based shots that are tailored to the new variant. Pfizer has said that a COVID-19 jab specifically targeting Omicron, as well as other existing variants, will begin human trials later this month and could be available as early as March.

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European Commission approves cystic fibrosis treatment for six to 11-year-olds

Pharma Times

There is currently no cure for cystic fibrosis (CF), a debilitating, progressive condition with over 10,830 people in the UK currently diagnosed with the disease.

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Life sciences predictions for 2022

pharmaphorum

As the COVID-19 pandemic continues to impact the healthcare landscape, and the digital transformation of the life sciences industry gathers pace, what can we expect to see in 2022? In this webinar, senior members from Healthware Group discuss the key trends and developments set to shape the industry and present their predictions for the year ahead. Join us on Friday 21 January at 2.00pm CET to find out how life science companies can stay ahead of the competition in 2022.

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Using only 100 atoms, electric fields can be detected and changed

Scienmag

Bioelectricity, the current that flows between our cells, is fundamental to our ability to think and talk and walk. Credit: KATYA KADYSHEVSKAYA AT USC Bioelectricity, the current that flows between our cells, is fundamental to our ability to think and talk and walk. In addition, there is a growing body of evidence that recording and […].

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What HCPs think about mandatory vaccination

pharmaphorum

What HCPs think about mandatory vaccination. The practice of making vaccinations mandatory within a population has always been controversial. Historically, the first example of this was during the smallpox epidemic in the 1800s , when some European countries attempted to make vaccination against the disease compulsory. While it is hard to argue against the overall aim of disease eradication, there are many ethical, medical, and social issues intertwined with the idea of enforcing vaccination.

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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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In Southern Africa, Success Against H.I.V. Offers Hope for Beating Back Another Virus

NY Times

A former Africa correspondent, who covered the height of the AIDS epidemic there 15 years ago, finds lessons in the remarkable progress against that virus for our current fight.

Drugs 88
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BMS cuts $3.15bn deal with Century for cancer cell therapies

pharmaphorum

Bristol-Myers Squibb chief executive Giovanni Caforio has promised to invest in the company’s pipeline at the virtual JP Morgan Healthcare Conference, and demonstrated that commitment by licensing up to four cancer cell therapy candidates from Century Therapeutics. BMS is paying $150 million upfront in cash and equity to kick off the alliance with another $3 billion in additional payments that will be forthcoming if the projects advance as hoped.

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New treasure trove of globular clusters holds clues about galaxy evolution

Scienmag

A survey completed using a combination of ground and space-based telescopes yielded a treasure trove of previously unknown globular clusters – old, dense groups of thousands of stars that all formed at the same time – in the outer regions of the elliptical galaxy Centaurus A. The work presents a significant advance in understanding the architecture […].

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Medicare Proposes to Cover Aduhelm Only for Patients in Clinical Trials

NY Times

If the preliminary decision is finalized this spring, it would sharply limit the number of patients who use the expensive drug.

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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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Is more better? Amounts and frequency of milk replacer fed to calves under heat stress

Scienmag

Philadelphia, January 11, 2022 – Calves raised during the heat of summer have reduced growth, increased disease incidence, and higher mortality rates compared with those raised in temperate environments or neutral thermal conditions. The reduced average daily weight gain observed in the summer can be partially attributed to heat stress. In a new report published […].

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The Retail Pharmacy Outlook for 2022

Drug Channels

As I have highlighted in previous posts, retail pharmacies are experiencing a period of intense competition that continues to pressure prescription profits. What's more, the pharmacy shakeout is accelerating, as smaller competitors exit and larger companies reduce store count. . In the video below, I provide a brief overview of key challenges facing retail pharmacy this year.

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Accumulated heat in the upper ocean is at record levels, again!

Scienmag

The world’s oceans are hotter than ever before, continuing their record-breaking temperature streak for the sixth straight year. The finding based on the latest data through 2021 comes at the end of the first year of the United Nations’ Decade of Ocean Science for Sustainable Development Goals, the 17 inter-locked goals to maintain human societies […].

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Melatonin for Sleep: How the Aid Works

NY Times

The “vampire hormone” can act like a dose of sunset, tricking your body into feeling like it’s time to sleep.

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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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rTMS as a treatment for Veterans with cognitive impairment and multiple co-morbidities

Scienmag

Palo Alto, California – January 10, 2022: Current treatments for Alzheimer’s disease are of limited effectiveness and do not halt the progression of the disease and associated cognitive decline. A recent study, published in the Journal of Alzheimer’s Disease, showed that a novel treatment, repetitive transcranial magnetic stimulation (rTMS), may have the potential of improving […].

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UK market developments: GHO Capital invests in RoslinCT, Symbiosis expands viral therapy capabilities

BioPharma Reporter

Healthcare investors, GHO Capital Partners LLP, have invested in Scotland based, RoslinCT, a contract development and manufacturing organization (CDMO) focused on advanced cell therapies.

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Winds of change bring winter rain to eastern Arabia

Scienmag

The Arabian Peninsula is one of the most arid regions in the world, making it important to understand how climate change could affect local rainfall patterns. Now, data comparisons have shown that changing winter rainfall over the peninsula since the 1980s can be linked to an ocean-atmospheric phenomenon affecting sea surface temperatures in the central […].

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Blue Note leukaemia DTx gets FDA breakthrough tag

pharmaphorum

A prescription digital therapeutic (DTx) for leukaemia patients developed by Blue Note Therapeutics has been awarded breakthrough device status by the FDA. The DTx, called BNT200, is described as a first-of-its-kind DTx to treat anxiety and depression in adults with acute myeloid leukaemia (AML) who are hospitalised for a regimen of high-intensity induction chemotherapy.

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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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How much do students learn when they double the speed of their class videos?

Scienmag

Recorded lectures have become a routine part of course instruction during the COVID-19 pandemic, and college students often try to pack more learning into a shorter span by watching these recordings at double their normal speed or even faster. But does comprehension suffer as a result? Credit: Courtesy of Dillon Murphy Recorded lectures have become […].

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Variant-proofing vaccines: Novel candidates seek to offer broad protection

BioPharma Reporter

While the last two years have seen the successful development of COVID-19 vaccines, the emergence of variants highlights the speed at which the pandemic - or indeed any other virus threat - can evolve. As a result, development of novel vaccine candidates that could offer broad protection is being stepped up.

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Molecular paddlewheels propel sodium ions through next-generation batteries

Scienmag

DURHAM, N.C. — Materials scientists at Duke University have revealed paddlewheel-like molecular dynamics that help push sodium ions through a quickly evolving class of solid-state batteries. The insights should guide researchers in their pursuit of a new generation of sodium-ion batteries to replace lithium-ion technology in a wide range of applications such as data centers […].

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Chasing Roche, Merck unveils adjuvant lung cancer data for Keytruda

pharmaphorum

Merck & Co’s Keytruda is the undisputed market leader in immunotherapy for non-small cell lung cancer (NSCLC), but was leapfrogged by Roche’s Tecentriq in the early-stage, adjuvant treatment setting. Now, it’s hoping to fight back with new phase 3 data. In the KEYNOTE-091 trial, Keytruda (pembrolizumab) significantly improved disease-free survival compared to placebo when given after surgery to remove NSCLC tumours, regardless of their level of PD-L1 expression, meeting one

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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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International study identifies predictors of severe outcomes in children with COVID-19

Scienmag

A new international study offers a clearer picture of the impact of COVID-19 infection and the risk of severe outcomes on young people around the world. Credit: Leah Hennel/Alberta Health Services A new international study offers a clearer picture of the impact of COVID-19 infection and the risk of severe outcomes on young people […].

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Is The Skinny Label Back From the Dead?

FDA Law Blog

By Sara W. Koblitz — Since the August 2021 decision in GSK v. Teva , the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. With the District Court of Delaware’s January 4 decision in a similar case (brought by GSK’s lawyers), Amarin v. Hikma , the generic industry can have some hope.

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Modular super-enhancer controls retinal development

Scienmag

Enhancers are regions of DNA that do not code for proteins, but control how genes are expressed. Super-enhancers are clusters of enhancers that together regulate genes with important roles in cell identity. Scientists at St. Jude Children’s Research Hospital studied the Vsx2 super-enhancer and its role in the development of the retina. Their assessment showed the super-enhancer has four […].

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Is The Skinny Label Back From the Dead?

FDA Law Blog

By Sara W. Koblitz — Since the August 2021 decision in GSK v. Teva , the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. With the District Court of Delaware’s January 4 decision in a similar case (brought by GSK’s lawyers), Amarin v. Hikma , the generic industry can have some hope.

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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.