STAT

JANUARY 27, 2023

After weeks of deliberation, Pfizer was scolded by a U.K. pharmaceutical industry trade group after its chief executive officer made misleading statements in a media interview about the need to vaccinate young children against Covid-19. The fracas began when the Pfizer chief, Albert Bourla, gave an interview to the BBC and discussed the idea of vaccinating children between five and 11 years old, a course of action that had not yet been approved by regulators in the U.K.

Vaccines 363

Vaccines 363

PharmaVoice

JANUARY 24, 2023

A longtime leader in the respiratory space, AstraZeneca has hammered another stake in the ground with its newest asthma treatment, Airsupra.

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pharmaphorum

JANUARY 27, 2023

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. Evusheld (tixagevimab and cilgavimab) was cleared by the FDA towards the end of 2021, becoming the first antibody to be authorised for prevention of COVID-19 infection, and it rapidly found use among people with compromised immune systems, such as cancer chemothe

Chemotherapy 135

Chemotherapy Immunity Immunization Vaccines 135

European Pharmaceutical Review

JANUARY 25, 2023

The first major study on the efficacy of DMT in treating any mental health condition showed a remission rate of 57 percent following a single dose, in a Phase IIa trial for major depressive disorder (MDD). “SPL026 (intravenous DMT) with supportive therapy was shown to have a significant antidepressant effect that was rapid and durable, with a remission rate of 57 percent at three months following a single dose of SPL026,” stated Dr Carol Routledge, Chief Medical and Scientific Officer at Small P

Labelling 133

Labelling 133

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

STAT

JANUARY 26, 2023

Fasten your seat belts, folks. We’re about to hit some turbulence. If you’re reading this, you’re interested in the discussion on the future of Covid-19 vaccination that’s going to take place today in a meeting of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee. We at STAT can’t predict the outcome, but we know enough to expect that this meeting will feature some heated debate.

Vaccines 317

Vaccines 317

PharmaVoice

JANUARY 26, 2023

Elon Musk’s takeover of Twitter has upended the ways pharma companies communicate with doctors online. Now new social strategies are emerging.

Communication 147

Communication 147

pharmaphorum

JANUARY 26, 2023

2022 was a banner year for genomics. In March, the collaborative T2T consortium published the first complete telomere-to-telomere sequence of the human genome, filling in the last 8% of the 3 billion base pairs that make up our DNA. And in the UK specifically, genomics remained high on the national agenda, with several significant government programmes and investments announced – including the Newborn Genomes Programme in healthcare and the Precision Breeding Bill in the agricultural sector.

Adverse Reactions 129

Adverse Reactions Vaccines 129

STAT

JANUARY 23, 2023

Massachusetts General Hospital is launching a prospective trial of an artificial intelligence tool designed to predict patients’ risk of lung cancer, a crucial area of inquiry amid rising incidence of the disease in never-smokers. The trial, to begin later this year, will test the accuracy and usefulness of an AI system the hospital developed with researchers at the Massachusetts Institute of Technology’s Jameel Clinic.

Hospitals 312

Hospitals 312

PharmaVoice

JANUARY 26, 2023

At SFA Therapeutics, patients are the “focus” of Ira Spector’s approach to changing the course of autoimmune disease.

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Pharma Times

JANUARY 27, 2023

Therapy involves patients with paediatric-onset hypophosphatasia – a rare bone disease

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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Communication

European Pharmaceutical Review

JANUARY 26, 2023

Yescarta ® ▼(axicabtagene ciloleucel; axi-cel) is now the first chimeric antigen receptor (CAR) T-cell therapy and first personalised immunotherapy to be recommended for routine use on the NHS in England. This is based on final draft guidance from the National Institute for Health and Care Excellence (NICE). The therapy by Gilead Sciences and Kite is indicated for eligible adults with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who have already bee

Chemotherapy 124

Chemotherapy Immunity Immunization 124

STAT

JANUARY 23, 2023

Scientists at the Food and Drug Administration propose making Covid vaccination a regular, once-a-year shot that is updated to match current strains of the SARS-CoV-2 virus, according to documents posted by the FDA on Monday. For people who are older or immunocompromised, the FDA would recommend two annual doses of the revised shot.

Documentation 312

Documentation Vaccines 312

PharmaVoice

JANUARY 26, 2023

With a rapidly expanding oncology pipeline and a new approval in HIV, Johanna Mercier discusses Gilead’s quest to transform.

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130

Pharma Times

JANUARY 23, 2023

Treatment is a maintenance therapy for certain patients with acute myeloid leukaemia

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European Pharmaceutical Review

JANUARY 23, 2023

The US Food and Drug Administration (FDA) has granted fast track designation (FTD) for Evaxion Biotech’s personalised cancer immunotherapy. The FTD is for EVX-01, in combination with Keytruda ® for patients with metastatic melanoma (MM). ”We are extremely pleased that our cancer vaccine candidate EVX-01 has received the FDA fast track designation, as it enables a potentially faster approval of the vaccine,” stated Per Norlén, CEO at Denmark-based Evaxion.

Immunity 124

Immunity Immunization Vaccines 124

STAT

JANUARY 26, 2023

Advisers to the Food and Drug Administration voted Thursday to back a plan whereby all Covid vaccines would move to the formulation used for the updated boosters, a step toward the goal of creating a single annual Covid shot for most Americans. The panel said that a single vaccine would both be more effective and less confusing to both patients and health care workers.

Vaccines 280

Vaccines 280

PharmaVoice

JANUARY 25, 2023

As Calcium’s medical director, Lazar is leveraging next-generation innovation to create strategic connections between science and marketing for healthcare brands.

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PhRMA

JANUARY 26, 2023

Mental illness represents a broad spectrum of health conditions affecting mood, thinking and behavior. These conditions include depression, bipolar disorder, schizophrenia, substance use disorder, anxiety disorders, eating disorders, obsessive compulsive disorder and post-traumatic stress disorder, among others. Each of these illnesses often varies in its degree of severity, ranging from mild to moderate to severe, and may occur together.

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Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

European Pharmaceutical Review

JANUARY 23, 2023

There are major concerns about microbial contamination in cannabis, US Food and Drug Administration (FDA) researchers observed in a study. Multiple cases have been reported of infections associated with cannabis use caused by fungi and bacteria in immunocompromised individuals using inhaled cannabis material. Investigational New Drug (IND) applications for cannabis as therapeutics tested in clinical trials must comply with FDA’s requirements and standards for drug products.

Compounding 119

Compounding 119

STAT

JANUARY 27, 2023

When institutions in the United States and other high-income countries embark on collaborations to improve health or the delivery of health care in low-income countries, they do it with the best of intentions. But intentions aren’t good enough. Projects conducted by trainees at schools of medicine, public health, and other health disciplines in high-income countries can often make the problems they set out to address worse.

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PharmaVoice

JANUARY 25, 2023

The pharma giant's CEO Joaquin Duato and CFO Joseph Wolk showed that they're optimistic about reaching lofty goals despite hard economic times.

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Pharma Times

JANUARY 25, 2023

Data shows that STC-15 exhibits efficacy as a single agent and in combination with venetoclax

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Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

Outsourcing Pharma

JANUARY 24, 2023

Research emerging from the University of Toronto found that using machine learning models was able to guide the design of long-acting drug formulations.

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STAT

JANUARY 26, 2023

WASHINGTON — The FDA is giving up on trying to figure out a way to regulate CBD on its own. The agency announced Thursday that it is formally calling on Congress for help — and, according to one official, looking for guidance on other hemp products like Delta 8 THC, too. For nearly four years, the Food and Drug Administration has been laboring to craft a solution that would allow CBD to be legally sold in capsules, gummy vitamins, and various foods, even though the agency also cons

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PharmaVoice

JANUARY 24, 2023

Data discrepancies between study phases and indications could provide clues about why some trials have better racial and ethnic diversity than others.

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European Pharmaceutical Review

JANUARY 25, 2023

The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for exagamglogene autotemcel (exa-cel), the first regulatory submission for a CRISPR-based medicine. Through the validation, exa-cel is indicated for the treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The MAA from Vertex Pharmaceuticals and CRISPR Therapeutics is supported by two global Phase III studies.

Labelling 111

Labelling 111

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pharmaphorum

JANUARY 27, 2023

The emergence of COVID-19 resulted in staffing challenges that have continued to have a sustained, negative impact on clinical trial workflows. In fact, 76% of healthcare professionals have recently cited feelings of burnout, leading to a turnover rate twice as high as before the pandemic and increased levels of vacant positions across clinical research sites.

Medical Records 111

Medical Records Hospitals 111

STAT

JANUARY 23, 2023

Hospitals have bemoaned rising employee expenses throughout the pandemic, as they’ve paid workers more to prevent them from jumping to competitors, pursuing traveling gigs, or leaving the profession completely. But some, like those in Texas, have been able to bring in traveling nurses and other temporary staff on the taxpayers’ dime.

Hospitals 263

Hospitals 263

PharmaVoice

JANUARY 23, 2023

Cultivate relationships with HCPs in gated social platforms with content that will thrive.

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Pharmaceutical Technology

JANUARY 23, 2023

Systemic lupus erythematosus (SLE) is a systemic, inflammatory, chronic autoimmune disease that can affect multiple organs simultaneously or sequentially, with a relapsing and remitting nature. While SLE can affect multiple major organ systems in the body, one of its most severe manifestations is renal (kidney) involvement, known as lupus nephritis (LN).

Labelling 111

Labelling Immunity Immunization 111

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