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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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

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

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Chemotherapy Immunity Immunization Vaccines 135

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

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 328

Documentation Vaccines 328

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 148

Communication 148

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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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 333

Vaccines 333

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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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

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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 128

Adverse Reactions Vaccines 128

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 327

Hospitals 327

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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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.

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Compounding 119

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.

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

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 294

Vaccines 294

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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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

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.

pharmaphorum

JANUARY 24, 2023

Drastic steps need to be taken if the UK is to reverse a steep decline in medicines manufacturing in recent years, according to a cross-industry coalition. A just-published report from the Medicines Manufacturing Industry Partnership (MMIP) – set up by the UK government and biopharma industry in 2014 to drive growth in the category – says the sector has the potential to be a driver for the UK economy in the next decade.

Pharmaceutical Manufacturing 111

Pharmaceutical Manufacturing 111

STAT

JANUARY 26, 2023

A loophole in prescription drug regulation exposes American consumers to false and misleading claims of drug ads via on-line businesses promoting potent drugs without accurate information about their risks and benefits. Many countries prohibit direct-to-consumer advertising of prescription drugs. The United States allows it, but only if pharmaceutical companies comply with standards for accuracy and balance established and enforced by the Food and Drug Administration.

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Pharmaceutical Companies Pharmaceutical Companies 266

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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European Pharmaceutical Review

JANUARY 26, 2023

Typical extractables and leachables (E/L) studies aim to identify, quantify and ultimately minimise any impurities that can migrate from packaging into a final product or drug. Gas or liquid chromatography-mass spectrometry (LC/MS) or (GC/MS) have been widely used in extractables studies however, there are several challenges associated with E&L analyses including: Detection and quantification of unknowns Sensitivity and detection at trace levels Reducing uncertainty factors Increasing s

Packaging 111

Packaging 111

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Pharmaceutical Technology

JANUARY 22, 2023

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients. Jardiance is currently being evaluated as a potential therapy for reducing kidney disease progression and cardiovascular death risk in CKD adult patients.

Diabetes 105

Diabetes 105

STAT

JANUARY 26, 2023

WASHINGTON — It’s not every day that the pharmaceutical industry, the NAACP, a cancer center, and a nonpartisan think tank are all lobbying to achieve the same policy goal. But an effort to expand Medicare coverage for obesity drugs has managed to unite them all, and many more groups across the health care industry, too.

Drug Pricing 256

Drug Pricing 256

pharmaphorum

JANUARY 27, 2023

Johnson & Johnson has been cleared to continue a lawsuit filed last year against drug benefit programme SaveOnSP, which claims it defrauded a payment assistance programme for patients out of “at least $100 million.” The complaint – originally filed in May 2022 in a New Jersey federal court – alleges that SaveOnSP took advantage of J&J’s Janssen CarePath programme, which covers eligible patients’ out-of-pocket expenses for 44 of its more expensive prescription drug

Health Insurance Companies 105

Health Insurance Companies Specialty Pharmacies Documentation 105

European Pharmaceutical Review

JANUARY 27, 2023

The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Once implemented the manufacturing regulatory framework will apply to all point of care (POC) products manufactured in the UK, such as: Advanced therapy medicinal products (ATMPs), such as cell therapy , gene therapy and tissue engineered products 3D prin

Hospitals 105

Hospitals 105

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Pharmacy Management

PhRMA

JANUARY 25, 2023

Earlier this month, the American Cancer Society (ACS) released its annual report, Cancer Statistics 2023, finding the overall cancer mortality rate has declined 33% since peaking in 1991, leading to an estimated 3.8 million averted cancer deaths over this period. The report notes the continued decline in death rates since 1991, including a 1.5% decrease between 2019 and 2020 alone, increasingly reflects advances in prevention and treatment—including new medicines which have improved survival acr

Documentation 101

Documentation 101

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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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.

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Medical Records Hospitals 110

European Pharmaceutical Review

JANUARY 27, 2023

To help expand access to medicines in low- and middle-income countries (LICs) Eli Lilly and Company has announced it will provide $1.15m to a new cold chain capacity initiative. The investment will enable an estimated 150 medical-grade refrigeration units to be installed at 25 Life for a Child partner facilities in Africa, Latin America, the Caribbean and Southeast Asia.

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Communication Diabetes 105

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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