Sat.Jan 14, 2023 - Fri.Jan 20, 2023

article thumbnail

HIV vaccine being developed by Johnson & Johnson fails clinical trial

STAT

Yet another experimental HIV vaccine has failed. The National Institute of Allergy and Infectious Diseases reported Wednesday that a Phase 3 clinical trial of a vaccine was stopped because the vaccine was ineffective at preventing HIV infection. The vaccine was being developed by Janssen, the vaccine division of Johnson & Johnson.

Vaccines 363
article thumbnail

After ‘limping along,’ Novavax sees a path forward

PharmaVoice

With a new CEO and a long-term booster strategy, the company believes there’s plenty of room to grow in the COVID-19 vaccine space.

Vaccines 274
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Pharmaceutical microbiology: key developments 2022

European Pharmaceutical Review

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. Dr Tony Cundell, PhD, Principal Consultant, Microbiological Consulting, LLC. Miriam Guest, Principal Microbiologist at AstraZeneca. Regulation, particularly Annex 1, was identified as a key focus for 2022.

Vaccines 128
article thumbnail

AI continues to gain momentum in the biopharmaceutical industry in 2023

Pharmaceutical Technology

While the biopharmaceutical industry has been impacted and pressured by various factors such as the Covid-19 pandemic, inflation, the Ukraine-Russia war, ongoing supply chain issues, and a challenging economic environment, collaboration between pharma companies and emerging technologies providers continues to grow, especially in the research and development (R&D) field, offering some resilience in times of geopolitical and economic disruptions.

article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

article thumbnail

Mix-it-yourself Wegovy? Some are trying risky sources for weight-loss drugs

STAT

With a few clicks, Daniel added the chemical to his online cart and ordered it. In less than a week, a vial containing white powder arrived at his house. He used a syringe to measure out sterile water and eject it into the vial to dissolve the powder. Then, with a different syringe, he drew up about a quarter of a milliliter of the solution and injected it into his lower abdomen.

Diabetes 349
article thumbnail

FDA’s 2022 drug approvals fall short of recent norms

PharmaVoice

The U.S. agency’s lower number of novel drug approvals followed several controversies surrounding a 2021 Alzheimer’s approval.

246
246

More Trending

article thumbnail

CARsgen and Huadong Medicine to commercialise CT053 in mainland China

Pharmaceutical Technology

CARsgen Therapeutics has announced a col labor ation with Huadong Medicine to commercialise zevorcabtagene autoleucel (zevor-cel), CT053, in mainland China. The fully human, autologous BCMA CAR T-cell product candidate of CARsgen, CT053 has been developed to treat relapsed/refractory multiple myeloma (R/R MM). It comprises autologous T cells that are modified genetically with a CAR including a complete human anti-BCMA single-chain fragment variant that has a high binding affinity.

article thumbnail

A new study links social media use to changes in teen brains. Is that a bad thing?

STAT

Today’s teens and tweens have never known a world without social media. There are still a lot of open questions about how sites like TikTok and Instagram may shape their development — and stories focusing on the potential negative impacts of social media tend to dominate the news. But a recent study published in JAMA Pediatrics is the latest in a growing body of research that suggests the relationship that young people have with social media is too complicated to be categorized as

333
333
article thumbnail

Pro sports’ COVID protocols led to real-world data impacts for pharma

PharmaVoice

After years of pioneering new methods for using data and technology to improve patient health outcomes, IQVIA’s Christina Mack is on the cusp of a research revolution.

148
148
article thumbnail

Switzerland and US sign drug inspection agreement

European Pharmaceutical Review

A Mutual Recognition Agreement (MRA) relating to pharmaceutical Good Manufacturing Practice (GMP) has been signed between Switzerland and the US. Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

article thumbnail

Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

article thumbnail

Let’s Get Social: The Ascendancy of Social Media to the Top of the Media Mix

PharmExec

Fran Pollaro talks with Amanda Powers-Han, chief marketing officer at Greater Than One, a full-experience marketing agency dedicated to healthcare, about what’s trending in early 2023 for pharma media mixes.

111
111
article thumbnail

The addiction crisis is causing a spike in endocarditis cases. Hospitals are struggling to respond

STAT

Increased injection drug use has led to a spike in cases of the life-threatening heart condition endocarditis , with cases rapidly accelerating since the onset of Covid-19. The increased case count is one of the lesser-known side effects of the deadly addiction epidemic. But patients with endocarditis, an inflammation of the heart lining caused by infection, require complex, thoughtful care — care that the U.S. health system is ill-equipped to provide.

Hospitals 298
article thumbnail

The M&A hunt is on — here are the prime targets

PharmaVoice

Companies with advanced molecular therapies, oncology assets and obesity treatments could be fuel for a dealmaking fire this year.

163
163
article thumbnail

MHRA authorises BRUKINSA® in Great Britain for two cancers

European Pharmaceutical Review

Two marketing authorisations for BRUKINSA ® (zanubrutinib) have been granted in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA). The indications are for adults with chronic lymphocytic leukaemia (CLL) and for adults with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. The MHRA’s authorisation is significant “… as there is no targeted treatment currently authorised for MZL patients other than chemoimmunotherapy

Labelling 119
article thumbnail

Best Practices to Streamline Compensation Management: A Foundation for Growth

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.

article thumbnail

Hospital Universitario and Josep Carreras develop cell therapy for leukaemia

Pharmaceutical Technology

Spain’s Hospital Universitario 12 de Octubre researchers, along with the Josep Carreras Leukaemia Research Institute, have developed a new cell therapy based on STAb cells to treat a type of leukaemia. The Spanish Association Against Cancer (AECC) provided funding for the new STAb therapy development. It could be used for T-Cell Acute Lymphoblastic Leukaemia (T-ALL) treatment in patients for whom bone marrow transplantation and chemotherapy failed to work.

Hospitals 110
article thumbnail

Mental health benefits of gender-affirming hormones for teens persist for two years in new study

STAT

Trans and nonbinary teenagers who receive gender-affirming hormones experience less depression and anxiety and more satisfaction with life than before the treatment, according to a new study published Wednesday in the New England Journal of Medicine. Researchers followed over 300 adolescents across the U.S. for two years after initiating hormone treatment.

280
280
article thumbnail

Focusing on smaller biotechs to have a big impact on society

PharmaVoice

Marcus Delatte discusses how and why he focuses his expertise on counseling smaller companies and mentoring the next generation of technical experts.

130
130
article thumbnail

UK medical cannabis manufacturer granted GMP registration

European Pharmaceutical Review

The first good manufacturing practice (GMP) registration of a UK pharmaceutical facility for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API) has been granted since the legalisation of medical cannabis in 2018. Celadon Pharmaceuticals’ Midlands site is now registered by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for GMP manufacturing.

Labelling 119
article thumbnail

Position Your Pharmacy for Expansion

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.

article thumbnail

Amvuttra recommended by NICE for amyloidosis

Pharma Times

Therapy is among the first to receive a positive draft recommendation under streamlined pilot process

141
141
article thumbnail

STAT+: Hip and knee replacements go better when performed by high-volume surgeons, new study finds

STAT

A new study underscores the importance of the adage “practice makes perfect,” especially when it comes to surgery. It’s long been understood that the frequency at which surgeons perform and hospitals host complex procedures has a bearing on how patients fare, but the study from the Clarify Health Institute makes the link even clearer.

Hospitals 266
article thumbnail

UBC crowns Bekki Brown as its new CEO with a clear mandate to grow

PharmaVoice

The first-time CEO is tapping into decades of operational expertise to help bring real-world data into the mainstream.

130
130
article thumbnail

UK ATMP clinical trials report 2022 published

European Pharmaceutical Review

The Cell and Gene Therapy (CGT) Catapult has published its ‘ UK Advanced Therapy Medicinal Products (ATMP) Clinical Trials Report 2022 ’. In the data, T cells were revealed as the most commonly investigated cell type continuing to increase. The research observed this cell type took up 58 percent of UK ATMP clinical trials in 2022. . Matthew Durdy, Chief Executive of CGT Catapult commented: “It is encouraging to see continued growth of UK clinical trial activity, demonstrating the UK as a favoura

article thumbnail

Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

article thumbnail

US eyes link between Pfizer bivalent COVID jab and stroke

pharmaphorum

Regulatory authorities in the US are investigating a possible link between the new Pfizer/BioNTech bivalent COVID-19 booster vaccine and strokes in people aged 65 or over, but still recommend the shots. Monitoring has pointed to a possible higher risk of ischaemic stroke in the 21-day period post-vaccination in this age group compared to 22 to 44 days post-vaccination, according to an announcement on the Centre for Disease Control and Prevention (CDC) website. “Although the totality of the

Vaccines 111
article thumbnail

STAT+: Moderna says RSV vaccine worked, setting stage for competition with GSK and Pfizer

STAT

Moderna’s vaccine against the respiratory syncytial virus, or RSV, reduced the rate of lower respiratory disease in people over 60 in a Phase 3 trial, the company said Tuesday. The result will increase competition in a soon-to-be crowded market. The drug giants Pfizer and GlaxoSmithKline have already presented results for their RSV vaccines in older individuals, and have been preparing for what could be a brisk marketing battle.

Vaccines 286
article thumbnail

Woman of the Week: Genetika+’s Talia Cohen Solal

PharmaVoice

The CEO is aiming to build a “brain-in-a-dish” to treat all patients for better mental health outcomes.

130
130
article thumbnail

Moderna joins the Association of the British Pharmaceutical Industry

European Pharmaceutical Review

Moderna has joined the Association of the British Pharmaceutical Industry (ABPI) , the UK’s leading pharmaceutical industry body. As the newest member of the ABPI, the membership will help Moderna to build on its wider long-term commitment to expand its footprint and investment in the UK. Key to the company’s ambitions for global growth will be a new state-of-the-art vaccine research, development and manufacturing facility in the UK.

Vaccines 110
article thumbnail

5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

article thumbnail

Scottish Medicines Consortium recommends Merck’s Tepmetko

Pharma Times

Therapy is the first oral MET inhibitor treatment option for certain advanced NSCLC adult patients

138
138
article thumbnail

In the search for therapies for solid tumors, companies are turning to a novel target: claudin-6

STAT

On Target is a recurring feature from STAT that dives deep into the most promising drug targets in oncology. This column is adapted from the new STAT Report : Targeting cancer: the new frontier of immunotherapy and precision oncology. Targeted immunotherapies like CAR-T have been remarkably successful in combating blood cancers like chronic lymphocytic leukemia.

281
281
article thumbnail

A Moderna tie-up ushers in new era for CytomX

PharmaVoice

The antibody-focused company followed up a tough year with big partnerships to keep the ball rolling.

130
130
article thumbnail

mRNA vaccine trial shows efficiency in older adults with RSV

European Pharmaceutical Review

mRNA-1345 demonstrated vaccine efficacy (VE) of 83.7 percent in Moderna’s mRNA vaccine Phase III trial targeting respiratory syncytial virus (RSV) in older adults. Stéphane Bancel, Moderna’s Chief Executive Officer observed that the results represent an important step forward in preventing lower respiratory tract disease (RSV-LRTD) in adults over 60 years old.

Vaccines 105
article thumbnail

Celadon receives good manufacturing practice approval

Pharma Times

MHRA approval relates to the company’s midlands-based drug development facilities