October, 2022

article thumbnail

PDUFA and BsUFA reauthorizations are wins for patients

PhRMA

America relies on the U.S. Food & Drug Administration (FDA) to keep pace with the scientific advancements happening every day in labs across the country. That’s why the recently enacted Prescription Drug User Fee Act (PDUFA VII) and Biosimilar User Fee Act (BsUFA III) are both great news for biopharmaceutical innovation and for patients. With these programs reauthorized for another five years, the FDA can continue doing its vital work reviewing medicines.

FDA 302
article thumbnail

Embrace Artificial Intelligence in the Pharmacy

Drug Topics

As technology advances in all areas of life, it is no surprise that technology is becoming more prevalent in independent pharmacy.

Insiders

Sign Up for our Newsletter

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

Trending Sources

article thumbnail

Vitamin D Shows Promise in Lowering Risk of Cardiovascular Disease

Pharmacy Times

A new review identified vitamin D as an important factor in maintaining endothelial progenitor cell health and function, which can impact risk of developing cardiovascular disease.

174
174
article thumbnail

Boston University researchers’ testing of lab-made version of Covid virus draws government scrutiny

STAT

Research at Boston University that involved testing a lab-made hybrid version of the SARS-CoV-2 virus is garnering heated headlines alleging the scientists involved could have unleashed a new pathogen. There is no evidence the work, performed under biosecurity level 3 precautions in BU’s National Emerging Infectious Diseases Laboratories, was conducted improperly or unsafely.

145
145
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

CVS Health supports future of pharmacy through minority scholarship program

Drug Store News

The scholarships represent a commitment to an inclusive community and promoting diversity of thought, background, perspective and experience to advance pharmacy education and improve patient health.

145
145
article thumbnail

Meet Florence, WHO’s AI-powered digital health worker

pharmaphorum

An artificial intelligence-powered digital health worker has been unveiled by the World Health Organisation (WHO) as its latest tool for disseminating reliable health information to the public. Originally developed by New Zealand tech company Soul Machines with support of the Qatar Ministry of Health, the first version of the virtual health worker was used to combat misinformation about the pandemic.

Vaccines 145

More Trending

article thumbnail

Mental Health and CBD: What's the Latest Info

Drug Topics

Drug Topics® is joined by Dr. Alex Capano, Chief Science Officer at Ananda professional to discuss what CBD is used for mental health, where research should go next, and how to ensure that patients are getting effective CBD products.

201
201
article thumbnail

Cancer Vaccine May be Effective for Melanoma Patients

Pharmacy Times

A researcher suggests that novel immune modulating cancer therapies like cancer vaccines can be more effective and safer alternative to previous cancer immunotherapies.

Vaccines 168
article thumbnail

Opinion: Maternity care in the U.S. is in crisis. It’s time to call the midwife

STAT

After pushing for several hours, my patient looks exhausted but happy, clutching her seconds-old newborn to her chest. As I help her put her baby to breast for the first time, she isn’t thinking about anything other than the tiny human blinking up at her. As well she shouldn’t.

145
145
article thumbnail

GSK speeds up the race to bring first RSV vaccine for older adults to market

Pharmaceutical Technology

After decades of setbacks, the respiratory syncytial virus (RSV) vaccine field has bounced back with positive Phase III trial results in older adults. There are currently five players in the race, with vaccines in Phase III of development from GlaxoSmithKline (GSK) , Pfizer , Johnson & Johnson , Moderna and Bavarian Nordic. However, recent data from GSK’s sub-unit vaccine, GSK-3844766A, have pushed the candidate to the top, with the highest efficacy demonstrated in a pivotal trial to date.

Vaccines 135
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

article thumbnail

Verge Genomics takes AI-sourced drug for ALS into clinic

pharmaphorum

Verge Genomics has joined a select group of biotechs who have taken a drug discovered and developed using artificial intelligence into human testing. The small-molecule PIKfyve inhibitor – called VRG50635 – has been administered to the first subject in the phase 1 trial involving healthy volunteers, according to the San Francisco-based biotech, which was founded in 2015 by Alice Zhang and Jason Chen.

article thumbnail

Mental Illness Awareness Week – A time for reflection

PhRMA

Each first week of October, Americans all across the country take time to reflect on an issue which is increasingly recognized as impacting everyone, whether it be directly as it does me, or indirectly through a family member or friend: mental illness. Mental Illness Awareness Week is an opportunity to raise awareness about the impacts of mental illness and to better understand and educate communities about what it means to face a mental illness, deal with significant moments of stress throughou

Insurance 272
article thumbnail

PTSD Therapies on the Fast Track

Drug Topics

Several drugs with novel mechanisms of action have been put on the pathway for speedier approval decisions by the FDA. Phase 2 and 3 trials are underway.

FDA 211
article thumbnail

Teamwork, Technology Helps to Strengthen Pharmacy Services

Pharmacy Times

Bri Morris, PharmD, senior director of Education and the Long-Term Care Division at the National Community Pharmacists Association, discusses the importance of teamwork in the pharmacy.

162
162
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

Opinion: Messaging — the unrecognized coefficient in pandemic control — matters

STAT

A little over a century ago, scientists working in laboratories discovered that microbes were the cause of many epidemics. Once they understood that, they began to put their faith more and more in laboratory science. This major transformation, called the bacteriological revolution, began in the 1880s. During this period, diphtheria was one of the leading causes of death among mostly poor children in New York City.

145
145
article thumbnail

Robotic capsule could replace injected biologics

European Pharmaceutical Review

Scientists at MIT have demonstrated that a novel robotic capsule could potentially replace conventional biologic injection methods by tunnelling through the intestinal mucus barrier to deliver insulin. The research, published in the journal Science Robotics described how the new drug delivery system can transport large protein and small-molecule drugs, like vancomycin, an antibiotic peptide.

136
136
article thumbnail

Thérèse Coffey criticised for giving leftover antibiotics to a friend

The Guardian - Pharmaceutical Industry

Health secretary accused of ‘monumental stupidity’ for saying she had shared a prescribed medication Doctors have rounded on the health secretary, ThĂ©rèse Coffey, after she admitted to sharing prescription medicines with others, actions the British Medical Association described as both dangerous and against the law. Coffey told civil servants in a meeting last month that she had given leftover antibiotics to a poorly friend, an admission that came as the discussion on how to alleviate pressures

131
131
article thumbnail

Busting 3 Myths About Copay Coupons

PhRMA

Insurer-imposed barriers like high deductibles and coinsurance shift the cost of life-saving care onto patients. Manufacturers and others have stepped forward to assist patients who face high out-of-pocket costs, using programs like copay coupons to help eligible, commercially insured patients afford their out-of-pocket costs. In fact, the share of patients staying on treatment for one year increased by up to 47% when patients used copay coupons.

Insurance 263
article thumbnail

Follow the Money

Drug Topics

As he prepared to move house, our columnist was struck by the similarities between a yard sale and the prescription drug pricing infrastructure.

200
200
article thumbnail

Wearables Made for the Pharmaceutical Industry

Pharmacy Times

Purpose-built assisted reality solutions help streamline processes and maintain regulatory compliance from the laboratory to the factory floor.

181
181
article thumbnail

Human neurons implanted in a rodent’s brain lead a rat to water — and make it drink

STAT

The scientist flicked on a laser, filling the rat’s brain with blue light. The rodent, true to its past two weeks of training, scampered across its glass box to a tiny spout, where it was duly rewarded with a drink of water. From the outside, this would appear to be a pretty run-of-the-mill neuroscience experiment, except for the fact that the neurons directing the rat to its thirst-quenching reward didn’t contain any rat DNA.

143
143
article thumbnail

Novel cancer therapeutic synthesised by Stanford researchers

European Pharmaceutical Review

Research published in the journal Nature Chemistry , shows how researchers from Stanford University in the US uncovered a promising new method to synthetically manufacture the compound tigilanol tiglate, named EBC-46, which could offer targeted medicine for cancer and other diseases. Natural sources of the compound can only be found in a small section of the Northeastern Australia rainforest, in fruit seeds from the blushwood tree ( Fontainea picrosperma ).

article thumbnail

Cloud robotics labs are accelerating drug discovery and development

Pharmaceutical Technology

Drug discovery and development is an incredibly expensive and time-consuming process, taking between 12 and 18 years, and costing on average between $2 billion and $3 billion. Considering the low chances of success, with only 10% of drug candidates making it into clinical development, pharma companies must prevent the increased erosion of profit margins.

article thumbnail

In their own words: Insured Americans struggle to navigate complex coverage

PhRMA

A survey of more than 5,000 Americans conducted with Ipsos found that nearly 40% of insured Americans struggle to understand what their health insurance covers.

Insurance 265
article thumbnail

Industry Trends: What to Watch For

Drug Topics

From biosimilars to artificial intelligence, these are the trends poised to take community pharmacy by storm.

article thumbnail

Pharmacists Can Affirm Transgender, Non-Binary Patients

Pharmacy Times

A presentation at the AMCP Nexus conference focuses on the health care disparities and pharmacotherapy options for gender affirmation.

181
181
article thumbnail

STAT+: European Prosecutor’s Office confirms it’s investigating European Union Covid vaccine contracts

STAT

In an unusual step, the European Public Prosecutor’s Office (EPPO) confirmed it has opened an investigation into the Covid-19 contracts signed by the European Union, a move that comes shortly after numerous members of the European Parliament harshly criticized a lack of transparency surrounding an agreement with Pfizer. The EPPO is an independent public prosecution office that is responsible for investigating, prosecuting, and bringing to judgment crimes such as fraud, money laundering an

Vaccines 143
article thumbnail

Janssen leads effort to cut waste in digital health devices

pharmaphorum

A consortium of industry and academic groups – led by Johnson & Johnson’s pharma division Janssen – has been set up to tackle the environmental impact of digital health products, specifically aimed at minimising waste that could end up in landfill. The Digital Health in a Circular Economy (DiCE) group was formed earlier this year with the aim of developing ways to “design, collect, directly reuse, refurbish, remanufacture, and recycle digital health devices.” The programme

Labelling 124
article thumbnail

Participation push: How retail pharmacies can innovate clinical trials

Drug Store News

CVS Health Clinical Trial Services was launched in 2021 with the goal of developing and executing a community-centric model for clinical trials.

137
137
article thumbnail

Word of the Month: What is Long COVID?

PhRMA

What is Long COVID?

Vaccines 290
article thumbnail

What CBD Brings to the Table for Dermatologic Concerns

Drug Topics

Drug Topics® is joined by Dr. Alex Capano, Chief Science Officer at Ananda professional to discuss what CBD is used for in dermatology.

200
200
article thumbnail

Artificial Intelligence is Changing the Face of Pharmacovigilance

Pharmacy Times

Pharmaceutical companies are looking into AI as the new method to not only reduce research and development costs, but also prevent costly errors.

article thumbnail

Which diet and health habits are backed by science? Now there’s a tool for that

STAT

Does eating red meat increase one’s risk of heart disease? Would eating more vegetables help? Is leaving high blood pressure untreated really a death wish? The answers might vary, depending on who a person asks, which friend or TikTok nurse, and when. Researchers at the University of Washington want to make it easier to find current, evidence-based health advice.

141
141
article thumbnail

Innovative Medicines Fund and the opportunity for ICSs to mobilise NICE approvals

pharmaphorum

In June, NHSE and NICE published details on the Innovative Medicines Fund, which will help improve patient access to cutting-edge medicines, with a particular focus on rare diseases, and ensure global pharmaceutical and biotech organisations continue to prioritise the UK as a launch destination. Join us on Wednesday 23rd November at 12:30 GMT / 13:30 CET / 7:30 am EST as the panel discuss how the Innovative Medicines Fund works, what the implications are for industry organisations in securing fu

122
122