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

article thumbnail

The FDA might yank cold medicines from shelves — and that could be just the beginning

PharmaVoice

Phenylephrine’s future is up in the air with an FDA committee saying it’s not effective and a class action lawsuit alleging false advertising. What comes next could have big repercussions.

300
300
article thumbnail

Researchers try to tease out possible ties between long Covid and menopause

STAT

When she stopped getting her period in March 2022, Daryn Schwartz wasn’t especially concerned. At 42, she had recently come off birth control, and figured her cycles were still adjusting. When it hadn’t come back by the summer, she sought gynecological care, but was told to wait it out. So she did, with no changes. She was having other symptoms, too — fatigue, chronic pain, and difficulty focusing.

364
364
Insiders

Sign Up for our Newsletter

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

article thumbnail

First-in-class phosphate absorption inhibitor approved by FDA

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. Ardelyx’s first-in-class oral treatment is indicated to reduce serum phosphorus in adults with chronic kidney disease ( CKD ) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant to phosphate binder therapy.

article thumbnail

UCL study suggests changes to improve MRI scans for prostate cancer

Pharma Times

The research aims to make MRIs more available to men and improve treatment decisions - News - PharmaTimes

150
150
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

Actor and epilepsy advocate Greg Grunberg wants the world to ‘talk about it’

PharmaVoice

The actor of “Heroes” and “Star Wars: The Force Awakens” fame is starring in another role as a patient advocate for people with epilepsy.

347
347
article thumbnail

The fight for control of methadone, addiction treatment’s ‘miracle molecule’

STAT

A doctor, a patient advocate, and the most powerful figure in the methadone treatment industry presented competing visions for the future of American addiction medicine this week — a conversation that touched on stigma, patients’ rights, and a stark divide in health provider attitudes toward patients with addiction. The debate centered on a single question: whether U.S. doctors should be able to prescribe methadone, a medication used to treat addiction to drugs like fentanyl and he

363
363

More Trending

article thumbnail

AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

FDA Law Blog: Biosimilars

By Gail H. Javitt & Steven J. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The first article—“Is the Eye the Window to Alzheimer’s?

article thumbnail

Has the science of anti-aging caught up with the dream of a longer life?

PharmaVoice

Billionaire investors and a new crop of longevity biotechs are betting big money on a lifespan-altering tipping point.

307
307
article thumbnail

Serotonin levels are depleted in long Covid patients, study says, pointing to a potential cause for ‘brain fog’

STAT

If you’ve been following the mystery of long Covid since it emerged in 2020, you’ll recall interferons and serotonin have been clues from the start as combatants in the body’s prolonged battles against the virus. Theories about why symptoms persist long after the acute infection has cleared often point to two suspects: viral reservoirs where SARS-CoV-2 lingers and inflammation sparked by the infection that doesn’t subside.

364
364
article thumbnail

MHRA finds fake Ozempic pens in UK supply chain

The Pharmacist

Pre-filled pens falsely labelled as Ozempic have been identified in the UK supply chain, the Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed. The pens were identified before reaching UK patients, and all affected pens have now been recalled and accounted for, the MHRA said. The products were imported from legitimate suppliers in Austria […] The post MHRA finds fake Ozempic pens in UK supply chain appeared first on The Pharmacist.

Labelling 119
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

Starvation stress key in Micrococcus luteus cleanroom survival

European Pharmaceutical Review

A paper by Tim Sandle, Head of Microbiology, Risk Management and Sterility Assurance at Bio Products Laboratory Ltd has underlined the importance of proper cleanroom disinfection practices by elucidating on the robust survival mechanism of the bacterium Micrococcus luteus (M. luteus). As “one of the most abundant organisms on the outer layer of human skin” M. luteus is a common contaminant recovered from cleanrooms, according to Sandle.

116
116
article thumbnail

The PharmaVoice 100: Rare disease warriors

PharmaVoice

Biopharma leaders pounding away at rare diseases so patients with few other options can have healthier lives.

277
277
article thumbnail

Is there a nursing shortage in the United States? Depends on who you ask

STAT

Hospitals are frustrated with a nationwide nursing shortage that’s only gotten worse since the pandemic. In 2022, the American Hospital Association quoted an estimate that half a million nurses would leave the field by the end of that year, bringing the total shortage to 1.1 million. At the same time, National Nurses United insists there isn’t a nurse shortage at all.

Hospitals 363
article thumbnail

Focussing on finding value in health sciences marketing

pharmaphorum

In this latest instalment of the pharmaphorum podcast, web editor Nicole Raleigh speaks with life sciences advisor Randall Hein, CEO of Heinsight LLC, and health sciences marketing expert Krystle Buntemeyer, CEO of SCORR Marketing, about the trends and changes for health sciences marketing over the past few years.

116
116
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

Parkinson’s UK grants £400,000 to research projects in Scotland

Pharma Times

The two projects will investigate the potential causes of Parkinson’s disease - News - PharmaTimes

141
141
article thumbnail

Hyloris wins painkiller approval amidst amplified anti-opioid efforts

Pharmaceutical Technology

The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.

145
145
article thumbnail

Zuckerberg and Chan announce a New York biohub to build disease-fighting cellular machines

STAT

Meta founder Mark Zuckerberg and his wife, pediatrician and philanthropist Priscilla Chan, announced on Wednesday plans to invest $250 million over 10 years to establish a new “biohub” in New York City focused on building a new class of cellular machines that can surveil the body and snuff out disease. The new initiative, publicly revealed at the 2023 STAT Summit and previewed exclusively to STAT, is the latest program from the Chan Zuckerberg Initiative, or CZI, a company the coup

363
363
article thumbnail

Beam to lay off 100 employees, seek partners in research restructuring

BioPharma Dive

The base editing specialist will prioritize medicines for sickle cell and alpha-1 antitrypsin deficiency, while trimming its plans for other programs in cancer and hepatitis B.

111
111
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

Pharmacists’ Role in Treating Substance Use in Adolescents 

National Association of Boards of Pharmacy

Young People and Substance Use Disorder October is Youth Substance Use Prevention Month , highlighting prevention and treatment efforts to keep adolescents drug free. Although drug use has always been a concern for teens, there are specific challenges that today’s youth face. Thankfully, since the coronavirus disease 2019 (COVID-19), a National Institutes of Health survey has shown that illicit use of drugs in teens has decreased, with 11% of eighth graders, 21.5% of 10th graders, and 32.6% of 1

article thumbnail

Novo Nordisk stops trial of Ozempic in kidneys as interim analysis shows success

Pharmaceutical Technology

In October 2023, Novo Nordisk announced that its trial studying Ozempic (semaglutide) in diabetic CKD patients, will come to a halt almost a year prior to its planned completion.

Diabetes 111
article thumbnail

STAT+: Zuckerberg and Chan on track to put $50 billion toward science: ‘That’s the trajectory we’re on’

STAT

Mark Zuckerberg and Priscilla Chan sit atop a fortune that is currently valued at $113 billion, and they’ve promised to give almost all of it away. Their philanthropic funding group, the Chan Zuckerberg Initiative, is committed to investing in an array of fields, including science, education, housing insecurity, and expanding access to startup capital to entrepreneurs of color.

article thumbnail

Sanofi treatment could slow type 1 diabetes progression

European Pharmaceutical Review

TZIELD (teplizumab-mzwv) has demonstrated TZIELD’s potential to slow disease progression in newly diagnosed children and adolescents with Stage 3 type 1 diabetes. Data from the Phase III PROTECT clinical trial , presented at the 2023 Annual ISPAD Conference, showed that superior beta cell preservation was observed compared to placebo. As the primary endpoint, 94.9 percent of participants in the TZIELD group maintained peak C-peptide levels ≥0.2 pmol/mL.

Diabetes 111
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

BrainStorm, after setbacks, withdraws approval application for ALS drug

BioPharma Dive

A panel of FDA advisers last month found BrainStorm’s data unconvincing. The company now says a Phase 3b study will be needed for its NurOwn cell therapy to have a shot at an approval.

111
111
article thumbnail

Deep brain stimulation could improve memory loss in Alzheimer’s disease

Pharma Times

The new technology was safely trialled on 20 healthy volunteers for the first time ever - News - PharmaTimes

135
135
article thumbnail

Michael J. Fox on how far Parkinson’s research has come: ‘We don’t want to be celebrated. We want to get things done.’

STAT

When Michael J. Fox was diagnosed with Parkinson’s disease at age 29, his clearest symptom was a small one — his pinky finger was twitching. But even by that stage, 70% to 80% of a patient’s dopamine-producing cells are already gone, Fox said. “What happens in that time, that shadowy place?” Fox said, referring to the period before his pinky finger first started twitching.

342
342
article thumbnail

Sustainability crucial for pharma’s supply chain future

European Pharmaceutical Review

According to sustainability results from CPHI’s Annual Survey 2023, sustainability goals and metrics are now being implemented across the pharma supply chain , with the rate of adoption accelerating quickly. Most contract development and manufacturing organisations (CDMOs) are expected to use them within the next two years. This is a significant shift from last year’s survey when the expectation was that changes would take up to five years, the data showed.

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

Ultragenyx to spin out new company around Alzheimer’s gene therapy

BioPharma Dive

CEO Emil Kakkis says the company's findings are too exciting to ignore, but the “high-risk, high-return” venture needs to be pursued outside the organization.

107
107
article thumbnail

UKRI awards £10m in funding to tackle antimicrobial resistance

Pharma Times

UK researchers can apply to receive a share of £3m to set up transdisciplinary networks - News - PharmaTimes

131
131
article thumbnail

STAT+: How one scientist’s determination made Novo Nordisk an obesity-drug powerhouse

STAT

Lotte Bjerre Knudsen was still getting used to all the empty benches in her lab when she ran into a tall man with black wide-framed glasses in the hallway: Mads Krogsgaard Thomsen, the new head of research at the Danish drugmaker Novo Nordisk, and her new boss. He was just one of many changes she had found upon returning from maternity leave earlier that week — along with the departures of nearly every colleague with whom she had spent the last three years struggling to create a potential

Diabetes 356
article thumbnail

Counterfeit diabetes pens identified in EU and UK

European Pharmaceutical Review

According to the European Medicines Agency (EMA), pre-filled pens falsely labelled as the type 2 diabetes medicine Ozempic ( semaglutide , 1mg, solution for injection) have been identified at wholesalers in the EU and the UK. The pens, with labels in German, originated from wholesalers in Austria and Germany. There are differences in the appearance between the falsified pen and the original pen.

Diabetes 105
article thumbnail

Real World Evidence (RWE) for Pharma Marketing – Quiz

PharmaState Academy

"The Quiz competition is on! Participate Now! Note: You can participate only 1 time. Participation by using another name & email id will lead to disqualification. The winner will be announced after profile verification. Once you're a winner, you will not be considered for the prizes for another two months. Note: You can participate only 1 time. Participation by using another name & email id will lead to disqualification.