Trending Articles

article thumbnail

Year-long fallout over retracted trans youth paper highlights new research era

STAT

Last year, a Springer Nature journal published a study surveying 1,700 parents of adolescents and young adults with gender dysphoria. Just a few months later, the study was retracted because there had been no formal process for those parents to consent to the study. But the story didn’t end there. Ongoing fallout from the paper and its retraction has opened up an internal rift among academic editors and journal staff that led to one editor’s resignation, as first reported by Retrac

342
342
article thumbnail

Getting IND ready — how companies can avoid common traps

PharmaVoice

Overpromising, overcommitting and neglecting CMC are a few of the pitfalls that cause sponsors to stumble when submitting a new drug application.

147
147
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

STAT+: Express Scripts sues FTC over a ‘biased’ report about pharmacy benefit managers

STAT

Express Scripts, one of the largest pharmacy benefit managers in the U.S., filed a lawsuit on Tuesday demanding that a recent Federal Trade Commission report accusing industry middlemen of raising drug prices be vacated. In scathing language, the company argued the report was “seventy-four pages of unsupported innuendo leveled … under a false and defamatory headline.

article thumbnail

Who’s winning in biotech’s tight market?

PharmaVoice

Three of the largest fundraising rounds in 2024 show where investors are willing to place their bets in biotech.

244
244
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

2275 pharmacies have closed so far in 2024

Ramblings of a pharmacist

“It’s not the way I wanted it to go,” he says sadly. “You do what you’re supposed to do. You go to college, get a doctorate, start a small business in a small town, support the community and it’s not even close to being a viable option.” “This isn’t because the community didn’t support us. It’s because we lose money on every prescription we fill.” Those are the words of Tom Wullstein, owner of Brandon Pharmacy.

article thumbnail

Three biotechs raise $700M in rare burst of IPO activity

BioPharma Dive

The offerings by Bicara, Zenas and MBX give a glimpse into what industry insiders describe as a backlog of mature startups waiting for the right opportunity to test public markets.

131
131

More Trending

article thumbnail

Agility in action: 5 ways to fast-track your clinical trial

PharmaVoice

Five ways to beat study timeline pressures and get medicines to patients faster.

235
235
article thumbnail

RPS announces proposals to become Royal College

The Pharmacist

The Royal Pharmaceutical Society (RPS) has today (12 September) announced proposals to become the 'Royal College of Pharmacy', with charitable status. It said the suggestion was the outcome of a 'comprehensive independent review' of its constitution and governance, which has taken place over the past 18 months. As a Royal College, the RPS said it […] The post RPS announces proposals to become Royal College appeared first on The Pharmacist.

article thumbnail

Ten-year survival data show long-term benefit of immunotherapy in melanoma

BioPharma Dive

Final follow-up results suggest Opdivo and Yervoy could be close to a cure for some people with advanced melanoma, shifting how doctors administer follow-up care.

125
125
article thumbnail

Novavax announces availability of Covid-19 vaccine in US pharmacies

Pharmaceutical Business Review

This vaccine is intended for individuals aged 12 and above and is now stocked at pharmacies including CVS Pharmacy, Walgreens, Rite Aid among others. The vaccine has been granted Emergency Use Authorization by the US Food and Drug Administration on 30 August 2024. This authorisation allows for the distribution of Novavax’s updated vaccine, which is the only protein-based option available in the country for the upcoming fall season.

Vaccines 111
article thumbnail

From Payroll Pains to Growth Gains: Streamlining Payroll & HR for Success

Speaker: Joe Sharpe and James Carlson

In the world of small business management, the challenge of managing payroll & HR efficiently while scaling operations can be overwhelming. Yet, with the right strategies in place, these challenges can become opportunities for growth and innovation. In this session, Joe Sharpe, Senior Director of Managed Payroll Services at IRIS, will reveal practical methods and expert insights for outsourcing and streamlining payroll processes, resulting in substantial time and resource savings.

article thumbnail

Opinion: Tested in Africa, used in America

STAT

At the recent annual International AIDS Conference, a startling presentation about the newest wonder drug in HIV prevention brought a raucous standing ovation. Lenacapavir, a novel drug given as an injection under the skin every six months, was 100% successful in preventing HIV in adolescent girls and young women in two countries in Africa. It felt to many like a generational moment.

Vaccines 338
article thumbnail

Biopharma prepares to pivot from China as Biosecure Act advances

PharmaVoice

After the House of Representatives passed the Biosecure Act last week, U.S. biotechs could be forced to cut ties with five Chinese contract partners.

162
162
article thumbnail

One in five patients struggle to get medication

The Pharmacist

One in five (20.1%) patients in England had problems obtaining their prescription medication this summer, according latest Office of National Statistics (ONS) figures. However, 85% of adults using pharmacy services said they were ‘very satisfied’ or ‘satisfied’ with the service they received. This exceeded the 67.4% of adults who tried to contact their GP practice […] The post One in five patients struggle to get medication appeared first on The Pharmacist.

112
112
article thumbnail

Ascendis trial data piles pressure on BioMarin

BioPharma Dive

Summary study results show Ascendis’ drug for achondroplasia could be competitive to BioMarin's Voxzogo, which is the foundation of the latter company's growth plans.

107
107
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

FDA clears sleep apnoea feature for new Apple Watch

pharmaphorum

Apple has the FDA authorisation it needs to bring its software for detecting sleep apnoea to the Apple Watch, coinciding with the launch of its new operating system for the wearable.The Breathing Disturbances function is part of watchOS 11, which makes its debut today alongside the release of the latest Apple Watch Series 10 which was revealed at the company's new product reveal earlier this month and is due to become available on 20th September.

105
105
article thumbnail

Q&A: The U.S. can, and should, do more on H5N1 bird flu, a top WHO official says

STAT

More work needs to be done by the agricultural sector to get to the bottom of — and put a stop to — transmission of H5N1 bird flu in dairy cattle in the United States, a senior World Health Organization official said over the weekend. Maria Van Kerkhove, the WHO’s acting director of epidemic and pandemic preparedness and prevention, said the world is watching how the U.S., with its advanced scientific expertise, is responding to this outbreak.

363
363
article thumbnail

F2G raises $100 million to combat innovation 'paucity in antifungals

Outsourcing Pharma

One year after a rejection by the US Food and Drug Administration (FDA), the UK firm F2G has raised $100 million to push its candidate olorofim to the market for the treatment of rare fungal infections in 2026.

101
101
article thumbnail

ADC developed by Daiichi, Merck outperforms chemo in lung cancer trial

BioPharma Dive

The FDA previously rejected patritumab deruxtecan over manufacturing issues. Tuesday's study data should boost the companies' case, however.

114
114
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

ESMO 2024 – Today’s oncological roots are branching

pharmaphorum

ESMO 2024 began on Friday 13th September. Prof Andres Cervantes discussed how building trust has been a several generation development, following five decades of effort in the oncological space.

115
115
article thumbnail

Opinion: What the doctors’ protests in India are missing

STAT

In early August, a doctor was raped and murdered in a Kolkata public hospital by a “ civic volunteer ” who was neither a patient nor a staff member. The crime has enraged and rattled the medical profession in India. For weeks now, doctors have been protesting throughout the country, demanding among other things “justice for the victim” and a safer work environment.

Hospitals 357
article thumbnail

FDA inspection backlog overseas threatens new drug approvals

PharmaVoice

The FDA’s backlog of overseas drug manufacturer inspections is still mounting — and new drugs could be delayed as a result.

147
147
article thumbnail

Welsh community pharmacies to get 'above-inflation investment'

The Pharmacist

The Welsh Government has announced an 'above-inflation investment' for community pharmacies in Wales – the details of which will be negotiated with Community Pharmacy Wales (CPW). Cabinet secretary for health and social care Mark Drakeford announced this week that he would uplift the pay of NHS staff on Agenda for Change contracts by 5.5%, and […] The post Welsh community pharmacies to get 'above-inflation investment' appeared first on The Pharmacist.

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

Gene therapy startup emerges with green light for first-of-its-kind trial

BioPharma Dive

Spun out of research at Nationwide Children’s Hospital, Vironexis claims it will be the first company to start a study testing a cancer drug delivered via the adeno-associated viruses commonly used in genetic medicines.

Hospitals 116
article thumbnail

ESMO: Enhertu shows its worth in brain metastases

pharmaphorum

Women with HER2-positive breast cancer can be treated with AstraZeneca and Daiichi Sankyo's Enhertu, regardless of whether their cancer has spread to the brain, according to a new study.The results of the open-label DESTINY-Breast12 trial – reported at the ESMO cancer congress in Barcelona – showed that nearly two-thirds (61.6%) of patients with brain metastases at baseline who were treated with the HER2-directed antibody-drug conjugate (ADC) were alive without disease progression at one year.

Labelling 111
article thumbnail

Pediatricians’ obesity guidelines rest on shaky evidence about eating disorder risks

STAT

To address soaring rates of childhood obesity, the American Academy of Pediatrics last year endorsed tactics it once considered risky.  “Watchful waiting” had been standard practice, in part from concern that a doctor’s focus on weight could inadvertently plant the seed for stigma or eating disorders like anorexia and bulimia.

353
353
article thumbnail

How a radiopharma up-and-comer builds momentum in a surging space

PharmaVoice

Big Pharma is embracing the radiopharmaceuticals boom that was a long time in the making.

182
182
article thumbnail

US FDA approves Eli Lilly’s drug for eczema

Express Pharma

Eli Lilly said on Friday the U.S. Food and Drug Administration approved its eczema drug for use in adults and children above 12 years old. The drug, which is an injectable medicine and branded Ebglyss, will be available in the next few weeks, the company said. Eczema, also known as atopic dermatitis, is an inflammatory skin condition that can cause itching, rashes and dry patches.

104
104
article thumbnail

Moderna, trailing rivals, checks its RSV shot expectations

BioPharma Dive

During an investor presentation Thursday, executives admitted to being overly optimistic their vaccine could wrest significant market share away from GSK's and Pfizer's products this year.

Vaccines 111
article thumbnail

Apple AirPods get FDA okay for use as OTC hearing aids

pharmaphorum

It's known that excessive use of earbuds at high volumes can cause hearing loss, so somewhat ironic that the FDA has just authorised software that can turn Apple AirPods into hearing aids.The green light is for Hearing Aid Feature (HAF), an app compatible with Apple's AirPods Pro earbuds that amplifies sounds and can be used for people aged 18 and over with perceived mild to moderate hearing impairment.

113
113
article thumbnail

STAT+: Genentech, a biotech with a storied past, confronts new turbulence in the present

STAT

For decades, the biotech company Genentech has carved out a reputation in the industry as a scientist’s paradise, a place where researchers have developed new therapies in-house and published high-impact papers. But the recent closure of a high-profile research group and multiple rounds of layoffs have many in the scientific community — including some of the company’s current and former employees — concerned about the biotech’s future and scientific strate

350
350
article thumbnail

After the Lykos debacle, what’s next for psychedelic therapies?

Pharmaceutical Technology

While Lykos Therapeutics’ MDMA therapy was rejected by the FDA, psychedelic therapy advocates remain optimistic about the sector.

116
116
article thumbnail

Wanbury announces new API product portfolio and launch plans

Express Pharma

Wanbury has announced the launch of its new active pharmaceutical ingredients (API) product portfolio for FY24-25. The company outlined a range of products to be commercialised, which cover therapeutic areas including anti-diabetics, antidepressants, anti-histamines, analgesics, anti-inflammatory drugs, antitussives, and anaesthetics. The new products, which are set to be launched in the upcoming fiscal year, include APIs like, Sertraline HCl, Diphenhydramine HCl, Diphenhydramine Citrate, Metfor

Diabetes 105