Sat.Jun 14, 2025 - Fri.Jun 20, 2025

article thumbnail

Top Pharmacy Residency Interview Questions and Tips

UWorld | RxPrep

Prepare for success with this guide to pharmacy residency interview questions, sample answers, and expert tips to help you excel.

40
article thumbnail

STAT+: Gilead won U.S. approval for HIV prevention shot, but when will low-income countries gain sufficient access?

STAT

Now that Gilead Sciences has won U.S. regulatory approval for its groundbreaking HIV prevention drug , the company has another hurdle to clear — ensuring the medicine can be accessed in low-income countries where the disease remains a stubborn problem. As far as Gilead is concerned, the groundwork exists to meet that goal. Last October, the drugmaker reached voluntary licensing agreements to eventually make lenacapavir available in 120 mostly low- and lower-middle-income countries.

Insiders

Sign Up for our Newsletter

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

article thumbnail

FDA to speed reviews for drugs supporting ‘national interests’

PharmaVoice

A new pilot program announced by FDA Commissioner Dr. Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.

219
219
article thumbnail

Gene therapy faces fresh uncertainty as two more top FDA officials depart

BioPharma Dive

The reported dismissal of high-ranking CBER officials Nicole Verdun and Rachael Anatol resurfaced lingering concerns about how gene therapies will be regulated under new FDA leadership.

128
128
article thumbnail

Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

article thumbnail

eXmoor and Signadori Bio enter cell therapy partnership

Pharma Times

Subscribe Advertise About us Follow Follow Follow Follow GO Magazine PharmaTimes Magazine Archive Web Exclusives News Competitions Appointments Business Insights Webinars Thought Leadership Jobs eXmoor and Signadori Bio enter cell therapy partnership by Emily Kimber | 19th Jun 2025 | News Signadori is advancing a platform designed to overcome the challenges of treating solid cancers eXmoor Pharma and Signadori Bio have entered into a partnership aimed at advancing a gene-modified monocyte-derive

122
122
article thumbnail

STAT+: Off-the-shelf stem cell therapy for type 1 diabetes continues to show positive results

STAT

Twelve people with type 1 diabetes who received an investigational off-the-shelf stem cell therapy were able to produce their own insulin and keep healthy blood glucose levels for at least one year, Vertex Pharmaceuticals said Friday. After three months, none of them suffered severe bouts of low blood sugar. After 12 months, out of the 12 participants, 10 no longer needed to inject insulin.

Diabetes 362

More Trending

article thumbnail

New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. 1 Rather than representing a radical break from established practice, the document builds on decades of scientific and regulatory experience, proposing that – under certain well-defined conditions – the demonstration of bio-similarity might rely more heavily on advanced analytical characterisation and pharmacokinetic (

article thumbnail

People With Severe Diabetes Are Cured in Small Trial of New Drug

NY Times

Most in a small group of patients receiving a stem cell-based infusion no longer needed insulin, but the drug may not suit those with more manageable type 1 diabetes.

Diabetes 111
article thumbnail

Opinion: Six former CDC vaccine advisory committee chairs warn: U.S. risks losing access to life-saving immunizations

STAT

As former chairs of the CDC’s Advisory Committee on Immunization Practices ( ACIP ), we are deeply alarmed by the growing politicization of vaccines — a public health innovation that has saved 154 million lives globally. While politicization of science is not new, the escalating distrust in science across the political spectrum, and its intrusion into the vaccine ecosystem, now threatens the very infrastructure that has long protected Americans from infectious diseases.

Immunity 363
article thumbnail

FDA approves twice-yearly shot of Gilead drug for HIV prevention

BioPharma Dive

The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market dominated by oral medicines.

114
114
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

‘HIV-ending’ drug could be made for just $25 per patient a year, say researchers

The Guardian - Pharmaceutical Industry

As regulator prepares to approve lenacapavir in the US, campaigners are urging the manufacturer, Gilead, to make it ‘available and affordable for all who need it’ A drug with the potential to “end the HIV pandemic” will launch in the US this week – as a new study reveals it could be sold for 1,000 times less than its possible price tag. Lenacapavir, given as a twice-yearly injection, can prevent someone from being infected with HIV, according to clinical trial results.

111
111
article thumbnail

Sun Pharma appoints Kirti Ganorkar as Managing Director, announces key managerial shifts

Express Pharma

Sun Pharmaceutical Industries announced the appointment of Kirti Ganorkar as the Managing Director to succeed Dilip Shanghvi, effective September 1, 2025, with the entire business and all functions reporting to him. This appointment is subject to approval of the shareholders at the upcoming Annual General Meeting. Ganorkar has been heading India Business at Sun Pharma since June 2019.

99
article thumbnail

CDC workers fired from prominent STI, hepatitis labs are rehired

STAT

The staff of two world-class laboratories at the Centers for Disease Control and Prevention that were slated to be closed in a round of cuts announced in April have been informed that their terminations have been canceled. The CDC’s sexually transmitted disease laboratory and its viral hepatitis laboratory were targets of layoffs initiated by the U.S.

362
362
article thumbnail

FDA blocks trials that send US cells to 'hostile' countries

pharmaphorum

The FDA says it will review clinical trials that send US citizens' cells to 'hostile countries' as leadership at the agency in this area is sidelined.

105
105
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

Prothena to lay off majority of staff; Zealand shares obesity drug data

BioPharma Dive

Prothena will cut 63% of its workforce and evaluate a “range of business options.” Elsewhere, Zealand revealed data for a dual-acting obesity drug and Biogen kicked off a new late-stage trial.

107
107
article thumbnail

Sheffield scientists and AstraZeneca develop new machine learning model for inverse protein folding

Express Pharma

In a study published in Nature Machine Intelligence , researchers from the University of Sheffield, in collaboration with AstraZeneca and the University of Southampton, have developed a machine learning framework that demonstrates improved accuracy in inverse protein folding compared to existing methods. Inverse protein folding involves identifying amino acid sequences that form a desired 3D protein structure.

article thumbnail

STAT+: Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official

STAT

The ouster of the Food and Drug Administration’s chief regulator of cell and gene therapies earlier this week came immediately after a disagreement with her boss over the review of a cell therapy for Duchenne muscular dystrophy, STAT has learned.  The regulator, Nicole Verdun, had scheduled an advisory committee meeting to review the therapy developed by Capricor Therapeutics.

334
334
article thumbnail

The Top 15 Specialty Pharmacies of 2024: How PBMs, Health Systems, and Independents Are Shaping the Market (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: What’s Next for Retail Pharmacy: Data, Debate, and Disruption. I’ll be joined by special guest Antonio Ciaccia, CEO of 46brooklyn Research, and President of 3 Axis Advisors. Click here to see the original post from April 2025. Drug Channels Institute’s (DCI’s) latest analysis reveals that PBM-affiliated specialty pharmacies continue to dominate the dispensing of specialty drugs.

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

How new medicines become available on the NHS

The Pharmacist

New medicines can transform the treatment and prevention of disease, improving – and in many cases saving – lives. But no health system has unlimited resources. This creates a political and technical challenge for governments and health systems which must decide which drugs to make available and to whom. Few areas of health policy are […] The post How new medicines become available on the NHS appeared first on The Pharmacist.

92
article thumbnail

Lupin signs licensing deal with Sino Universal Pharmaceuticals to supply Tiotropium DPI in China

Express Pharma

Lupin has entered into a licence and supply agreement with Sino Universal Pharmaceuticals (SUP) for the commercialisation of Tiotropium Dry Powder Inhaler (DPI), 18 mcg/capsule, in the Chinese market. The product is indicated for the treatment of chronic obstructive pulmonary disease (COPD). According to the terms of the agreement, SUP will be responsible for securing regulatory approvals required to market Tiotropium DPI in China.

103
103
article thumbnail

Opinion: Curbing the overdose crisis requires professional standards, patient safety

STAT

One of us, Ryan, fights every single day to maintain long-term recovery from a substance use disorder that nearly cost him everything. The other, Teresa, lives with the permanent, aching void left by the loss of her beloved son Spencer at age 24 to a preventable overdose. This loss came after losing her 17-year-old son, Graham, in 2014 shortly after leaving rehab.

295
295
article thumbnail

AI-powered orchestration: Bringing the benefits to personalized therapy

Pharmaceutical Technology

Supply chains for a new generation of therapies are complex, costly, and require meticulous management to ensure patient safety and regulatory compliance. AI can transform cell and gene therapy (CGT) orchestration by automating manual processes, improving productivity, enhancing supply chain visibility and improving scalability.

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

Genentech's Bittenbender named board chair at BIO

pharmaphorum

Genentech's Fritz Bittenbender becomes chair of the Biotechnology Innovation Organization at a challenging time for the sector.

90
article thumbnail

FDA to speed reviews for drugs supporting ‘national interests’

BioPharma Dive

A new pilot program announced by FDA Commissioner Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.

88
article thumbnail

STAT+: U.K. decision blocks a pair of Alzheimer’s drugs from access through its national health service

STAT

LONDON — A U.K. health agency reiterated on Thursday that the limited benefits of a pair of new Alzheimer’s drugs do not justify their high prices, meaning the medicines won’t be made available through the National Health Service. The decision by the U.K.’s cost-effectiveness watchdog reflects how health authorities in different parts of the world have taken different approaches with the drugs, which are the first to have shown they can slow the progression of the dis

article thumbnail

Eli Lilly genetic medicine acquisition to address cardiovascular risk

European Pharmaceutical Review

Eli Lilly and Company has agreed to acquire Verve Therapeutics, Inc. in a deal set to advance genetic medicines for individuals at risk of cardiovascular disease. This acquisition has a potential total value of up to approximately $1.3 billion. Verve’s lead programme (VERVE-102) involves a potential first-in-class in vivo gene editing therapy.

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

A Message from President Annagrace Malamsha for Commonwealth Pharmacists Day 2025​

Commonwealth Pharmacists Association

A Message from President Annagrace Malamsha for Commonwealth Pharmacists Day 2025 Dear Colleagues, It brings me and the Commonwealth Pharmacists Association (CPA) great pleasure to observe Commonwealth Pharmacists Day 2025.

80
article thumbnail

Addressing US FDA challenges in Indian sterile drug manufacturing – Part 2

Express Pharma

Rising expectations for scientific rationale One consistent theme across FDA communications, including 483s, Warning Letters, and guidance documents is the demand for sound scientific justification behind design and operational decisions. Whether it’s the hold time between filtration and filling, the location of EM plates, the frequency of visual inspection, or the number of media fill runs – decisions must be supported by documented rationale based on QRM (Quality Risk Management) princip

article thumbnail

Opinion: The MAHA children’s health report mis-cited our research. That’s sloppy — and worrying

STAT

P.T. Barnum, American showman and circus master, famously said, “There’s no such thing as bad publicity.” Or did he?

363
363
article thumbnail

A longer ‘winter’: Public funding slowdown heightens pressure on biotech startups

BioPharma Dive

A dramatic pullback in public biotech investment catalyzed by economic and regulatory upheaval is putting even more stress on startups navigating a yearslong downturn.

81
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.