pharmaphorum

FEBRUARY 28, 2025

From discovery to delivery: Fast-tracking patient access to life-saving rare disease treatments Mike.

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STAT

FEBRUARY 26, 2025

The Food and Drug Administration canceled an upcoming vaccine advisory committee meeting to discuss influenza virus strains, according to committee member Paul Offit.  The meeting was scheduled for March 13. Committee members received a cancellation email — which was first reported by Jeremy Faust of Inside Medicine — on Wednesday afternoon.

Vaccines 363

Vaccines 363

PharmaVoice

FEBRUARY 24, 2025

Health agency job cuts and a newly-established MAHA commission leave many unanswered questions about potential reforms and impact on drug approvals.

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Express Pharma

FEBRUARY 23, 2025

Chairman of Zydus, Pankaj Patel, emphasised the importance of people in organisational success during the launch of the School of Ultimate Leadership (SOUL) in Gujarat on Friday. Speaking at the event, formally inaugurated by Prime Minister Narendra Modi, Patel stated, People are the core to anything you do. The only mantra to succeed in any business is to take care of your people; other things will follow.

Communication 101

Communication 101

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.

The Pharmacist

FEBRUARY 25, 2025

Action on medicine shortages is vital to prevent another tragedy, the health and social care secretary has been urged. Charities and MPs have said the death of a man with epilepsy whose pharmacy was unable to supply his medication adds urgency to their calls for a review into the issue. David Crompton, aged 44, died […] The post 'Vital' health secretary intervenes over medicines shortages, urge MPs appeared first on The Pharmacist.

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European Pharmaceutical Review

FEBRUARY 26, 2025

A study has demonstrated a new approach to prepare tablets for intestinal drug delivery by combining two 3D printing techniques. Using both selective laser sintering (SLS) and fused deposition modelling (FDM), the technique has potential to achieve delayed and prolonged drug release, according to the findings. Key findings from the 3D printing drug delivery study [a] laser speed of 90 mm s1 was suitable for producing [3D printed tablet] cores with relatively short disintegration time and suffici

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Express Pharma

FEBRUARY 26, 2025

MO Alternate Investment Advisors (MO Alts) has agreed to invest up to INR 460 crores for a majority stake in Mega Fine Pharma (Megafine).The Sanghvi Family, one of the founding-promoter groups, has also participated in this transaction, increasing their stake in the Company. Megafine, established in 1995, is an export-focused Active Pharmaceutical Ingredient (API) company based in Mumbai.

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The Pharmacist

FEBRUARY 27, 2025

Peers in the House of Lords have voted to exempt pharmacies from having to pay increased National Insurance contributions (NICs) from April. The amendment to the National Insurance Contributions (Secondary Class 1 Contributions) Bill says that specified employers, including those contracted to provide NHS pharmacy services, should only need to contribute 13.8%.

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STAT

FEBRUARY 27, 2025

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered to their inbox. Health care investor Kevin Tang buys “zombie” biotechs to shut them down. It’s a counterintuitive, but ingenious solution to the sector’s intractable problem  covered in last week’s newsletter.

Drug Development 322

Drug Development 322

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

Communication

PharmaVoice

FEBRUARY 27, 2025

Recursion CFO Ben Taylor discusses the state of AI M&A and what companies should look for as the industry moves to new data technologies and systems.

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Express Pharma

FEBRUARY 27, 2025

Glenmark Pharmaceuticals Inc., USA (Glenmark) has launched Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) Multiple-Dose Vial. The product is bioequivalent and therapeutically equivalent to Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) of BPI Labs, LLC (NDA 205029). This launch qualifies for 180 days of Competitive Generic Therapy (CGT) exclusivity under section 505(j)(5)(B)(v) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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The Pharmacist

FEBRUARY 26, 2025

Guidance for the education and training of pharmacists and pharmacist independent prescribers has been updated to reflect commitments to sustainability, the General Pharmaceutical Council (GPhC) has announced. The updated guidance highlights the crucial role of pharmacists as medicines experts in working towards the more environmentally sustainable use of medicines and decreasing their associated carbon footprint […] The post GPhC updates education and training guidance to support sustaina

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STAT

FEBRUARY 27, 2025

The public and pharmaceutical companies are calling for changes in drug regulation and the costs of medicines. They are right to do so. Companies want to see products approved faster for financial reasons, and patients want medicines that can improve their lives. The two are inextricably tied, and realizing those goals requires tossing out the broken system we have in exchange for a superior system that is richer in data and evidence.

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Pharmaceutical Companies Pharmaceutical Companies 293

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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.

FDA Law Blog: Biosimilars

FEBRUARY 23, 2025

By Steven J. Gonzalez & Allyson B. Mullen As the device industry is well aware, one of the greyest areas in device regulation (of which there are many) is determining when changes to a 510(k)-cleared device trigger the need for a new clearance. FDA requires a new 510(k) clearance when a modification to an existing 510(k)-cleared device (or other existing device subject to 510(k) requirements) could significantly affect the safety or effectiveness of the device.

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Documentation 64

PharmaVoice

FEBRUARY 26, 2025

The number of candidates in development has nearly doubled over the past 15 years.

Vaccines 165

Vaccines 165

The Pharmacist

FEBRUARY 27, 2025

A committee of influential MPs has called for an update on the highly anticipated economic review of community pharmacy in England. The Health and Social Care Committee (HSCC) has today asked NHS England to share when it anticipates the economic analysis of the community pharmacy sector will be fully completed, and if it intends to […] The post MPs ask NHS England if, when and how it will publish economic review of pharmacy appeared first on The Pharmacist.

Community Pharmacies 110

Community Pharmacies 110

STAT

FEBRUARY 28, 2025

2025 bracket Welcome to STAT Madness, a bracket-style contest to find the best innovation in science and medicine. Explore groundbreaking innovations from top institutions and help crown the 2025 STAT Madness champion. Your vote determines who advances in this competition celebrating the best in biomedical research.

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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.

Express Pharma

FEBRUARY 26, 2025

Dr Reddys Laboratories has recently announced that it has received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) manufacturing facility (CTO-2) in Bollaram, Hyderabad. The update follows the companys earlier intimation on November 19, 2024 regarding the USFDA inspection at the facility.

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PharmaVoice

FEBRUARY 28, 2025

The company is leaning on its subcutaneous technology to deliver long-acting options that could prevent patients from cycling through drugs.

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The Pharmacist

FEBRUARY 27, 2025

There are MPs in Westminster advocating for community pharmacy funding, Dr Beccy Cooper MP told the sector at an event hosted by the Pharmacy Vaccinations Development Group this week. The event set out how community pharmacies could increase vaccination uptake and help the NHS reach those it had historically struggled to. And it accompanied the […] The post 'You have advocates in Westminster', MP tells community pharmacy appeared first on The Pharmacist.

Community Pharmacies 83

Community Pharmacies Vaccines 83

STAT

FEBRUARY 26, 2025

This story will be updated. A child in Texas has died from measles, officials said Wednesday , the first known death in the current large outbreak in West Texas and the first death from measles in the country since 2015.

Vaccines 364

Vaccines 364

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.

BioPharma Dive

FEBRUARY 24, 2025

Cavazzoni stepped down from her role as head of the FDA’s main drug review office in mid-January. She will succeed Aida Habtezion.

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Pharma Times

FEBRUARY 26, 2025

Updated data from phase 2 study reveals survival benefit

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Express Pharma

FEBRUARY 23, 2025

Lupin has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its manufacturing facility in Somerset, New Jersey. The report follows an inspection conducted from 27 January to 31 January 2025. Nilesh Gupta, Managing Director of Lupin, stated, We are very pleased to have received the EIR for our Somerset facility.

Pharmaceutical Manufacturing 66

Pharmaceutical Manufacturing 66

STAT

FEBRUARY 28, 2025

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. It’s almost March! Which means voting for our annual STAT Madness competition starts Monday. I will see you in the brackets.

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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.