STAT

FEBRUARY 20, 2025

In ongoing trials of Eli Lilly’s next-generation obesity drug, several trial participants are running into an issue they never expected: They are losing too much weight. One participant lost 22% of her weight in nine months — substantially faster than the rate seen with approved GLP-1 drugs like Wegovy or Zepbound. Her weight dropped so much that researchers reduced her dose of the treatment, called retatrutide.

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Drug Development 363

LifeProNow

FEBRUARY 2, 2025

January 30, 2025: “The U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.

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Adverse Reactions Labelling Drug Development 130

The Pharmacist

FEBRUARY 18, 2025

Pharmacists are experiencing 'moral injury' with more than half of pharmacy professionals reporting that medicines shortages have impacted their mental health and wellbeing, according to the Royal Pharmaceutical Society (RPS). Its most recent workforce wellbeing survey also found that inadequate staffing was affecting wellbeing for 70% of pharmacy professionals, with just 35% of pharmacists able […] The post Medicines shortages causing 'moral injury', suggests RPS survey appeared

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Safe Biologics

FEBRUARY 4, 2025

Michael Reilly in RealClearHealth: Don’t Let a “Lame Duck” Congress Gamble with Patient Health On December 20th, RealClearHealth published an op-ed by ASBM Executive Director Michael Reilly discussing concerns that the Biosimilar Red Tape Elimination Act would lower standards for biosimilar medications. The opinion highlights concerns that this bill might be included in the end of year continuing resolution bill, without properly considering the impacts on patients.

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Biosimilars Immunity Immunization 130

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 Guardian - Pharmaceutical Industry

FEBRUARY 8, 2025

When the pharma firm cancelled plans for a major expansion of its Merseyside plant last month, there was no shortage of questions or blame over responsibility At a tense meeting with senior civil servants on the afternoon of 29 January, the chair of AstraZeneca, Shaun Grady, pulled the plug on a planned 450m expansion of its childhood flu vaccine factory in Merseyside bringing a year and a half of negotiations to an abrupt halt.

Vaccines 120

Vaccines 120

Express Pharma

FEBRUARY 12, 2025

The nutraceutical market is expanding rapidly, valued at $6.11 billion in 2024 and projected to reach $11.55 billion by 2030, according to a GlobeNewsWire report. However, pharma companies eager to tap into this growth, face a complex road ahead. Regulatory ambiguity, for instance, serves as a double-edged sword. On the one hand, relatively less regulatory control eases market entry; on the other, they expose pharma players to intense competition from both established FMCG brands and agile start

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Documentation Labelling 99

PharmaVoice

FEBRUARY 12, 2025

As drug development priorities shift, pharma companies need to understand younger patients to improve their reputation.

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Drug Development 262

The Pharmacist

FEBRUARY 7, 2025

Patients in England have lost around seven million hours of pharmacy access in the last two years, analysis from the National Pharmacy Association (NPA) has suggested. And around one in eight have seen their local pharmacy close for good, the NPA said. Inadequate funding could force pharmacies to reduce access by a further one million […] The post Seven million hours of pharmacy access lost in two years 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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Drug Patent Watch

FEBRUARY 11, 2025

The Dark Side of Innovation: How Companies Use Drug Patents to Block Competitors As we celebrate the breakthroughs in medical research and the development of life-saving treatments, it's essential to acknowledge the complex landscape of pharmaceutical innovation. Behind the scenes, companies are employing clever tactics to protect their intellectual property and block competitors from entering the market.

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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

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 100

Communication 100

STAT

FEBRUARY 6, 2025

In an era punctuated by school shootings and ongoing debates about gun control and gun rights, America’s public schools continue to be riddled with safety concerns. According to the New York Times, “Since 2017, tens of millions have been spent by the federal government on mass shooter training, and states have spent even more.”  The result of our culture’s focus on crisis management over prevention is more  security staff  in high schools than there are

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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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The Pharmacist

FEBRUARY 6, 2025

Two batches of nitrofurantoin 100mg prolonged-release capsules have been recalled after a small number of packs were found to contain an additional tablet of nitrofurantoin. Nitrofurantoin is used to treat Urinary Tract Infections (UTIs), and six 100mg modified release capsules can be supplied under the NHS England Pharmacy First Patient Group Direction (PGD) for uncomplicated […] The post Nitrofurantoin recall as extra tablet found in packs of UTI antibiotics appeared first on The Pharmac

Community Pharmacies 115

Community Pharmacies 115

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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

Drug Patent Watch

FEBRUARY 20, 2025

The Unseen Heroes of the Pharmaceutical Industry: Achieving High-Quality Standards in Generic Drugs As we navigate the complex world of healthcare, it's easy to overlook the unsung heroes who work tirelessly behind the scenes to bring affordable, high-quality medications to the masses. I'm talking about the generic drug manufacturers who play a vital role in making life-saving treatments accessible to people worldwide.

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Express Pharma

FEBRUARY 7, 2025

The healthcare industry reported 107 mergers and acquisitions (M&A) deals worth $29.2 billion in January 2025, according to data from GlobalData. This is higher than the last 12-month (January 2024 to December 2024) average of 99 deals worth $14 billion. Johnson & Johnson announced the acquisition of Intra-Cellular Therapies, a biopharmaceutical company, for a total equity value of approximately $14.6 billion.

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Drug Development 96

STAT

FEBRUARY 8, 2025

The National Institutes of Health has made a landmark decision that could irreparably damage the backbone of American scientific innovation: a dramatic reduction in the indirect cost rate for research grants. This sweeping policy change sets the indirect rate to 15%, a stark contrast with the 60% or more that many institutions currently rely on for essential administrative and operational costs.

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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.

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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The Pharmacist

FEBRUARY 4, 2025

Prescribers must independently verify a persons weight, height and/or body mass index before prescribing weight-loss medication, new guidance from the General Pharmaceutical Council (GPhC) has mandated. And for all high-risk medicines, prescribing decisions cannot solely be based on information provided through an online questionnaire. Any information provided by a patient must be independently verified, either […] The post New rules for online pharmacies supplying weight-loss injections a

Online Pharmacies 109

Online Pharmacies 109

PharmD Live

FEBRUARY 12, 2025

As healthcare shifts toward value-based care, medication reconciliation has become a critical focus for reducing costs and improving patient outcomes. Discrepancies in medication regimens, particularly during care transitions like hospital discharge, are a leading cause of adverse drug events (ADEs). These preventable issues result in significant financial burdens on healthcare systems while compromising patient safety and care quality.

Medication Therapy Management (MTM) 59

Medication Therapy Management (MTM) Hospitals Pharmacy Technician Communication 59

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

By Richard A. Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025. Come Monday March 3rd, if Congress does not pass a budget or continuing resolution, the FDA will enter a shutdown and shutter many offices and programs while Congress works out their inter-party squabbles on national priorities.

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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.

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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STAT

FEBRUARY 4, 2025

The National Institutes of Health is at a crossroads with the RECOVER Initiative, its flagship program to address long Covid. Designed to provide answers and treatments for the millions suffering from long-term effects of SARS-CoV-2 infection, the initiative has already received significant criticism for failing to prioritize the needs of patients and advance meaningful clinical trials.

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PharmaVoice

FEBRUARY 13, 2025

The two companies will let their long-running contract expire this year, and drugmakers will need to decide which is the best platform for them in a changing marketplace.

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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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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.

Pharma Leaders

FEBRUARY 4, 2025

The pharmaceutical industry is in a period of rapid transformation. Driven by innovation and evolving patient needs, companies face challenges balancing competitiveness, regulatory hurdles, R&D improvements, and diversity initiatives. Three key trends define this era: 1. Diversity in Clinical Trials: A Core Priority Diversity in trials is shifting from compliance to a core design element.

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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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Express Pharma

FEBRUARY 18, 2025

The fragile X syndrome (FXS) market across the US and Germany is projected to experience explosive growth, quadrupling from $28.7 million in 2025 to $111.9 million by 2030, a CAGR of 31.3 per cent (2025-2030), driven by the anticipated launch of two high-priced targeted therapies for FXS in 2027, according to GlobalData. GlobalDatas latest report, Fragile X Syndrome: Opportunity Assessment and Forecast -Update, anticipates a stable market until the projected US launches of Harmony Biosciences Zy

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Labelling 99

STAT

FEBRUARY 6, 2025

A strange thing happened weeks before the Food and Drug Administration approved the first treatment made with CRISPR gene editing , an all-but cure for certain patients with sickle cell disease. CRISPR Therapeutics, the biotech that co-developed the therapy, laid off about 50 employees. “We were dumbfounded,” said a scientist who was let go.

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