Drug Topics

FEBRUARY 10, 2025

Expert highlights the benefits of using apomorphine infusion to provide more consistent medication levels and reduce the unpredictable fluctuations.

FDA

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.

Hospitals

IDStewardship

FEBRUARY 12, 2025

In this article an infectious diseases pharmacist discusses important information to know about antibiotic minimum inhibitory concentrations. Authored By: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP Article posted12 February 2024 An antibiotic’s minimum inhibitory concentrations (MIC) is the lowest drugconcentration that prevents visible growth of a standard inoculum of a microorganism after ~24 hours of incubation.

Labelling

STAT

FEBRUARY 12, 2025

Where is DeepMind’s AI protein design spinout? The Alphabet-owned AI company took the biology world by storm in 2020 with AlphaFold2 , the protein structure prediction AI platform that “solved” a decades-old biology problem. In 2021, the company spun out Isomorphic Labs, an AI drug discovery company. But Isomorphic’s initial focus is on small-molecule drug discovery, with protein-based drugs remaining a distant twinkle in the company’s eye.

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

Patient Care

European Pharmaceutical Review

FEBRUARY 13, 2025

New analysis by VTT Technical Research Centre of Finland has highlighted the EUs completely underestimated costs of the newly enforced Urban Wastewater Treatment Directive. Based on the new cost estimates, pharmaceutical manufacturers in Finland alone will be required to fund 280816 million of these expenses, The directive , enforced on 1 January 2025, imposes an extended manufacturer responsibility on the removal of micro-pollutants from wastewaters.

Pharmaceutical Companies

Pharmacy Times

FEBRUARY 13, 2025

Panelists discuss how menopause marks a significant life transition, characterized by hormonal decline, reproduction cessation, and unique physiological changes requiring medical and emotional support. Health care professionals guide women through lifes reproductive stages, providing comprehensive health care from menarche to post menopause, focusing on individualized prevention of symptom management, and holistic well-being across hormonal transitions.

STAT

FEBRUARY 13, 2025

It’s no secret that life expectancy in the United States is among the lowest in the developed world and has been since long before the Covid-19 pandemic.  The United States  ranked  29 th  in life expectancy at birth among peer nations in the Organization for Economic Cooperation and Development despite spending almost twice as much on clinical care per person as the average OECD nation.

Insurance

European Pharmaceutical Review

FEBRUARY 14, 2025

A report by Cervicorn Consulting forecasts that the pharmaceutical water market will value $96.25 billion by 2033, with a CAGR of 9.26 percent between 2024 and 2033. Key drivers include a rise in demand for high-quality water in the pharmaceutical industry, automation and government initiatives. The research suggests that during the forecast period, the market will emphasise addressing the challenges associated with limitations with manual monitoring processes and operational efficiencies.

Vaccines

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

The FDA Law Blog

FEBRUARY 11, 2025

By Mark A. Tobolowsky & Frank J. Sasinowski The rare pediatric disease priority review voucher program remains in its sunsetting state the current authority only allows for granting of such vouchers if the drug was designated as a drug for a rare pediatric disease not later than December 20, 2024, and for which a rare pediatric disease product application is approved not later than September 30, 2026.

FDA

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.

STAT

FEBRUARY 13, 2025

Bill Cassidy had a blunt question for Robert F. Kennedy Jr.: “What’s it going to be?”  Cassidy was begging for the simplest possible concession from the man President Trump had chosen to serve as the nation’s top health care official. All he asked was that Kennedy declare “unequivocally” that vaccines do not cause autism.

Vaccines

European Pharmaceutical Review

FEBRUARY 11, 2025

Novartis has agreed to acquire Anthos Therapeutics, Inc., and will gain rights to a potential first-in-class biologic. Anthos has been developing the monoclonal antibody abelacimab as a treatment to prevent stroke and systemic embolism in individuals with atrial fibrillation, under a license from Novartis. The therapy is designed to induce effective haemostasis-sparing anticoagulation through Factor XI inhibition, preventing the activated form (Factor XIa) being generated.

The Guardian - Pharmaceutical Industry

FEBRUARY 9, 2025

Billions in EU Covid funding have gone unaccounted for. By hiding its business behind personal messaging, Brussels is dodging public scrutiny For weeks during the height of the Covid pandemic in early 2021, the European Commission president, Ursula von der Leyen, personally exchanged calls and texts with Albert Bourla, the CEO of the pharmaceutical company Pfizer.

Pharmaceutical Companies

The FDA Law Blog

FEBRUARY 11, 2025

By Larry K. Houck One of the most significant issues facing hospitals and other facilities is the diversion of controlled substances meant for patients by physicians, pharmacists, nurses and other trusted healthcare employees. Recent employee diversion of significant controlled substance quantities from hospitals has resulted in large civil monetary settlements, some in the millions of dollars, and costly compliance remediation programs to resolve allegations.

Controlled Substances

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

STAT

FEBRUARY 12, 2025

Between 2011 and 2020, 10 of the world’s largest pharmaceutical companies paid a combined $1.34 billion in fines to the U.S. government for bribing foreign officials in order to boost purchases of their medicines. The law that made it possible is the Foreign Corrupt Practices Act, which has been credited with making changes in long-standing industry business practices.

Pharmaceutical Companies

European Pharmaceutical Review

FEBRUARY 12, 2025

The European Commission has approved acoramidis as the first near complete TTR stabiliser (90 percent) to treat transthyretin amyloidosis in adults with cardiomyopathy (ATTR-CM) patients in the US and EU. BEYONTTRA (acoramidis) is indicated for adults with wild-type or variant ATTR-CM. This disease is progressively fatal and results in heart failure, BridgeBio Pharma, Inc. explained.

FDA

Drug Topics

FEBRUARY 12, 2025

Those who contributed to the arrest of Luigi Mangione, the suspect in the murder of UnitedHealthcare CEO Brian Thompson, are facing unjustified backlash. They are heroesnot snitches.

The FDA Law Blog

FEBRUARY 13, 2025

By Lisa M. Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ).

FDA

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Pharmacy Management Software

STAT

FEBRUARY 14, 2025

A member of the U.K. Parliament is calling for regulators to audit pharmaceutical companies that have made misleading statements to the public about their Covid-19 vaccines. And the move comes after Moderna was chastised for the second time in five months by a U.K. trade group over its attempts to recruit children into a late-stage clinical trial for its Covid shot.

Vaccines

PharmaVoice

FEBRUARY 12, 2025

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

Drug Topics

FEBRUARY 12, 2025

Crystal Zhou, PharmD, APh, AHSCP, BCACP, discussed her role as Lead Pharmacist of the Cut Hypertension Program.

PhRMA

FEBRUARY 11, 2025

Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The PhRMA blog welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view.

STAT

FEBRUARY 13, 2025

The National Institutes of Health and some VA regions are scouring existing grants using lists of flagged words, which include not just known trigger words for the Trump administration — trans, nonbinary, and diversity — but also “women” and  “Covid.”   The purpose of the lists remains unclear.

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.

Drug Topics

FEBRUARY 11, 2025

Poor cardiometabolic health is associated with cognitive impairment in later life, but there is no clear association between cardiometabolic trajectories and early markers.

PhRMA

FEBRUARY 12, 2025

Policies to contain health care costs by restricting access to medicines always come with the promise of making health care more affordable and reducing government spending. But what if they’re actually doing the opposite? A new study published in JAMA on Medicaid prescription denials exposes a harsh reality: denying access to medications doesn’t save Medicaid money, it’s shifting costs in a way that hurts both patients and taxpayers.

STAT

FEBRUARY 13, 2025

Robert F. Kennedy Jr., the activist-turned-politician with a long history of embracing anti-scientific views, will become the next secretary of the Department of Health and Human Services. Senators voted 52-48 on Thursday to confirm Kennedy to the role. Republican Sen. Mitch McConnell (R-Ky.) voted against RFK Jr., as did all Democrats.

Hospitals

PharmaVoice

FEBRUARY 11, 2025

What will it take for a clinical-stage biotech to break into the cardio space? One CEO thinks he has the answer.

Drug Topics

FEBRUARY 12, 2025

Cardiovascular health is known to be associated with the probability of having active or developing migraine in the future.

Pharmacy Times

FEBRUARY 13, 2025

The agency will now review the novel PCSK9 inhibitor for possible approval in patients with or at high risk of atherosclerotic cardiovascular disease.

FDA

STAT

FEBRUARY 13, 2025

WASHINGTON — Michael Lauer, deputy director of the National Institutes of Health’s extramural research, will leave the agency at the end of the week.  News of Lauer’s departure comes one day after Lawrence Tabak, the agency’s longtime second-in-command, retired , a move several agency sources described as “sudden” and “abrupt.

PharmaVoice

FEBRUARY 10, 2025

Fractyl Health is entering pivotal studies for a procedure that aims to be an ‘off ramp’ to GLP-1s and exploring how a one-time, ‘smart GLP-1’ gene therapy can Treat type 2 diabetes.

Drug Topics

FEBRUARY 12, 2025

Recently, there has been concern around glucagon-like peptide-1 receptor agonists and increase the risk of thyroid cancer, with liraglutide having a black box warning label for the disease.

Labelling