Mon.Mar 06, 2023

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The Role of the Pharmacist in Cannabis Legalization

Drug Topics

Now that more states are legalizing cannabis for medical and recreational use, pharmacists must step up to educate and counsel customers on safe use

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Why layoffs are not the answer to biopharma’s troubled market

PharmaVoice

As companies look to cut costs, an EY analyst urges them to consider not cutting staff.

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Pharmacists Are Crucial in Managing Endometriosis Symptoms

Drug Topics

Endometriosis has been linked with autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease, but more definitive research is needed

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Biosimilar insights to help marketers navigate the year ahead

PharmaVoice

Bracing for biosimilars? Learn how biosimilar launches differ from traditional biologics.

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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

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Racial, Ethnic Inequities Persist in Diabetes Care

Drug Topics

Significant differences in the use of insulin pump and/or CGM technology were noted based on demographic and socioeconomic factors

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Hospitals hope new Congress doesn't bring new DSH cuts to safety-net hospitals

Fierce Healthcare

Hospitals hope new Congress doesn't bring new DSH cuts to safety-net hospitals rking Mon, 03/06/2023 - 15:48

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Hospital-at-home steps out of the COVID-era through new Atrium Health, Best Buy partnership

Fierce Healthcare

Hospital-at-home steps out of the COVID-era through new Atrium Health, Best Buy partnership aburky Mon, 03/06/2023 - 17:17

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QMSR Harmonization Curiously Missing from Spring 2023 Regulatory Agenda

The FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert — A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. Part 820 with a newly named Quality Management System Regulation (QMSR) (see here ). The proposed rule was published on February 23, 2022 and was first heralded by FDA in 2018 and introduced in the Spring 2018 regulatory agenda.

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Lower margins, softer liquidity sets the stage for hospital dealmaking in 2023

Fierce Healthcare

Lower margins, softer liquidity sets the stage for hospital dealmaking in 2023 dmuoio Mon, 03/06/2023 - 13:56

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Incannex partners with Catalent to manufacture psilocybin

Pharmaceutical Technology

Incannex Healthcare has collaborated with New Jersey-based pharma company Catalent for the development and manufacturing of a cGMP-grade psilocybin drug product for clinical trials and potential commercial use. The drug product is designed for use in the psilocybin-assisted psychotherapy drug development programme of Incannex for generalised anxiety disorder.

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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.

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How providers like UAB, Parkland Hospital are supporting at-risk mothers using a device already in their pockets

Fierce Healthcare

How providers like UAB, Parkland Hospital are supporting at-risk mothers using a device already in their pockets aburky Mon, 03/06/2023 - 12:22

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Teijin Pharma and Novartis sign licence deal for kidney disease candidate

Pharmaceutical Technology

Teijin Pharma and Novartis have signed an exclusive global licence agreement for an investigational preclinical small molecule candidate for proteinuric kidney diseases. Under the licence deal, Novartis will gain exclusive global rights for the research, development, manufacturing, and commercialisation of the candidate for all potential indications.

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Transcarent to acquire part of AI-powered primary care startup 98point6

Fierce Healthcare

Transcarent to acquire part of AI-powered primary care startup 98point6 pminemyer Mon, 03/06/2023 - 10:55

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Temperature-stable tuberculosis vaccine induces immune response

European Pharmaceutical Review

The first clinical trial of any subunit tuberculosis (TB) vaccine in a temperature-stable form has found that ID93+GLA-SE, a freeze-dried vaccine, was safe. Investigators assessed whether administering a temperature-stable vaccine containing both ID93 and GLA-SE in a single vial would be as effective at inducing an immune response as a regimen in which non-thermostable ID93 and liquid GLA-SE are held in two vials and combined prior to injection.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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STAT+: At genome-editing summit, experts worry that rule changes on embryo research in China fall short

STAT

LONDON — The first gene-edited children were born in China five years ago , but it’s unlikely to happen again there anytime soon. That was the message Chinese scientists delivered Monday on the opening day of the Third International Summit on Human Genome Editing in London. While the widely condemned experiment conducted by He Jiankui violated two existing Chinese regulations dating back to 2003 — which prohibit genetically altered embryos from being implanted into people fo

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Bacterial co-infections cause twofold increase in mortality in COVID patients: study

Fierce Healthcare

Bacterial co-infections cause twofold increase in mortality in COVID patients: study fdiamond Mon, 03/06/2023 - 08:43

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STAT+: In North Carolina, a small hospital deal poses big antitrust questions

STAT

Hospital systems are turning to cross-market mergers to satiate their thirst for growth and avoid antitrust heat. But hospitals are also still signing other lower-profile deals, which experts believe inevitably lead to higher insurance premiums and create more medical bill stress for people in those communities. “Smaller mergers just don’t get the attention they deserve because they affect fewer people,” said Vivian Ho, a health economist at Rice University who studies hospi

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Increased physical activity reduces risk of hospitalisation in wide range of health conditions

Hospital Pharmacy Europe

Increased physical activity as a nonpharmacological intervention lowers the risk of hospitalisation across a wide range of health conditions In a study by US and UK researchers, it was found that increased physical activity lowers the risk of hospitalisation for a wide range of health conditions, highlighting the potential value of this non-pharmacological intervention.

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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.

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Opinion: STAT+: Developing new drugs starts with building the next generation of clinical investigators

STAT

Issues of fairness and justice echo across the health ecosystem, including drug development. Much of the conversation on improving equity in the development of novel therapeutics centers on increasing diversity in clinical trials. A key step in that direction begins with ensuring more equitable representation among clinical investigators. Engaging, recruiting, and retaining a diverse set of participants for clinical trials is critically important, as drugs can have different effects on people de

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Essential oil containing nasal spray reduces allergic rhinitis symptoms

Hospital Pharmacy Europe

An essential oil mixture used as a nasal spray gave rise to significant improvements in those with allergic sino-nasal symptoms An essential oil nasal spray gave rise to a 40% reduction in total sino-nasal symptoms according to data presented in an abstract presented at the American Academy of Allergy and Immunology (AAAAI) at San Antonio and published in a supplement to the Journal of Allergy and Clinical Immunology.

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Opinion: Congress must fix the IRA’s small molecule penalty

STAT

In opposing a fix to the 2022 Inflation Reduction Act, a leading voice in the effort to move the U.S. biopharmaceutical system toward European-style price controls cited “complicated details” in his reasoning for changing the law, adding that “getting it straight is critically important.” I couldn’t agree more.

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Moderna chooses mRNA vaccine manufacturing centre location

European Pharmaceutical Review

Harwell, the UK’s leading science and innovation campus in Oxfordshire will be the location of the Moderna Innovation and Technology Centre (MITC). This milestone follows the finalisation of Moderna’s ten-year strategic partnership with the UK government, announced in December 2022. Moderna is the latest organisation to join Harwell’s Health Tech cluster.

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STAT+: BridgeBio’s treatment for genetic cause of dwarfism accelerates growth in small study

STAT

A novel drug for the most common cause of dwarfism accelerated children’s growth in a small but closely watched clinical trial, the company BridgeBio said Monday, advancing the latest treatment in what has been a polarizing field of study. BridgeBio’s drug, a pill called infigratinib, increased the pace of growth by about 3 centimeters per year from baseline for a cohort of 10 children with achondroplasia, a rare genetic disorder that results in dwarfism and can lead to serious med

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Rucaparib provides better survival than usual care in metastatic prostate cancer

Hospital Pharmacy Europe

Rucaparib improves progression-free survival in metastatic, castration-resistant prostate cancer with BRAC alteration compared to usual care Using rucaparib in metastatic, castration-resistant prostate cancer and BRAC alteration leads to improved progression-free survival compared to physician’s choice of treatment according to the findings of a randomised trial by the TRITON3 investigators.

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STAT+: Heart repair, risky genes, and AI: the buzz from a giant cardiovascular conference

STAT

NEW ORLEANS — Aptly or paradoxically, thousands of the world’s leading cardiologists descended on the home of beignets, bouillabaisse, and beers sold to-go for a weekend-long dive into the latest developments in the science of keeping hearts beating healthily. While some noisy new data on a cholesterol drug consumed much of the oxygen, and the dawn of a new era of obesity treatment hung over the proceedings, there was time enough at the American College of Cardiology’s annua

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FDA approves omaveloxolone for treatment of Friedreich’s Ataxia

Hospital Pharmacy Europe

Omaveloxolone has received FDA approval for patients with the rare, progressive genetic neurodegenerative disorder Friedreich’s ataxia In a press release by the manufacturer , Reata, their drug omaveloxolone (brand name SKYCLARYS ) has become the first treatment to be approved for the treatment of Friedreich’s ataxia, an ultra-rare, genetic, progressive neurological disorder.

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Operations Data Challenges Limit the Value Realized from Pharma 4.0

ISPE

Operations Data Challenges Limit the Value Realized from Pharma 4.0 Trudy Patterson Mon, 03/06/2023 - 11:50 iSpeak Blog iSpeak Operations Data Challenges Limit the Value Realized from Pharma 4.0 Michael Krause 6 March 2023 Pharmaceutical and biotech portfolios continue to transition from high volume blockbusters to a diversified set of lower volume, targeted therapeutics.

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Combination therapy significantly improves pulmonary hemodynamics

European Pharmaceutical Review

A once-daily, single tablet (fixed dose) combination therapy of macitentan and tadalafil (M/T STCT), significantly improved pulmonary hemodynamics (blood flow through pulmonary blood vessels) in pulmonary arterial hypertension (PAH) patients in a Phase III study ( NCT03904693 ). PAH is a rare, progressive blood vessel disorder that can lead to right heart failure.

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Frontotemporal dementia study expanded by Centogene

Outsourcing Pharma

Mutation in the progranulin (GRN) gene is just one of several hereditary factors that can cause frontotemporal dementia, a rare and rapidly progressive neurodegenerative disease.

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Learning from lecanemab: a breakthrough treatment

European Pharmaceutical Review

With nearly 10 million new cases of dementia of every year 1 , the increasing prevalence of Alzheimer’s disease (AD), the most common form of the condition, has prompted researchers and the pharmaceutical industry to seek novel, effective solutions. Presence of amyloid beta plaques are one of the hallmarks of AD. Keen to learn more about lecanemab’s promising potential to treat the disease, EPR caught up with Dr Michael Irizarry, Senior Vice President of Clinical Research and Deputy Chief Clinic

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A letter from the executive editor: The Obesity Revolution

STAT

Dear Readers, Let me call your attention to an important new series at STAT: “The Obesity Revolution.” Over the coming days and months, we’ll examine a class of obesity drugs that is transforming patients’ lives, dividing medical experts, and spurring one of the biggest business battles in years.

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AZ, Daiichi's Enhertu posts trial win in numerous cancer types. Is a tumor-agnostic approval next?

Fierce Pharma

AZ, Daiichi's Enhertu posts trial win in numerous cancer types. Is a tumor-agnostic approval next?

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Dr Reddy’s snaps up generic manufacturer’s US portfolio

Outsourcing Pharma

The Indian company seals deal with Mayne Pharma Group to acquire its portfolio of US products in a multimillion dollar deal.

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