STAT

FEBRUARY 13, 2024

WASHINGTON — Lawmakers are considering increasing doctors’ Medicare pay in an upcoming government funding package, but their policy would only partially offset cuts providers saw earlier this year, three lobbyists and two sources familiar with the talks told STAT. Physicians’ groups have agitated for Congress to undo a roughly 3.4% Medicare pay cut this year, resulting from the expiration of pandemic-era bonuses lawmakers chose to give the industry.

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Packaging 295

PharmaVoice

FEBRUARY 13, 2024

As backlash builds for the recently announced matchup, critical questions remain over its impact.

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STAT

FEBRUARY 13, 2024

Major insurance companies like UnitedHealthcare and Humana have edged out private equity firms from investing in Medicare Advantage, according to a new report. But investors have found pockets of profits by backing companies involved in enrolling seniors in MA plans and keeping track of them once they’re there. They’re investing in insurance brokerages, marketers, in-home assessment companies, and “insurtechs,” the report said, based on a new analysis of deals in the

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pharmaphorum

FEBRUARY 13, 2024

In this episode of the pharmaphorum podcast, web editor Nicole Raleigh welcomed Dr Hans Eriksson, chief medical officer at HMNC Brain Health, a precision psychiatry biopharma company, to discuss his work exploring current studies into the use of ketamine in mental health, HMNC Brain Health having last year announced topline results from a Phase 2 study looking at a take-at-home, oral ketamine option for Treatment Resistant Depression (or TRD).

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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.

STAT

FEBRUARY 13, 2024

The assault on the development of new lifesaving therapies continues apace. Recently, the First Appellate Division of California Appeals held that companies not only have to defend products they have developed and marketed, but also those they have not. In 2001, Gilead secured FDA approval of tenofovir disoproxil fumarate (TDF), one of first medicines to treat HIV — a product still on the market, despite the potential side effect of causing skeletal and kidney damage.

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Drug Development 270

pharmaphorum

FEBRUARY 13, 2024

Biogen’s Skyclarys is the first approved medicine for the inherited neurological disease Friedreich’s ataxia (FA) in the EU, after getting a green light from the European Commission.

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The Pharmacist

FEBRUARY 13, 2024

Regular bouts of moderate to vigorous activity can protect patients with type 2 diabetes from developing kidney disease, a research study has found. Overweight and obese people with type 2 diabetes who undertook moderate to vigorous physical activity every week were significantly less likely to progress to chronic kidney disease than those who undertook minimal […] The post Exercise reduces risk of kidney disease in patients with type 2 diabetes appeared first on The Pharmacist.

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Diabetes 105

STAT

FEBRUARY 13, 2024

KalVista Pharmaceuticals said Tuesday that its oral, on-demand treatment for the swelling “attacks” commonly experienced by patients with a genetic condition called hereditary angioedema achieved the goals of a Phase 3 clinical trial. Based on the study results, the company plans to submit a marketing application to the Food and Drug Administration by the middle of the year.

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Drug Development 238

pharmaphorum

FEBRUARY 13, 2024

CRISPR technology is revolutionising gene editing and paving the way for innovative advancements in various fields. Explore the exciting potential and future possibilities of this cutting-edge technology.

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STAT

FEBRUARY 13, 2024

A California biotech developing a combination therapy with the obesity drug Zepbound has raised a $170 million Series D round. The company, BioAge, raised money from more than a dozen investors. Sofinnova Investments led the round, which also included Eli Lilly and Amgen’s venture arms and previous investor Andreessen Horowitz. BioAge’s primary focus is in developing medications that boost a person’s healthspan, or the number of healthy years a person lives.

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Pharmacy Management

PharmaVoice

FEBRUARY 13, 2024

No amount of excitement can prevent failures stemming from safety, efficacy, cost and other speed bumps along the way.

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STAT

FEBRUARY 13, 2024

Seven months after US drug regulators fully approved Biogen’s treatment for Alzheimer’s disease, only about 2,000 patients are taking the medicine nationwide, the company said Tuesday. Biogen’s chief executive, Christopher A. Viehbacher, said as the firm released fourth-quarter earnings that he had expected the slow uptake and sees considerable demand for the medication.

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The Pharmacist

FEBRUARY 13, 2024

The Comirnaty (Pfizer-BioNTech) Covid vaccine will be available to pharmacies to offer privately as of next month, it has been announced. The move comes after a licensing change from the Medicines and Healthcare Regulatory Agency (MHRA) which has made the Comirnaty vaccine available for private sale in Great Britain. The Comirnaty vaccine needs to be […] The post Pharmacies can offer private Pfizer Covid jabs from March appeared first on The Pharmacist.

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Vaccines 99

STAT

FEBRUARY 13, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hi! It’s Meghana. Today, some amazing intel on Merck’s Ebola vaccine: Turns out, it can reduce risk of death, even after a person has been infected. Also, investors bet on another obesity drug — this time from BioAge, which is combining Zepbound with a pill that keeps muscle wasting at bay.

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Vaccines Drug Pricing Drug Development 199

Express Pharma

FEBRUARY 13, 2024

During the inspection, the facility received 10 observations Dr Reddy’s Laboratories notified stock exchanges that its formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad, has been issued an Establishment Inspection Report (EIR) by the US Food and Drug Administration following an inspection conducted in October 2023. According to Dr Reddy’s, the USFDA has categorised the inspection outcome as Voluntary Action Indicated (VAI).

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pharmaphorum

FEBRUARY 13, 2024

Researchers have used proteomics data from the UK Biobank to identify protein biomarkers in blood that could give warning of dementia years before diagnosis

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Express Pharma

FEBRUARY 13, 2024

NIPiCON 2024 served as a pivotal forum for knowledge dissemination, networking, and collaborative endeavours aimed at shaping the trajectory of pharmacy practice and the healthcare sector The 7th Nirma Institute of Pharmacy International Conference (NIPiCON 2024), held from February 7th to 9th, 2024, organised by the Institute of Pharmacy, Nirma University, Ahmedabad, focused on the theme “NextGen Therapeutics: Multidisciplinary Research Approaches for Drug Development and Delivery –

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Drug Development 97

Pharmaceutical Technology

FEBRUARY 13, 2024

The MHRA kicks off phase two of the Yellow Card biobank to explore the genetic link to side effects of direct oral anticoagulants.

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BioPharma Dive

FEBRUARY 13, 2024

Newly named partner Anthony Philippakis and managing partner Krishna Yeshwant spoke with BioPharma Dive about biotech’s newfound optimism and their investing “North Star.

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European Pharmaceutical Review

FEBRUARY 13, 2024

The first CRISPR/Cas9 gene-edited therapy has been granted a marketing authorisation by the European Commission (EC). Vertex Pharmaceuticals’ CASGEVY ( exagamglogene autotemcel [exa-cel]) is conditionally approved individuals 12 years and over with severe sickle cell disease characterised by recurrent vaso-occlusive crises or transfusion-dependent beta thalassemia.

Hospitals 90

Hospitals 90

The Pharmacist

FEBRUARY 13, 2024

More than two-thirds of pharmacists in England are feeling ‘under additional pressure’ since the launch of Pharmacy First, a snapshot poll by the National Pharmacy Association (NPA) has suggested. The survey of almost 100 NPA members also saw almost a third (31%) finding the new service ‘harder to implement’ than they had expected. Over 10,000 […] The post Pharmacy First launch ‘by no means easy’, suggests NPA poll appeared first on The Pharmacist.

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European Pharmaceutical Review

FEBRUARY 13, 2024

In January, United States Pharmacopeia (USP) published revisions to previous drafts of chapters about using rapid microbiological methods (RMM), with a specific focus on short-life products. <72> Respiration-Based Microbiological Methods for the Detection of Contamination in Short-Life Products The changes for the proposed chapter the detection of contaminants in short-life products.

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pharmaphorum

FEBRUARY 13, 2024

Texas judge has thrown out the first lawsuit brought by PhRMA claiming Medicare negotiation of drug pricing is unconstitutional

Drug Pricing 102

Drug Pricing 102

Outsourcing Pharma

FEBRUARY 13, 2024

Biogen Inc. has taken a step closer to bringing its âgroundbreaking treatmentâ to patients with a rare, genetic, life-shortening, debilitating, and neurodegenerative disorder.

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Pharmaceutical Technology

FEBRUARY 13, 2024

The regulatory greenlight makes it the only gene therapy available in Europe for sickle cell disease and TDT.

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Outsourcing Pharma

FEBRUARY 13, 2024

Japanese pharmaceutical company Shionogi has announced the first peer-reviewed publication of its phase 3 study investigating ensitrelvir to treat patients with mild to moderate COVID-19 in Japan, South Korea and Vietnam.

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Pharmaceutical Companies Pharmaceutical Companies 109

The Pharmacist

FEBRUARY 13, 2024

An inconsistent approach to the chief pharmacist role across integrated care boards (ICBs) in England has seen ‘wide differences in the scope, influence and responsibilities’ of those in post, the Royal Pharmaceutical Society (RPS) has warned. In a new report reflecting on the last 12 months, the RPS has highlighted ‘significant’ progress across the different […] The post ‘Inconsistent approach’ to ICB chief pharmacist roles appeared first on The Pharmacist.

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World Pharma News

FEBRUARY 13, 2024

New research from global health system Cleveland Clinic has mapped changes in tumor-related bacteria to uncover potential new strategies to combat the rise of young-onset colorectal cancer (CRC) in people under the age of 50. The research reveals differences in tumor-related bacteria associated with young-onset colorectal cancer.

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BioPharma Dive

FEBRUARY 13, 2024

BioAge’s Series D will fund a study combining its medicine with Eli Lilly’s Zepbound, a strategy the company hopes could help people lose weight while maintaining muscle mass.

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Express Pharma

FEBRUARY 13, 2024

To support clinical trial storage and logistics requirements of healthcare customers both within India and those shipping to India FedEx Express unveiled its FedEx Life Science Center in Mumbai, to meet and support the clinical trial storage and logistics requirements of healthcare customers both within the India market and those shipping to India from around the world.

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Packaging Documentation Labelling 71

BioPharma Dive

FEBRUARY 13, 2024

The biotech's drug quickly alleviated symptoms of the swelling attacks associated with hereditary angioedema, supporting the idea it could be an oral alternative to existing medicines.

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pharmaphorum

FEBRUARY 13, 2024

Roche has turned to artificial intelligence specialist PathAI to accelerate its development of digital pathology technologies that can be used to match patients with drug treatments and support new drug development. The alliance is with Roche Tissue Diagnostics (RTD), a unit of the Swiss pharma group that is concerned with the development of tissue-based tools to improve the diagnosis of cancer and grew out of Roche’s acquisition of Venta Medical Systems in 2008.

Drug Development 67

Drug Development 67

BioPharma Dive

FEBRUARY 13, 2024

The Series B round will fund development of antibody-drug conjugates now in clinical testing, among them a rival to AbbVie’s ovarian cancer drug Elahere.

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Drug Patent Watch

FEBRUARY 13, 2024

Annual Drug Patent Expirations for ZMAX Zmax is a drug marketed by Pf Prism Cv and is included in one NDA. There are two patents protecting this drug. This drug… The post New patent expiration for Pf Prism drug ZMAX appeared first on DrugPatentWatch - Make Better Decisions.

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Pharma in Brief

FEBRUARY 13, 2024

The Federal Court ( FC ) has found the brand name of a biologic drug to be confusingly similar to the brand name of a drug used to treat the same disorder, but with a different active ingredient. The application of the ordinary test for trademark confusion was not affected by the fact that the names of both products had been approved by Health Canada.

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Biosimilars Documentation 59