STAT

JANUARY 16, 2024

Last fall, the World Health Organization and some national drug regulators urged influenza vaccine manufacturers to drop the component known as B/Yamagata from flu vaccines as quickly as possible, citing the fact that this lineage of flu B viruses appears to have been snuffed out during the Covid-19 pandemic. It might seem like that request would be as simple as deciding to leave blueberries out of a mixed-fruit smoothie.

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Vaccines 343

PharmaVoice

JANUARY 16, 2024

On the heels of two FDA approvals for microbiome-based therapies, interest in the space is gaining steam.

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STAT

JANUARY 16, 2024

The Food and Drug Administration on Tuesday approved a CRISPR-based medicine to treat beta thalassemia, an inherited blood disorder. It’s the same potentially curative therapy cleared by the FDA in December to treat sickle cell disease. The expanded approval of the therapy, called Casgevy, was widely expected but came two months ahead of the FDA’s decision deadline, known as a PDUFA date.

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PharmaVoice

JANUARY 16, 2024

FDA Commissioner Dr. Robert Califf recently spoke about the future of AI and machine learning and the need for constant vigilance to improve healthcare systems.

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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

JANUARY 16, 2024

In her final presentation for health policy class at the University of Chicago, first-year medical student Robin Ji informed her classmates that the Food and Drug Administration does not require randomized controlled trials of most medical devices. Her peers’ immediate reaction was disbelief. “One classmate kept asking me, are you sure?

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Medical Schools 317

The Guardian - Pharmaceutical Industry

JANUARY 16, 2024

Darius Hughes was a key figure in Pfizer’s pioneering Covid vaccine drive. Now he has changed companies – and sees a big future for mRNA technology The man who launched Pfizer’s Covid-19 vaccine in the UK three years ago – when 90-year-old Margaret Keenan in Coventry became the first person in the world to receive one – is now overseeing the construction of a manufacturing and research centre in Oxfordshire for rival US jab maker Moderna.

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Vaccines 123

The Pharmacist

JANUARY 16, 2024

More than 90% of community pharmacies have signed up to deliver Pharmacy First in England, pharmacy minister Dame Andrea Leadsom has said. In a written answer published yesterday, the parliamentary under-secretary for health and social care confirmed that the service would launch in ‘early 2024’. And she said that ‘over 90% of community pharmacies have […] The post Over 90% of pharmacies signed up for Pharmacy First, says minister appeared first on The Pharmacist.

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Community Pharmacies 105

STAT

JANUARY 16, 2024

You’re reading the web version of Health Care Inc.,  STAT’s weekly newsletter  following the flow of money in medicine.  Sign up  to get it in your inbox every Monday.  Hospitals want you to look here, not over there Hospital leaders took pains to draw investors’ attention to their sizable cash and investment reserves at JPM.

Hospitals 303

Hospitals 303

Drug Patent Watch

JANUARY 16, 2024

A recent article published in the Journal of Cheminformatics addresses the challenge of confirming the patent status of newly developed compounds, particularly in the pharmaceutical industry, where generating novel structures… The post An AI Approach to Generate Novel Pharmaceuticals using Patent Data appeared first on DrugPatentWatch - Make Better Decisions.

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Compounding 115

STAT

JANUARY 16, 2024

If her social media accounts are any indication, model, cookbook author, television personality, and entrepreneur Chrissy Teigen is a wonderful mother. Many parents regard her as a role model. That’s why I found it disappointing to learn that Teigen is a spokesperson for the Cord Blood Registry, which advocates for the collection of umbilical cord blood at birth for future use.

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Pharmacy Management

BioPharma Dive

JANUARY 16, 2024

The agency’s decision to expand use of Casgey, which won a landmark OK for sickle cell disease in December, comes more than two months ahead of schedule.

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STAT

JANUARY 16, 2024

More than half of those responsible for registering clinical trials and reporting results fail to do so over confusion about key requirements, according to a new survey that highlighted ongoing difficulties in achieving transparency surrounding study data. Specifically, 52% said their major challenges involved sorting out the types of clinical trials that must be registered, when a trial should be registered, and when and for which trials information from summary results must be submitted to a U

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The Pharmacist

JANUARY 16, 2024

Pharmacists have been asked to share their experience of patients refusing prescriptions due to cost, as part of a survey launched by the Prescription Charges Coalition. The survey will feed into the coalition’s ongoing campaign to have prescription charges scrapped for people with long-term conditions in England. Coalition members the Royal Pharmaceutical Society (RPS) and […] The post Pharmacists surveyed on prescription charges appeared first on The Pharmacist.

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STAT

JANUARY 16, 2024

Dewpoint Therapeutics, the buzziest startup trying to tackle a new field of biology called biomolecular condensates, laid off 15% of its staff on Tuesday and acknowledged that a pair of collaboration deals with pharma companies had fallen apart. The downsizing is temporary, CEO Ameet Nathwani told STAT. The company needed to hire new employees with expertise to help move the company’s first drugs into clinical trials and expand its AI capabilities.

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pharmaphorum

JANUARY 16, 2024

In addition to bringing treatment and hope to patients without alternatives, early access programmes provide further information on a product’s safety and efficacy data in real-world conditions.

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STAT

JANUARY 16, 2024

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine.  Sign up here  to receive it in your inbox on Tuesdays and Thursdays. Bertagnolli’s burgeoning NIH agenda Monica Bertagnolli is just two months into directing the $48 billion NIH, but she has a  laundry list of challenges ahead of her.

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The Pharmacist

JANUARY 16, 2024

The NHS online recruitment system Oriel is now open for pharmacy employers across community and general practice to advertise their training placements to pharmacist trainees. For the first time, placements must provide trainees with experience in both a dispensing and a patient facing setting, with access to a designated prescribing practitioner. During a recent webinar, […] The post NHSE shares advice for listing training placements on Oriel appeared first on The Pharmacist.

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STAT

JANUARY 16, 2024

I am getting bent out of shape over surgeons telling patients they cannot get a knee replacement because they are above a certain BMI cutoff. Here’s a familiar scenario: A patient with a high body weight and BMI limps down the hall to my exam room. “How have you been?” I ask. He sighs. “I still can’t get a new knee.

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pharmaphorum

JANUARY 16, 2024

Roche’s Tecentriq has become the first PD-1/PD-L1 inhibitor to be cleared in the EU in a subcutaneous form that will make dosing easier for patients and healthcare providers

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STAT

JANUARY 16, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello! Hope you had a restful and reflective long weekend. Today, we talk a lot about regulatory policy — for flu vaccines and for physicians. We also speak with the new NIH director about how she’s finding a balance between government and industry priorities, and explore the feared brain drain from the new, $500 million research initiative th

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Vaccines Drug Pricing Drug Development 205

Express Pharma

JANUARY 16, 2024

“The alert issued by IPC was to advise doctors and patients to monitor the possibility of an adverse drug reaction of mefenamic acid, which does not in any way impact the safety, efficacy and high quality of the brands that are established and supported by clinical studies,” Blue Cross Laboratories, which makes meftal and meftal-spas, said in a statement In the backdrop of a caution by the Indian Pharmacopoeia Commission (IPC) against mefenamic acid, a major component of painkiller m

Adverse Reactions 101

Adverse Reactions Documentation 101

pharmaphorum

JANUARY 16, 2024

In a new episode of the pharmaphorum podcast, host Nicole Raleigh welcomes Carl Hansen, CEO of AbCellera, for a conversation on the discovery and acceleration of antibody therapeutics.

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Express Pharma

JANUARY 16, 2024

Under the agreement, JFCR will join Parexel’s Global Site Alliance network for oncology clinical trials and providing more opportunities for Japanese patients to participate in cancer research Parexel and the Japanese Foundation for Cancer Research (JFCR) has announced a strategic alliance to accelerate access to oncology clinical trials in Japan. Under the agreement, JFCR will join Parexel’s Global Site Alliance network for oncology clinical trials and providing more opportunities for Japanese

Hospitals 100

Hospitals 100

European Pharmaceutical Review

JANUARY 16, 2024

The European Commission (EC) has approved the EU’s first PD-(L)1 cancer immunotherapy for subcutaneous injection. Roche’s Tecentriq ® (atezolizumab) was first approved in Great Britain in August 2023. Compared with standard intravenous (IV) delivery, Roche stated that its monoclonal antibody biologic shortens treatment time by approximately 80 percent.

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Hospitals 95

The Pharmacist

JANUARY 16, 2024

The pharmacy regulatory model was ‘designed in a different era’ and could need a creative rethink in order to be ‘right for the future’, the chief executive of the General Pharmaceutical Council (GPhC) has said. In an evidence session to the parliamentary Health and Social Care Committee (HSCC) today, Duncan Rudkin highlighted ‘gaps’ in current […] The post Regulation needs ‘creative’ approach to be fit for the future appeared first on The Pharmacist.

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pharmaphorum

JANUARY 16, 2024

DISCO Pharma has emerged from stealth with €20m in seed financing that will be used to advance its surfaceome cancer target-hunting platform

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Express Pharma

JANUARY 16, 2024

The upcoming Union Budget 2024-2025 will determine how well India progresses with regard to achieving its stated objectives of becoming the ‘Pharmacy to the World’ and embracing ‘OneHealth’ principles. The government must continue incentivising R&D and manufacturing to boost growth and innovation in the industry, something which was particularly evident in the Promotion of Research and Innovation in Pharma Med-Tech Sector (PRIP) scheme from the previous budget.

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Pharmaceutical Technology

JANUARY 16, 2024

XNK Therapeutics has received scientific recommendation from the EMA's Committee for Advanced Therapies (CAT) for its product evencaleucel.

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Express Pharma

JANUARY 16, 2024

The Pre series A funding will be pivotal for Zingavita’s growth and marketing initiatives Zingavita has announced the successful closure of Rs 10 crore Pre-series A funding round led by Anicut Capital. The investment is poised to catalyse Zingavita’s expansion into new product development focusing on targeted nutrition. Following Dheeraj Nagpal’s recent appointment as cofounder at the company, the round welcomes marquee investors from the Pharma and FMCG space.

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BioPharma Dive

JANUARY 16, 2024

Relationships with Speaker Bureau faculty are among the most important that a biopharmaceutical company nurtures.

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Drug Channels

JANUARY 16, 2024

My recent Drug Channels Outlook 2024 webinar covered 12 key trends that will shape the commercial environment this year. The video excerpt below highlights my commentary on trend #2: the rapid growth of anti-obesity GLP-1 agonist drugs. As I explain, this growth will challenge payer and channel economics, while boosting profits for patient reimbursement hub businesses and pharmacy benefit managers (PBMs).

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BioPharma Dive

JANUARY 16, 2024

While investment remains lower than in other areas of drug R&D, executives and VCs speak of growing momentum for a field that’s been overlooked in the past.

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Pharmaceutical Commerce

JANUARY 16, 2024

Cureus report discuss the value of AI, but the medical community must remain aware of privacy pitfalls.

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Outsourcing Pharma

JANUARY 16, 2024

An alliance between KBI Biopharma Inc., and Argonaut Manufacturing Services Inc., has been formed so biopharma clients can receive end-to-end drug substance and drug product manufacturing solutions.

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Drug Development 75

PharmaTech

JANUARY 16, 2024

CellVoyant has raised £7.6 million in seed funding to speed up the development of novel cell therapies.

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