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.

Vaccines 362

Vaccines 362

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: 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

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?

Medical Schools 353

Medical Schools 353

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.

Vaccines 138

Vaccines 138

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

Private equity gets a bad rap in health care. But some doctors see that kind of cash and consolidation as the only way for their practices to survive — and now, they’re taking that message to Washington. Lower pay, difficult negotiations with insurance companies, regulatory requirements from both government and commercial payers, expensive and inefficient IT systems, and the challenge of competing against hospital systems have created a “cascade of problems that seem like th

Hospitals 343

Hospitals 343

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

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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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

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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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 105

Adverse Reactions Documentation 105

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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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.

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.

Hospitals 98

Hospitals 98

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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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 105

Hospitals 105

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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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.

Compounding 101

Compounding 101

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

Vaccines 252

Vaccines Drug Pricing Drug Development 252

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

The Government of Uttar Pradesh (GoUP) is organising a ‘Pharma Conclave’ in Hyderabad on January 18, 2024. The Conclave is being held in collaboration with the Bulk Drug Manufacturers Association of India (BDMAI), Indian Drug Manufacturers Association (IDMA) – TS and AP Chapter and other associations to attract investments in the healthcare and pharma sector in Uttar Pradesh.

Packaging 103

Packaging Pharmaceutical Companies Pharmaceutical Companies 103

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.

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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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.

Community Pharmacies 93

Community Pharmacies 93

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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Pharmacy Management

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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Outsourcing Pharma

JANUARY 16, 2024

Clinical-stage drug delivery and development company DelSiTech has made the biggest single financing round in its history with the successful completion of a â10 million deal.

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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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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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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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