STAT

MAY 26, 2023

When a new and hoped-to-be safer oral polio vaccine started to make its way into use in March 2021, there was huge optimism that this long-needed tool would help the polio eradication campaign quell a growing problem that was — and is still — complicating efforts to stamp out polio forever. Two years later, expectations surrounding the new vaccine, known as novel oral polio vaccine type 2, or nOPV2 for short, are moderating a bit.

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Vaccines 278

PharmaVoice

MAY 26, 2023

Executives honored by the Healthcare Businesswomen’s Association share the key traits that help them drive results.

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STAT

MAY 26, 2023

A recent report from the National Academies of Sciences, Engineering and Medicine (of which one of us, GC, is an author) shows that underrepresentation of population subgroups in clinical research is bad for the health of Americans. For instance, recent research showed that appropriate dosing for an often- prescribed blood thinner, warfarin, differs due to genetic variants.

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PharmaVoice

MAY 26, 2023

If federal lawmakers don’t vote to raise the debt limit by early June, these FDA actions could be impacted.

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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

MAY 26, 2023

In a wave of anti-LGBTQ legislation , 19 U.S. states thus far have banned at least some gender-affirming health care for minors — care that is evidence-based and supported by the major medical and professional organizations. The state of Texas may soon add to that count, with legislators passing a bill last week that Governor Greg Abbott has promised to sign when it comes across his desk.

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Pharmaceutical Technology

MAY 26, 2023

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib. Fruquintinib is a selective and potent oral VEGFR -1, -2 and -3 receptors inhibitor and is used for the treatment of adults with previously treated metastatic colorectal cancer. Fruquintinib will be the first and only highly selective inhibitor of these receptors approved in the US.

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Pharmaceutical Technology

MAY 26, 2023

The immuno-oncology market continues to evolve as treatments establish their presence across different types of cancer, having seen approvals in multiple indications in the past decade. While the market was worth over $6 billion in 2012, this has now grown to nearly $48 billion only a decade later, said Avigayil Chalk, PhD, GlobalData’s Senior Oncology and Haematology analyst, at an immuno-oncology webinar held on May 23.

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Immunity Immunization Vaccines Compounding 105

STAT

MAY 26, 2023

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.  Omada Health  announced it will launch  a new service  to help employers respond to the soaring demand for  e xpensive GLP-1 weight loss treatments like Wegovy.

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Pharmaceutical Technology

MAY 26, 2023

Krystal Biotech has received approval from the US Food and Drug Administration for topical gene therapy VYJUVEK to treat dystrophic epidermolysis bullosa (DEB) in adults and in children aged six months and above. VYJUVEK is designed to address the underlying genetic cause of the disease. An excipient gel applied topically is a key component of the therapy, which is supplied by Krystal’s client, Berkshire Sterile Manufacturing (BSM).

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STAT

MAY 26, 2023

Neuralink can now study its brain implant in humans after securing a go-ahead from the Food and Drug Administration. It’s a critical turning point for the Elon Musk-led company — but the startup, however closely watched, is playing catch-up compared to its peers in the neurotechnology field. “In terms of first in human, Neuralink is almost two decades behind,” said JoJo Platt, a neurotech strategist.

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Pharmacy Management

European Pharmaceutical Review

MAY 26, 2023

The UK Chancellor has announced a £650 million life sciences growth package (Life Sci for Growth) to help deliver the Science and Technology framework through reforming regulation, boosting investment and driving up talent and skills. Bringing together 10 different policies, the package includes: A total of £121 million to improve commercial clinical trials to bring new medicines to patients faster Up to £48 million of new money for scientific innovation to prepare for any future health emergenc

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Packaging Vaccines Drug Development 101

STAT

MAY 26, 2023

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still taking shape, but we hope to check in on the Pharmalot ancestors, hang with our shortest person, promenade with the official mascot, and squeeze in a listening party — the rotation will include this , this , this and this.

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Express Pharma

MAY 26, 2023

Eisai Co has announced that it will grant a total of 625 million yen to the Global Health Innovative Technology Fund (GHIT Fund) to fund the third phase of its activities, which will take place in the five-year period from FY2023 to FY2027. The GHIT Fund is a public-private partnership, co-established in April 2013 by Japanese pharma companies (including Eisai), the Japanese government, and the Bill & Melinda Gates Foundation, for the purpose of accelerating development of new medicines to c

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Vaccines 98

STAT

MAY 26, 2023

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.   That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Outsourcing Pharma

MAY 26, 2023

A drug that has the ability to âtransform the landscapeâ for people living with metastatic colorectal cancer (CRC) has been granted priority review by the US Food and Drug Administration (FDA).

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Pharma Times

MAY 26, 2023

Life Sciences Council meeting hosted by chancellor Jeremy Hunt has unfolded in Downing Street

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European Pharmaceutical Review

MAY 26, 2023

The Medicines and Healthcare products Regulatory Agency ( MHRA ) has announced that new international regulatory recognition routes for medicines will be established using approvals from the EU, Switzerland, US, Canada, Australia, Singapore and Japan. According to the MHRA, the recognition routes mark the start of a new international recognition framework for medicines that will be in place by the first quarter of 2024.

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Vaccines 86

Pharma Times

MAY 26, 2023

Therapy has been developed for use among children and adolescents with growth hormone deficiency

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Express Pharma

MAY 26, 2023

Pharmanovia, a company that commercialises novel medicines and revitalises, extends and expands the lifecycle of established medicines, has announced increased targets to divert 40 per cent of its air shipments to sea in 2023, and 75 per cent by the end of 2028. Pharmanovia revealed the significant progress made towards achieving its ESG initiatives in its new Sustainability Report.

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Packaging 81

The Pharmacist

MAY 26, 2023

A genetic ‘biobank’ will be launched on 1 June 2023 by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to understand how a patient’s genetic make up can impact the safety of their medicines. Known as the Yellow Card biobank, the biobank will contain genetic data and patient samples and be used by scientists […] The post Adverse reactions biobank to launch next month appeared first on The Pharmacist.

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Adverse Reactions 83

PharmExec

MAY 26, 2023

Ahead of ASCO and BIO, Michael Bailey CEO of AVEO Oncology, discusses the company becoming a LG Chem subsidiary and the future for drug development in the combined entity.

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Drug Development 98

The Pharmacist

MAY 26, 2023

People aged between 50 and 64 years old will not be eligible for a free flu vaccination in the 2023/24 season, the government announced yesterday in its flu vaccination programme letter. But the Pharmaceutical Services Negotiating Committee (PSNC) has said that the government should explain to patients in this age bracket why they won’t be […] The post Government must communicate free flu jab eligibility change to patients, says PSNC appeared first on The Pharmacist.

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Communication Vaccines 79

pharmaphorum

MAY 26, 2023

Elon Musk’s Neuralink says FDA has cleared human trial Phil.

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The Pharmacist

MAY 26, 2023

Community pharmacies across the UK can now sign up to new quality improvement standards for palliative and end of life care. The Daffodil Standards, born from a partnership between the Royal Pharmaceutical Society (RPS) and charity Marie Curie, set out areas of good practice and hope to help improve the care provided to patients approaching […] The post New palliative care standards provide ‘roadmap’ for pharmacies appeared first on The Pharmacist.

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Community Pharmacies 76

Pharmaceutical Technology

MAY 26, 2023

Chronic disease tech company Convatec Group has partnered with Beta Bionics to manufacture the insulin delivery system iLet Bionic Pancrease. According to Beta Bionics, this is the only first and only automated insulin delivery system that carries 100% of doses and does not require carb counting. The device received US Food and Drug Administration 510(k) clearance last week for those ages six years and above living with type 1 diabetes.

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Diabetes Online Pharmacies 59

World Pharma News

MAY 26, 2023

Initial findings from a study of nearly 10,000 Americans, many of whom had COVID-19, have uncovered new details about long COVID, the post-infection set of conditions that can affect nearly every tissue and organ in the body. Clinical symptoms can vary and include fatigue, brain fog, and dizziness, and last for months or years after a person has COVID-19.

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Pharmaceutical Technology

MAY 26, 2023

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir). The label is specified for the treatment of “mild-to-moderate Covid-19 in adults who are at high risk for progression to severe COVID-19, including hospitalisation or death.

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Labelling Immunity Immunization 59

pharmaphorum

MAY 26, 2023

Primary care a weak link in trials, says O’Shaughnessy Phil.

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PharmaTech

MAY 26, 2023

Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.

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GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: June 3, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”. – Author unknown, commonly misattributed to Charles Darwin They say change is the only constant in business.

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Documentation Packaging Communication Customer Service 52

Pharma and Life Sciences Blog

MAY 26, 2023

Discover the Value of AI in Driving M&A Opportunities annmarie@AZglo… Fri, 05/26/2023 - 22:50 Enterprise leaders are always looking for ways to expand their business through acquisition. But the real question is — does the deal make sense? The answer lies in technology, specifically in leveraging AI, automation and advanced analytics. In this report — How AI Can Help Identify and Accelerate M&A Synergy Opportunities — discover how ChatGPT and other tools can support the human decision-making pro

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GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: May 28, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”. – Author unknown, commonly misattributed to Charles Darwin They say change is the only constant in business.

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Documentation Packaging Communication Customer Service 52

epicur

MAY 26, 2023

Well-managed pharmacy inventory is key to a veterinary practice’s ability to provide quality care to its patients and boost profitability. Inventory costs represent the second-highest expense in veterinary hospitals and clinics, frequently eating up 20% or more of gross revenue. Strategic inventory management has become central to a veterinary practice’s success due to: Rising labor and overhead costs in recent years Increasing client demand for fast, convenient ordering and delivery options for

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Compounding Prescription Management Hospitals Communication 52

Putting Patients First Blog

MAY 26, 2023

Biosimilars briefing Event Time: 2:00 - 3:00 p.m. ET Event Location: Virtual The National Health Council invites you to join us for a webinar on the latest developments with biosimilars on Monday, June 12 at 2 p.m. ET. Though biosimilar treatments have been utilized in some disease states, like oncology, for some time, growing investment into these products is presenting more opportunity for adoption in the U.S. across broader disease areas.

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Biosimilars Communication 52

PharmaTech

MAY 26, 2023

Myrna Wilson, director, Global Marketing, Strategic Growth and Technical Sales, Pharmaceutical Ingredients, Univar Solutions, discusses the state of the biopharma supply chain, movements in the patent industry, and more.

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