STAT

AUGUST 25, 2023

With last fall’s chaotic early start to the respiratory virus season still fresh in the public memory, federal health authorities are trying to move quickly to convey the impression that this year will be different. In a briefing for reporters Thursday, senior officials of the Centers for Disease Control and Prevention and the Food and Drug Administration detailed the various countermeasures available to combat Covid-19, RSV, and influenza, and discussed the expected timing on the rollout

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PharmaVoice

AUGUST 25, 2023

FDA Commissioner Robert Califf suggested larger reforms are needed to bolster the generic drug industry and prevent future medication shortages.

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STAT

AUGUST 25, 2023

A group of Nigerian, British, and U.S. doctors have discovered a genetic variant that increases the risk of Parkinson’s disease in people of African and mixed-African descent and is not seen in those with European ancestry, a finding that could improve treatment of the movement disorder in a vastly underserved population. “It could be a major mechanistic basis of Parkinson’s disease in African populations,” the researchers said in their paper , published this week in

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Pharmaceutical Technology

AUGUST 25, 2023

The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.

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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

AUGUST 25, 2023

Just weeks after Novo Nordisk announced that its obesity drug Wegovy cut the risk of heart complications in a major trial, the company now has results from a different study showing the treatment can also benefit people with a common type of heart failure. The results, published Friday in the New England Journal of Medicine, found that among people with obesity and heart failure with preserved ejection fraction, or HFpEF, those taking Wegovy experienced greater improvements in symptoms and physi

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BioPharma Dive

AUGUST 25, 2023

According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S. market against Biogen’s inflammation-regulating medicine Tysabri.

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PharmExec

AUGUST 25, 2023

The Generic Drug User Fee Amendments, designed to facilitate the delivery of safe and effective generic drugs to the public and improve the predictability of the ANDA assessment process, has undergone changes that will impact the pre-ANDA and ANDA approval process—and ultimately the path for generic drugs to approval.

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STAT

AUGUST 25, 2023

NEW YORK — A fourth-year medical student, a music therapist, a child psychiatrist, and a physician-researcher stared at their laptops, puzzling over the combination of words that would make a supposedly intelligent system — NYU Langone’s customized version of ChatGPT — think about health care problems in a way that was useful to them.

HIPAA 227

HIPAA 227

Pharma Times

AUGUST 25, 2023

The decision follows a recent recommendation from the European Medicines Agency’s human medicines committee - News - PharmaTimes

Vaccines 103

Vaccines 103

STAT

AUGUST 25, 2023

Neumora, a neuroscience startup founded by VC Arch Venture Partners, hopes to become one of the few biotechs to go public this year. The company filed paperwork for an IPO with the Securities and Exchange Commission on Friday. It did not state how many shares it plans to sell or at what price. The biotech had begun planning for an IPO last year, STAT reported in June 2022.

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Pharmacy Management

European Pharmaceutical Review

AUGUST 25, 2023

A paper published in Molecules has detailed a strategy and evaluation approach for acceptable classification of species usually detected in migration studies. This can therefore support extractable and leachable (E&L) studies. Migration studies are one of the few domains of QA/QC pharmaceutical analysis employing wide-scope screening methodologies, the paper noted.

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Compounding Packaging 95

STAT

AUGUST 25, 2023

When the American Academy of Pediatrics reaffirmed its support for gender-affirming care earlier this month, and called for a systematic review of the evidence, some swaths of the public saw the move as casting doubt on the benefits of such care. But the AAP and other experts say the systematic review only indicates their confidence in the current standards of care, and their awareness of a need to stay on top of the evidence amid a changing political landscape in which anti-trans legislation &#

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BioPharma Dive

AUGUST 25, 2023

Neumora’s filing late Friday, along with that of radiopharmaceutical startup RayzeBio earlier this week, could be an important test of the biotech IPO market.

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Drug Development 98

STAT

AUGUST 25, 2023

Advancements in LLMs such as ChatGPT and GPT-4 have generated substantial excitement. Many see these models as assistants or even potential replacements for time-intensive tasks, like patient-physician communication through the electronic health record. Designed to serve numerous downstream applications, these models convert data into representations that are useful for multiple tasks.

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Labelling Communication 218

European Pharmaceutical Review

AUGUST 25, 2023

The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision? According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments.

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Documentation Pharmaceutical Manufacturing 94

STAT

AUGUST 25, 2023

Good morning Pharmalittle students. This is Allison DeAngelis, filling in for Ed Silverman while he’s away from the Pharmalot campus. I debated assigning you a “What I did on my summer vacation” essay to write over the weekend. Instead, we’re going to discuss the latest healthcare news! Here are the major headlines of the day.

Vaccines 180

Vaccines Drug Development 180

BioPharma Dive

AUGUST 25, 2023

After trial results showed the obesity drug can prevent heart attacks, the company now has data indicating it can help people with heart failure, too.

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Express Pharma

AUGUST 25, 2023

Vildagliptin SR and Metformin SR tablets are available in four strengths: 50 mg/500 mg, 50 mg/1000 mg, 100 mg/500 mg, and 100 mg/1000 mg Akums Drugs and Pharmaceuticals unveils a solution in the fight against diabetes-Vildagliptin SR and Metformin SR tablets. Designed to cater to patients with type 2 diabetes mellitus who have found inadequate control with metformin monotherapy, this combination promises effective glycemic control.

Diabetes 90

Diabetes 90

Drug Channels

AUGUST 25, 2023

Today’s guest post comes from Chris Dowd, Senior Vice President of Market Development at ConnectiveRx. Chris discusses how such copay adjustment programs as accumulators and maximizers impact patients. He also discusses current legal cases that cover prescription medication access. To learn more, register for ConnectiveRx’s free October online panel discussion with Chris: The Battle Over Accumulators and Maximizers: What You Need to Know for 2024.

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Express Pharma

AUGUST 25, 2023

When breast cancer cells spread to other parts of the body it is called secondary or metastatic breast cancer and although treatable cannot be cured Researchers at the University of Sheffield are testing new combinations of drugs to treat breast cancer that’s spread to the bone with the help of funding from Breast Cancer Now. The charity has awarded Professor Penelope Ottewell at the University of Sheffield £142,714, to investigate whether a drug called radium-223, which is used to treat prostat

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Pharmaceutical Technology

AUGUST 25, 2023

Soliris is already approved to treat refractory generalised myasthenia gravis in adults in different regions.

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Express Pharma

AUGUST 25, 2023

API and Ipsos, supported by GSK, conducted a survey to understand the awareness and adoption of vaccination by adults above 50 years of age A recently conducted survey by The Association of Physicians of India (API) and Ipsos, in 16 cities among adults aged 50 years and older, their caregivers and doctors has yielded compelling insights into why there is low adoption of adult immunisation in India.

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Vaccines Diabetes 85

The Pharmacist

AUGUST 25, 2023

A ‘large number’ of Serious Shortage Protocol (SSP) claims submitted by pharmacy owners have been deemed invalid by the NHS Business Services Authority (NHSBSA), Community Pharmacy England (CPE) has said. This is due to ‘incorrect endorsements’ being applied by the Patient Medication Record (PMR) system or by pharmacy staff, the pharmacy negotiator said.

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Community Pharmacies Medical Records 73

Express Pharma

AUGUST 25, 2023

This product will be manufactured at Lupin’s Pithampur facility in India Lupin has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application for Pirfenidone Tablets, 267 mg and 801 mg, to market a generic equivalent of Esbriet Tablets, 267 mg and 801 mg of Hoffmann La Roche Inc.

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The Pharmacist

AUGUST 25, 2023

The number of drug related deaths in Scotland in 2022 was at its lowest level in five years but still significantly higher than the most recent UK average, according to figures released this week by the National Records of Scotland. Though The Scotsman suggested today that the actual toll could be even higher if ‘secondary’ […] The post Drug misuse deaths in Scotland ‘still far too high’ appeared first on The Pharmacist.

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Pharma Times

AUGUST 25, 2023

The disease-modifying therapy is approved to treat all indications covered by Tysabri - News - PharmaTimes

Biosimilars 85

Biosimilars 85

Outsourcing Pharma

AUGUST 25, 2023

STARLIMS, a company that provides enterprise informatics solutions has acquired Labstep, a research and development (R&D) electronic laboratory notebook (ELN).

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pharmaphorum

AUGUST 25, 2023

Semaglutide scores again, this time in heart failure Phil.

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Outsourcing Pharma

AUGUST 25, 2023

Emerald Cloud Lab (ECL) was the worldâs first highly automated cloud laboratory, was set up by two friends, Brian Frezza and D.J Kleinbaum who grew up together and joined forces after their PhDs to found the company.

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Welltopia Pharmacy

AUGUST 25, 2023

Find relief from digestive imbalances with Candibactin. Discover how to incorporate this natural supplement into your holistic approach to gut health for optimal digestion and improved gut microbiome balance.

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Drug Patent Watch

AUGUST 25, 2023

Annual Drug Patent Expirations for ORLADEYO Orladeyo is a drug marketed by Biocryst and is included in one NDA. It is available from one supplier. There are seven patents protecting… The post New patent for Biocryst drug ORLADEYO appeared first on DrugPatentWatch - Make Better Decisions.

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Pharma and Life Sciences Blog

AUGUST 25, 2023

Reducing Your Environmental Impact While Managing Cost and Risk annmarie@AZglo… Fri, 08/25/2023 - 23:21 Procurement and supply chain leaders face a clear challenge: efficiently managing costs while strengthening resilience and improving sustainability. Considering that supply chain emissions account for up to 80% of an organization’s total carbon footprint, according to a GEP-sponsored North Carolina State University study, they have their task cut out for them.

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Drug Patent Watch

AUGUST 25, 2023

Annual Drug Patent Expirations for SKYLA Skyla is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are five patents… The post New patent for Bayer Hlthcare drug SKYLA appeared first on DrugPatentWatch - Make Better Decisions.

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Pharma and Life Sciences Blog

AUGUST 25, 2023

The Must-Have Procurement Software Capabilities for Navigating Today’s Complex, Uncertain Market annmarie@AZglo… Fri, 08/25/2023 - 23:40 Having the right procurement software is essential to control costs, mitigate risk and drive sustainability in today’s economic turbulence. With so many vendors and solutions out there, you need a way to separate the best from the rest.

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Drug Patent Watch

AUGUST 25, 2023

Annual Drug Patent Expirations for NOURIANZ Nourianz is a drug marketed by Kyowa Kirin and is included in one NDA. It is available from one supplier. There are four patents… The post New patent for Kyowa Kirin drug NOURIANZ appeared first on DrugPatentWatch - Make Better Decisions.

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