STAT

MAY 22, 2024

A second human case of bird flu infection linked to the current H5N1 outbreak in dairy cows has been detected, in a farm worker who had exposure to infected cows, Michigan state health authorities announced on Wednesday. In a statement , health officials said the individual had mild symptoms and has recovered. Evidence to date suggests this is a sporadic infection, with no signs of ongoing spread, the statement said.

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PharmaVoice

MAY 22, 2024

Direct-to-consumer platforms offer consumers an online path to sourcing popular medications, but some therapeutic areas may be better suited for the business model.

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STAT

MAY 22, 2024

UnitedHealth Group should be released from a lawsuit that alleges its algorithm-based technology prematurely cut off care to its Medicare Advantage members, the company said in court filings this week, because patients and their families did not finish Medicare’s appeals process. “Plaintiffs have failed to exhaust the exclusive administrative appeal process set by the Medicare Act,” UnitedHealth’s lawyers argued.

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PharmaVoice

MAY 22, 2024

Companies like UpScriptHealth led the charge with online prescriptions decades ago, and now the industry is catching on to solve some of healthcare’s most pressing issues.

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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

MAY 22, 2024

Less than a month ago, researchers reported for the first time the ability to scan wastewater for signs of the H5 influenza virus currently sickening dairy cows in at least nine states across the U.S. That technology is now at the threshold of real-world use. WastewaterSCAN, an infectious disease-tracking sewage surveillance network led by Stanford University and Emory University in partnership with Verily Life Sciences, has begun scaling up H5-specific testing of samples from all of its 190 sit

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The Pharmacist

MAY 22, 2024

There are many reasons why pharmacists should be leading providers of menopause advice and care in primary care – not least for their personal wellbeing – suggests pharmacist and menopause lead at NHS England, Bukky Ayoade As pharmacists, we are gatekeepers of healthcare, entrusted with the wellbeing of our patients. However, amid our commitment to […] The post Menopause care needs all of our attention appeared first on The Pharmacist.

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pharmaphorum

MAY 22, 2024

A think tank set up by former UK Prime Minister Tony Blair has called for the formation of a public-private trust that could oversee the sharing of anonymised patient data with trusted researchers.

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STAT

MAY 22, 2024

In an abrupt change of course from plans earlier in the month, at-home test maker Cue Health is laying off all of its employees and shutting down as of Friday, May 24. The company, which grew to prominence during the Covid-19 pandemic as the maker of one of the only molecular at-home tests for the virus, has been teetering on the edge of insolvency for months.

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pharmaphorum

MAY 22, 2024

GSK’s follow-up to its severe asthma therapy Nucala has shown its value in a pair of phase 3 trials, reducing exacerbations compared to placebo with dosing once every six months. The company says new IL-5 inhibitor depemokimab (formerly GSK3511294) has the potential to become the first ultra-long-acting biologic for severe asthma with a six-monthly dosing schedule.

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STAT

MAY 22, 2024

Cytokinetics, a drugmaker that is expected to soon launch a promising new heart therapy called aficamten, said Wednesday that it had agreed to pay biotech firm Royalty Pharma a higher royalty on the medicine in return for up to $575 million, which will be used to fund the marketing of the drug and Cytokinetics’ ongoing research and development efforts.

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Pharmaceutical Companies Pharmaceutical Companies 302

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pharmaphorum

MAY 22, 2024

The debate rages on as NICE considers a 'clinically distinct disease' classification. Learn how this decision could reshape the STA process and patient treatment options.

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STAT

MAY 22, 2024

Biogen is joining the industry’s fervor over immune and inflammatory disease drug development with a new acquisition. The Cambridge, Mass., drugmaker announced Wednesday that it will acquire Human Immunology Biosciences , or HI-Bio, for $1.15 billion and up to $650 million in additional payments if certain milestones are met. HI-Bio, which is based in San Francisco, is developing therapies for immune-mediated diseases like primary membranous nephropathy and IgA nephropathy, both of which

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European Pharmaceutical Review

MAY 22, 2024

The European Commission (EC) has approved the first and only biosimilar versions of the reference medicines Xgeva ® and Prolia ® in Europe. Sandoz shared that Wyost ® (denosumab) is approved for treating cancer-related bone disease. Jubbonti ® (denosumab) is authorised as an osteoporosis treatment. The decision by the EC “is a major step in advancing the Sandoz growth strategy”, the company asserted.

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Biosimilars 98

STAT

MAY 22, 2024

WASHINGTON — There are three FDA-approved drugs for treating alcohol use disorder. But a different medication, one frequently used off-label for the condition, could provide greater benefit to patients with alcohol-associated liver disease, a new study suggests.  The data, presented this week as an abstract at Digestive Disease Week in D.C., suggest anti-seizure gabapentinoids might be a simple and effective treatment for slowing the progression of alcohol-associated liver disease.

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Labelling 324

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.

pharmaphorum

MAY 22, 2024

Lawmakers across the political divide have accused the pharma industry of abusing the patent system to keep the prices of their products as high as possible.

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STAT

MAY 22, 2024

During the Covid-19 pandemic, vaccines were the main line of defense. Startlingly effective shots quickly helped immunize a large portion of the population — at least initially, and in high-income countries. Antiviral treatments were not as impactful. Remdesivir requires transfusions, which made it difficult to access; Paxlovid is easier to obtain, but has more unpleasant side effects, and carries the risk of rebound.

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pharmaphorum

MAY 22, 2024

Digital health firm Click Therapeutics has bought the assets of Better Therapeutics to speed up development of a prescription digital therapeutic for obesity

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STAT

MAY 22, 2024

History and literature are replete with cautionary tales on the dangers of pretending to be someone — or something — you aren’t. Many digital health companies failed to heed the lesson, and the results have been predictable. Technology has upended virtually every known industry and customer experience, health care included. Sadly, health care is at or near the bottom when it comes to providing users with good experiences.

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PharmaTech

MAY 22, 2024

The company is collaborating with the Access to Oncology Medicines Coalition to expand patient access to immuno-oncology therapy Opdivo.

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STAT

MAY 22, 2024

The Food and Drug Administration is poised to tell drug and medical device makers how to better include people of color in the clinical trials that test whether products work and are safe, an agency official said Wednesday. Those guidelines are five months late. To ensure that drugs work for everyone, they must be tested on a representative sample of people.

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Pharmaceutical Technology

MAY 22, 2024

As the nitrosamine scandal continues, we explore the advancements in parenteral packaging materials that are reducing the risk of this contaminant in modern injectables.

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Packaging 97

STAT

MAY 22, 2024

Digital therapeutics company Click Therapeutics announced Wednesday it will acquire the assets of Better Therapeutics, developer of a software-based treatment for diabetes. Click, which did not disclose how much it is paying for the assets, hopes to adapt Better’s tech for use alongside GLP-1 medications. Better Therapeutics announced in March that it was delisting from the Nasdaq stock exchange and shutting down operations as it sought strategic alternatives.

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Diabetes 277

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.

Pharma Times

MAY 22, 2024

The nanocage technology combines both mRNA and traditional virus-based vaccines to create virus-like efficacious vaccines

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Vaccines 109

STAT

MAY 22, 2024

Thanks to new regulatory frameworks like the Food and Drug Administration’s Breakthrough Therapy designation , drugs are coming to market faster than ever. A 2024 analysis of drugs included in this program showed they had 23% shorter clinical development timelines than those that were not part of the program, with no negative effects on their safety profiles.

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Pharmaceutical Companies Pharmaceutical Companies Drug Development 273

European Pharmaceutical Review

MAY 22, 2024

A total of 33 regulatory authorities have been granted designation as World Health Organization ( WHO ) Listed Authorities under the WLA framework. The agencies holding this status have been approved and validated as compliant and committed to upholding the “highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines ”.

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Vaccines Pharmaceutical Manufacturing 93

STAT

MAY 22, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. About a month ago, when I first started writing this newsletter, I shared the devastating news that the famed rat hole here in Chicago  was being removed. But as summer approaches, it appears there now may be a new animal-shaped indentation for us all to obsess over — the  Chicago cicada hole.

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Drug Pricing Drug Development Vaccines 231

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Pharmacy Management

Pharma Times

MAY 22, 2024

Currently the third most common cancer in the UK, lung cancer affects 40,000 people annually

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STAT

MAY 22, 2024

Good morning from San Diego. This is Jonathan Wosen, West Coast biotech and life sciences reporter, filling in for Ed Silverman while he’s away from the Pharmalittle campus. I’m not a coffee drinker, but who needs caffeine when you’ve got the raw adrenaline rush of drug industry news to jolt you awake? If you don’t believe me, just read these items.

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Compounding Labelling Hospitals 229

Drug Patent Watch

MAY 22, 2024

Annual Drug Patent Expirations for NOCDURNA Nocdurna is a drug marketed by Ferring Pharms Inc and is included in one NDA. It is available from one supplier.

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STAT

MAY 22, 2024

If you ask a chatbot how to cause a pandemic, it will suggest the 1918 influenza virus, according to researcher Kevin Esvelt. It will even tell you where to find the gene sequences online and where to purchase the genetic components. Esvelt is a biologist and MIT professor whose work has included altering the genes of mice to prevent the spread of Lyme disease.

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Express Pharma

MAY 22, 2024

Strides Pharma Science (Strides) recently announced that its stepdown wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for the generic version of Sucralfate Oral Suspension, 1gm/10 mL, from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Carafate 1gm/10mL of AbbVie.

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