Fri.Aug 09, 2024

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Opinion: Noah Lyles’ collapse with Covid: How not to manage health at the Olympics

STAT

Noah Lyles, a 27-year-old from Gainesville, Florida, has had himself quite an Olympics. He won a gold medal in a photo finish in the 100-meter dash on August 4. He went on to win a bronze medal in the 200-meter dash four days later, then collapsed in a heap and needed a wheelchair to get off the track, suggesting that sports officials and team doctors have put athletes’ health last, not first, during the Paris Olympics.

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Pharma execs react to final drug price negotiations with Medicare

PharmaVoice

Here’s what the leaders of the companies with the 10 drugs in the first wave of price negotiations with Medicare said about how the new prices will impact their portfolio.

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Trending Sources

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FDA approves EpiPen alternative, a nasal spray for anaphylaxis

STAT

On Friday, the Food and Drug Administration approved the first needle-free treatment for adults and kids with severe allergic reactions. The approval introduces a competitor from ARS Pharma to older epinephrine products, like the EpiPen. Neffy, as the product is called, is a nasal spray that delivers the same drug used to treat anaphylaxis. It is ARS’ flagship product.

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In tone-setting verdict, FDA rejects MDMA as a therapy aid for PTSD

BioPharma Dive

The decision to turn down an application from Lykos Therapeutics comes at a pivotal time for psychedelics research, which, after decades of dismissal, has recently gained momentum.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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CDC slightly increases risk bird flu could cause a pandemic in latest assessment

STAT

The Centers for Disease Control and Prevention issued a new risk assessment of the H5N1 bird flu virus circulating in dairy cows on Friday, increasing slightly its estimate of the chance it poses of triggering a pandemic. The new assessment , developed using the CDC’s influenza risk assessment tool or IRAT, gauged the risk the virus might someday cause a pandemic at 5.79, up from a previous score of 5.12 from an assessment of a related virus conducted in April 2023.

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With pharma in ‘catbird seat,’ biotechs get less upfront in drug partnerships

BioPharma Dive

Recent data from J.P. Morgan indicates early-stage startups are getting smaller upfront payments in alliances than a few years ago, a trend industry insiders attribute to weaker leverage in deal talks.

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More Trending

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Merck bets $700M on an antibody drug’s potential in immune diseases

BioPharma Dive

The deal hands Merck a cancer medicine already in human testing, but that the company sees as a potential treatment for autoimmune conditions, too.

Immunity 117
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STAT+: A bespoke genetic therapy is helping Susannah. Can similar drugs be made at scale for other rare diseases?

STAT

Will it work? It was the question everyone around Susannah Rosen kept asking. Since infancy, she’d lived with a rare neurologic disease. She’d struggled to walk and talk, only to have the degenerative disease mostly rob her of those skills. Hardly a day passed without her suffering seizures, leaving her in need of constant care. But in October 2022, Susannah’s family had reason to be hopeful.

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Balancing cost and value with TCO

Express Pharma

Optimising TCO in the pharma sector demands a holistic approach Rajendra B Chunodkar, President – Manufacturing Operations, Lupin Optimising TCO without compromising on quality and compliance requires a multifaceted approach, often involving: Contract Development and Manufacturing Organizations (CDMOs): CDMOs offer specialised expertise and state-of-the-art facilities for drug product development and manufacturing.

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Opinion: Medicine needs fiction, especially now

STAT

The American medical system needs fiction because, as Albert Camus supposedly said , “Fiction is the lie through which we tell the truth.” And those in health care, from hospital administrators to clinicians and technicians, need to hear the real truth about health care. For decades, a small group of physician and nurse writers has provided behind-the-scenes looks at the experiences of being a doctor, the lives saved, the ones lost, and how the profession has changed the way many p

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Best Practices to Streamline Compensation Management: A Foundation for Growth

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.

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Amgen to open a new site in Hyderabad

Express Pharma

Amgen plans to open a new technology and innovation site in Hyderabad, India. The site, known as Amgen India, aims to accelerate digital capabilities across the global organisation to further advance Amgen’s pipeline of medicines. Amgen India will be located in HITEC City, a suburb of Hyderabad, occupying six floors of the RMZ Spire Tower 110. Hyderabad was selected for its talent across medicine, life sciences, data sciences and IT sectors.

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MDMA therapy is facing an imminent FDA decision. Here’s what you need to know

STAT

A decades-long campaign to legalize MDMA as a mainstream medical treatment will reach a climax as soon as Friday, with the Food and Drug Administration poised to decide whether the psychedelic should be approved as a treatment for post-traumatic stress disorder in conjunction with psychotherapy. The regulators face an Aug. 11 deadline to decide whether to sign off on the drug or reject it.

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Pharmacists eligible for Covid vaccination, government confirms

The Pharmacist

NHS Covid-19 vaccinations will be offered to 'frontline health and social care staff', including pharmacists and staff and volunteers working on the Covid-19 vaccination service, the government has confirmed. And patients aged over 65, care home residents and patients who are pregnant or in a clinical at-risk group will be eligible for the autumn booster, […] The post Pharmacists eligible for Covid vaccination, government confirms appeared first on The Pharmacist.

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Opinion: Small changes in food ‘choice environments’ in stores can make a healthy difference

STAT

I usually do my grocery shopping at the end of the day when I am tired, stressed, and hungry. In a word, I am vulnerable. The sugary beverages, candy, baked goods, and salty snacks located at the front entrance, aisle end caps, and checkout lanes can be hard to resist. The food industry knows this about me — and you. But small changes in the “choice architecture” can help people avoid these unplanned impulse purchases and choose healthy foods.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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Merck signs an MoU with Aragen

Express Pharma

Merck Life Science, India has signed a Memorandum of Understanding (MoU) with Aragen, an R&D and manufacturing solutions provider, in small molecules and biologics, to the global life sciences industries. The MoU was signed by Aditya Sharma, Head of Process Solutions, India Region, Merck Life Science, and Subodh Deshmukh, CEO, Aragen Bioscience.

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Morning Rounds: Another Ebola outbreak?

STAT

Want to stay on top of health news?  Sign up  to get our Morning Rounds newsletter in your inbox. I’m working on a playlist for an upcoming road trip. Got song suggestions for driving across vast landscapes? Email me: brittany.trang@statnews.

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AYUSH, PHD Chamber of Commerce and Industry organise conference on labelling and packaging provisions for ASU products

Express Pharma

AYUSH Committee, PHD Chamber of Commerce and Industry organised a Conference on Labelling and Packaging Provisions for ASU products recently at PHD House, New Delhi. The conference was graced by the Chief Guest Dr Kousthubha Upadhyay, Advisor (Ay.), Ministry of AYUSH, Government of India and Dr Tanweer Alam, Additional Director, Indian Institute of Packaging, Ministry of Commerce and Industry, Government of India as Guest of Honour.

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STAT+: Pharmalittle: We’re reading about a California bill to restrain PBMs, a U.K. trade group scolding Novo, and more

STAT

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 fairly modest. We hope to catch up on our reading, spend time with our Pharmalot ancestor, and promenade with the official mascots. We also hope to hold another listening party, where the rotation will likely feature this ,  this ,  this , and  this.

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Position Your Pharmacy for Expansion

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.

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Granules India gains ANDA approval for Trazodone tablets

Express Pharma

Granules India announced today that the US Food and Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Trazodone Hydrochloride Tablets USP, 50 mg, 100 mg, 150 mg, and 300 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug, Desyrel Tablets, 50 mg, 100 mg, 150 mg, and 300 mg, of Pragma Pharmaceuticals.

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Why did Novo pull heart failure paperwork for Wegovy?

STAT

Hey, humans. Today, we talk about the decades-long pursuit to get MDMA approved as a medicine for PTSD, in advance of Lykos Therapeutics’ Sunday PDUFA date. Also, we see a little girl’s ultra-rare disease improve after she was given a genetic medicine designed just for her, and more. The need-to-know this morning Merck acquired an experimental bispecific antibody from China-based Curon Biopharmaceutical for $700 million upfront, plus an additional $600 million in potential mileston

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Minutes to answers: Compliant chat builds more meaningful HCP relationships

pharmaphorum

Compliant chat ensures that Healthcare Professionals (HCPs) receive accurate information in a timely manner, fostering more meaningful relationships. Learn how to navigate compliance in your interactions with HCPs.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

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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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Lilly's tau drug for Alzheimer's flunks phase 2 test

pharmaphorum

Eli Lilly's oral tau drug fails to show efficacy in a phase 2 trial in Alzheimer's disease in another setback for the class

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Zydus gains final USFDA approval for Valbenazine Capsules

Express Pharma

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Valbenazine Capsules, 40 mg, 60 mg, and 80 mg (USRLD: Ingrezza Capsules). Valbenazine Capsules are indicated for the treatment of adults with tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts). Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Valbenazine Capsules, 40 mg, and

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KCL and UCL scientists develop accurate AI brain imaging model for research

Pharma Times

In the UK, there are an estimated 11 million people living with a neurological condition

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Pharmacies polled on Pharmacy First thresholds and impact of GP action

The Pharmacist

Community Pharmacy England (CPE) is asking community pharmacies how confident they feel about meeting the Pharmacy First clinical pathway thresholds as they rise in September and October. The survey, for independent and non-CCA multiples, also asks what the impact of GPs 'working to rule' has been since action began earlier this month. In September, pharmacies […] The post Pharmacies polled on Pharmacy First thresholds and impact of GP action appeared first on The Pharmacist.

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Study reveals genetic variants are more common in Parkinson’s disease patients

Pharma Times

The study revealed that 13% of patients have a genetic form of the neurological disease

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Eli Lilly boosts sales forecast by $3bn as diabetes and weight loss drugs propel revenue

Pharmaceutical Technology

Days after competitor Novo Nordisk posted underwhelming Wegovy sales, Eli Lilly cited “strong performance” for Zepbound and Mounjaro.

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Lilly says tirzepatide supply issues are resolving

pharmaphorum

Eli Lilly raises guidance for 2024 by $3 billion on strong growth for tirzepatide in diabetes and obesity and improved supply capacity

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One in three pharmacies considered closing amid riots

The Pharmacist

One in three pharmacies polled by the National Pharmacy Association (NPA) said they considered closing as riots spread across the UK over the last week. And over half of pharmacy teams said that they felt unsafe because of the violent unrest, the NPA said. More than one in ten (13%) of pharmacy teams reported that […] The post One in three pharmacies considered closing amid riots appeared first on The Pharmacist.

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Second time lucky at FDA for Citius' lymphoma drug

pharmaphorum

At the second attempt, the FDA has approved Citius Pharmaceuticals' Lymphir for rare lymphoma CTCL

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UK shortage of drug used to prevent brain damage in alcoholics

The Guardian - Pharmaceutical Industry

Experts say addiction patients are being treated as second-class citizens as ‘essential’ Pabrinex is withdrawn Doctors have warned that a severe shortage of an “essential” medicine used to help protect alcoholics from degenerative brain conditions could disproportionately affect “some of the most vulnerable” in society. Pabrinex, a multivitamin injection, is used to protect heavy drinkers from conditions such as Wernicke’s encephalopathy and Korsakoff syndrome, which can have symptoms similar to

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