Tue.Apr 23, 2024

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H5N1 bird flu virus particles found in pasteurized milk but FDA says commercial milk supply appears safe

STAT

WASHINGTON — Testing conducted by the Food and Drug Administration on pasteurized commercially purchased milk has found genetic evidence of the H5N1 bird flu virus, the agency confirmed Tuesday. But the testing, done by polymerase chain reaction, or PCR, cannot distinguish between live virus or fragments of viruses that could have been killed by the pasteurization process.

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Inside J&J’s strategy to de-gender clinical trials

PharmaVoice

Mark Wildgust, vice president of global medical affairs for J&J's oncology division, shares strategies for making clinical trials gender- and trans-inclusive.

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STAT+: FTC’s noncompete ban would force sweeping changes in health care, if it survives legal battle

STAT

The Federal Trade Commission approved a far-reaching noncompete ban Tuesday that could force sweeping changes across the health care industry. But those changes may not take effect for years — if they ever do — because the contentious rule will almost certainly be held up in litigation. Commissioners voted three to two in favor of approving the final rule banning noncompete agreements across all sectors of the economy, a change the agency says will lead to more new businesses and h

Hospitals 342
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FDA clears ImmunityBio’s bladder cancer drug at 2nd attempt

pharmaphorum

After rejecting ImmunityBio’s Anktiva last year, the FDA has now cleared the drug as a treatment for bladder cancer, making it the biotech's first commercial-stage product

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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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Opinion: EMTALA, a vital health law you’ve never heard of, is in danger

STAT

Anyone who has gone to a hospital’s emergency room expecting to receive medical care — not knowing where else to turn, uncertain whether a loved one is having a medical emergency and what can be done about it, or unsure if they can pay — has relied on a law they couldn’t name: the Emergency Medical Treatment and Labor Act (EMTALA).

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How do we unlock the potential of digital health?

pharmaphorum

Unlock the power of digital health through AI and clinical advancements. Learn how these technologies are shaping the future of healthcare and how to harness their potential.

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More Trending

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Innovative Strategies in Drug Repurposing

Drug Patent Watch

Drug repurposing, or identifying new therapeutic uses for existing drugs, is gaining significant momentum as a promising approach to accelerate drug development and reduce costs.

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STAT+: Telehealth startups see an opportunity in long-ignored, complex chronic diseases

STAT

If her neurologist moved to China, Lauren Stiles says she’d follow him there. “There’s so few doctors who do this,” said the New York-based president of patient advocacy group Dysautonomia International. In her world, informed, experienced specialists — particularly in the autonomic nervous system — are extremely rare.

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Encouraging early engagement to revitalise Europe’s pharmaceutical landscape

pharmaphorum

In an on-site interview at Reuters Pharma Europe in Barcelona, this week’s podcast saw Tommy Bramley, SVP of market access and healthcare consulting at Cencora, discuss revitalising Europe’s pharmaceutical landscape and leveraging legislation for health and competitiveness.

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STAT+: NIH postdocs will get a raise next year — but not as much as they hoped

STAT

The National Institutes of Health will raise the minimum salary for postdoctoral researchers to $61,008 next year, the agency announced Tuesday, responding to growing calls from young life scientists to provide a living wage. The 8% pay bump is far short of the increase to $70,000 that was recommended by an NIH working group late last year. But the agency noted in a press release that it’s the largest year-over-year update for NIH-funded postdocs since 2017.

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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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New Drug Application of Zydus’ Desidustat tablets by China Medical System Holdings accepted in China

Express Pharma

Zydus Lifesciences announced that the New Drug Application (NDA) of Desidustat Tablets has been accepted by the National Medical Products Administration of China (NMPA). CMS International Development and Management, a wholly-owned subsidiary of China Medical System Holdings (CMS) obtained an exclusive license for the Product from Zydus in 2020. Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney D

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STAT+: Day One drug for common childhood brain tumor approved by FDA

STAT

D ay One Biopharmaceuticals said Tuesday the Food and Drug Administration approved its pill for one of the most common forms of childhood brain tumors, called pediatric low-grade glioma. The authorization is particularly notable because industry has historically developed few drugs for children with cancer, focusing instead on adults and often only years later testing their molecules in younger patients.

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Pharmacy First: Top tips for managing acute sore throats

The Pharmacist

CLINICAL UPDATE The Pharmacy First service in England enables pharmacists to diagnose and treat seven specific conditions, which should hopefully reduce some of the current pressures on general practice. This series of guides assumes that pharmacists are familiar with the clinical pathways and requirements for Pharmacy First. The articles explore some key aspects of each […] The post Pharmacy First: Top tips for managing acute sore throats appeared first on The Pharmacist.

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STAT+: Health care lobbying giants spent big as little got done in Congress

STAT

WASHINGTON — Congress did nothing this spring to rein in how pharmacy benefit managers operate, which is precisely the outcome the industry’s lobbyists wanted. And the PBM industry spent big to get that result, new disclosures show. The Pharmaceutical Care Management Association, the industry’s biggest trade group, spent a whopping 71% more on lobbying in the first three months of this year compared with 2023, increasing its spending from $2.8 million to $4.8 million.

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Novartis names ex-BMS CEO Caforio as chair amid strong Q1

pharmaphorum

Novartis has proposed ex-BMS CEO Caforio as the successor to chair Joerg Reinhardt when he steps down next year, as it posts a strong set of Q1 results

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Opinion: Lessons to psychiatrists-in-training from the CIA’s mind-control projects

STAT

My chief resident gave me a strange look when I arrived for another day of work at the Mayo Clinic one morning. “Something you’re not telling us?” she asked, gesturing to the two letters on my desk from the Central Intelligence Agency. The jokes — about how I was secretly working for America’s international spy service — wrote themselves.

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LogiPharma Europe 2024: LogiPharma Commercial Director Discusses Themes of the Show

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Nicholas Saraceno, Will Robinson, Commercial Director, LogiPharma, talks themes of this year's event and future plans for the show.

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STAT+: Accreditation agencies take on telehealth with new virtual care standards

STAT

In the early days of the pandemic, as social distancing forced patients out of doctors’ offices, health care organizations scrambled to offer care online. In turn, health care accreditation organizations rushed to tweak their standards, filling a void in best practices for virtual visits. But as telehealth has matured, accreditation bodies — typically nonprofits that offer a seal of approval to organizations that pass their audits — are trying to address the nuance of digita

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EC approves Pfizer’s Emblaveo for multidrug-resistant infections

Pharmaceutical Technology

The European Commission (EC) has granted marketing authorisation for Pfizer’s EMBLAVEO (aztreonam-avibactam), aimed at treating adults with multidrug-resistant infections where treatment options are limited.

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Opinion: Bashing accelerated approval isn’t supported by the data

STAT

The Food and Drug Administration’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint” of overall survival (progression-free survival). Overall survival is usually considered the gold standard in oncology because people with cancer generally want to take medications that can help them live longer.

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EU approves Pfizer antibiotic for superbug infections

pharmaphorum

Pfizer’s Emblaveo has been approved in the EU with a first-in-class indication in multidrug-resistant (MDR) infections. The drug – a combination of beta-lactam antibiotic aztreonam with beta-lactamase inhibitor avibactam – is the first drug of this type to get a green light from the European Commission to treat serious infections caused by MDR Gram-negative bacteria in adults.

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STAT+: Anticompetitive hospital mergers skate by due to FTC’s shallow resources

STAT

Over the past two decades, hundreds of hospital mergers have escaped federal antitrust scrutiny and led to both higher prices and less competition, a new study shows. But the study’s authors, and other researchers, believe the Federal Trade Commission’s hands often are tied. The agency simply doesn’t have enough money or people to crack down on all anticompetitive hospital deals, and some state laws shield hospital mergers from federal review completely.

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Vivalink and RSRT collaborate to improve Rett syndrome research with wearable technology

Outsourcing Pharma

In a major partnership aimed at accelerating research into Rett syndrome, a rare neurological disorder predominantly affecting girls, digital healthcare solutions company Vivalink, has joined forces with the Rett Syndrome Research Trust (RSRT).

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STAT+: Pharmalittle: We’re reading about Lilly buying a plant, a Pfizer antibiotic, and more

STAT

Top of the morning to you, and a fine one it is. There is nothing like being greeted with clear blue skies and cool breezes upon waking up today on the Pharmalot campus. Birds are chirping, squirrels are scavenging, official mascots are barking. And we are similarly engaged in early-in-the-day rituals of our own — firing up the trusty coffee kettle for another cup of stimulation.

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Semaglutide helps heart failure symptoms in patients with obesity and type 2 diabetes

The Pharmacist

Semaglutide could be beneficial in helping to treat patients with type 2 diabetes and obesity-related heart failure, a study has shown. In a trial of more than 600 patients with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide led to several benefits after one year. This included larger reductions in heart […] The post Semaglutide helps heart failure symptoms in patients with obesity and type 2 diabetes appeared first on The Pharmacist.

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Opinion: STAT+: Use evidence to support early coverage of gene therapy after accelerated approval

STAT

Gene editing and therapy to replace missing or defective genes is one of the most exciting recent medical developments, offering tremendous hope for people with rare diseases and genetic conditions. With so little known about the long-term risks of gene therapy, we contend that the safest and best value to both patients and society will emerge within a framework of early evidence-development strategies following early coverage decisions.

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Trial reveals mechanisms that contribute to impact of malnutrition and HIV infection

Pharma Times

Severe acute malnutrition is responsible for nearly half of all child deaths globally and affects 17 million children annually

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STAT+: Looking for signs of growth in Biogen’s earnings

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello! Don’t recognize the avatar above? I’m Elaine, the new co-author of this newsletter. I’m very excited to be here. Scroll down to the last item for more about me. The need-to-know this morning Novartis  raised its financial outlook  for the year after reporting better-than-expected sales and earnings for the first quarter

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Shakeup at BenevolentAI continues with job, programme cuts

pharmaphorum

BenevolentAI is embarking on another round of job losses, closing its US office, and shelving its software-as-a-service business to extend its cash reserves into the third quarter of 2025.

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On the Go: Pharmacy Solutions for Summer Travel Medications

PioneerRx

The summer is rapidly approaching. From getting ready for graduation ceremonies to preparing for your favorite user conference (hello, Catalyst Connect 2024).

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Front Line Medical Technologies achieves CE marking for transforming aortic occlusion

Outsourcing Pharma

In a remarkable development, Front Line Medical Technologies Inc., an innovator in trauma care medical devices, has announced the attainment of CE marking for its COBRA-OS (Control of Bleeding, Resuscitation, Arterial Occlusion System).

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Sanofi’s oral BTK programme gets back on track

pharmaphorum

Phase 3 readout allows Sanofi to prepare US and EU filings for oral BTK inhibitor rilzabrutinib in immune thrombocytopenia (ITP), its first indication

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Quotient Sciences new platform disrupts conventional drug development processes

Outsourcing Pharma

At CPhI North America, Quotient Sciences is looking forward to reconnecting with its customers and giving them a preview of how we are looking to expand Translational Pharmaceutics further within the US.

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Boehringer Ingelheim and Ochre Bio partner on liver disease in deal worth over $1bn

Pharma Times

Chronic liver disease and associated cirrhosis account for one million deaths every year

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Oncimmune setting its sights on the interplay between autoantibodies and age-related conditions

Outsourcing Pharma

Oncimmune Holdings plc, a prominent autoantibody profiling company catering to the pharmaceutical and biotechnology sectors, is expanding its horizons by delving into the realm of biomarkers for age-related diseases.

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