STAT

JUNE 28, 2024

Federal agencies’ longtime authority to regulate industries was significantly weakened by a Supreme Court decision on Friday. The 6-3 decision, though it stems from cases on fishing regulations , will ripple across government agencies that have broadly interpreted the powers handed to them by Congress since a 1984 decision known as Chevron. The so-called Chevron doctrine laid out that courts should generally defer to federal agencies’ reasonable interpretations of their authority w

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PharmaVoice

JUNE 28, 2024

The next wave of targeted ADC therapies is on the horizon, and these three potential rising stars could help carry the field forward.

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STAT

JUNE 28, 2024

A blind employee of the Department of Veterans Affairs is suing the federal agency on grounds that their new electronic health records system makes it impossible for her to do her job. A clinical social worker, Laurette Santos has worked for the VA for a decade, but when the agency switched to Oracle Health’s Cerner EHR in 2022, her productivity plummeted.

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Department of Veterans Affairs Cerner 277

pharmaphorum

JUNE 28, 2024

The House Ways and Means Committee in the US voted in favour of a new bill which would end a two-decade-long restriction on the coverage of drugs to treat obesity under Medicare.The Treat and Reduce Obesity Act of 2023 (TROA) was originally intended to overturn the restriction completely, but has been hugely scaled back in its scope.

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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

JUNE 28, 2024

WASHINGTON — The U.S. response to the Covid-19 pandemic got politically messy. A Friday Supreme Court ruling could frustrate government responses to public health emergencies even further. The Supreme Court struck down a long-standing legal doctrine that directed judges to defer to reasonable federal agency interpretations of ambiguous or technically challenging aspects of the law.

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Express Pharma

JUNE 28, 2024

The 10th edition of PharmaLytica, organised by Informa Markets in India concluded at HITEX, Hyderabad. With a focus on redefining the pharmaceutical industry in the post-COVID era, PharmaLytica 2024 offered a platform for stakeholders to engage in discussions covering the full spectrum of pharma machinery and packaging, lab analytical and cleanroom solutions, and pharmaceutical ingredients.

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Packaging Biosimilars Labelling Vaccines 97

The Pharmacist

JUNE 28, 2024

Reuben Dunbar shares how the Pride in Pharmacy training and support programme aims to help pharmacy teams feel confident in the ways they can provide more equitable healthcare to LGBTQ+ people. Why is Pride in Pharmacy important for both pharmacy teams and patients? The aim of Pride in Pharmacy is for every LGBTQ+ person to […] The post Pride in Pharmacy: confidence in providing equitable healthcare appeared first on The Pharmacist.

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STAT

JUNE 28, 2024

Days after an advisory committee resoundingly voted for the Food and Drug Administration to reject MDMA as medical treatment, the founder of the company that applied for approval was ebullient. Rick Doblin, who has spent decades driving forward MDMA research, told a psychedelics conference in the Netherlands that his dream was not simply possible, but likely.

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Express Pharma

JUNE 28, 2024

Indian Pharmaceutical Alliance (IPA) concluded the 9th edition of the Global Pharmaceutical Quality Summit 2024. The theme for the summit was, ‘Advances in Manufacturing and Quality – Patient Centricity’. The two-day summit brought together industry leaders, global regulators, quality experts, and stakeholders to foster knowledge exchange and deliberate on areas of importance in shaping the pharmaceutical landscape in India.

Biosimilars 88

Biosimilars Documentation 88

STAT

JUNE 28, 2024

The drug policy world has been left torn by the Supreme Court’s ruling on Thursday that Purdue Pharma’s bankruptcy deal could not move forward if it included legal protections for the company’s billionaire owners. In one camp are those who were eager to see the agreed-upon $6 billion settlement put to work preventing and treating opioid addiction.

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Pharmacy Management

Pharmaceutical Technology

JUNE 28, 2024

On 17 June, Amylyx acquired the rights to Eiger Biopharmaceutical’s experimental GLP-1 receptor antagonist, avexitide, for $35.1m.

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STAT

JUNE 28, 2024

Rocket Pharmaceuticals said Friday that the Food and Drug Administration rejected its gene therapy for an ultra-rare, sometimes fatal immuno-deficiency syndrome, saying the company needed to submit more information to prove it can safely manufacture the product. The New York-based biotech said the FDA asked for only “limited” additional information.

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Immunity Immunization 242

BioPharma Dive

JUNE 28, 2024

Federal courts will no longer have to defer to agency regulations for interpretation of ambiguous statutes, a ruling that could have significant impact on the FDA and CMS.

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STAT

JUNE 28, 2024

Scientific breakthroughs will enable a future of personalized drug discovery, where precision medicine makes it possible to receive the right dose of the right medicine at the right time. America’s ability to lead this global frontier of medicine is contingent upon our willingness to recognize China as a competitor and respond accordingly. But often overlooked in this essential conversation is the importance of investing more in U.S. biotech firms and innovation ecosystems — includ

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Express Pharma

JUNE 28, 2024

The osteoporosis market, the prevailing metabolic bone disorder globally, which is characterised by reduced bone mineral density and increased fracture risk, is set to experience a compound annual growth rate (CAGR) of 5.4 per cent across the seven major markets (7MM*) from $10.5 billion in 2023 to $17.9 billion in 2033, forecasts GlobalData. GlobalData’s latest report, “Seven-Market Drug Forecast and Market Analysis”, reveals the rising popularity of expensive anabolic therapies and increasing

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Biosimilars Compounding Pharmaceutical Companies Pharmaceutical Companies 80

STAT

JUNE 28, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning! Today, we discuss how a House committee has overwhelmingly voted in support of four health-related bills. Also, there’s still reason to believe that MDMA-assisted therapy could win FDA approval, and more.

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Drug Pricing Drug Development 216

The Pharmacist

JUNE 28, 2024

NHS England (NHSE) is has issued an update on potential changes to its service specifications in light of recent legislative amendments that allow pharmacy technicians to supply medicines under patient group directions (PGDs). In a primary care bulletin sent last night, NHSE said it was ‘developing processes’ to ‘consider updating’ NHS service specifications ‘in light […] The post NHSE updates on PGD change for pharmacy technicians appeared first on The Pharmacist.

Pharmacy Technician 79

Pharmacy Technician 79

STAT

JUNE 28, 2024

A new and effective class of anti-obesity medicines, along with lifestyle interventions and sometimes bariatric surgery, can help stem the rising tide of obesity in the United States. But outdated rules set by the Centers for Medicare and Medicaid Services make access to these new medicines nearly impossible for the 50 million Americans covered by Medicare and its prescription drug coverage program.

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pharmaphorum

JUNE 28, 2024

Amazon’s strategy in telehealth has coalesced around a pay-per-visit and subscription-based model under a new brand – Amazon One Medical.

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STAT

JUNE 28, 2024

A Cassava Sciences collaborator and paid consultant has been indicted by a federal grand jury on charges of defrauding the National Institutes of Health in grant applications supporting the company’s controversial Alzheimer’s drug, the U.S. Department of Justice announced on Friday. Hoau-Yan Wang, 67, a neuroscientist at the City University of New York, published key papers supporting the effectiveness of simufilam, an experimental Alzheimer’s therapy Cassava is now testing

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Documentation 219

Express Pharma

JUNE 28, 2024

Orchid Pharma, announced the launch of its new drug – Cefepime-Enmetazobactam, which has been approved for the treatment of complicated Urinary Tract infections (cUTI), Hospital-Acquired Pneumonia (HAP) and Ventilator-Associated Pneumonia (VAP) indications. Orchid Pharma has partnered with Cipla to ensure widespread and rapid distribution of this antibiotic combination across India.

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Hospitals Drug Development 70

STAT

JUNE 28, 2024

Health care provider Optum has backed away from its plan to purchase Steward Health Care’s national physicians group, dealing a major setback to Steward’s efforts to bolster its finances after filing for bankruptcy. Optum, an arm of health insurance giant UnitedHealth, struck a preliminary deal in March to acquire Stewardship Health for an undisclosed sum.

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Hospitals 204

BioPharma Dive

JUNE 28, 2024

Advisers to the agency unanimously recommended use of Capvaxive in older adults and in certain younger ones, putting it in the same tier as Pfizer's competing Prevnar shot.

Vaccines 68

Vaccines 68

STAT

JUNE 28, 2024

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 , this , and this.

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Immunity Immunization 200

Express Pharma

JUNE 28, 2024

At the 2nd Conference on Traditional Medicine ‘AYUSH Practices for Sustainable Wellness’ Chief Guest Dr Manoj Nesari, Advisor, Ministry of Ayush, Govt. of India spoke on how The Ministry of AYUSH has seen growth, evidenced by a series of initiatives and substantial market expansion. In 2014, the market size for Ayurveda products was around $3 billion.

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Hospitals Compounding 67

STAT

JUNE 28, 2024

WASHINGTON — Vape manufacturers are taking a victory lap over a Supreme Court decision that could dramatically weaken the Food and Drug Administration’s power to regulate tobacco and nicotine products as regulators see fit. The court on Friday overturned a judicial rule, known as the Chevron doctrine, which instructed courts to defer to regulators on certain legal issues.

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BioPharma Dive

JUNE 28, 2024

European drug regulators voted for a third time not to renew the approval of Translarna. Elsewhere, Sanofi invested in a brain disease biotech and Esperion sold royalties to help pay off a loan.

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Biosimilars 63

STAT

JUNE 28, 2024

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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Pharma Times

JUNE 28, 2024

The study found an increase in incidence among young people and people from deprived areas

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STAT

JUNE 28, 2024

The owners of a drug wholesaler have been indicted for their alleged role in a conspiracy to distribute misbranded and diverted HIV pills, the latest effort by federal authorities to target a widespread scheme to pump the medicines into the U.S. pharmaceutical supply chain. Patrick Boyd and Charles Boyd, who own Safe Chain Solutions, along with a broker, Adam Brosius, were indicted for allegedly buying more than $90 million of “heavily discounted” prescription drugs from a handful

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Documentation 172

Drug Patent Watch

JUNE 28, 2024

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.

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Pharmaceutical Business Review

JUNE 28, 2024

This designation is a significant milestone in the development of TUB-040, which is based on Tubulis’ proprietary P5 technology. TUB-040 is a next-generation NaPi2b-targeting Exatecan ADC with superior biophysical properties. It has demonstrated effective and durable responses in preclinical models, including those for ovarian cancer. The candidate is currently undergoing a multicentre Phase I/IIa study, NAPISTAR 1-01 (NCT06303505), focusing on patients with platinum-resistant high-grade ovarian

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Drug Patent Watch

JUNE 28, 2024

Annual Drug Patent Expirations for RINVOQ Rinvoq is a drug marketed by Abbvie and is included in two NDAs. It is available from one supplier. There are thirty-three patents protecting this drug.

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Pharmaceutical Commerce

JUNE 28, 2024

The latest news for pharma industry insiders.

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Drug Patent Watch

JUNE 28, 2024

Annual Drug Patent Expirations for XYWAV Xywav is a drug marketed by Jazz and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug.

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