Drug Topics

MAY 6, 2024

Mycophenolate mofetil oral suspension is the only FDA-approved ready-to-use liquid formulation.

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FDA 180

Pharmacy Times

MAY 6, 2024

In an ambitious effort to address the ongoing uncertainty within the 340B Program space, 6 senators released a draft discussion bill earlier this year titled the SUSTAIN Act.

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STAT

MAY 6, 2024

WASHINGTON – Two New York University professors collaborated directly with executives of the vaping company Juul without disclosing those relationships to academic journals or Congress, a STAT investigation reveals. At the height of the youth vaping crisis, when many public health experts were calling for sweeping action that could upend the entire industry, David Abrams and Ray Niaura emerged as two authoritative voices willing to defend vaping — despite its growing popularity amo

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Documentation 141

Pharmacy Times

MAY 6, 2024

The new administration method, which is co-formulated with rHuPH20, is usable in previous approved nivolumab indications for solid tumors in adult patients.

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FDA 144

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

MAY 6, 2024

For more than 30 years, Alzheimer’s researchers have thought of APOE4 as a major genetic risk factor for most cases of the devastating neurologic disease. But a new study published on Monday argues that this gene variant plays an even more important role than scientists had realized and causes a distinct form of Alzheimer’s. Researchers analyzed data from more than 13,000 people, including nearly 800 APOE4 homozygotes, people who carry two copies of the gene variant.

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Pharmacy Times

MAY 6, 2024

A new treatment for postpartum depression has been developed with rapid onset, cutting down the time it has taken previous treatments to take effect by weeks or months.

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Pharmacy Times

MAY 6, 2024

The authors emphasize that additional research addressing disparities and including race, age, and ethnicity should be conducted.

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Fierce Pharma

MAY 6, 2024

As BioNTech continues to endure a sharp decline in COVID-19 vaccine sales, the German mRNA specialist is looking ahead to the next leg of its commercial journey. | With plans to have at least 10 potentially registrational trials underway by the end of 2024, BioNTech is plotting the first wave of its market debut in oncology from 2026 onward.

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Vaccines 122

STAT

MAY 6, 2024

What happens when you catapult cancer into space? Or shoot stem cells toward the stars? Catriona Jamieson, a hematologist and director of the Sanford Stem Cell Institute at the University of California, San Diego, has done both. Through collaborations with organizations like NASA, her lab has sent tumors and stem cells aboard private spaceflights like SpaceX CRS-24 and the recent Axiom-3 mission to be studied in the International Space Station.

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Drug Topics

MAY 6, 2024

Discover how SureCost can help your pharmacy reduce the impact of staff shortages and streamline operations. With a surge in patients requiring more complex care, pharmacies face increasing pressure to meet both patient needs and business demands. Explore the origins and impact of these shortages and the challenges faced by pharmacy teams while learning how Smarter Purchasing practices can help alleviate these burdens on staff.

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Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

STAT

MAY 6, 2024

A new study looking at the distribution of receptors that flu viruses can attach to in different cow tissues may help to explain the pattern of illness being seen in the outbreak of H5N1 bird flu in U.S. dairy cattle — and also is sparking debate about the implications of the cow outbreak for human disease. The study, a preprint that hasn’t yet been through peer review by a scientific journal, found that tissue from the mammary gland contains abundant receptors of the kind to which

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Fierce Healthcare

MAY 6, 2024

The Hospital Insurance Trust Fund will be fully solvent for longer than previously projected, according to an annual Medicare Trustee report. | The Medicare Hospital Insurance Trust Fund won't run out of money as quickly as expected. Here's how federal officials are reacting.

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Hospitals Insurance 120

Drug Topics

MAY 6, 2024

Researchers continue to report on the rise of syphilis in the US, with recent cases exhibiting rare symptoms in the eyes, ears, and brain.

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Fierce Pharma

MAY 6, 2024

Amneal Pharmaceuticals has agreed to pay $272.5 million to settle approximately 900 lawsuits brought by state, local and Native American jurisdictions claiming that the New Jersey generics producer | Amneal Pharmaceuticals has agreed to pay $272.5 million to settle approximately 900 lawsuits brought by state, local and Native American jurisdictions claiming that the New Jersey generics producer fueled the opioid crisis by failing to act on suspicious opioid orders.

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Advertisement

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.

Pharmacy Management Software

Pharmaceutical Commerce

MAY 6, 2024

Radio frequency identification (RFID) not only helps hospitals boost their medication safety standards, as it also allows clinicians to continue to provide quality patient care.

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Patient Care Hospitals 111

Fierce Healthcare

MAY 6, 2024

Employers are in a strong position to lead the charge in changing the conversation around obesity care, according to a new report from the Milken Institute. | Employers are in a strong position to lead the charge in changing the conversation around obesity care, according to a new report from the Milken Institute.

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Drug Topics

MAY 6, 2024

The specialty drug market has exploded, and will continue to grow across sectors such as oncology and neurology.

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The FDA Law Blog

MAY 6, 2024

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C).

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FDA Documentation 105

STAT

MAY 6, 2024

Children and adolescents diagnosed with high blood pressure have double the risk of major cardiovascular problems as adults, a new study that followed them into their 20s and 30s reports.  It’s another example of a serious disease striking people at younger ages than in previous generations and should serve as a call to action for routine blood pressure screening in primary care, Rahul Chanchlani, the senior author of the new study, told STAT.

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Fierce Pharma

MAY 6, 2024

“Our next question will come from Andrew Baum with Citi.” | Citi analyst Andrew Baum, after covering Pfizer for more than a decade, will join the Big Pharma company as chief strategy and innovation officer. In the role, he'll oversee the drugmaker's portfolio management and business development activities.

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The Checkup by Singlecare

MAY 6, 2024

Metronidazole , sold under brand names including Flagyl and Metrosa, is an antibiotic used to treat infectious diseases of the reproductive system, gastrointestinal tract, respiratory tract, skin, and other parts of the body. It’s FDA approved to treat parasitic infections and sexually transmitted diseases such as trichomoniasis ( Trichomonas vaginalis ), and it’s one of the medications recommended for the treatment of bacterial vaginosis (BV) —a vaginal infection that is common during pregnancy

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FDA 104

pharmaphorum

MAY 6, 2024

The Novo Nordisk Foundation, the Bill & Melinda Gates Foundation, and Wellcome have joined forces to tackle some of the most pressing threats to human health and wellbeing. The new initiative gets underway with $300 million in funding over three years earmarked for handling infectious diseases and antimicrobial resistance (AMR), addressing climate change, and raising our understanding of how nutrition can impact immunity, disease, and the development of children.

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Immunization 100

PharmaVoice

MAY 6, 2024

With many chemo and ADHD drugs stuck in stubborn shortages, several agencies are looking for new solutions to boost supplies.

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Fierce Healthcare

MAY 6, 2024

Embattled health system Steward Health Care filed for bankruptcy on Monday, a move it says is critical to continue to treat patients as it navigates its financial issues. | Embattled health system Steward Health Care filed for bankruptcy on Monday, a move it says is critical to continue to treat patients as it navigates its financial issues.

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European Pharmaceutical Review

MAY 6, 2024

New results from a Phase I/II clinical trial of a CRISPR/Cas9 gene editing therapy show that around 79 percent of patients with a rare form of inherited blindness experienced “measurable improvement”. The BRILLIANCE trial included 14 participants (12 adults and two children) who received an injection of EDIT-101 in one eye. These individuals had a form of Leber Congenital Amaurosis (LCA) caused by mutations in the centrosomal protein 290 (CEP290) gene.

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Hospitals 94

Drug Topics

MAY 6, 2024

Data from 2024 are being used as a way to predict what changes may be on the way for 2025.

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Fierce Pharma

MAY 6, 2024

In a flurry of updates Monday, ADC Therapeutics revealed that it's selling $105 million in new shares while also touting results for antibody-drug conjugate Zynlonta from a small investigator-initi | ADC Therapeutics provided several company updates Monday, including that it's raising $105 million through a sale of common shares and pre-funded warrants.

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European Pharmaceutical Review

MAY 6, 2024

Following a review on the suitability of different technologies, researchers have determined that “[nucleic acid amplification techniques] NATs combined with an efficient extraction method” is the fitting alternative for compendial mycobacterial testing in biological products. The current challenge in mycobacterial testing information on using mycobacterial testing for the quality control of biologicals is limited, the paper noted.

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pharmaphorum

MAY 6, 2024

Boehringer drug shows promise in diabetic macular ischaemia (DMI), a common and irreversible complication of the eye in people with diabetes with no approved therapies

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STAT

MAY 6, 2024

You’re reading the web version of Health Care Inc., STAT’s weekly newsletter following the flow of money in medicine. Sign up to get it in your inbox every Monday. About that 90,000 number UnitedHealth Group CEO Andrew Witty faced Congress last week, where lawmakers pressed him on the Change Healthcare cyberattack (my colleague Brittany Trang  watched the hearings closely  and tried to break down  what it all means ).

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Insurance Hospitals 89

pharmaphorum

MAY 6, 2024

Pfizer has named Citi analyst Andrew Baum as its chief strategy and innovation officer, taking point on portfolio management and capital deployment

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Drug Topics

MAY 6, 2024

The market is sensitive to both upstream and downstream pressures that impact drug pricing.

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pharmaphorum

MAY 6, 2024

Shah Capital has stepped up its campaign for change at vaccine producer Novavax, lobbying against the re-election of three directors and executive pay packages in a letter to fellow stockholders. The hedge fund says it wants to send a “strong and clear message” to the board at Novavax, reiterating the claim – first made a few weeks ago – that the company is “being hindered by an overly conservative board and management that clings to failed strategies.

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Packaging Vaccines 89

Fierce Healthcare

MAY 6, 2024

As a proud Colombian, Maria Artunduaga, M.D., wanted her startup to have a Spanish name that could easily be pronounced in English. | Every founder has a different story to tell about naming a startup. Two main approaches exist: do it yourself or outsource help. It all comes down to what they can afford.

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