Tue.Nov 22, 2022

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How HTA-based price controls could worsen health outcomes and health disparities

PhRMA

Concerns about the cost of health care have led to calls for the use of health technology assessments or HTAs by the federal government. This would allow government agencies to make important decisions about patient access to health care based on their determination of the value of new tests and treatments.

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Opinion: A tripledemic hurricane is making landfall. We need masks, not just tent hospitals

STAT

A viral hurricane is making landfall on health care systems battered by three pandemic years. With the official start of winter still weeks away, pediatric hospitals are facing crushing caseloads of children sick with RSV and other viral illnesses. Schools that promised a “return to normal” now report widespread absences and even closures from RSV and flu in many parts of the country , contributing to parents missing work in record numbers.

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Putting Delaware patients first: Protecting Patient Assistance Programs

PhRMA

Patients with chronic health conditions in Delaware are seeing a new wave of relief thanks to Governor John Carney, members of the Delaware legislature and more than 40 patient groups. The recently passed SB267 will make it easier for vulnerable patients to be able to afford their brand medications.

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Real-world data show updated Covid-19 boosters increase protection against infection

STAT

The updated Covid-19 boosters increase people’s protection against symptomatic infection from the coronavirus, according to some of the first estimates of how the shot is performing in the real world and in people, not just in lab experiments. What’s more, that protection was even stronger when people waited a longer period of time since their last dose of the original shot.

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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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Pharmacist Publishes Children’s Book About Getting Your Flu Shot

Pharmacy Times

Our Best Shot (OBS) is a new children’s book explaining why we should get an annual flu shot and it is not something to fear…and adults may even benefit, said the author.

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STAT+: FDA approves a gene therapy for the inherited bleeding disorder hemophilia B

STAT

The Food and Drug Administration on Tuesday approved the first gene therapy to treat people with hemophilia B, an inherited bleeding disorder. The one-time treatment, called Hemgenix, was developed by the Dutch biotech company UniQure and will be marketed by CSL Behring, an Australian pharmaceutical company.

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Why doesn’t the U.S. have at-home flu tests?

STAT

Flu season is underway. RSV is putting record numbers of children in hospitals. And health professionals are gearing up for another Covid winter. With so many potential viruses in play, it would be helpful if Americans had a way to distinguish between different ailments at home. And when it comes to the flu in particular, at-home testing could help telehealth doctors decide when it makes sense to prescribe treatments like Paxlovid and Tamiflu, which need to be administered within a specific time

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Study Suggests Long COVID-19 Is Prevalent, Risk Varies Among Populations

Pharmacy Times

Findings support the potential protective association of vaccination in reducing long COVID, although it does not appear to eliminate the risk.

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Forms of Cardiovascular Disease Tied to Blinding Eye Disease

Drug Topics

Mount Sinai study is the first to identify that heart attack, stroke and heart failure are linked to a specific type of age-related macular degeneration.

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FDA Accepts BLA for Genmab’s Epcoritamab to Treat Relapsed/Refractory LBCL

Pharmacy Times

Agency’s action date is May 21, 2023, for the first subcutaneous bispecific antibody approved for the treatment of large B-cell lymphoma.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Umoja and IASO partner to develop therapies for haematological malignancies

Pharmaceutical Technology

Umoja Biopharma has signed a research agreement with IASO Biotherapeutics (IASO Bio) to develop off-the-shelf therapies for haematological malignancies. Under the alliance, the companies will assess the induced cytotoxic innate lymphocytes (iCIL) platform of Umoja with chimeric antigen receptors (CARs) of IASO to develop the next generation of widely accessible, easily available cell therapies.

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Analysis Results Show Reductions in HPV-Related Diseases After Using Merck’s Gardasil

Pharmacy Times

Data from an updated systematic literature review show positive outcomes for both cervical and non-cervical disease in men and women.

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Using UHPLC-MS/MS for trace detection of ?-lactam antibiotics

European Pharmaceutical Review

A paper, published in Molecules , has developed validated the use of ultra-performance liquid chromatography with triple quadrupole mass spectrometry, or UHPLC-MS/MS, for identification and detection of the ?-lactams cephapirin and ceftiofur in cleaning solutions of the production reactors. Trace detection of ?-lactam antibiotics in cleaning rinse solutions and manufacturing aids in pharmaceutical facilities is crucial and regulated.

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5 Genomic Subgroups Show Promise in Helping Predict Clinical Outcomes for CLL

Pharmacy Times

Investigators believe the findings can refine predictions, after independent evaluation, by identifying different modes of genetic alteration.

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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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Clinical trials authorised for 3D-printed ulcerative colitis drug

European Pharmaceutical Review

Triastek, Inc. a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs. T21 is Triastek’s third FDA IND clearance for a 3D-printed medicine.

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GSK will pull Blenrep from US market after failed trial

pharmaphorum

GSK confirmed this morning that the disappointing readout from the DREAMM-3 trial of multiple myeloma therapy Blenrep reported earlier this month means that it will take the drug off the US market. The company said it has started the processing for withdrawing the marketing authorisation for Blenrep (belantamab mafodotin) at the request of the FDA. Some patients will be able to continue to receive the drug via a compassionate use programme.

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How Clinical Trials Can Thrive in the Digital Era

PharmExec

The Digital Medicine Society (DiMe) CEO Jennifer Goldsack and Takeda’s Head of Digital Health Sciences, Data Sciences Institute Shoibal Datta describe the current landscape of digitized clinical trials and the decisions needed to fully utilize their potential.

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A simple screening question could help millions of women prevent cardiovascular disease. Why aren’t we using it?

STAT

Early one afternoon in 2000, Monique Shields, just a few weeks shy of her 30th birthday, left her busy day as an executive assistant at Starbucks’ corporate headquarters to go to her routine prenatal checkup. Feeling healthy, as she had throughout her 34 weeks of pregnancy, she stopped by her home outside of Seattle, changed into her flip-flops, and drove the five minutes to the appointment at her obstetrician’s office.

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The next era of Greater Boston’s biotech boom

PharmaVoice

How Boston became the biotech capital of the U.S., and is now preparing for the next era of life sciences growth.

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Top 5 Reasons to Attend the 2023 ISPE Aseptic Conference

ISPE

Top 5 Reasons to Attend the 2023 ISPE Aseptic Conference. Trudy Patterson. Tue, 11/22/2022 - 11:50. iSpeak Blog. iSpeak. Top 5 Reasons to Attend the 2023 ISPE Aseptic Conference. Christa B. Myers. Nidhi C. Shah. Chervee Ho, Head of Asia Pacific. 22 November 2022. 1) Committed People Move the Industry. Christa B. Myers. Aseptic and Sterile Products Market Director.

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Japan grants emergency regulatory approval for Shionogi’s Covid-19 drug

Pharmaceutical Technology

The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted emergency regulatory approval for Shionogi ’s new anti-SARS-CoV-2 drug, Xocova (ensitrelvir fumaric acid, S-217622), for Covid-19. This approval under the emergency regulatory approval system is granted under the Article 14-2-2 of the Pharmaceuticals and Medical Devices Act, the company noted.

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One-third of U.S. labs have stopped using race-based equations to diagnose kidney disease

STAT

Even as a child, La’Tonzia Adams was interested in diagnosing disease. One day, when she noticed a bump on her chest, she decided to look up “chicken pox” in the Webster’s dictionary at her grandmother’s house to figure out if her symptoms matched the illness. “I remember I scratched it, and it was watery,” said Adams.

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Merck to acquire Imago for $1.35 billion

European Pharmaceutical Review

Merck has announced it will acquire biopharma Imago BioSciences, Inc for around $1.35 billion in total equity value, to facilitate development of Imago’s lead candidate bomedemstat (IMG-7289), an investigational oral lysine-specific demethylase 1 (LSD1) inhibitor for myeloproliferative neoplasms (MPNs). ”Robert M. Davis, President and Chief Executive Officer at Merck declared, “This acquisition of Imago strengthens our presence in the growing field of haematology.”.

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State attorneys general call on Apple to beef up privacy protections for reproductive health information

Fierce Healthcare

State attorneys general call on Apple to beef up privacy protections for reproductive health information. hlandi. Tue, 11/22/2022 - 12:32.

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U.K. analysis shows one dose of monkeypox vaccine yields strong protection

STAT

An analysis released Tuesday by U.K. health officials indicates that even one dose of the monkeypox vaccine provides strong protection against the virus. Researchers at the U.K. Health Security Agency estimated that one dose of the vaccine was 78% effective at protecting against infection 14 or more days after vaccination.

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Risk of Infection Increases with Longer Duration of Bispecific Antibody Therapy in Multiple Myeloma

Pharmacy Times

Researchers also noted an increasing rate of seroconversion with COVID-19 booster vaccination series.

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MetroHealth System board ousts CEO after investigation reveals $1.9M in unapproved performance bonuses

Fierce Healthcare

MetroHealth System board ousts CEO after investigation reveals $1.9M in unapproved performance bonuses. dmuoio. Tue, 11/22/2022 - 11:29.

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Study: Primary COVID-19 Vaccines Found to Not Increase Risk of Herpes Zoster

Pharmacy Times

Subgroup analyses suggest that a primary dose of the COVID-19 vaccine does not increase risk of herpes zoster infection, regardless of age, immunocompromised status, and type of vaccine administered.

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Advocacy groups press FTC to probe GPOs' role in supply chain shortages

Fierce Healthcare

Advocacy groups press FTC to probe GPOs' role in supply chain shortages. rking. Tue, 11/22/2022 - 16:21.

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Magazine: What Rishi Sunak can do for the UK pharma industry

Pharmaceutical Technology

It's the last issue of Pharmaceutical Technology Focus in 2022, and a lot of changes have occurred over the year, not just in the pharma space, but also from a geopolitical, financial and energy perspective. Most recently, after a tumultuous 45 days, Liz Truss resigned as the UK’s prime minister paving the way for Rishi Sunak to take on the mantle. In this issue, we talk to different stakeholders in the pharmaceutical space to gauge what the sector is hoping Sunak achieves in his tenure when it

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How bacteria-enabled technology for wounds could also help cancer patients

PharmaVoice

Evelina Vågesjö, co-founder and CEO of the immunotherapy company Ilya Pharma, is working on a new modality to speed wound healing.

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FDA priority review for AbbVie lymphoma bispecific antibody

European Pharmaceutical Review

The US Food and Drug Administration ( FDA ) has accepted priority review of AbbVie’s Biologics License Application of epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody (BsAb), for adults with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. The application is supported by results from the LBCL cohort of the EPCORE NHL-1 open-label, multi-centre Phase I/II trial evaluating the safety and preliminary efficacy of epcori

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STAT+: ‘Digital health is late to the party’: Can telehealth help hospitals mitigate their carbon footprints?

STAT

As the world stares down the barrel of climate change, the health care system — which is responsible for about 9% of all U.S. greenhouse gas emissions — is finally starting to take action. Hospitals, in particular, are working to stem their impact, and have held up telehealth as a prime strategy to cut down on carbon, by eliminating millions of miles of travel to and from health care centers.

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Examining Treatment Options for Rosacea and Acne

Drug Topics

Addressing the 2 inflammatory conditions requires careful consideration of the therapies to use.

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