Thu.Jul 27, 2023

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Cases of alpha-gal syndrome caused by tick bites on the rise, CDC reports

STAT

For many Americans, the warmer spring and summer months bring backyard barbecues and scenic hikes — along with a chorus of cicadas, mosquitoes galore, and hypervigilant self-checks for ticks. Often, insect bites only cause mild discomfort but new reports from the Centers for Disease Control and Prevention warn that a food allergy caused by ticks is on the rise in the U.S.

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GSK confident in RSV vaccine launch, but sets expectations for ‘steady build’

BioPharma Dive

GSK expects its respiratory syncytial virus vaccine will be a multibillion dollar product. But at the beginning it’s predicting a slower launch than for its fast-selling shingles shot.

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Mitch McConnell’s abrupt episode has an important public health takeaway

STAT

The handling of Senate Minority Leader Mitch McConnell’s abrupt medical issue this week is raising concerns among medical experts that the event sent a potentially dangerous public-health message — that when someone experiences an episode with symptoms like McConnell’s, they can simply return to work as though nothing had happened.

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5 Strategies to Strengthen Relationships with HCPs

Pharma Marketing Network

Developing strong and meaningful relationships with Healthcare Professionals (HCPs) is vital for healthcare organizations, pharmaceutical companies, and medical device manufacturers alike. These partnerships not only improve patient outcomes but also foster mutual trust and collaboration. In this blog, we will explore five effective strategies to enhance your relationship-building efforts with HCPs and ultimately achieve better healthcare outcomes.

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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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Ending health disparities requires full federal government, National Academies panel says

STAT

To narrow the nation’s deeply entrenched health disparities, a permanent entity with regulatory powers should be created by the president to oversee health equity efforts across the entire federal government, says a report issued Thursday by the National Academies of Science, Engineering, and Medicine. In its many recommendations, the committee that wrote the report called for Congress to create a scorecard to assess how new federal legislation might affect health equity; urged all federa

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Lilly adds to case for Mounjaro’s weight-loss benefits with new study data

BioPharma Dive

The results showed that enrollees who’d already lost weight after diet and exercise shed pounds after receiving Mounjaro, while those who stopped treatment gained weight back.

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Merck, chasing Pfizer, claims study success for new pneumonia vaccine

BioPharma Dive

The pharma said its latest shot, which covers 21 strains of bacteria, cleared two Phase 3 trials and in some cases spurred a stronger immune response than Pfizer’s Prevnar 20.

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STAT+: How the first over-the-counter birth control pill in the U.S. got its ‘unapologetic’ design

STAT

It’s not every day that a marketing team is tasked with designing the branding and packaging of the first over-the-counter birth control pill to be sold in the U.S. This was the challenge, and the opportunity, faced by the team behind Opill, the landmark pill from drugmaker Perrigo that received approval from the Food and Drug Administration earlier this month.

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DrugPatentWatch reveals NIH funding for patents

Drug Patent Watch

Here’s a summary of a new article that used DrugPatentWatch data: NIH Funding for Patents That Contribute to Market Exclusivity of Drugs Approved 2010–2019 and the Public Interest Protections of… The post DrugPatentWatch reveals NIH funding for patents appeared first on DrugPatentWatch - Make Better Decisions.

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Biden announces an advanced cancer research initiative as part of the bipartisan ‘moonshot’ effort

STAT

WASHINGTON — President Biden’s administration on Thursday announced the first cancer-focused initiative under its advanced health research agency, aiming to help doctors more easily distinguish between cancerous cells  and healthy tissue during surgery and improve outcomes for patients. The administration’s Advanced Research Projects Agency for Health, or ARPA-H , is launching a Precision Surgical Interventions program, seeking ideas from the public and private sectors

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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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NICE lowers threshold for weight-loss surgery referrals

The Pharmacist

Patients should no longer have to attempt weight loss by non-surgical interventions before referral to bariatric surgery, under new NICE guidance. They also no longer have to be ‘generally fit for anaesthesia and surgery’ before referral to a specialist weight management service, which will instead undertake this assessment. A new update to the clinical guideline for […] The post NICE lowers threshold for weight-loss surgery referrals appeared first on The Pharmacist.

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STAT+: VC firm starts a new synthetic biology incubator, headed by a former Broad Institute scientist

STAT

Venture capital firm RA Capital is starting a new incubator, setting the stage for the firm to create new startups over the next several years that hone in on synthetic biology, a long-gestating field that insiders say is getting renewed interest. The Boston-based VC’s incubator is called RASyn, and will be led by Robert Nicol, according to people familiar with the firm’s plans.

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FDA Approves First Nonprescription Birth Control

PharmExec

Frederique Welgryn, global vice president for women's health, Perrigo, shares insight into the approval of Opill (norgestrel), a progestin-only contraception, in this exclusive Q&A.

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STAT+: A conflict of interest behind the warning on Apellis’ eye drug? The optics are not good

STAT

The eye disease physician in charge of a committee that flagged a rare but severe side effect involving a newly approved drug from Apellis Pharmaceuticals has financial ties to a competing drugmaker. The conflict raises questions about his supervision of an emerging safety issue for patients and its impact on the financial health of Apellis. Peter Kaiser, a retinal disease expert who runs the Cole Eye Institute at the Cleveland Clinic, failed to report consulting fees and stock ownership in Iver

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ABPI reacts to new vital vaccination report

Pharma Times

New HSCC document deems the UK’s vaccination position to be at risk - News - PharmaTimes

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STAT+: HCA says smaller share of spending going to labor

STAT

The chief executive of the country’s biggest hospital chain said Thursday that labor costs are now lower as a percent of revenue than they were before the pandemic. “And again, that’s in the face of a very difficult labor market,” HCA Healthcare CEO Sam Hazen noted on the company’s second quarter earnings call. Health care providers and insurers are in the full swing of releasing their second-quarter earnings, and HCA tends to outperform its peers.

Hospitals 194
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Innovative solid-state storage for biologics developed

European Pharmaceutical Review

A paper published in ACS Synthetic Biology has demonstrated a novel method for storing biological materials such as RNA and proteins via solid-state storage. This would be as a pill or a tablet, which can be dissolved in water for on-demand use. The innovation by researchers at California Polytechnic State University in the US could help overcome current limitations in the storage and handling of products derived from living cells.

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Biogen’s sticky situation, Wegovy’s risks, & biotech insider trading

STAT

Why do CEOs talk like that? Do biotech stock tips make good gifts? And what do Anthony Fauci and Stéphane Bancel have in common? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we discuss why Wall Street was less than convinced by Biogen’s attempt to assuage concerns about its credibility.

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Lupin announces resolution of USFDA warning letter for its two facilities

Express Pharma

This is after the satisfactory evaluation of the corrective actions taken by the company in response to the warning letter that was issued on November 6, 2017 Lupin has announced that it has received correspondence from the USFDA that it has now addressed the concerns raised in the warning letter for its facilities in Goa and Pithampur Unit-2, Indore.

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STAT+: Midwest health systems Fairview and Sanford call off $14 billion merger

STAT

Sanford Health and Fairview Health Services have for the second time scrapped their planned merger , the systems announced Thursday.  The plan to create a $14 billion health system with just shy of 60 hospitals encountered significant resistance from the University of Minnesota, whose main teaching hospital in Minneapolis is part of Fairview. University leaders and state officials alike soured on the idea of the hospital being owned by an out-of-state entity.

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FDA declines to review Biohaven’s latest drug in setback to pipeline

BioPharma Dive

While the FDA doesn’t think the brain disease treatment merits an evaluation, Biohaven is still pushing for one and has requested a further meeting.

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STAT+: The once-hot market for biotech jobs and lab space has cooled. What now?

STAT

When Crystal Shih Byers left her job at Novartis in 2020, she was excited to make the leap into a smaller startup. Byers had spent almost nine years at Novartis, most recently helping lead a group that worked on gene therapy. But pharmaceutical companies are large and complex, and she craved more immediate impact. “I was looking for a place where I could be in the room,” she says.

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First dose completed in phase 1 cannabinoid study

Pharma Times

OCTP aims to demonstrate the lead candidate’s safety, tolerability and pharmacokinetic profile - News - PharmaTimes

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ADC demonstrates meaningful survival data for HER2 cancers

European Pharmaceutical Review

ENHERTU ® (trastuzumab deruxtecan) has demonstrated clinically meaningful progression-free survival (PFS) and overall survival (OS) in topline results from the primary analysis of the ongoing DESTINY-PanTumor02 Phase II trial. The data was for previously treated patients across multiple HER2 expressing advanced solid tumours, two secondary endpoints.

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Merck and Moderna initiate phase 3 study evaluating V940

Express Pharma

V940-001 is the first phase 3 study of a planned comprehensive clinical development program being initiated following the positive primary analysis of the phase 2b KEYNOTE-942/mRNA-4157-P201 trial reported at AACR and ASCO earlier this year Merck known as MSD outside of the United States and Canada, and Moderna has announced the initiation of the pivotal phase 3 randomised V940-001 clinical trial evaluating V940 (mRNA-4157), an investigational individualised neoantigen therapy (INT), in combinat

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EMA publishes clinical trial plan for public health emergencies

Outsourcing Pharma

The EMA organized a task force made up of various stakeholders to gather insights on potential EU-level actions to improve the set up of clinical trials during public health emergencies.

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Approval expanded for generalised myasthenia gravis medicine

European Pharmaceutical Review

The first targeted therapy approved for paediatric patients with generalised myasthenia gravis (gMG) has been approved in the EU. Soliris (eculizumab) has been authorised for expanded use in children and adolescents aged six to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive (Ab+). This decision by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP).

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Pfizer announces executive leadership to advance oncology research and development strategy

World Pharma News

Pfizer Inc. (NYSE: PFE) today announced changes to its executive leadership team to further advance its aspirations to discover and develop new medicines and vaccines, with an emphasis on oncology. Effective today, Chris Boshoff, M.D.

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Minority participation doubles average with Columbia Uni diversity drive

Outsourcing Pharma

Columbia University is running three separate efforts to improve diversity within clinical trials, and it released data showing that early improvements could be seen.

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Pharmacists must play ‘critical role’ in vaccine delivery, MPs recommend

The Pharmacist

An influential group of MPs has recommended that pharmacists should play a ‘critical role’ in vaccine delivery to tackle challenges around access. The Health and Social Care Committee (HSCC) highlighted low vaccination rates in England in particular, in a report published today as part of the committee’s inquiry into preventing ill-health. And the committee said […] The post Pharmacists must play ‘critical role’ in vaccine delivery, MPs recommend appeared first on The Pharmacist.

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Pfizer warns of supply shortages after tornado hits manufacturing facility

Outsourcing Pharma

Pfizerâs North Carolina facility was struck by a tornado that caused severe damage to the location and the surrounding area.

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Scotland funding deal shows government can’t get Pharmacy First ‘on the cheap’

The Pharmacist

Health minsters in England could learn from Scotland's recent community pharmacy funding agreement about the need to invest in the pharmacy network in order successfully a deliver Pharmacy First service, Phoenix UK Group managing director Steve Anderson has suggested. The deal for Scotland’s contractors that was agreed last week was ‘not just a good outcome […] The post Scotland funding deal shows government can’t get Pharmacy First ‘on the cheap’ appeared first on The Pharmacist.

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Nanotech delivery boosts efficacy of common ectopic pregnancy drug

Outsourcing Pharma

Research by Oregon State University used nanoparticles to deliver methotrexate, which worked at lower doses than are normally delivered.

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GSK reports rise in profit in Q2 2023

Pharmaceutical Technology

GSK has reported an adjusted operating profit of £2.17bn in Q2 2023, which is an almost 8% increase from the £2.

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Oncotype DX: Breast cancer, genomics, and rethinking the oncology paradigm

pharmaphorum

Oncotype DX: Breast cancer, genomics, and rethinking the oncology paradigm Mike.

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