Sat.Mar 18, 2023 - Fri.Mar 24, 2023

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Opinion: There is no epidemic of autism. It’s an epidemic of need

STAT

On Thursday, the Centers for Disease Control and Prevention announced another increase in the prevalence of autism among children. In a pair of new reports — one focused on 8-year-olds and one on 4-year-olds — the CDC found that 1 out of every 36 children has autism. This is a significant increase from the 2021 estimate of 1 in 44 , which was a big jump from 1 in 110 in 2006.

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Viral roots: A look at how modern outbreaks began

PharmaVoice

As experts wrestle with COVID-19’s lab leak versus animal market debate, here’s what experts say are the suspected origins for some of the worst viral outbreaks in the last century.

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Calquence granted first regulatory approval in China for adults with previously treated mantle cell lymphoma

LifeProNow

March 23, 2023: “AstraZeneca’s Calquence (acalabrutinib), a next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been conditionally approved in China for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This is the first approved indication for Calquence in China.

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Kite releases pivotal CAR T therapy Phase III study results

European Pharmaceutical Review

Primary overall survival (OS) analysis results from Kite’s Phase III ZUMA-7 study showed a statistically significant improvement for CAR T-cell therapy Yescarta ® in OS versus historical treatment. Yescarta demonstrated a 2.5-fold increase in patients who were alive at two years and did not experience cancer progression or require the need for additional cancer treatment compared to standard of care (SOC).

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Opinion: I finally got used to practicing telepsychiatry. Now the DEA wants to change everything

STAT

I am by no means telepsychiatry’s biggest fan. But since March 2020, when my practice of outpatient psychiatry changed overnight, I have adapted to it. I have learned to get up between appointments so I don’t sit in front of a computer all day and how to fit in patient visits while on a work trip. I still prefer being in the actual room with a patient, but I accept this is the way my job looks now.

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‘The Last of Us’ might be fiction, but fungi are a looming threat

PharmaVoice

Fungal infections are a growing challenge for hospitalized patients, and new treatments are badly needed.

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PulmCrit Hot Take: Steroid for severe pneumonia (CAPE COD trial)

EMCrit Project

Steroid is worthless for pneumonia! Wait, a new study shows it's beneficial! Hang on, a fresh meta-analysis shows that steroid it's useless! And wait, here's a fresh NEJM study showing mortality benefit!! This feels like a roller coaster. What's going on here? Several factors may explain this: Steroid is beneficial, but only in a subset […] EMCrit Project by Josh Farkas.

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Marburg fever outbreak in Equatorial Guinea widens, WHO reports

STAT

The ongoing Marburg fever outbreak in Equatorial Guinea is significantly larger than has previously been acknowledged, according to new information released Wednesday by the World Health Organization, which warned there may be undetected chains of transmission of the deadly virus in the West African country. The update, the first in nearly a month, shows that the number of confirmed and probable cases has grown from nine to 29, with cases having been reported in three different provinces over a

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Making the leap from the lab to the boardroom

PharmaVoice

Four academics-turned-executives share what they’ve learned about the pivot point between life sciences academia and entrepreneurship.

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Identifying origin of fungi in cleanrooms

European Pharmaceutical Review

In a recent video , pharmaceutical microbiology expert Tim Sandle highlighted areas of concern and attention relating to mycological contamination control in manufacturing. Pharmaceutical product recalls due to fungal contamination have been increasing. These, together with environmental monitoring trend data, highlight several fungal contamination issues associated with pharmaceutical cleanrooms , cold rooms and other controlled areas.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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At EpiBiologics, a pair of Genentech alumni wants to make next-gen protein degraders

BioPharma Dive

Armed with a $50 million Series A round, the startup is building off of research from a lab run by protein engineering pioneer Jim Wells.

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Tanzania reports a Marburg outbreak, Africa’s second this year

STAT

Africa is grappling with not one, but two outbreaks of Marburg fever, a disease that causes symptoms and a death rate comparable to Ebola, its viral cousin. Health officials in Tanzania announced Tuesday that they had confirmed the country’s first-ever Marburg outbreak, involving at least eight people so far, five of whom have died. One of the people who died is a health care worker.

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What would you fix with a ‘magic wand’? Pharma leaders chime in about clinical trials

PharmaVoice

How life science execs would transform clinical trials with a little hocus pocus.

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Three in four pharmacies experiencing a pharmacist shortage, MPs told

The Pharmacist

Almost three-quarters of pharmacies are experiencing a shortage of pharmacists, members of parliament were told at a roundtable event this week. MPs from across the political spectrum attended the event at parliament on Tuesday hosted by cross-sector campaign group Save Our Pharmacies. Community pharmacy leaders set out the challenges facing the sector, including early results […] The post Three in four pharmacies experiencing a pharmacist shortage, MPs told appeared first on The Pharmacis

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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Biotech startups face ‘Series A cliff’ as venture capital stays cautious

BioPharma Dive

Series A rounds have been easy to secure in the last few years, but industry watchers say they haven't seen a corresponding increase in Series B's as startups struggle to recruit new investors.

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‘That scares me’: New childhood obesity guidelines still face a long road to consensus

STAT

This is part of a series about new obesity drugs that are transforming patients’ lives, dividing medical experts, and spurring one of the biggest business battles in years. Read more about The Obesity Revolution. The rise of childhood obesity in the United States did not happen quickly. But, to medicine, “it sort of cropped up overnight,” says Bob Siegel, a pediatric obesity specialist at Cincinnati Children’s.

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This GSK clinical data leader embraces the ‘Rubik’s cube’ problem: solving for all sides at once

PharmaVoice

The clinical data space is rapidly changing the face of the industry, GSK's Mayank Anand said — and the way organizations adopt technology is a critical part of the equation.

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IRA Impacts: Cancer treatment research and development

PhRMA

Last month marked the one-year anniversary of the reignited Cancer Moonshot, the White House’s ambitious goal of reducing the death rate from cancer by at least 50% over the next 25 years. Much of the positive trends in declining cancer mortality, down 33% since peaking in 1991, is driven in large part by innovative medicines researched and developed by America’s biopharmaceutical companies.

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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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Novartis releases long-term data for SMA gene therapy

European Pharmaceutical Review

Data from LT-001, Novartis’ ongoing 15-year long-term follow-up (LTFU) study of one-time gene therapy Zolgensma ® (onasemnogene abeparvovec), revealed significant milestone achievements for spinal muscular atrophy (SMA) patients. The latest data from two LTFU studies LT-001 and LT-002 was presented at the 2023 MDA Clinical & Scientific Conference.

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Tuberculosis cases nearly back to pre-pandemic levels, data show

STAT

Early in the Covid-19 pandemic, new diagnoses of tuberculosis dropped like a stone in the United States. Data released Thursday by the Centers for Disease Control and Prevention suggest the pandemic effect has pretty much worn off; TB is nearly back to pre-2020 levels. “We’re getting … close to where we were pre-pandemic; not quite back yet with increases in cases in the last two years,” Philip LoBue, director of the CDC’s division of tuberculosis elimination,

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Everyone says they’re patient-centric, but have they really walked the walk?

PharmaVoice

Life science leaders provide practical tips on how to create a sustainable patient-focused culture.

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InvisiShield and Gladstone partner to develop intranasal preventatives

Pharmaceutical Technology

Pre-clinical-stage biotechnology firm InvisiShield Technologies has partnered with Gladstone Institutes to develop intranasal preventatives against airborne viral infections including influenza, respiratory syncytial virus (RSV) and SARS-CoV-2. Under the partnership terms, InvisiShield will offer technical support, as well as funding to develop the intranasal preventatives.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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Novo partners with Dewpoint to mine an emerging field for new drugs

BioPharma Dive

The companies will collaborate to identify compounds that could treat insulin resistance by targeting shape-shifting cellular droplets known as biomolecular condensates.

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Opinion: Will there be any emergency doctors to see you in the future?

STAT

In the emergency room today, everyone is suffering. Many emergency medicine physicians are struggling to provide quality care amid staffing shortages, increased pressure to meet productivity metrics, and frustrated patients battling prolonged wait times. Their situation is compounded by a sense that they have been abandoned by hospital leadership, leading to increasing levels of physician burnout and attrition.

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Developing novel therapies for NASH

European Pharmaceutical Review

Following the recent announcement of topline results from 89bio’s Phase IIb trial, ENLIVEN, evaluating FGF21 analogue pegozafermin for nonalcoholic steatohepatitis (NASH), a serious liver condition, EPR spoke with Dr Hank Mansbach, the company’s Chief Medical Officer. NASH currently has no approved treatments. Caused by excess fat, it is referred to as the ‘silent killer’, as most affected individuals don’t exhibit symptoms until liver damage has already occurred.

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RFID: The future of smart labelling?

Pharmaceutical Technology

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. As computing has developed in the past decade, so has the potential to store and use information in the cloud.

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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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Sanofi, Regeneron surge as Dupixent scores in COPD trial

BioPharma Dive

The two companies gained billions of dollars in market value after their antibody drug succeeded against a disease that’s been difficult to treat with biologic medicines.

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Study finds same small rise in breast cancer risk in many forms of hormonal birth control

STAT

Pills, patches, implants, and injections — the various forms of hormonal birth control have different formulations and doses of estrogen, progestin, or both. One might think, then, that they may have an unequal influence on breast cancer risk, but a new study in PLOS Medicine on Tuesday suggests that’s not so. The analysis found that most forms of hormonal birth control, regardless of their formulation, seem to confer roughly the same, small increase to breast cancer risk.

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CPHI Pharma Awards marks 20th anniversary

European Pharmaceutical Review

The 20 th anniversary edition of the CPHI Pharma Awards is open for entries. Three new categories have been created to reflect the surge of innovation sweeping the industry, from new methodologies to sustainability and philanthropic initiatives. The CPHI Pharma Awards 2023 will celebrate global leaders from across 12 categories, including returning categories spanning development and manufacturing of devices and drugs, alongside packaging , supply chain, sustainability, regulatory compliance, an

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Biohaven licenses Hangzhou Highlightll’s BHV-8000 to treat brain disorders

Pharmaceutical Technology

Biohaven has purchased the exclusive global rights for oral, brain-penetrant dual Tyrosine Kinase 2 (TYK2)/Janus Kinase 1 (JAK1) inhibitor, BHV-8000 (previously TLL-041), which treats immune-mediated brain disorders , from Hangzhou Highlightll Pharmaceutical. The deal gives Biohaven global rights for the development of BHV-8000, excluding regions of China.

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FDA staff signal support for Biogen ALS drug, but highlight data hurdles

BioPharma Dive

In documents released Monday, agency staff appeared inclined to approve Biogen’s tofersen, which failed in its main trial. Gathering confirmatory evidence of its benefit could be difficult, however.