Sat.Nov 05, 2022 - Fri.Nov 11, 2022

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‘We’re sick of watching women die’: In Michigan, doctors rally to protect abortion access

STAT

GRAND RAPIDS, Mich. — Doctors are on the frontlines of a political battle raging across the country, as abortion rights are added to the ballot in the first election since the Supreme Court overturned Roe v. Wade. Michigan is at the heart of the struggle. “Doctors fought hard for these rights because we’re sick of watching women die,” Melissa Bayne, an OB-GYN in Fremont, Mich., told the audience at a rally Saturday in Grand Rapids.

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The legacy of Glen de Vries: Our last interview with the pioneering entrepreneur

PharmaVoice

Recorded just weeks before his passing, our sit-down interview with the legendary medical sciences entrepreneur showcased his passion for pushing the industry toward its next frontier.

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A Culture of Quality: The Catalyst to Accelerate Innovation

PharmExec

Why enabling a shared culture of quality across an organization is key to maintaining pharma’s recent pace of innovation wins—while inspiring new levels of confidence.

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First human trials of lab-grown red blood cells start in UK

pharmaphorum

Blood cells grown in a laboratory have been given to people for the first time in a clinical trial being carried out by researchers in the UK, in the hope that plentiful supplies of rare blood groups can be manufactured to order. A team from the universities of Bristol and Cambridge, NHS trusts and NHS Blood and Transplant (NHSBT) have started giving small quantities of the lab-grown red blood cells – a couple of teaspoons full – to two healthy volunteers to see if they are safe.

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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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U.S. set to face third Covid winter without key tools and treatments

STAT

The country is heading into its third Covid winter without crucial tools we’ve relied on at previous points in the pandemic, both as governments roll back their responses and as the virus outruns some of our most important medicine-cabinet defenses. Free at-home tests are no longer showing up at people’s doorsteps. States are reporting outbreak data less frequently, and globally, testing and surveillance programs have been curtailed.

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flipMD by GoodRx decreases physician burnout through medical matchmaking

PharmaVoice

Using flipMD, organizations can find, vet, connect with and source practicing board-certified physicians from all specialties for contract, project-based or full-time assignments.

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More Trending

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First patients given lab-grown blood cell transfusion

European Pharmaceutical Review

Lab-grown blood cells have been transfused into a second patient in the world’s first-of-a-kind clinical trial , opening up future treatments for blood disorders such as sickle cell if found safe and effective. Stem cells from blood donors were separated and grown to produce modified red blood cells at NHS Blood and Transplant ( NHSBT ) Advanced Therapies Unit in Bristol.

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‘The tipping point is coming’: Unprecedented exodus of young life scientists is shaking up academia

STAT

SAN DIEGO — Rayyan Gorashi is keeping her options open. After all, she’s still a second-year bioengineering Ph.D. student at UC San Diego, and there are so many careers to explore. Patent law has been high up on her list ever since a class she took in college. There’s also regulatory affairs. Oh, and science publishing sounds interesting, too.

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This plant-based gel stops bleeding in seconds — and might have potential in drug delivery

PharmaVoice

29-year-old biotech founder Joe Landolina is hoping to capitalize on major possibilities in the human health market through his startup Cresolin and just inked a research partnership with Walter Reed.

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Can gene therapies for haemophilia defend their high price tags?

Pharmaceutical Technology

Despite their potential multi-million-dollar sticker price, if haemophilia treatments by BioMarin and CSL Behring prove durable, they could help patients save money compared to current treatments, experts note. On November 2, the Institute for Clinical and Economic Review (ICER) released its updated evidence aimed at measuring the clinical effectiveness and cost of the two haemophilia gene therapies.

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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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Pandemic boost to decentralised trials is here to stay

pharmaphorum

Due to the pandemic, decentralised trial solutions made the shift from an emerging trend to a crucial element of drug development. Ben Hargreaves examines the latest research suggesting that this transition looks set to become a permanent feature of trials in the years to come. The pharmaceutical industry’s role in developing effective vaccines against COVID-19 was a major benefit to the industry.

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Opinion: Violence against health care workers is on the rise. They deserve protection

STAT

There is no place for violence in civil society. Yet stabbings, shootings, threats and other violent attacks have become frighteningly common, including in America’s hospitals and other health care settings. As leaders of national associations representing hospitals and emergency physicians, we know the intimidation and violence endured by medical professionals every day.

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Woman of the Week: 82VS’s Trier Bryant

PharmaVoice

Welcome to the Woman of the Week podcast, a weekly discussion that illuminates the unique stories of women leaders who are catalyzing change throughout the life sciences industry. You can check out all our podcast episodes here. Not every leader makes it their mission to go where the fire.

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UK MHRA approves Pfizer-BioNTech’s bivalent Covid-19 booster

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 and BA.5 sub-variants. Indicated for usage as a booster in people aged 12 years and older, the modified vaccine is the second bivalent shot of the companies to obtain approval in the region.

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Planning appeal blocks Lilly’s €400m plant in Ireland

pharmaphorum

Eli Lilly plans for a new biopharmaceutical manufacturing facility in Ireland that will be used to produce active ingredients for its biologic medicines, including its new Alzheimer’s candidate donanemab, has been blocked by a planning objection. Lilly had already secured planning approval from Limerick City and County Council for the plant at the Raheen Business Park.

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California bans flavored tobacco products, including vapes

STAT

WASHINGTON – On Tuesday, Californians overwhelmingly voted to ban all flavored tobacco products in the state. The move makes California by far the largest state to ban such products, which are already illegal in a smattering of smaller states, including Rhode Island, New Jersey, and Massachusetts.

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3 ways pharma can weather a recession

PharmaVoice

If “winter is coming” in the form of a recession, pharmas can take advantage of an inherent resiliency by crushing these three fundamentals.

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Minoryx and Neuraxpharm team to provide new therapy for rare CNS disorders

European Pharmaceutical Review

Minoryx Therapeutics focused on the development of treatments for orphan central nervous system (CNS) disorders and the Neuraxpharm Group announced the completion of a strategic licence agreement. Under the agreement, Minoryx grants Neuraxpharm exclusive European rights to its lead candidate: leriglitazone. Neuraxpharm obtains exclusive rights to commercialise leriglitazone in Europe and will join with Minoryx to continue the further development of leriglitazone.

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NICE backs use of MSD’s KEYTRUDA for triple-negative breast cancer

pharmaphorum

For the first time, patients in England with triple-negative breast cancer (TNBC) will be able to access immunotherapy at an earlier stage of their treatment journey, as Merck & Co/MSD’s KEYTRUDA is granted the go-ahead for use in patients with high-risk early-stage or locally advanced TBNC. The National Institute for Health and Care Excellence (NICE) has recommended the use of KEYTRUDA (pembrolizumab) as an option with chemotherapy for neoadjuvant, and alone as adjuvant treatment afte

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STAT+: Unexpected troubles hit large medical billing firm R1 RCM, part-owned by Ascension

STAT

The stock price of R1 RCM tanked by roughly 50% this week after the large medical billing and collections company reported an unexpected $30 million loss in the third quarter. R1’s revenue fell in part because health insurers have taken longer to pay claims to R1’s hospital and physician clients, and because it’s been more difficult to collect on patient bills.

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Novo Nordisk’s quantum bet on ‘world changing’ computing

PharmaVoice

Behind the pharma giant’s plans to build the first quantum computer by 2034 to accelerate drug development.

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EC grants approval for Sanofi-GSK’s Covid-19 booster

Pharmaceutical Technology

The European Commission (EC) has granted approval for Sanofi and GSK ’s monovalent, recombinant-protein-based, adjuvanted Covid-19 vaccine, VidPrevtyn Beta, as a booster in adults aged 18 years and above. It is indicated as a booster in people of this age group who were earlier inoculated with a Covid-19 vaccine. The latest development comes after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion on vaccine use.

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The ins and outs of the life sciences: top hires for October 2022 

pharmaphorum

In this new segment from pharmaphorum, we collect the most significant hirings, firings, and recruitment stories from across the industry. This month, we highlight new appointments from Lumeris, Lineage Cell Therapeutics, 1910 Genetics, and ADC Therapeutics. . Ben Grabski, Lumeris. Lumeris, a value-based care managed services operator for health systems, has appointed Ben Grabski as chief financial officer.

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Colorado poised to become second state with legalized ‘medicinal psychedelics’

STAT

Colorado looks set to legalize magic mushrooms in this week’s midterm elections, with the group opposing the ballot question conceding defeat. As of Thursday afternoon, Proposition 122 was passing with 51.4% of the vote, though the referendum is still too close to call officially, with 89% of the vote counted. Colorado would be the second state to legalize psychedelics, following Oregon’s 2020 passage of a similar ballot question.

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Chasing that ‘Time magazine cover potential’

PharmaVoice

Rami Elghandour was already retired. Then CAR-T specialist Arcellx lured him back into the industry to try to change the world.

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5 Tips to Prepare your Pharmacy for the Holiday Season

Digital Pharmacist

The holiday season is upon us! What a fun time you and your pharmacy team. With all the holiday cheer though, definitely comes stress. Have no fear, we are here to help your pharmacy team prepare and have the best holiday season yet. . Below are 5 simple tips to prepare your pharmacy for the holidays. 1. Outline the Holiday Hours for your Customers.

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Top CME with Gift Card Offers for 2022

Board Vitals - Pharmacist

While it seems we only just started 2022, time flies! The end of the year is fast approaching, and soon many clinicians will be in a hurry to complete their annual continuing medical education requirements. Those with employer-sponsored CME allowances will need to spend their remaining 2022 CME allowance by the December 31st deadline. Many CME activity providers offer ways to earn CME conveniently online and some even include a complimentary gift card to popular retailers such as Amazon.

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Legal at one clinic, illegal at another: How abortion bans make gestational age even less precise

STAT

If you want to understand the fickleness of pregnancy and the American laws that regulate it, one place to start would be a gas station in Iowa City, where a 31-year-old sat in the passenger seat of a gray Hyundai, making frantic calls. Her name was Stephanie Dworak, it was September 2021, and she was 20 weeks and five days pregnant. She’d already looked into the abortion clinics in her home state of Nebraska.

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While CAR-T wait times remain ‘heartbreaking,’ researchers push for innovations that could help

PharmaVoice

Facing an unprecedented manufacturing bottleneck, a new coalition is aiming to create the next generation of CAR-T therapies.

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AstraZeneca reports 9% rise in Q3 2022 total revenue

Pharmaceutical Technology

AstraZeneca has reported an 11% rise in total revenue to $10.98bn in the third quarter (Q3) 2022 as against $9.87bn in the year-ago quarter. For the quarter ending on 30 September 2022, product sales were reported at $10.59bn from $9.7bn in Q3 last year, indicating a growth of 9%. In the third quarter of 2022, core earnings per share (EPS) were recorded to be $1.67, signifying a 55% increase while reported EPS was $1.06.

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AstraZeneca’s Farxiga data shows widespread undiagnosed chronic kidney disease

Pharma Times

INSIDE-CKD study involves patients from across France, Germany, Italy, the US and Japan

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In a first, a fatal enzyme deficiency is treated in the womb

STAT

To protect this child from the same genetic disease that killed two older siblings, treating her as soon as she was born might only work so well, the doctors knew. So they dialed back the therapeutic clock, delivering the medication to her as a fetus. Now 16 months old, Ayla appears totally healthy. She still requires weekly doses of the medication, an enzyme that she can’t produce on her own, but she has no symptoms of the condition she inherited, the most serious form of the rare Pompe

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After numerous setbacks, here’s where the Huntington’s pipeline stands

PharmaVoice

A look at emerging treatments and where there’s hope for patients.

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Pill to prevent pre-eclampsia gets UK fast track for development

The Guardian - Pharmaceutical Industry

Exclusive: MHRA grants innovation passport to drug that could prevent women from developing condition A new pill that could prevent pre-eclampsia has become the first pregnancy drug to be fast-tracked for development by the UK’s drug regulator. Scientists at MirZyme Therapeutics, a biopharmaceutical company, believe they have developed a drug that when given to women from 20 weeks of pregnancy could stop them developing the condition.

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Breakthrough Therapy Designation for Pfizer bispecific antibody

European Pharmaceutical Review

Pfizer Inc. has announced its B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb) elranatamab for relapsed or refractory multiple myeloma (RRMM) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). The designation is based on six months of follow-up data from a Phase II study ( NCT04649359 ) evaluating the safety and efficacy of a 76mg weekly (QW) dose of elranatamab, which showed overall response rate (ORR) was 61 percent. .

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