Tue.Oct 17, 2023

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Measuring the long-term cost of restricting abortion access

STAT

When Diana Greene Foster and her team at the University of California, San Francisco, started their study on the lives of women who were denied abortions in 2008, they sought to investigate a rather commonly held view: That having an abortion hurt women’s mental and physical health, including by leading to PTSD and drug and alcohol use disorder.

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The FDA might yank cold medicines from shelves — and that could be just the beginning

PharmaVoice

Phenylephrine’s future is up in the air with an FDA committee saying it’s not effective and a class action lawsuit alleging false advertising. What comes next could have big repercussions.

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STAT+: How one scientist’s determination made Novo Nordisk an obesity-drug powerhouse

STAT

Lotte Bjerre Knudsen was still getting used to all the empty benches in her lab when she ran into a tall man with black wide-framed glasses in the hallway: Mads Krogsgaard Thomsen, the new head of research at the Danish drugmaker Novo Nordisk, and her new boss. He was just one of many changes she had found upon returning from maternity leave earlier that week — along with the departures of nearly every colleague with whom she had spent the last three years struggling to create a potential

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From the rainforest to Wall Street — Jaguar Health’s big play for revitalization

PharmaVoice

A pharma with a massive collection of rainforest-derived plants needs a regulatory win to overcome last year’s financial decline.

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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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STAT+: It’s time for the FDA to halt Cassava Sciences’ Alzheimer’s clinical trials

STAT

The Food and Drug Administration should halt Cassava Sciences’ ongoing clinical trials in Alzheimer’s disease. That, and other thoughts on the fallout from the City University of New York investigation that raised serious doubts about the science underpinning the company’s experimental drug simufilam. Patient safety is paramount to the FDA, so stopping Cassava’s two Phase 3 studies is the ethically correct thing to do.

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Parkinson’s UK grants £400,000 to research projects in Scotland

Pharma Times

The two projects will investigate the potential causes of Parkinson’s disease - News - PharmaTimes

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More Trending

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Focussing on finding value in health sciences marketing

pharmaphorum

In this latest instalment of the pharmaphorum podcast, web editor Nicole Raleigh speaks with life sciences advisor Randall Hein, CEO of Heinsight LLC, and health sciences marketing expert Krystle Buntemeyer, CEO of SCORR Marketing, about the trends and changes for health sciences marketing over the past few years.

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Breast cancer is deadlier for Black women. A study of mammograms could help close the gap

STAT

Are 3D  mammograms  better than standard 2D imaging for catching advanced cancers? A clinical trial is recruiting thousands of volunteers — including a large number of Black women who face disparities in breast cancer death rates — to try to find out.

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Novo Nordisk stops trial of Ozempic in kidneys as interim analysis shows success

Pharmaceutical Technology

In October 2023, Novo Nordisk announced that its trial studying Ozempic (semaglutide) in diabetic CKD patients, will come to a halt almost a year prior to its planned completion.

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Watch: A conversation with the 2023 STAT Wunderkinds

STAT

E ach year, STAT sets out to celebrate the unheralded heroes of science and medicine, poring over hundreds of nominations from across North America in search for the next generation of scientific superstars. This year’s class of 28 Wunderkinds were selected from more than 170 brilliant researchers. In this video, we chat with Ahmed Ahmed, who studies the impact of unionization on health care workers; Josh Tycko, who’s focused on epigenetic editing; Kristine Chua, who studies how bi

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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 recommends Roche biologic for lymphoma

European Pharmaceutical Review

In final guidance , the National Institute for Health and Care Excellence (NICE) has recommended glofitamab as a new treatment option for advanced lymphoma. NICE’s recommendation coincides with the Medicines and Healthcare Products Regulatory Agency (MHRA) granting a licence for glofitamab” The bispecific monoclonal antibody (BsAb) treatment is indicated for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more systemic treatments.

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STAT+: When Medicare paid doctors differently, fewer patients had heart problems

STAT

WASHINGTON — Doctors lowered the incidence of heart disease and strokes among their patients when Medicare rewarded them for focusing on sicker patients, according to research of a pilot program released Tuesday in the Journal of the American Medical Association. The pilot program didn’t increase overall costs at all. The five-year pilot program is one of many that Medicare has run since the Affordable Care Act created an office to test whether Medicare payment policies can influen

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With $56M, a Mayo Clinic-backed startup takes aim at radiopharmaceutical roadblocks

BioPharma Dive

Nucleus RadioPharma, a contract developer and manufacturer, is expanding at a time when investment is pouring into the radiopharmaceutical drug field.

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STAT+: Revenue cycle management company Waystar files for IPO

STAT

Revenue cycle management company Waystar filed for an initial public offering Monday with the Securities and Exchange Commission. The company did not specify how many shares it plans to offer or what share price it is targeting. Previous reports have pegged the company’s potential valuation at $8 billion, which would make it larger than competitor R1 RCM, which is valued at a $5.5 billion market cap.

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FDA issues draft guidance on alternative tools for facility assessments

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has published draft guidance on how it intends to use alternative tools for assessing drug manufacturing facilities identified in pending marketing applications. For example, the applications are New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), or a Biologics License Applications (BLAs).

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STAT+: Pharmalittle: People with obesity harmed by exclusion from studies; Teva sues Colorado over ‘unconstitutional’ program

STAT

Rise and shine, everyone, another busy day is on the way. We can tell, in part, because the official mascots are racing about the grounds at top speed and the number of cars and trucks passing outside our window is picking up. But this is to be expected, yes? So as we collect our thoughts about the day ahead, we are firing up the coffee kettle for another cup of stimulation.

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Navigating DSCSA Compliance: Finding the Right Partner

PioneerRx

As you might have heard, there’s been a slight change of plans in the world of DSCSA compliance. On August 30, the FDA announced a “1-year stabilization period.

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As Pfizer slashes revenue projections, Moderna says it “remains comfortable”

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here with the latest twist in the GLP-1 saga, some drama in the world of Covid-19 booster shots, and the debut of the 2023 STAT Wunderkinds.

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Diakonos Oncology’s dendritic cell vaccine shows promise despite development hurdles: GlobalData

Express Pharma

Cellipoint Bioservices entered an agreement with Diakonos Oncology in October 2023 for the development and manufacturing of DOC1021, an autologous dendritic cell (DC) vaccine. The collaboration was announced after Diakonos Oncology revealed promising results of the ongoing Phase I trial evaluating DOC1021 in newly diagnosed patients with glioblastoma multiforme (GBM) administered following surgical intervention and standard postoperative chemoradiation.

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AI startup Leucine raises $7m for drug manufacturing digital twin platform

Pharmaceutical Technology

As AI applications in drug manufacturing widen, Leucine’s digital twin of the shop floor helps automate compliance and improve safety.

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Researchers find PCSK9 inhibitors could treat abdominal aortic aneurysms

Pharma Times

The condition is responsible for 2,200 annual deaths in the UK - News - PharmaTimes

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Exploring mRNA’s Potential

PharmaTech

Chris Spivey, editorial director, hosts a wide ranging discussion on the COVID-19 pandemic response, future government communications, and healthcare funding for mRNA with experts Dr. Kate Broderick, Chief Innovation Officer, Maravai LifeSciences and Dr. Tom Madden, President & CEO at Acuitas Therapeutics. Highlights include supply chain modalities, ensuring a fully trained manufacturing workforce, combining delivery with gene editing innovations, epigenetic approaches to modulate gene expre

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Linde starts up new air separation unit in Hyderabad

Express Pharma

Praxair India (a Linde company) announced the commencement of commercial production at its air separation unit (ASU) at Patancheru in Hyderabad, Telangana on October 14, 2023. This plant will be producing in total 250 tonnes per day of gases including liquid medical oxygen, nitrogen and argon, catering to the requirements of healthcare, pharma and other industrial sectors of the region.

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AstraZeneca's leading lung cancer drug, Tagrisso, accepted and granted priority review in the US

Outsourcing Pharma

AstraZenecaâs supplemental new drug application (sNDA) for lead lung cancer drug Tagrisso (Osimertinib) in combination with chemotherapy has been accepted and granted priority review in the US.

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Spark Therapeutics partners with SpliceBio for gene therapy

Pharmaceutical Technology

SpliceBio will license Spark Therapeutics’ propriety protein splicing platform to develop a gene therapy for renal disease.

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Drug-delivery technique for brain cancer shows growing promise

World Pharma News

A technique developed by University of Texas at Dallas and UT Southwestern Medical Center researchers to deliver medication through the blood-brain barrier has shown promise in a preclinical study for treating glioblastoma, the most common human brain cancer. The researchers demonstrated the method in mice in a study published online Aug. 15 in Nature Communications.

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Novo’s Uli Stilz on biotech innovation and the future of diabetes drugs

BioPharma Dive

The Danish drugmaker's innovation hub in Boston has teamed up with the Broad Institute, Mass General Brigham, Harvard and Yale, expanding its research into cardiometabolic diseases.

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BREAKING: Agreement with AstraZeneca highlights Saama's drug development vision

Outsourcing Pharma

Saama, a provider of artificial intelligence (AI) based solutions, announced today (October 17) that it has formed a multi-year agreement with biopharma giant, AstraZeneca.

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Q&A With Dr. Ronald A. Morton, Chief Medical Officer, Urology, Boston Scientific

PharmExec

Morton discusses his transition from working as a urologist to the C-suite.

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Roche builds gene therapy portfolio with SpliceBio deal

pharmaphorum

Roche builds gene therapy portfolio with SpliceBio deal Phil.

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Roche is stuck on molecular glue

BioPharma Dive

One month after Roche’s Genentech inked a similar deal, the Swiss pharma is now paying $50 million to work with Monte Rosa on molecular glue medicines for cancer and neurological diseases.

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Owkin signs up another pharma partner for its AI platform

pharmaphorum

Owkin signs up another pharma partner for its AI platform Phil.

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Weight Management and Health for People Living with Chronic Conditions

Putting Patients First Blog

Weight Management and Health for People Living with Chronic Conditions 10/17/2023 Weight Management and Health for People Living with Chronic Conditions (PDF) Executive Summary Obesity is one of the most critical nutritional diseases in today’s world. While research behind obesity intervention have, for the past few decades, circumnavigated topics like diet and workout programs, modern medicine has proven that medical interventions, in conjunction with diet and exercise, can drastically ai

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VR-based navigation test may detect Alzheimer’s

pharmaphorum

VR-based navigation test may detect Alzheimer’s Phil.

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Guest Post: In Celebration of National Pharmacy Month

Putting Patients First Blog

Guest Post: In Celebration of National Pharmacy Month October 17, 2023 By Susan Cantrell, CEO of the Academy of Managed Care Pharmacy With October devoted to National Pharmacy Awareness, I wanted to take this opportunity to talk about the outstanding efforts of managed care pharmacists across the United States. As CEO of the Academy of Managed Care Pharmacy (AMCP), I frequently see and hear about these activities — how so many in the world of managed care pharmacy consistently strive to impro