Thu.May 09, 2024

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Bird flu keeps rewriting the textbooks. It’s why scientists are unsettled by the U.S. dairy cattle outbreak

STAT

Twenty-seven years ago today, a 3-year-old boy in Hong Kong developed a sore throat, spiked a fever, and started to cough. Six days later, he was hospitalized; six days after that, he died of acute respiratory distress caused by viral pneumonia. Testing showed the toddler, who’d had contact with sick chickens before becoming ill, had been infected with H5N1 bird flu.

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Lilly’s donanemab will face an Alzheimer’s adcomm in June, setting the stage for a Leqembi showdown

PharmaVoice

The FDA announced a June advisory committee date, potentially introducing a new Alzheimer’s treatment to compete with Eisai and Biogen’s Leqembi.

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Opinion: H5N1 communication has been strictly for the birds. Didn’t the federal government learn anything from Covid?

STAT

When it comes to federal agencies communicating to the public about H5N1 bird flu, it feels like a classic case of Yogi Berra’s déjà vu all over again. In the wake of pointed criticism about its failure to release new information about the growing H5N1 outbreak in livestock, the Animal and Plant Health Inspection Service of the U.S.

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The judicial microscope on abortion meds puts FDA and industry in a precarious spot

PharmaVoice

The recent SCOTUS case involving mifepristone exposes the risk of drug safety determinations by judicial fiat.

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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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A new cholera vaccine will increase supply, but will it be enough to manage global outbreaks?

STAT

Weeks after the global public health community sounded the alarm on the shortage of cholera vaccine, the World Health Organization moved to prequalify a new cholera vaccine last month. The vaccine is a simplified version of the two existing oral vaccines, both produced by Korean vaccine manufacturer EuBiologics Co. The company will begin making the new vaccine, called Euvichol-S, this year.

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Report warns economic instability has hit UK drug discovery

pharmaphorum

A UK report has said that inflation and geopolitical instability have led to a “dramatic drop” in investment in smaller companies developing new medicines, with a knock-on effect on the entire life sciences industry.

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More Trending

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Patients 'put at risk' as pharmacies face medicine shortages 'multiple times a day'

The Pharmacist

Eight in 10 pharmacy team members report that medicine shortages are putting patients’ health at risk, according to a survey by Community Pharmacy England (CPE). The Pressures Survey, completed by more than 900 pharmacy owners and over 2,000 pharmacy team members, found that medicine supply issues were affecting the majority of pharmacy teams (72%) ‘multiple […] The post Patients 'put at risk' as pharmacies face medicine shortages 'multiple times a day' appeared first o

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STAT+: Drug supplies for millions would be jeopardized by U.S. crackdown on China biopharma industry, trade group says

STAT

U.S. legislation that would sever ties with Chinese drugmakers would jeopardize the drug supply for millions of American patients if it’s passed, the biotechnology industry’s main trade group has told Congress. Congress is considering legislation, called the BIOSECURE Act, that would make it difficult for Chinese contract development and manufacturing organizations to do business with biotechnology companies that work with the U.S. federal government.

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New metric predicts burden of participating in trials

pharmaphorum

A new metric developed by Phesi can predict the burden that clinical trials will impose on patients, allowing amendments that can improve the design, efficiency and cost

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STAT+: Getting Alzheimer’s treatment to those who need it poses particular challenges

STAT

A host of hurdles are slowing the adoption of the new Alzheimer’s drug Leqembi, experts involved in the treatment of patients said Wednesday, from complicated logistics to the fact that many people don’t recognize that their memory loss is a disease soon enough. Some patients still grapple with whether they want to be diagnosed, even though a treatment exists, the experts said, speaking during a STAT virtual event.

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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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Understanding the evolution of container closure integrity testing

pharmaphorum

How have drug container closure testing methods changed over time? This post explores the history and development of techniques to evaluate container integrity.

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Opinion: Caring for young caregivers, a hidden population

STAT

The intersection of the mental health crisis among young Americans and the growing burden of unpaid caregiving is generating an expanding, particularly vulnerable, and unacknowledged population: young people who act as caregivers for siblings with special health care needs, physically or mentally ill parents, ailing grandparents, or other loved ones.

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LogiPharma Europe 2024: Delivering Agility in Supply Chains Through Building Multimodal Cold Chain Networks

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Cathy O'Brien, VP of Sales, UPS Healthcare discusses her masterclass on delivering agility in supply chains by building a multimodal cold chain network while also reducing risks at LogiPharma Europe 2024.

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Listen: Everything you need to know about H5N1 bird flu

STAT

What happens when a common virus jumps from birds to cows? And should we be concerned? This week on “The Readout LOUD,” STAT senior infectious diseases reporter Helen Branswell walks us through ongoing H5N1 outbreak in the U.S. and issues with monitoring the spread.

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AlphaFold 3 takes structure predictions well beyond proteins

pharmaphorum

Google DeepMind and Isomorphic Labs' newly launched AlphaFold 3 extends the power of the AI model to 'all life’s molecules'

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Exact Sciences’ stock tumbles amid worries cancer detection firm’s growth may slow

STAT

Exact Sciences reported first-quarter revenues this week that beat market expectations, and the cancer detection company’s executives still believe they’re on track to meet expected 2024 revenue. That’s usually good news. Yet Exact shares are down nearly 11% on Thursday, dipping to $53.12 within the first few hours of trading. During after-hours trading on Wednesday, shortly after Exact released its financial updates, shares tumbled as low as $47.24.

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Oregon and Lantern collaborate to develop drug candidate for various cancer indications

Pharma Times

Anticancer drugs will be responsible for 90% of nearly 612,000 predicted US cancer deaths in 2024

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Yet another big financing round in immunology

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. Congratulations on almost making it to the end of the week! For that, I have a little treat for you at the bottom of the newsletter.

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OneChain’s CAR T trial treats its first cortical T-cell ALL patient

Pharma Times

The subtype accounts for 20% of all T-cell leukaemias, a rare form of blood cancer which produces too many abnormal T-cells

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Q&A with Jennifer Adair, researcher on a mission to increase global access to gene therapies

STAT

BALTIMORE — Gene and cell therapies have transformed a handful of devastating disorders in the U.S. and Europe, with more treatments on the way. But those technologies have largely failed to reach most of the world. These lags are ubiquitous in the current drug development system, where new therapies are approved in wealthy countries and then slowly leak out to low- and middle-income countries, many years later.

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Pharmacists must be kept 'better in the loop' over medicine shortages

The Pharmacist

Community pharmacists must be kept better informed about medicine shortages, with greater transparency required from supply chains, the chief executive of the Independent Pharmacies Association (IPA) has urged. Dr Leyla Hannbeck also said the fact that pharmacists are unable to make minor amendments in the case of medicines shortages ‘has to change’.

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STAT+: Cytokinetics set to pitch its heart drug to physicians — and Big Pharma suitors

STAT

This is the online edition of Adam’s Biotech Scorecard, a new subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered every Thursday to their inbox. I love the Cytokinetics story. There’s so much at stake with aficamten, not to mention all the ups and downs from previous drug-development efforts and now the speculation about a possible takeover.

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Qila.io collaborates with Mascot Spincontrol to bring transparency in clinical research

Express Pharma

Blockchain-as-a-service company Qila.io has partnered with global clinical research center Mascot Spincontrol to bring about transparency in clinical research through blockchain. The aim of the collaboration is to ensure that clinical trial data is secure, transparent and tamper-proof so that integrity of research outcomes is maintained. According to its statement, partnership will enhance transparency in clinical research, fortify data security, and instill greater confidence among stakehol

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STAT+: Pharmalittle: We’re reading about Takeda restructuring, Pfizer settling Zantac suits, and more

STAT

Rise and shine, everyone, another busy day is on the way. We can tell because countless birds are chirping outside our window, the pace of motor vehicles passing by our window is picking up, and the official mascots are busy foraging for snacks on the official grounds. As for us, we are engaged in the usual ritual of brewing cups of stimulation. Our choice today is orange cream.

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Oxford/AZ Covid-19 vaccine to be discontinued

European Pharmaceutical Review

Withdrawal of the marketing authorisation for the COVID-19 vaccine (ChAdOx1-S [recombinant]) Vaxzevria (SRD) by the European Medicines Agency on 7 May, follows a request by AstraZeneca. “Global demand for all COVID vaccines is now much lower and overall supply exceeds demand. This is in marked contrast to the early part of the pandemic when supply was limited and distribution very limited, especially in poorer countries.

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Report highlights challenges facing life sciences sector amid economic turbulence

Outsourcing Pharma

A collaborative report released today (May 9) by Medicines Discovery Catapult (MDC), sheds light on the challenges facing the life sciences sector amidst recent economic turbulence.

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Takeda targets ‘efficiency’ in restructuring, pipeline cuts

BioPharma Dive

The company is discontinuing an array of early drug programs, including several in oncology, as it prioritizes investment in six late-stage assets.

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Proving ROI for digital endpoints

pharmaphorum

Jennifer Goldsack of DiME talks in this podcast about the ROI for digital endpoints for pharma. Data shows digital endpoints drives meaningful engagement with healthcare providers.

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Do You Have Adequate Pharmacy Staffing Coverage This Summer?

The Script

Summer is right around the corner! Ensure you have your staffing plan in place with help from our team at Rx relief!

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Anixa expands cancer vaccine collaboration with Cleveland Clinic

Pharmaceutical Technology

Anixa Biosciences has expanded its partnership with Cleveland Clinic to develop additional vaccines for cancers.

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Significant strides made in Nxera Pharma's oral compound for neurological conditions

Outsourcing Pharma

Neurocrine Biosciences Inc. has initiated its phase 1 clinical study, marking a significant stride in the evaluation of NBI-1117567, an investigational small molecule, oral compound developed by Nxera Pharma.

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Solving Access Barriers in Biomarker Testing: 5 Tips for Manufacturers

Drug Channels

Today’s guest post comes from Hannah Baxter, Associate Partner at The Dedham Group; Jen Klarer, Partner, Head of Cell & Gene Therapy at The Dedham Group; and Carolyn Zele, Advisor, Solution Consulting at MMIT. The authors discuss the access barriers facing patients who need biomarker testing. They discuss five ways manufacturers can prevent these barriers from affecting patients.

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Novo taps another Flagship startup in search for next obesity drugs

BioPharma Dive

The deal with Metaphore Biotechnologies is the third to emerge from a Flagship alliance that’s meant to boost the Danish drugmaker’s pipeline of weight loss medicines.

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US agencies collaborate to address regulation for biotechnology products

European Pharmaceutical Review

Regulatory agencies in the US across three sectors: agriculture and environmental, have produced a joint plan to “update, streamline, and clarify” regulations and oversight mechanisms for biotechnology products. The plan, developed by the US Environmental Protection Agency (EPA), the US Food and Drug Administration (FDA), and the US Department of Agriculture (USDA), helps to address US President Biden’s related goals, including and improving the “transparency, predictability, coordination, and

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Royalty Pharma pays startup $525M for stake in Sanofi MS drug

BioPharma Dive

The deal gives the company milestone payments and royalties to a medicine, frexalimab, that Sanofi licensed from biotech ImmuNext and expects to be a future blockbuster.

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