Wed.Jun 07, 2023

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How the public health lessons of Covid can help Americans protect themselves from wildfire smoke

STAT

An unusually early and ferocious outbreak of forest fires across Canada has sent unprecedented amounts of smoke pollution to regions of the eastern United States unaccustomed to such hazards. Three years after the onset of the Covid-19 pandemic, the ensuing air pollution has once again put respiratory health at the forefront of many North Americans’ minds.

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ACMT Toxicology Visual Pearl: Marcel the Shell with Toxins

ALiEM - Pharm Pearls

The venom from this pictured snail shares a primary mechanism of action with what other deadly toxin? Alpha-latrotoxin Botulinum toxin Bufotoxin Tetanus toxin Sarin Reveal the Answer Answer: 3. Botulinum toxin The cone snail contains alpha-conotoxin which is a potent nicotinic receptor antagonist similar to botulinum toxin and can cause muscular paralysis.

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STAT+: ‘We don’t agree’ on drug pricing policy, FDA chief tells biotech leaders

STAT

BOSTON — The drug industry has spent the past year speaking against new mechanisms that could limit how much governments or insurers pay for certain new medicines. Robert Califf, the Food and Drug Administration chief, walked on stage Wednesday and told a crowd of biotech leaders that drug costs needed fixing. “We don’t agree,” said Califf, referring to a conversation he had backstage with Ted Love , the new chair of the Biotechnology Innovation Organization.

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Ranking reveals biopharma’s most innovative companies

PharmaVoice

IDEA Pharma’s 12th index finds that Pfizer and AstraZeneca reign supreme again.

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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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The Canada wildfires are exposing the harmful effects — and health inequities — of air pollution

STAT

Wildfires blazing in and around Quebec are creating hazardous health conditions throughout North America. Over 100 million people were under alerts for unhealthy air quality as of Wednesday, and people in the Northeast and Midwest — areas that typically don’t deal with the effects of wildfires — are confronting orange-tinged, hazy skies and newly urgent questions about the harmful effects of air pollution.

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Woman of the Week: Marinus Pharmaceuticals’ Christy Shafer

PharmaVoice

The chief commercial officer shares how the company “beat the odds” to bring a rare disease drug to market.

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More Trending

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Eli Lilly achieving significant gains in obesity results

Pharmaceutical Technology

Eli Lilly has achieved significant gains in the past quarter, leading to it becoming the most valuable pharmaceutical company in the world, with a market cap of $420bn, surpassing Johnson & Johnson. The recent rallying of Lilly’s market value has come as the result of two major announcements: its blockbuster type 2 diabetes (T2D) drug Mounjaro (tirzepatide) successfully completed its second final-stage trial for obesity, and its experimental treatment for Alzheimer’s disease completed its Ph

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Reanimated hearts donated after death work just as well for transplants, study finds

STAT

A new method of heart transplantation that uses machines to reanimate donor hearts from people who have died is just as good as traditional heart transplantation, a new study finds. If adopted broadly in the U.S., the procedure that could expand the donor pool by 30%. The adjusted six-month survival rate of patients undergoing the new method was 94%, compared with 91% among patients who underwent the traditional method, according to the study published in the New England Journal of Medicine Wedn

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ZyVersa Therapeutics inches closer to European patent approval for VAR 200

Pharmaceutical Technology

ZyVersa Therapeutics has received a notice of intention to grant from the European Patent Office for its patent application for the cholesterol efflux mediator VAR 200 (2-hydroxypropyl-beta-cyclodextrin). The application was filed for the treatment of diabetic nephropathy/diabetic kidney disease. The Phase IIa-ready VAR 200 is being developed to reduce renal cholesterol and the lipid accumulation that damages the filtration system of kidneys in glomerular diseases patients.

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Opinion: How the conversation about moral injury in health care is changing

STAT

In the new book “If I Betray These Words,” I tell the story, with Simon Talbot, of Rita Gallardo (a pseudonym): Deployed in the desert Middle East, confined to a military base ringed by Hesco barriers and razor wire, Dr. Rita Gallardo’s only escape from the horrors of the combat-shattered bodies of young service members was dreaming of the life she might build later.

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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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Janssen seeks US FDA approval of new indication for Carvykti

Pharmaceutical Business Review

Carvykti is intended to treat adults with relapsed or refractory multiple myeloma who have previously received a minimum of one line of therapy including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide. Janssen’s sBLA is supported by findings from the Phase III CARTITUDE-4 study of Carvykti. This first randomised study has been designed to assess the safety and efficacy of the therapy versus daratumumab, pomalidomide and dexamethasone (DPd) or pomalidomide,

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STAT+: Buoyed by cancer advances, new ASCO president also stresses honest prognosis

STAT

CHICAGO — As a busy weekend at the American Society of Clinical Oncology annual meeting wound down, Lynn Schuchter accepted a gavel from Eric P. Winer, cueing the start of her one-year term as the society’s president. Come Monday, the first official day of her presidency, Schuchter was looking ahead to her year as president. She was also still energized from the plenary session the day before — which Schuchter said was one of the best she’d ever seen.

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Only 46% of diabetes patients had all recommended checks last year

The Pharmacist

Fewer than half of diabetes patients had all recommended checks last year, an audit has found. More needs to be done to address the backlog of routine diabetes care and avoid preventable deaths from the condition, the Diabetes UK report warned. Too many patients with both type 1 and type 2 diabetes were missing on […] The post Only 46% of diabetes patients had all recommended checks last year appeared first on The Pharmacist.

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GSK’s RSV vaccine wins European approval

STAT

LONDON — The European Commission approved GSK’s RSV vaccine, the company said Wednesday, bringing to the market the first such tool that can protect older adults from the common respiratory bug.   The vaccine, Arexvy, was authorized for adults 60 and older. Arexvy won U.S. regulatory licensure last month , as did another RSV immunization , Pfizer’s Abrysvo.

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NHS weight-loss pilot announced but drug supply concerns continue

The Pharmacist

The NHS has announced a £40m pilot to explore ways to make specialist drugs accessible to patients living with obesity outside of hospital settings. But one pharmacy leader has called attention to ongoing problems with supply of semaglutide and emphasised that pharmaceutical interventions must be supported by diet and lifestyle changes. The pilot, announced today, […] The post NHS weight-loss pilot announced but drug supply concerns continue appeared first on The Pharmacist.

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Opinion: Want to help with medical breakthroughs? Donate some extra cells to a biobank

STAT

Right now, it’s possible that cells from my body are growing in a lab somewhere and are being used to test new cancer drugs. After I was  diagnosed with neuroendocrine tumors , a rare type of cancer, I went through surgery to remove the tumors and chose to donate them to a biobank. I gave consent for the cells from my tumors to be used to create cell lines and organoids (three-dimensional tissue cultures) as models to study neuroendocrine tumors, since it is a poorly understood, unde

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Fosun Pharma and IFC to build new drug manufacturing plant in Africa

Pharmaceutical Technology

Shanghai Fosun Pharmaceutical (Group) is to collaborate with the International Finance Corporation (IFC) to construct a new pharmaceutical production facility and distribution hub near Abidjan, Côte d’Ivoire. The IFC will provide two loans totalling $53.49m (€50m) to Fosun Pharma’s subsidiaries. The funding will support the new production plant and distribution hub, which is aimed at enhancing access to high-quality medicines in Africa.

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Akili Interactive releases video game treatment for adult ADHD with no prescription required

STAT

Following positive top-line data released in May, Akili Interactive announced it will release its video game treatment for attention deficit hyperactivity disorder to adults who want to use it. EndeavorOTC, an adult version of Akili’s Food and Drug Administration-cleared video game for children, is now live in the Apple App Store and can be accessed without a consultation with a doctor or a prescription.

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With new startup Bitterroot, Forty Seven founder takes aim at heart disease

BioPharma Dive

Co-founded by Stanford University professor Irv Weissman, the company debuted with $145 million and plans to use CD47 antibodies, best known as potential cancer immunotherapies, to reduce the risk of heart attacks.

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Opinion: Listen: Why forced treatment can’t fix substance use disorder

STAT

When a loved one is living with serious substance use disorder and refuses to get help, sometimes it seems like the only solution is to force them into it. In many states, people can be “arrescued” — that is, forced under penalty of law into a treatment program that is nearly identical to being incarcerated, down to orange jumpsuits.

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Cell and Gene Therapy Catapult opens new laboratories

European Pharmaceutical Review

As its first facility in Scotland, the Cell and Gene Therapy Catapult (CGT Catapult) has opened new laboratories located in the Edinburgh BioQuarter, at the University of Edinburgh’s Institute of Regeneration and Repair. With its new 350m 2 high-specification laboratory space, CGT Catapult aims to provide expertise, resources and technology to help cell therapy developers improve their manufacturing processes and navigate the complex regulatory requirements involved in bringing these therapies t

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STAT+: While other states, countries have biotech envy, Massachusetts can’t find enough workers

STAT

While other states and nations came to the global BIO 2023 convention in Boston this week on the hunt for investors and companies to grow their biotech sectors, Massachusetts has a different problem: It can’t find enough workers to fill positions. For the second straight day, the state’s focus at the BIO podiums and the convention’s Massachusetts pavilion Tuesday was on recruiting employees for a rapidly expanding industry, as Governor Maura Healey announced new workforce in

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EDQM publishes annual report

European Pharmaceutical Review

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published its annual report , summarising the organisations 2022 highlights. Petra Doerr, Director of EDQM, Council of Europe, commented in the report on the current challenges of drug shortages in the pharmaceutical supply chain and its impact on the industry’s resilience and goals towards sustainability.

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STAT+: With digital therapeutics businesses flailing, the industry descends on D.C. to make the case for coverage

STAT

This week, the leading advocacy group for digital therapeutics companies is gathering the industry’s leaders for what might look like an ordinary conference. But before the panels, the coffee breaks, and the fireside chats kick off, they’re conducting a lobbying blitz. A top priority at the Digital Therapeutics Alliance’s first summit is to advance the industry’s marquee bill, the Access to Prescription Digital Therapeutics Act.

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NICE nod for AstraZeneca’s Lynparza

Pharma Times

Therapy treats patients with specific types of ovarian, fallopian tube or primary peritoneal cancer - News - PharmaTimes

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STAT+: ASCO showcased the payoff for new cancer medicines: longer lives

STAT

CHICAGO —  Well, that’s a wrap. The biggest meeting in cancer research — and, really, one of the biggest annual conferences for the pharmaceutical industry as a whole — has drawn to a close. What did we learn from this year’s annual meeting of the American Society of Clinical Oncology? Here’s one lesson: New cancer medicines, given enough time, can be shown to affect the thing patients care about most — whether they live or die.

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ASCO 2023 – Arun Krishna

pharmaphorum

With a 51% reduction in deaths, AstraZeneca’s ADAURA trial was one of the breakout stories of this year’s ASCO. In Chicago, Editor in Chief Jonah Comstock was able to sit down with AstraZeneca Head of Lung Cancer Commercial Arun Krishna to dive in a little bit on this practice-changing study.

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STAT+: After missing vaccine glory in pandemic, GSK looks to dominate other diseases

STAT

BOSTON — GSK has been developing vaccines under one corporate guise or another for 140 years, ever since a rural Pennsylvania doctor started pumping smallpox shots out of a converted chicken house in 1882, but the company may be most known today for the vaccine it didn’t build. The British pharma elected not to develop its own Covid shot.

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How can biopharma strengthen its resilience?

European Pharmaceutical Review

The global biopharma industry’s resilience has decreased since 2021, a report by Cytiva has found. Using feedback from 1250 pharma and biopharma executives in 22 countries, the research sought to find out how has the biopharma industry has evolved over the past two years and what areas the industry should seek to improve. The five areas evaluated for resilience were: Supply chain resilience Access to talent Strength of the R&D ecosystem Manufacturing agility Effectiveness of government

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STAT+: Pharmalittle: U.K. launches pilot to expand access to weight loss drugs; European Union approves RSV vaccine

STAT

Top of the morning to you, and a fine one it is. Well, sort of. We are unexpectedly hunkering down due to a steady stream of smoke wafting our way from north of the border. The world is changing, yes? Nonetheless, the middle of the week is here and so we will congratulate you on making it this far. Remember, there are only a couple more days until the weekend arrives.

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Critical Components of a Robust Readmission Reduction Program

cureatr

When patients return to the hospital within 30 days for the same condition, it should raise some questions: Were they discharged too early? What was the quality of their follow-up care? Were these patients appropriately educated about the transition out of the hospital?

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Four things for CMS to keep in mind as they implement changes to Part D

PhRMA

The Inflation Reduction Act (IRA) makes significant changes to Part D’s benefit structure and coverage, which will require careful policy development and thoughtful implementation. On Monday, PhRMA submitted comments on the Calendar Year 2025 Part D Redesign changes, outlining key considerations for the Centers for Medicare and Medicaid Services (CMS) to help mitigate against potential disruptions to seniors’ access to medicines through Part D.

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Bayer strengthens gene therapy portfolio with lipid nanoparticle technology from Acuitas Therapeutics

World Pharma News

Bayer AG is joining forces with Acuitas Therapeutics, Inc., a biotechnology company specializing in the development of lipid nanoparticle (LNP) delivery systems for molecular therapeutics. Acuitas' LNP technology will support Bayer's in vivo gene editing and protein replacement programs by specifically delivering RNA payloads to the desired target organ, the liver.

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How generative AI could change the life sciences landscape - an interview with Indegene

Outsourcing Pharma

With generative AI continuing to create a buzz, OSP took the opportunity to speak to Indegene, a digital-first, life sciences commercialization company that helps biopharmaceutical, emerging biotech and medical device companies develop products. Talking to Tarun Mathur and Sameer Lal, we found out how they thought AI could change the life sciences landscape.

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BASF Pharma Solutions, life science business of Merck KGaA launch new standard for electronic exchange of quality and regulatory data

Express Pharma

BASF Pharma Solutions and the Life Science business of Merck KGaA, Darmstadt, Germany announced the launch of a new standard for the electronic transfer of quality and regulatory documentation from suppliers to users in the pharma/biopharma industry. The Standard Quality and Regulatory Documentation (StaQRD) electronic data standard includes quality and regulatory compliance data.