Mon.Jul 31, 2023

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National panel will explore requiring free Covid tests

STAT

WASHINGTON — The U.S. Preventive Services Task Force will discuss recommending Covid-19 screening, the first step in requiring insurers to permanently cover the tests at no cost to patients. The national panel of experts will convene and “determine whether and how Covid-19 screening might be considered within the Task Force’s scope,” chair Michael Barry wrote in a letter to Sen.

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A pharma banking on the success of past blockbusters

PharmaVoice

180 Life Sciences is on a mission to see if the anti-TNF technology that produced a blockbuster could work for a range of other conditions.

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Trending Sources

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As wildfires burn, scientists race to understand the health dangers of prolonged exposure

STAT

More than 120 million Americans — one-third of the U.S. population — have been living under air quality alerts this summer, with citizens in New York City, Chicago, and Detroit at times experiencing some of the unhealthiest air in the world. The hazy conditions, fed by an unprecedented surge in Canadian wildfires likely fueled by climate change, has grounded planes, canceled outdoor sporting events, and filled emergency rooms with asthma patients.

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BridgeBio explores path forward for muscular disease drug

BioPharma Dive

According to the company, FDA officials have signaled openness to using a surrogate endpoint for assessing accelerated approval of a treatment for limb-girdle muscular dystrophy.

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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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Opinion: I’m a tick biologist whose body seems to kill off ticks

STAT

Sometimes people call me “the tick guy,” but I’m a mammal guy by training. Although I respect ticks, I don’t fear them, especially after developing an immunity that kills them when they try to bite me. Back in 1991 I joined some colleagues at the Cary Institute in New York on a project devoted to understanding the responses by eastern deciduous forests in the United States to stress and damage.

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Strategies to Boost Your Pharmacy’s Front-of-House Sales

Digital Pharmacist

To boost your pharmacy’s storefront sales, the best place to start is by understanding the importance of pharmacy marketing and making sure you are taking the necessary steps to optimize your front-end sales. With the right strategies, you can increase customer loyalty, drive more sales, and establish yourself as a reliable pharmacy in your community.

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Attracting Young Talent in Pharma

PharmExec

Rebekah Martin, senior VP of reward, inclusion, and talent acquisition at AstraZeneca, discusses ways to address the need for talent in pharma, how pharma can increase more interest in young talent, and how many roles in pharma will require a degree in the coming years in this Pharmaceutical Executive Podcast video.

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Opinion: New attacks on the drug industry would have made my breakthrough sickle cell treatment impossible

STAT

I was born in Alabama in the Jim Crow South, one of eight siblings in a hard-working Black farming community. Our family doctor, a leading figure in the community, inspired me to follow in his footsteps and help people in need. Years later, while working as a physician in Massachusetts, I was appalled to observe how many medicines failed to benefit society’s most vulnerable, in particular people of color.

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Better information sharing could cut discharge medication errors by 40%

The Pharmacist

New digital information standards could cut medication errors when people go into or are discharged from hospital in England by nearly 40%, say researchers. And while a healthcare professional, usually a pharmacist, would still be needed to do medicines reconciliation, better information sharing could speed up the process, the researchers said. Analysis by a team […] The post Better information sharing could cut discharge medication errors by 40% appeared first on The Pharmacist.

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STAT+: New safety details link Apellis eye drug to rare cases of blindness. Cause still unknown

STAT

Five elderly people have been blinded by a severe side effect after receiving injections of a newly approved treatment for eye disease from Apellis Pharmaceuticals. The frequency of this side effect — a severe type of eye inflammation — is low but its cause remains unknown. The new safety information related to the Apellis drug, called Syfovre, was presented Saturday by a committee of eye disease experts at the annual meeting of the American Society of Retinal Specialists (ASRS).

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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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‘Business continuity plans’ now required for temporary pharmacy closures

The Pharmacist

Community pharmacy owners in England will be required to have a ‘business continuity plan’ for temporary closures as of today, following changes to legislation. However, it is understood that NHS England will be advising integrated care boards (ICBs) to take a ‘sympathetic approach’ to the change over the next three months. Changes to the NHS […] The post ‘Business continuity plans’ now required for temporary pharmacy closures appeared first on The Pharmacist.

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STAT+: Flow Neuroscience shows promising results in trial of brain-stimulation headset for depression

STAT

Flow Neuroscience, a small Swedish company treating depression with brain-stimulating headsets, released early data on Monday showing that its device relieved depressive symptoms in clinical trials.  The company has not yet formally written up the data for a journal. But Flow leaders have included the data in an application for Food and Drug Administration approval and provided STAT with topline data ahead of releasing them publicly.

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A Long Time Coming: DEA Regs Finally Authorize Schedule II Prescription Partial Fills

FDA Law Blog: Biosimilars

By Larry K. Houck — President Barack Obama signed the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) intended to reverse serious prescription drug abuse trend in the United States on July 22, 2016. CARA amended the Controlled Substances Act (“CSA”) to enable physicians or patients to request pharmacists to partially fill prescriptions for schedule II substances including opioids and to allow remaining quantities to be filled up to 30 days after issuance of the prescription (up to 72

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STAT+: Medicare wants to improve Alzheimer’s care, but sidesteps drug prices

STAT

WASHINGTON — Medicare announced Monday a pilot program aimed at improving dementia care and reducing the strain on unpaid caregivers, but it does not deal with controlling the price of new Alzheimer’s drugs. The pilot is voluntary. Physician practices that participate will get a lump-sum payment for each dementia patient in their care.

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Tips for Traveling with Medication

Community Pharmacy

Summer is an ideal time to travel, and no matter where you are going, packing the medication you need is essential to enjoying your break from routine. Before you hit the road though, it’s worth taking the time to ensure your prescriptions are prepared to make the journey with you. Whether you have a specific condition that requires daily support or just want to be prepared in case of an emergency, a solid travel medication strategy helps protect not just your health but peace of mind.

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Listen: Why Covid-19 wasn’t the ‘great equalizer’

STAT

When the Covid-19 pandemic began in 2020, some experts assumed the virus would affect everyone even-handedly, regardless of their race or socioeconomic background. But the reality of Covid proved to be far from the “great equalizer” — Black and brown communities had higher rates of infection and death. Among the factors exacerbating Covid-19’s impact is America’s legacy of racial and economic segregation.

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CDKL5 deficiency-associated seizure treatment approved in EU

European Pharmaceutical Review

The first treatment for children and adolescents who have epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) has been approved in the EU by the European Commission (EC). EC has granted approval of ZTALMY ® (ganaxolone) oral suspension as adjunctive treatment in CDD patients from two to 17 years old. The European regulatory body’s decision “represents a significant milestone” according to Dr Scott Braunstein, Chairman and Chief Executive Off

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STAT+: Sage hopes for a blockbuster in fast-acting antidepressant now before FDA

STAT

Cheryl Meier had watched clinical trial enrollment announcements for years — but always for her sons’ type 1 diabetes, never for herself. Her OB-GYN had put her on Effexor for her depression 20 years ago, and it worked well enough — she could sleep for the first time in her life, and she no longer cried at every little thing. But it never worked for her dark thoughts.

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Venus Remedies gets marketing authorisation for cancer drugs from Philippines, Paraguay, Georgia and Moldova

Express Pharma

Venus Remedies has extended its reach in the Association of Southeast Asian Nations (ASEAN) region, South America and Eastern Europe with marketing approvals for key cancer drugs from Philippines, Paraguay, Georgia and Moldova. With this, the company has secured 506 marketing approvals for its oncology products across 76 countries. Venus Remedies has secured marketing approval for topotecan from Philippines and product registration for irinotecan in Paraguay, docetaxel in Georgia and topotecan a

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First patient dosed in Immutep’s soft tissue sarcoma trial

Pharma Times

The phase 2 study involves company’s eftilagimod alpha therapy - News - PharmaTimes

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Artificial intelligence solution that can detect lesions during colonoscopies cleared by FDA

Outsourcing Pharma

The US Food and Drug Administration (FDA) has today (July 31) given clearance via its 510(k) process to one of the artificial intelligence solutions cleared for colonoscopy.

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Personalised mRNA cancer vaccines: Moderna and Merck & Co versus BioNTech and Roche

Pharmaceutical Technology

While messenger ribonucleic acid (mRNA)-based cancer vaccines have been in development for decades, their development had languished.

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Alexion, AstraZeneca Rare Disease, enters agreement with Pfizer to acquire a portfolio of preclinical rare disease gene therapies

World Pharma News

Alexion, AstraZeneca Rare Disease, announced that it has entered a definitive purchase and licence agreement for a portfolio of preclinical gene therapy programmes and enabling technologies from Pfizer Inc. (Pfizer). The agreement furthers Alexion and AstraZeneca's commitment to advancing next-generation genomic medicines with the addition of complementary pipeline assets and innovative technologies.

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Alexion to acquire Pfizer’s rare disease gene therapies for $1bn

Pharmaceutical Technology

Alexion has signed a definitive agreement for acquiring and licencing Pfizer’s early-stage gene therapy portfolio for rare diseases.

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Biogen to acquire rare disease drugmaker for $7.3b

European Pharmaceutical Review

Biogen has agreed to acquire Reata Pharmaceuticals for a total of $7.3 billion. This follows the first and only approved treatment for rare neuromuscular disease Friedreich’s ataxia authorised by the US Food and Drug Administration (FDA) in February 2023. Reata Pharmaceuticals’ orphan drug SKYCLARYS ® (omaveloxolone) is under review by the European Medicines Agency (EMA) for market authorisation in Europe.

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Removing snags in cell and gene therapy manufacturing processes with robotics

Pharmaceutical Technology

Deploying robots in pharmaceutical manufacturing will remove snags in cell and gene therapies and enable breakthroughs

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Glenmark gets ANDA approval for Saxagliptin Tablets, 2.5 mg and 5 mg

Express Pharma

Glenmark Pharma has received final approval by the United States Food & Drug Administration (US FDA) for Saxagliptin Tablets, 2.5 mg and 5 mg, the generic version of Onglyza Tablets, 2.5 mg and 5 mg, of AstraZeneca AB. Glenmark’s Saxagliptin Tablets, 2.5 mg and 5 mg, will be distributed in the US by Glenmark Pharma, USA. According to IQVIA sales data for the 12‐month period ending June 2023, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately $100.7 million.

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Rx Machina: How AI is transforming pharma sales

Pharmaceutical Technology

Pharma sales have undergone a seismic transformation after Covid-19, with the adoption of artificial intelligence tools.

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Okyo reaches clinical trial agreement with Tufts

Pharma Times

Novel therapy, OK-101, offers a potential way of relieving neuropathic corneal pain - News - PharmaTimes

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Polar Leasing Adds an Ambient Temperature Pharmaceutical Storage Unit to Its Repertoire

Pharmaceutical Commerce

Product is expected to maintain a steady temperature setting between 65°F (18°C) and 80°F (27°C).

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Interview: How Vivoryon Theraputics is making its mark in the Alzheimer’s disease space

Outsourcing Pharma

Vivoryon Therapeutics is a precision medicine company focused on bringing first-in-class therapies to patients suffering from age-related diseases.

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Using co-creation to tackle health inequalities through transformation

pharmaphorum

Using co-creation to tackle health inequalities through transformation Mike.

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B Corp certification for 'force for good' Phastar after rigid 12-month review

Outsourcing Pharma

Phastar, a biometrics contract research organization (CRO) can now officially call its business âa force for goodâ after it received B Corp certification.

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SCG Therapy Opens Cell Therapy Manufacturing Facility in Singapore

PharmaTech

The new facility is set to utilize and extend SCG's capabilities in advanced cell therapy manufacturing and off-the-shelf human-induced Pluripotent Stem Cell (iPSC) technology.

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Enteric delivery of my API: how to make it right? | Lonza

Express Pharma

In this video: Julien Lamps, Global Product Manager, Lonza Capsules & Health Ingredients Topics covered: + How to gain actionable insights on how to overcome challenges around enteric delivery + Learn about the advantages offered by Capsugel® Enprotect® capsules + Understand how Capsugel® Enprotect® capsules can help with your next development project The post Enteric delivery of my API: how to make it right?

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