Mon.Sep 18, 2023

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Why doesn’t the U.S. have more Black midwives?

STAT

In the wake of growing alarm over the disproportionately high rates of maternal mortality in the U.S., maternal health experts have been pushing for changes — including expanding the midwife workforce. Studies have shown that deliveries attended by midwives tend to have fewer complications and better outcomes, partially because midwife training relies less on medical intervention, leading to fewer C-sections.

Hospitals 363
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Endangered horseshoe crabs could lead the charge in pharma’s animal-free future

PharmaVoice

An effort to spare the species from blood collection is one of many ways the industry is turning away from animals for R&D.

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STAT+: David Liu startup to focus on getting CRISPR therapy to hard-to-reach cells

STAT

David Liu, the Broad Institute biochemist behind two powerful forms of genome editing, is launching a company focused on delivering gene-editing machinery to precise cells and tissues in the body, STAT has learned. The company, known as Nvelop, already raised a $100 million seed round last year, according to PitchBook. It is being run by Jeff Walsh, a former top executive at Bluebird Bio, and it recently recruited Bluebird’s head of research, Melissa Bonner, according to two people with k

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De-risking visible particles through component selection

PharmaVoice

The visual inspection of injectable drug product has been a regulatory requirement since 1936, however, successful implementation of the standard has been challenging for many organizations.

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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: Where are HHS and the FTC on online privacy for people with substance use disorder?

STAT

The era of rampant, unconsented, and unregulated online data collection may finally be winding down for consumer health data. But the advances in consumer privacy have not yet fully reached the millions of people with health information related to their drug use, substance use disorder treatment, or recovery. In July, two key agencies for consumer health privacy, the Department of Health and Human Services and the Federal Trade Commission, sent  letters  to 130

Hospitals 312
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New RSV vaccines can be powerful tools, but rollout poses test

BioPharma Dive

Public health officials, as well as drugmakers, are trying to raise awareness of RSV among older adults at risk, and convince them to get an additional respiratory shot alongside those for COVID and flu.

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More Trending

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Pfizer’s Vydura recommended by NICE for acute migraines

Pharma Times

The treatment is the first oral GPCR receptor antagonist class recommended for NHS use - News - PharmaTimes

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STAT+: Medicare wants to increase payments for heart rehab. Hospitals see an opening to get more

STAT

Medicare plans to pay more for a type of cardiac rehabilitation that takes place in certain outpatient clinics owned by hospitals. Medicare has admitted it is doing so due to an error in reading federal law, but it also goes against the grain of the current environment, where support for site-neutral payments has never been higher. Some members of Congress and health care experts are pushing for a system that would not pay hospital outpatient departments more for identical services that are prov

Hospitals 303
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FDA approves Pfizer/BioNTech and Moderna’s adapted COVID-19 vaccines

Pharma Times

The updated vaccines more closely target current circulating variants - News - PharmaTimes

Vaccines 148
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STAT+: Pharmalittle: U.S. Chamber and feds clash on Medicare price negotiation; South Africa probes J&J over TB-drug pricing

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was restful and invigorating because now that familiar routine of meetings and deadlines and what-not has returned. As you might expect, we are coping by quaffing a few cups of welcome stimulation — our flavor today is southern pecan — and, as always, we invite you to join us.

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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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Maximizing Drug Patents’ Value: Strategies for Biomedical Companies

Drug Patent Watch

The article “Maximizing the Value of Drug Patents Before Losing Exclusivity” discusses strategies for biomedical companies to maximize the value of their drug patents before the exclusivity period expires. In… The post Maximizing Drug Patents’ Value: Strategies for Biomedical Companies appeared first on DrugPatentWatch - Make Better Decisions.

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Vividion Therapeutics starts Phase I clinical trial in advanced solid tumors with KEAP1 activator

World Pharma News

Vividion Therapeutics, Inc. (Vividion), announced today that it has initiated dosing of patients in a Phase I oncology clinical trial of its investigational oral Kelch-like ECH Associated Protein 1 (KEAP1) activator, VVD-130037. Vividion is a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders, and a wholly owned and independently operated subsidiary of Ba

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NICE to recommend rimegepant as first acute migraine treatment

The Pharmacist

NICE has approved rimegepant as the first treatment for acute migraine, in draft guidance published this month. Around 13,000 could benefit from rimegepant (Vydura, Pfizer), said NICE after signing off its use in adults who have tried at least two triptans but they did not work well enough. It can also be used for those […] The post NICE to recommend rimegepant as first acute migraine treatment appeared first on The Pharmacist.

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Making us more human: Applying artificial intelligence to your clinical resourcing and talent acquisition strategy

BioPharma Dive

With the rise of ChatGPT and artificial intelligence (AI), there are many ways the clinical staffing industry can use AI advantageously while removing the stigma that the rise of technology can be dehumanizing.

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Biocon Board appoints Peter Bains as Group CEO

Express Pharma

Biocon has approved the appointment of Peter Bains as the Group CEO, with effect from September 18, 2023. He will be reporting directly to Biocon Group Chairperson, Kiran Mazumdar-Shaw. Bains has accordingly stepped down from his role on the Biocon Board as an Independent Director with immediate effect, to assume this strategic executive responsibility.

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Advanced therapy collaboration network launched in Scotland

European Pharmaceutical Review

The Cell and Gene Therapy Catapult (CGT Catapult) , supported by Scotland’s national economic development agency, Scottish Enterprise, has launched a new cooperative network to foster collaboration and increase knowledge sharing across the Advanced Therapy Medicinal Products (ATMP) industry in Scotland. Events, as well as talks from industry leaders and networking opportunities, will be coordinated by a new ‘Scottish Advanced Therapy Medicinal Products (ATMP) and Vaccines Network’ to aid individ

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Signal: Illumina leads $15m investment in Broken String Biosciences

Pharmaceutical Technology

Embattled biotech giant Illumina has led series A funding into genomics mapping company Broken String Biosciences.

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Novadiscovery’s trial simulation predicts AstraZeneca phase 3 results

Outsourcing Pharma

The French-U.S. company Novadiscovery has hailed a âwatershed moment for clinical trial designâ as its trial simulation tool successfully predicted the outcome of a phase 3 oncology trial run by AstraZeneca.

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Dassault Systèmes introduces ‘Emma Twin’ Avatar

Express Pharma

Dassault Systèmes introduced “Emma Twin,” an avatar designed to raise awareness of the key role that virtual twins have in advancing healthcare and the innovations that are shaping the future of medicine. Through a social media programme, Emma Twin will share stories explaining how the virtual twin of her body was created from anonymous health data to be used for an infinite number of tests that give doctors and researchers a profound understanding of diseases and the effects of new and improved

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FDA revises biosimilar guidelines for clearer drug labelling

Pharmaceutical Technology

The FDA released a draft guidance giving advice on the correct labelling of biosimilar and interchangeable biosimilar products.

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Orchard nears FDA decision on rare disease gene therapy

BioPharma Dive

Three years after gaining European approval, Libmeldy is now under U.S. review with a deadline set for March.

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How pharma wants to break the efficacy ceiling in IBD

Pharmaceutical Technology

Despite major shifts in the IBD landscape, most approaches that go beyond targeting inflammation remain in the earlier stages of development.

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First treatment for myelofibrosis with anaemia approved

European Pharmaceutical Review

The first and only treatment for anaemic patients with myelofibrosis has been approved by the US Food and Drug Administration (FDA). Ojjaara (momelotinib) is indicated for intermediate or high-risk myelofibrosis, a blood cancer, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia), in adults with anaemia.

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Pharmacy First PGDs ‘being worked through’

The Pharmacist

The patient group directions (PGDs) that will enable community pharmacists in England to provide a common conditions service are currently being worked through by government and NHS England (NHSE), Community Pharmacy England (CPE) chief executive Janet Morrison has confirmed. The service will utilise seven PGDs to allow community pharmacists to treat – including with antibiotics […] The post Pharmacy First PGDs ‘being worked through’ appeared first on The Pharmacist.

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CHMP’s September 2023 meeting highlights

European Pharmaceutical Review

The European Medicines Agency (EMA)’s human medicines committee (CHMP) recommended nine new medicines for approval during its meeting in September 2023. The committee recommended granting a marketing authorisation for Ebglyss (lebrikizumab). This medicine is indicated for treating moderate-to-severe atopic dermatitis in adults and adolescents. To treat glioma, a type of brain tumour, the CHMP gave a positive opinion for Finlee (dabrafenib).

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GSK’s Ojjaara approved by FDA for patients with blood cancer and anemia

Outsourcing Pharma

The small molecule drug Ojjaara (momelotinib), developed by GlaxoSmithKline, has become the first U.S. Food and Drug Administration (FDA)-approved treatment for patients with the blood cancer myelofibrosis and anemia.

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Tactics Criminals Use to Sell Drugs Online  

National Association of Boards of Pharmacy

The United States is home to one of the most secure drug supply chains in the world, but criminals still find pathways to buy and sell prescription drugs—including controlled substances—often using websites and social media platforms to do so. We compiled information from experts about how criminals use online platforms to sell these drugs illegally and information to help you educate patients on protecting themselves and their loved ones.

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Astellas to pump $352 million into manufacturing facility in Ireland

Outsourcing Pharma

The Japanese firm Astellas Pharma will apply for planning permission to construct a drug manufacturing facility in Tralee, Co. Kerry, Ireland worth around â330 million ($352 million).

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FDA approves GSK’s new bone cancer drug, helping validate a billion-dollar bet

BioPharma Dive

The drug, known scientifically as momelotinib, is now cleared to treat myelofibrosis and will compete against rival medicines sold by Incyte and Bristol Myers Squibb.

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Allis.health – a digital health analyst in your pocket

pharmaphorum

Allis.health – a digital health analyst in your pocket Phil.

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Informa Connect’s Patient Support Services Congress

Drug Channels

Informa Connect’s Patient Support Services Congress November 7-9, 2023 | The Inn at Penn, Philadelphia, PA [link] Exclusive Offer – Be sure to use your exclusive promo code 23DC10 to save 10% off* of your registration. The Patient Support Services Congress is a dialogue-driven meeting that arms the industry with innovative trends and next-generation approaches to patient services for optimal performance.

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US researchers start trials of universal flu vaccine

pharmaphorum

US researchers start trials of universal flu vaccine Phil.

Vaccines 103
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Reclaiming registries for integrated evidence generation throughout the product life cycle

BioPharma Dive

As integrated evidence generation takes center stage for driving evidence-based decision making across the product life cycle, automated registries just might be the linchpin that pulls it all together.

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New patent expiration for Takeda Pharms drug ACTOPLUS MET XR

Drug Patent Watch

Annual Drug Patent Expirations for ACTOPLUS+MET+XR Actoplus Met Xr is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are five patents protecting this drug… The post New patent expiration for Takeda Pharms drug ACTOPLUS MET XR appeared first on DrugPatentWatch - Make Better Decisions.

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How to Improve Your Test Scores with BoardVitals’ New AI-Powered Risk Assessment Reporting

Board Vitals - Pharmacist

In today’s fast-paced academic world, where time is often our most valuable resource, it’s crucial to study smarter, not harder. BoardVitals’ new Risk Assessment Reporting offers an innovative way to make the most of your study time. This AI-powered performance metric makes it simple to pinpoint your highest risk subjects so you can focus your time on areas you need the most work.

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