Sat.Jul 30, 2022 - Fri.Aug 05, 2022

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Generic subscription services like Mark Cuban’s promise cheaper drugs — but will it work?

PharmaVoice

Companies like Cost Plus Drugs and DiRx can bring generics directly to consumers at a fraction of the price, but whether it’s enough to fix the inflated U.S. healthcare system is yet to be seen.

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Tapping into pharma’s growing opportunities in digital health

Pharmaceutical Technology

Soaring patient numbers are stretching hospital capacity across the globe, forcing healthcare providers and their partners to think laterally about how to meet the demand without doubling their resources. Smarter diagnostic tools and more sophisticated remote- and self-care models will have an increasingly important role to play, as long as any advances are seen to deliver excellent outcomes and a better patient experience.

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Trending Sources

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Connecting EHR to clinical trials: How to embrace the promise of real-world data

pharmaphorum

We all know that real-world data (RWD) from electronic health records (EHR) could boost clinical trial efficiency and improve patient outcomes – so what’s holding us back? It’s been more than two decades since the ground-breaking potential of using electronic health records (EHR) to inform clinical research was first mooted. Since then, progress has been slow, but the industry now has everything it needs to close the feedback loop between science, evidence, and care, said speakers at a recent Co

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Bristol Myers Squibb aims to improve disability diversity in clinical trials

European Pharmaceutical Review

Dubbed Disability Diversity in Clinical Trials (DDiCT), the initiative aims to provide recommendations on how to improve access, engagement, speed of enrolment and participation of people with disabilities in clinical trials. The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said.

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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 glimpse inside Bristol Myers Squibb’s integration with Celgene

PharmaVoice

Catherine Owen, senior vice president of major markets, discusses the hurdles — and successes — of bringing the two ‘powerhouses’ together.

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Moderna signs contract to supply Covid-19 booster vaccines to the US

Pharmaceutical Technology

Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. The contract comprises a $1.74bn award to produce and supply these vaccine doses and options to further procure up to 234 million additional doses of the company’s booster candidates. A bivalent booster candidate, the mRNA-1273.222 vaccine comprises Spikevax along with the Omicron BA.4/5 strain messenger RNA (mRNA).

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Vaccine Administration: The Growing Role of Prefilled Syringes

PharmaTech

The option of using prefilled syringes for vaccinations is not (yet) available for all types of vaccines. Stakeholders are working to expand that option while also pursuing other non-traditional routes of administration.

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Taking probiotics where they’ve never gone before

PharmaVoice

How Seed Health is transforming the microbiome therapeutic market with its pharma-focused drug development approach.

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North America is seeing a hiring boom in pharmaceutical industry machine learning roles

Pharmaceutical Technology

North America extended its dominance for machine learning hiring among pharmaceutical industry companies in the three months ending May. The number of roles in North America made up 63.9% of total machine learning jobs - up from 62.6% in the same quarter last year. That was followed by Europe, which saw a 0.6 year-on-year percentage point change in machine learning roles.

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Roche scores phase 3 win for subcutaneous Tecentriq, eyes filings

pharmaphorum

Roche’s Tecentriq could become the first drug in the PD-1/PD-L1 inhibitor class to be approved in a subcutaneous formulation, after the new version matched the original intravenous formulation in a phase 3 trial. The results of the IMscin001 study found that an injection of Tecentriq under the skin taking just a few minutes was non-inferior to a 30 to 60-minute infusion with the IV version in terms of pharmacokinetics – how the active ingredient behaves in the body after administration.

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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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Pharmacopoeias to further support vaccine development and supply

European Pharmaceutical Review

Ph. Eur. The European Pharmacopoeia (Ph. Eur.) Commission has established the mRNAVAC Working Party to begin working on quality standards to support the emerging field of messenger RNA (mRNA) vaccines. The newly created Working Party’s first task will be to develop a consolidated strategy for future standards addressing these vaccines and their components.

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How a speech analysis tool could transform diagnosis and research for Alzheimer’s and beyond

PharmaVoice

WinterLight’s machine learning platform assesses speech to more accurately identify neurodegenerative diseases.

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Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

Pharmaceutical Technology

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Last year, the companies entered a strategic collaboration. Subsequently, technology transfer as well as scale-up from the lab bench to the commercial facility of Samsung were carried out in a period of seven months.

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How the WHO hepatitis strategy measures up in the field

pharmaphorum

According to the World Health Organization (WHO), approximately 296 million people globally live with hepatitis B, with most unaware of their infection. Africa is the worst impacted region for hepatitis B with a prevalence of 7.5 percent compared to 0.5 percent in the Americas. Hepatitis C impacts an estimated 58 million people across the globe. Again, Africa is the worst-impacted region with a prevalence of 0.8 percent while the Americas see a prevalence of 0.5 percent.

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Big Data Steering Group to enhance data quality and discoverability under new workplan

European Pharmaceutical Review

The joint Big Data Steering Group of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) has published a third workplan, setting actions to be delivered by 2025. According to EMA, the new plan will further enhance the efficient integration of data analysis into the regulatory evaluation of medicinal products. “Using novel technologies and the evidence generated from big data will benefit public health by accelerating medicine development, improving treatment outcomes an

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‘Death by 1,000 cuts:’ How emerging tech could change the journey for ALS patients

PharmaVoice

EverythingALS aims to speed drug development through improved diagnostics.

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AbbVie reports 4.5% rise in Q2 2022 net revenues

Pharmaceutical Technology

AbbVie has reported net revenues of $14.6bn for the second quarter (Q2) of 2022 as against $14bn in the year-ago quarter, indicating a 4.5% rise on a GAAP basis. Net revenue surged by 6.1% on an operational basis during the quarter. The GAAP diluted earnings per share (EPS) for the quarter ended 30 June grew by 21.4% to 0.51 from $0.42 in Q2 2021. An 11.2% surge in adjusted diluted EPS of $3.37 was reported in Q2 this year against $3.03 in the prior-year quarter.

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Bayer tops pharma rankings for diversity, inclusivity

pharmaphorum

The largest pharma companies have all set themselves ambitious targets in recent years to improve representation for women and minority communities in their businesses, but are they meeting those diversity objectives? On the whole, yes, says a new study by reputation intelligence and media monitoring specialist alva , which delves through millions of content items across online and traditional media and other source materials to give a score on their diversity, equity and inclusion (DE&I) ef

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Dexcom ONE glucose monitoring system available on prescription

Pharma Times

System improves management for people with diabetes by offering finger prick-free monitoring

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Editas, Real Chemistry and Compass blaze new trails with pivotal C-suite hires

PharmaVoice

How these latest executive personnel changes are impacting the industry.

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GreenLight and US NIH partner to develop Covid-19 vaccine for variants

Pharmaceutical Technology

GreenLight Biosciences has entered a partnership with the US National Institutes of Health (NIH) for the development of Covid-19 vaccines, which offer broader protection against new variants and with durable effects. The company will jointly design and analyse messenger ribonucleic acid (mRNA) Covid-19 vaccines in partnership with the NIH unit National Institute of Allergy and Infectious Diseases’ Vaccine Research Center (VRC).

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Gilead Sciences’ push into oncology is paying off, as Veklury falters

pharmaphorum

Gilead Sciences’ investment in oncology has started to provide a solid return, with sales of cancer therapies breaching the $500 million threshold for the first time in the second quarter. Cell therapies Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) for lymphoma and leukaemia together brought in $368 million, up 68%, while antibody drug conjugate Trodelvy (sacituzumab govitecan) rose 79% to $159 million thanks to increased uptake in triple-negative breast canc

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UK recall of Clinigen’s Mexiletine hydrochloride hard capsules

European Pharmaceutical Review

Clinigen Healthcare is recalling three batches of Mexiletine hydrochloride hard capsules, indicated for the treatment of documented arrhythmias, due to a potential risk of under- or overdose, which could have consequences for the safety of patients. The Class 1 Medicines Recall Notification was published by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

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Woman of the Week: Alloy Therapeutics’ Heather Schwoebel

PharmaVoice

The CBO and COO is leaning on her experience navigating the unknown to turn Alloy into an innovation multiplier.

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Amgen to acquire biopharma firm ChemoCentryx for $3.7bn

Pharmaceutical Technology

Amgen has signed a definitive agreement to acquire biopharmaceutical company ChemoCentryx for $52 for each share in cash or a total enterprise cost of nearly $3.7bn. ChemoCentryx focuses on orally administered therapeutics for the treatment of inflammatory disorders, autoimmune ailments and cancer. For discovering, developing and marketing such treatments, the company targets the chemokine and chemoattractant systems.

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Keytruda fluffs its lines in prostate, liver cancer trials

pharmaphorum

Two phase 3 trials of Merck & Co’s Keytruda in metastatic castration-resistant prostate cancer (CRPC) and advanced liver cancer have ended in failure, proving once again that cancer immunotherapy studies can be a hit-and-miss affair. The CRPC trial – KEYNOTE-921 – looked at the combination of Keytruda (pembrolizumab) with docetaxel in more than 1,000 patients who had not been treated with chemotherapy before, but who had seen disease progression despite earlier treatment with an anti-h

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Blending human knowhow, artificial intelligence aids drug discovery

Outsourcing Pharma

A leader from pharmaceutical firm Astellas discusses how the company has put to use a discovery platform that combines human expertise, AI, and robotics.

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Open Orphan to commence influenza human challenge study

Pharma Times

Candidate exhibits a novel mechanism of action and differs considerably from previously approved drugs

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Governments and pharma relationships and implications for antimicrobial resistance

Pharmaceutical Technology

Before the Covid-19 pandemic, government-led investment and engagement in life sciences was relatively restricted worldwide, with the industry mostly funded via private investment. The pandemic forced governments to acknowledge that this status quo had to change. Since 2020, government agencies have provided funding for expensive late-stage vaccine development and the expansion of manufacturing capacity, as well as other key pharmaceutical activities.

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How can the pharma industry address the gap in talent recruitment and development?

pharmaphorum

Across the economy, several industries have seen a significant increase in staff turnover due to several factors including the COVID-19 pandemic, burnout, and increasing demand for workplace flexibility. This has resulted in staff and talent shortages, meaning that industries have been forced to respond quickly to stay afloat. In particular, for the pharmaceutical industry, these talent shortages bring about a host of difficult challenges.

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Three Technology Tactics for Overcoming Prior Authorization Hurdles

Drug Channels

Today’s guest post comes from Karina Castagna, SVP of Access and Adherence at OptimizeRx. Karina discusses the challenges health care providers and patients face in their quest to secure prior authorizations from payers. She argues that manufacturers adopt an electronic health record-based solution to facilitate access to therapies, from the point of prescription through the point of dispensing at the pharmacy.

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New life sciences development destined for Paddington

Pharma Times

The sites will maximise local and global benefits of NHS, research, industry and community partnerships

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ViiV agrees to expand access to long-acting HIV PrEP

European Pharmaceutical Review

ViiV Healthcare and the Medicines Patent Pool (MPP) have signed a new voluntary licensing agreement to increase access to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP) in least developed, low-income, lower middle-income and Sub-Saharan African countries. Through this agreement, selected generic manufacturers will have the opportunity to develop, manufacture and supply generic versions of cabotegravir LA for PrEP in 90 countries, subject to required regulatory approvals be

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Gilead snaps up MiroBio and its checkpoint agonists for $405m

pharmaphorum

Less than three years after being spun out of Oxford University, privately-held biotech MiroBio is heading for a takeover by Gilead Sciences in a $405 million deal. MiroBio was formed in 2019 to develop checkpoint agonist antibodies for autoimmune and inflammatory disorders that can be used to apply the “natural brakes” of the immune system.

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ICYMI: Patients across the country are sharing concerns about government price setting

PhRMA

As members of Congress continue to push forward misguided government price-setting policies under the guise of “negotiation,” patient advocates across the country have been speaking out in local media outlets about the potential consequences.

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