patients

Amnesty says COVID jab producers are causing human rights crisis

Amnesty International has slammed the six pharma companies behind the bulk of COVID-19 vaccine supplies of for not agreeing to waive their intellectual property rights and share the technology behind them. The charity says AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax, and Pfizer are fuelling an “unprecedented human rights crisis” as a result and their …

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Addressing the HIV epidemic in Eastern Europe and Central Asia

Working in partnership will be key, says Alex Kalomparis, vice president, public affairs, international at Gilead Sciences. 2021 marks 40 years since the first cases of HIV were reported. In that time, over 79 million people have been diagnosed with HIV, with more than 36 million dying from AIDS-related illnesses, more than any other infectious …

Addressing the HIV epidemic in Eastern Europe and Central Asia Read More »

Study finds 10% of medicines in England are overprescribed

An alarming number of people in England are being prescribed medicines unnecessarily, which could harm their health, according to a UK government review. The study, led by the Chief Pharmaceutical Officer for England Dr Keith Ridge, estimates that 10% of items dispensed in primary care are inappropriate or could be better served with alternative treatments. …

Study finds 10% of medicines in England are overprescribed Read More »

It’s time to do better for patients with rare neurological disorders

Global Gene’s Craig Martin introduces a new patient identification initiative that strives to improve diagnosis and access to clinical trials for all patients with rare CNS conditions. Rare diseases impact more than 30 million Americans, and 400 million people around the globe. Less than 5% of the more than 7,000 rare diseases have approved treatments. …

It’s time to do better for patients with rare neurological disorders Read More »

Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11

With positive phase 2/3 results for their COVID-19 vaccine Comirnaty in hand for the five to 11 age group, Pfizer and BioNTech are planning to move swiftly ahead with a filing for emergency use that could be approved in a matter of weeks. The data is the first generated with any COVID-19 vaccine in this …

Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11 Read More »

Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11

With positive phase 2/3 results for their COVID-19 vaccine Comirnaty in hand for the five to 11 age group, Pfizer and BioNTech are planning to move swiftly ahead with a filing for emergency use that could be approved in a matter of weeks. The data is the first generated with any COVID-19 vaccine in this …

Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11 Read More »

Consumerism is driving a bold new vision for home healthcare

Consumers want the healthcare industry to meet them where they are, and this shift in patient mindset has expanded the definition of home healthcare and who benefits from it, according to a panel at MedCity INVEST Digital Health conference.

A defining characteristic of successful patient support programs is the level of cross-functional collaboration

There is a distinct difference between outstanding patient support programs and less effective programs. A defining characteristic of successful programs is the level of cross-functional collaboration. By following the six strategies in this white paper, pharmaceutical companies can improve collaboration, enhance the patient experience, better protect patient data, reduce risk, improve compliance—and improve the overall …

A defining characteristic of successful patient support programs is the level of cross-functional collaboration Read More »

Taking stock of NHS medicines optimisation

Given the rising cost of medicines as a share of the NHS budget in England, the establishment of ICSs provides a timely opportunity to take stock on delivering medicines optimisation at local level, says NHS Gloucestershire CCG’s Ellen Rule. Medicines optimisation aims to improve health outcomes, service quality, and sustainability by ensuring patients are taking …

Taking stock of NHS medicines optimisation Read More »

Coalition formed to represent patient interests in digital health

Not enough is being done to ensure that patient voices are included in policymaking around digital health, says a new patient organisation in the UK, which aims to set that situation right. The Patient Coalition for AI, Data and Digital Tech in Health has brought together members of patient organisations, medical colleges and health charities …

Coalition formed to represent patient interests in digital health Read More »

Astellas reports fourth death in halted gene therapy trial

There has been a fourth patient fatality in Astellas’ clinical trial of its AT132 gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), which has been halted twice due to safety concerns. The latest suspension came after abnormal liver function tests (LFTs) were seen in a boy receiving the gene therapy, who has since …

Astellas reports fourth death in halted gene therapy trial Read More »

UK poised to announce booster COVID jabs for over-50s

The UK government is due to announce a large-scale booster vaccine campaign against COVID-19 for all adults aged 50 and over later today, adding to its plan for third doses for people with weakened immune systems. The plan will see millions of doses of the Pfizer/BioNTech mRNA vaccine administered across the autumn and winter to …

UK poised to announce booster COVID jabs for over-50s Read More »

NHS England starts largest ever trial of Galleri cancer blood test

A blood test called Galleri that could detect dozens of different forms of cancer before symptoms appear will start trials by the NHS in England involving around 140,000 subjects. Volunteers aged between 50 and 77 are being sought to trial the diagnostic developed by California biotech Grail, which spun out of Illumina in 2016 and …

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MHRA clears third doses of AZ, Pfizer COVID jabs

The UK medicines regulator has cleared the use of a third dose of both the AstraZeneca and Pfizer COVID-19 vaccines, in readiness for a possible booster campaign ahead of the winter months. The decision means there is now no impediment to starting a booster drive – assuming the Joint Committee on Vaccination and Immunisation (JCVI) …

MHRA clears third doses of AZ, Pfizer COVID jabs Read More »

Anxiety, Worry or Fear? Disappointment, Grief or Depression?

By HANS DUVEFELT Especially in these strange and uncertain times, many people feel uneasy. Some of them come to us with concerns over their state of mind. In primary care, our job is in large part to perform triage. We strive to identify patients who need referral, medication or further evaluation. We also strive, or …

Anxiety, Worry or Fear? Disappointment, Grief or Depression? Read More »

AZ CEO Soriot urges caution on COVID booster doses

The UK should think twice before backing widespread use of COVID-19 booster vaccinations, as to do so could place unnecessary burden on the NHS over the winter, according to AstraZeneca chief executive Pascal Soriot. In a letter to The Daily Telegraph newspaper with AZ’s head of biopharma R&D Mene Pangalos, Soriot write that the UK …

AZ CEO Soriot urges caution on COVID booster doses Read More »

UK pledges £5.4bn to NHS to ease COVID-19 treatment backlog

NHS England will get an extra £5.4 billion ($7.5 billion) in funding over the next six months to respond to COVID-19 and address a backlog in care caused by the pandemic, according to the UK government. The total includes £1 billion to get delivery of routine surgeries and treatments to patients delayed by COVID-19 back …

UK pledges £5.4bn to NHS to ease COVID-19 treatment backlog Read More »

Does Our Healthcare System Work for the Most Vulnerable Americans?

By DEBORAH AFEZOLLI, CARL-PHILIPPE ROUSSEAU, HELEN FERNANDEZ, ELIZABETH LINDENBERGER “Why did you choose this field?” Most physicians are asked this question at some point in their early careers. We are geriatrics and palliative medicine physicians, so when that question is posed to us, it is invariably followed by another: “Isn’t your job depressing?” No, our …

Does Our Healthcare System Work for the Most Vulnerable Americans? Read More »

Prof Nigel Osborne: Science is catching up with ‘medical music’

The internationally recognised composer, peace worker and musical therapy pioneer tells pharmaphorum how his emerging field stands at an important threshold. History provides a wealth of commentary on the emotional value of music. One of the earliest came from Plato, who concluded that “rhythm and harmony find their way into the inward places of the …

Prof Nigel Osborne: Science is catching up with ‘medical music’ Read More »

FDA firms up JAK inhibitor warnings after Xeljanz review

The FDA has concluded its safety review of Pfizer’s JAK inhibitor Xeljanz and Xeljanz XR, requiring revised warnings for the drugs as well as others in the class after finding evidence of elevated risks of serious heart-related events. After looking at the data from Pfizer’s long-term, post-marketing safety study – ORAL Surveillance – the US …

FDA firms up JAK inhibitor warnings after Xeljanz review Read More »

Taking a de-centralized approach to cure the Hepatitis C epidemic

This year’s World Hepatitis Day theme, ‘Hepatitis Can’t Wait,’ stresses the urgency of testing and treating viral hepatitis, as well as removing the stigma surrounding the disease and providing support for patients. Treatment for hepatitis C has evolved dramatically over the past decade. The introduction of direct-acting-antivirals has revolutionized the treatment landscape, leading the World …

Taking a de-centralized approach to cure the Hepatitis C epidemic Read More »

More trouble for Astellas as AT132 gene therapy trial is halted again

Astellas has halted dosing in a study of its AT132 gene therapy for the rare disease X-linked myotubular myopathy (XLMTM) for the second time after another serious adverse event (SAE) linked to possible liver damage. The ASPIRO trial of AT132 has been paused after abnormal liver function tests (LFTs) were seen in a patient receiving …

More trouble for Astellas as AT132 gene therapy trial is halted again Read More »

Health Insurance is a Stumbling Block in Many Patients’ Thinking

By HANS DUVEFELT I have a patient with no health insurance but a brand new Mercedes. He says he can’t afford health insurance. He cringes at the cost of his medications and our office visit charges. His car cost a lot of money and I know that authorized Mercedes dealers charge around $140/hour for their …

Health Insurance is a Stumbling Block in Many Patients’ Thinking Read More »

UK real-world study finds COVID-19 jab protection wanes

A study has found evidence that protection from the AstraZeneca and Pfizer/BioNTech COVID-19 vaccines starts fall off after a few months, but a UK government advisor says there’s no need to rush into a large-scale booster campaign. The results of the ZOE COVID study found that initial protection against infection a month after the second …

UK real-world study finds COVID-19 jab protection wanes Read More »

Improving access to treatments in challenging markets

The COVID-19 pandemic has highlighted the importance of ensuring a reliable supply of treatments across the globe at pace and speed. Jirair Ratevosian, executive director of global patient solutions and government affairs at Gilead Sciences, tells us how his company utilised previously developed partnerships and their knowledge of providing global access to HIV treatments to distribute …

Improving access to treatments in challenging markets Read More »

Blueprints for UK pharma-NHS joint working

Joint working could hold at least part of the answer to getting the NHS back on its feet after COVID, according to the ABPI. As the NHS begins to recover from the biggest crisis in its history, the biopharmaceutical industry is stepping up to the plate to offer its support and a new online repository of …

Blueprints for UK pharma-NHS joint working Read More »

Does draft RCT guide set the scene for future trials?

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. The Good Clinical Trials Collaborative (GCTC) has published a draft guidance document, and is asking for the life sciences sector to make …

Does draft RCT guide set the scene for future trials? Read More »

MHRA clears Moderna COVID vaccine for 12 to 17 year olds

The Moderna COVID-19 vaccine has become the second jab to be authorised for use in England, Scotland and Wales in children aged 12 to 17 after getting the nod from the Medicines and healthcare products Regulatory Agency (MHRA). It joins the Pfizer/BioNTech vaccine in being an option for that age group, having been approved in …

MHRA clears Moderna COVID vaccine for 12 to 17 year olds Read More »

Pfizer, BioNTech file for FDA approval of COVID booster shot

Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. The two companies have submitted data from a phase 1 trial in support of the booster dose to the US regulator, and …

Pfizer, BioNTech file for FDA approval of COVID booster shot Read More »

FDA authorises COVID booster jabs for at-risk people

The FDA has cleared the use of third dose of either the Pfizer/BioNTech or Moderna COVID-19 vaccines for people with weakened immune systems, but stopped short of a broader booster campaign. The emergency use authorisation (EUA) for the two mRNA-based vaccines has been amended so they can be used for solid organ transplant recipients or …

FDA authorises COVID booster jabs for at-risk people Read More »

Social Health: The Future of Healthcare Marketing

With advertisers preparing to spend up to $15 billion on influencer marketing by 2022, pharmaceutical and biotech companies are increasingly (and carefully) engaging trusted health social influencers to connect more authentically with consumers. As pharma starts to leverage a multitude of high-engagement channels like influencer marketing, online communities and virtual health services, the industry finds itself …

Social Health: The Future of Healthcare Marketing Read More »

Widespread use of health IT can cause burnout but also help curb it

In a HIMSS 21 Digital session, panelists detailed the dichotomy of technology advancement for clinicians. Though technology has made it harder for them to disconnect from work leading to burnout, IT tools can also be used to identify pain points and implement solutions to alleviate stress.

BioNTech says repeat doses may be better than modified COVID-19 jab

BioNTech has suggested that giving booster doses of its current Comirnaty (BNT162b2) COVID-19 vaccine may be a preferable strategy to modifying the Pfizer-partnered shot. The comments came on the German biotech’s second-quarter results call, during which BioNTech raised its forecasts for revenues it will book from sales of the vaccine to €15.9 billion (almost $19 …

BioNTech says repeat doses may be better than modified COVID-19 jab Read More »

UK extends COVID vaccination to 16 and 17-year-olds

The UK government has confirmed that the national COVID-19 vaccination campaign will be extended to include 16 and 17-year-old children, to tackle an increase in spread of the virus in younger age groups. The moves comes on the back of new advice from the Joint Committee on Vaccine and Immunisation (JCVI), which has concluded that …

UK extends COVID vaccination to 16 and 17-year-olds Read More »

How to balance the patient voice atop the shifting plates of HTA

The tectonic plates of healthcare technology assessment (HTA) have shifted – but where does the patient voice fit within this new evaluation paradigm? Recent advances in medical science, from genomics and gene therapies to artificial intelligence (AI), have transformed the healthcare landscape, and triggered a review of NICE’s methods and processes. Consultation on the proposals …

How to balance the patient voice atop the shifting plates of HTA Read More »

Germany confirms booster COVID jabs will start in September

Germany’s health ministry has said it will start offering booster COVID-19 vaccines to vulnerable people from next month, amid concerns about rising cases of the delta variant of the coronavirus. Health Minster Jens Spahn said the decision was also taken because of concerns that the immune response stimulated by COVID-19 vaccines may start to diminish …

Germany confirms booster COVID jabs will start in September Read More »

Have a chat to help others through loneliness

Looking back over the past 18 months, the Joni Mitchell lyric ‘you don’t know what you’ve got til it’s gone’ comes to mind. It’s only now, having been isolated, that we can appreciate how much small moments of contact with family and friends can mean. Bristol Myers Squibb’s Janice Creasy discusses how  and help reduce feelings …

Have a chat to help others through loneliness Read More »

Health literacy in the time of COVID-19

In a time when much of the media’s focus is on the ongoing COVID-19 pandemic and the differences in vaccination rates between various regions, countries, and socioeconomic groups, improving health literacy has never been more important. Impetus Digital’s Natalie Yeadon explores why. Health literacy is a complex phenomenon that involves both individuals and their local …

Health literacy in the time of COVID-19 Read More »

AZ says second COVID jab dose isn’t linked to rare clot reaction

A new analysis has suggested that the rare blood clot side effects linked to AstraZeneca’s COVID-19 vaccine Vaxzevria don’t occur after a second dose. The study in The Lancet examined cases of thrombosis with thrombocytopenia syndrome (TTS) from an AZ database encompassing around 5.62 million people who had received two doses of Vaxzevria in the …

AZ says second COVID jab dose isn’t linked to rare clot reaction Read More »

Tackling the ‘disease of systemic racism’ in clinical trials

A lack of racial diversity in clinical trials is a long-standing, well-documented problem that contributes to the stark health inequalities that have been brought into sharp focus by COVID-19. Tackling it, however, has not been easy, thanks in no small part to the reasons being as complex as they are multi-faceted. But, according to the …

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Rapid COVID immune status test launched in UK, Ireland

You’ve had your two COVID-19 jabs, but are you actually protected against infection? That’s a question that a fingerprick test launched today in the UK and Ireland could help to answer. The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics …

Rapid COVID immune status test launched in UK, Ireland Read More »

Study finds jabs cut severe variant COVID disease after one shot

A real-world study carried out in Canada had found that COVID-19 vaccines from AstraZeneca, Pfizer/BioNTech and Moderna reduce the chances of being hospitalised or dying from variants of concern dramatically, even after a single dose. AstraZeneca’s Vaxzevria was found to 87% effective after against the delta variant, which is now thought to be one of …

Study finds jabs cut severe variant COVID disease after one shot Read More »

Build back better: US pharma and the future of healthcare

America’s biopharmaceutical industry says it is “ready to do its part” in building a stronger, more resilient, affordable, and equitable health care system for all. COVID-19 highlighted both the challenges of the US healthcare system and the huge change potential of the country’s pharmaceutical industry. Now, as vaccination continues at pace, the sector has pledged …

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Build back better: US pharma and the future of healthcare

America’s biopharmaceutical industry says it is “ready to do its part” in building a stronger, more resilient, affordable, and equitable health care system for all. COVID-19 highlighted both the challenges of the US healthcare system and the huge change potential of the country’s pharmaceutical industry. Now, as vaccination continues at pace, the sector has pledged …

Build back better: US pharma and the future of healthcare Read More »

UK funds ‘long COVID’ research drive as restrictions ease

The UK government has provided almost £20 million ($27 million) in funding for 15 research projects aiming to look into the causes of long COVID, improve diagnosis and find new treatments for the condition. Long COVID is the term used to described people who still suffer from fatigue and other symptoms like breathlessness and muscle …

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UK funds ‘long COVID’ research drive as restrictions ease

The UK government has provided almost £20 million ($27 million) in funding for 15 research projects aiming to look into the causes of long COVID, improve diagnosis and find new treatments for the condition. Long COVID is the term used to described people who still suffer from fatigue and other symptoms like breathlessness and muscle …

UK funds ‘long COVID’ research drive as restrictions ease Read More »

The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor

During the last two decades, the landscape for psoriasis treatment has exploded. The advent of biologic therapies at the turn of the millennium and the subsequent development of T-cell targeted therapies and tumor necrosis factor (TNF) inhibitors have given patients therapeutic options beyond traditional treatments such as topical steroids, tar preparations, oral systemics, and light …

The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor Read More »

The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor

During the last two decades, the landscape for psoriasis treatment has exploded. The advent of biologic therapies at the turn of the millennium and the subsequent development of T-cell targeted therapies and tumor necrosis factor (TNF) inhibitors have given patients therapeutic options beyond traditional treatments such as topical steroids, tar preparations, oral systemics, and light …

The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor Read More »

The Case to Realign Parkinson’s Disease Research

By STEVEN ZECOLA If asked, the leaders of the research organizations working on Parkinson’s disease would say that they have made tremendous progress and are optimistic on finding a cure for the disease.  In truth, this viewpoint understates the magnitude of the challenge and results in insufficient resources being devoted to PD. Given the size …

The Case to Realign Parkinson’s Disease Research Read More »

UK study raises hopes of long COVID test within months

A diagnostic test to detect long COVID could be available within six to 12 months, following the discovery that patients with the chronic condition have distinctive antibodies in their blood.  Researchers at Imperial College London (ICL) led by Professor Danny Altmann told the BBC’s Panorama programme that they have identified a pattern of antibodies in …

UK study raises hopes of long COVID test within months Read More »

EMA finds possible link between mRNA COVID jabs and myocarditis

The EU medicines regulator has said that there is some evidence to suggest a possible link between mRNA-based vaccines for COVID-19 and rare cases of heart inflammation.  According to the EMA’s pharmacovigilance risk assessment committee (PRAC), labelling for Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax should be updated to reflect “very rare cases” of myocarditis and pericarditis …

EMA finds possible link between mRNA COVID jabs and myocarditis Read More »

How digital pathways are changing healthcare

As demonstrated throughout COVID, digital health is no longer experimental. Digital technologies are proving their value by allowing for better care, improved adherence and a more connected ecosystem between doctors, patients and pharma. Ampersand Health has been working in the space since 2015 and has seen it evolve from a niche approach with limited acceptance …

How digital pathways are changing healthcare Read More »

Israel says Pfizer jab less effective against COVID-19 delta

The Israeli Ministry of Health has reported data suggesting that the efficacy of the Pfizer/BioNTech COVID-19 vaccine has become less effective at preventing the spread of the coronavirus after the emergence of the delta variant. The vaccine still seems to be able to prevent hospitalisation and severe cases of COVID-19, but its efficacy in preventing …

Israel says Pfizer jab less effective against COVID-19 delta Read More »

Why I Seldom Recommend Vitamins or Supplements

By HANS DUVEFELT People here in northern Maine, as in my native Sweden, don’t get a whole lot of natural sunlight a good part of the year. As a kid, I had to swallow a daily spoonful of cod liver oil to get the extra vitamin D my mother and many others believed we all …

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UK body recommends COVID booster campaign in autumn

The UK’s Joint Committee on Vaccination and Immunisation (JCVI) has recommended that the NHS should start a COVID-19 booster shot programme in September, to run alongside the annual flu vaccine drive.  The programme should run in two stages, initially targeting elderly and vulnerable people and frontline health and social care workers like the initial vaccination …

UK body recommends COVID booster campaign in autumn Read More »

UK body recommends COVID booster campaign in autumn

The UK’s Joint Committee on Vaccination and Immunisation (JCVI) has recommended that the NHS should start a COVID-19 booster shot programme in September, to run alongside the annual flu vaccine drive.  The programme should run in two stages, initially targeting elderly and vulnerable people and frontline health and social care workers like the initial vaccination …

UK body recommends COVID booster campaign in autumn Read More »

Health Union Acquires WEGO Health

Health Union, the leader in building online health solutions for people living with chronic conditions, today announced that it has acquired WEGO Health, the world’s largest network of patient leaders – advocates, community leaders, creators and influencers. Combining Health Union’s targeted scale and depth in the condition experience with WEGO Health’s breadth of patient leaders …

Health Union Acquires WEGO Health Read More »

Supporting and empowering carers to make their voices heard

There are an estimated nine million carers in the UK, and their contributions to society, individually and as a group, are unparalleled. Nadine van Dongen and Antonella Porta remind us why carers are the unrecognised backbone of our society. Every day, carers look after some of the most vulnerable people around us, attending to their …

Supporting and empowering carers to make their voices heard Read More »

Privacy issues widespread with digital health apps, says BMJ

Developers of mobile health apps are comprehensively failing to safeguard the privacy of users, according to a study by researchers in Australia. The team from Macquarie University compared 15,000 free mobile health (mHealth) apps available on the Google Play store and compared their privacy practices to those found in 8,000 non-health apps, finding “serious problems …

Privacy issues widespread with digital health apps, says BMJ Read More »

COUCH Health Engages Mark Duman as Chief Strategy Officer

COUCH Health, a patient engagement agency, announced the appointment of Mark Duman as its Chief Strategy Officer (CSO). Taking charge of strategy development and execution for COUCH Health, Mark will oversee the expansion of COUCH Health’s mission to contribute to inclusive clinical trials that prioritise the patient experience. Mark will report directly to CEO Ash …

COUCH Health Engages Mark Duman as Chief Strategy Officer Read More »

AZ’s COVID jab tackles delta variant, but antibody fails clinical trial

The delta variant of COVID-19 may be holding back the lifting of lockdown restrictions in the UK, but there is some good news – the AstraZeneca/Oxford University vaccine seems to offer a high level of protection against it. Real-world data from Public Health England (PHE) suggests that the vaccine prevents 92% of hospitalisations in patients …

AZ’s COVID jab tackles delta variant, but antibody fails clinical trial Read More »

J&J must ditch 60m COVID jabs made at US plant, but 10m are okay, says FDA

The failings at a Baltimore, US factory making Johnson & Johnson’s COVID-19 vaccine mean that millions of doses of the shot will have to be jettisoned, according to an FDA update. The problems at the plant run by contract manufacturer Emergent BioSolutions first emerged a few weeks ago, after an FDA inspection uncovered a string …

J&J must ditch 60m COVID jabs made at US plant, but 10m are okay, says FDA Read More »

US orders 500m Pfizer/BioNTech COVID jabs for developing nations

The US government will buy 500 million more doses of the Pfizer/BioNTech COVID-19 vaccine that will be given to around 100 countries via the COVAX donation programme over the next two years. Pfizer and BioNTech are providing 200 million doses this year, and another 300 million in the first half of 2022, at a not-for-profit …

US orders 500m Pfizer/BioNTech COVID jabs for developing nations Read More »

Study links AstraZeneca COVID-19 shot to bleeding disorder ITP

Researchers in Scotland have identified a possible link between the Oxford University/AstraZeneca COVID-19 and a mostly mild and generally treatable bleeding disorder. The scientists examined real-world public health data from all individuals in Scotland who received either the AZ or Pfizer/BioNTech vaccines up until 14 April and found a possible association between the AZ shot …

Study links AstraZeneca COVID-19 shot to bleeding disorder ITP Read More »

Ensuring accessibility: Crossing the digital divide in healthcare

“Rarely does the answer come from the boardroom” – what can user experience teach us about building accessible digital health? No one should be left behind as the world embraces digital healthcare say leading user experience, voices. The experts discussed the benefits and merits of co-creation during a session on bridging the digital divide, held …

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NHS patient data upload delayed by two months, says UK

The UK’s decision to set back the start date of a new patient data-sharing scheme by two months has been welcomed by privacy campaigners, who have claimed it was being rushed through without sufficient public scrutiny. The centralised database of medical records from 55 million people was due to come online on 1 July, but …

NHS patient data upload delayed by two months, says UK Read More »

Millions of COVID jabs risk being wasted, says UNICEF

Rich nations are being asked to start donating COVID-19 vaccines to other parts of the world straight away, to avoid a glut of surplus supply in the coming months that could see millions of doses going to waste. In an open letter, UNICEF and a host of A list celebrities argue that G7 countries will …

Millions of COVID jabs risk being wasted, says UNICEF Read More »

Study finds “alarming” hike in antidepressant costs during COVID-19

Researchers in the UK have found that there was a four million rise in prescriptions for antidepressants in England during 2020, adding £139 million to NHS costs. The team from the University of Huddersfield said the findings highlight an “urgent need” for new mental health strategies to make sure antidepressants are being used appropriately, particularly …

Study finds “alarming” hike in antidepressant costs during COVID-19 Read More »

Value-based healthcare: Pandemic learnings and future musings

In the second part of our series from the ‘Patient Experience: Empathy and Innovation’ Digital Summit, we look at what COVID-19 can teach us about designing truly value-based healthcare.  Discussions of value-based healthcare provider contracts are often technical and far removed from the patient – but COVID has given us a chance to connect the …

Value-based healthcare: Pandemic learnings and future musings Read More »

UK is talking to AstraZeneca about beta variant COVID jab

The UK government is talking to AstraZeneca about ordering additional doses of its COVID-19 vaccine that will target the beta variant of SARS-CoV-2 virus first identified in South Africa, according to Health Secretary Matt Hancock. The AZ/Oxford University vaccine and other shots from Pfizer/BioNTech and Moderna are known to have less efficacy against the beta …

UK is talking to AstraZeneca about beta variant COVID jab Read More »

Closing the feedback loop to drive patient experience improvements

Is collecting near real time data the key to unlocking improvements in patient experience and national benchmarking? Small things can go a long way in terms of improving patient experience, but healthcare facilities cannot fix what they don’t know is broken. In the first of our series of articles from the Patient Experience: Empathy and …

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Healthcare fintech M&A expected to boost patient experience, provider operations

M&A activity in the healthcare finance technology is heating up, evidenced by large transactions such as Cedar buying OODA Health and R1 RCM buying VisitPay. Experts agree that this activity won’t end anytime soon, and it will have a positive impact on providers and patients.

Off Our Chests: No Secrets Left Behind

By CHADI NABHAN She was a successful corporate lawyer turned professional volunteer and a housewife. He was a charismatic, successful, and world-renowned researcher in gastrointestinal oncology. He was jealous of all breast cancer research funding and had declared that disease his nemesis. They were married; life was becoming a routine, and borderline predictable. Both appeared …

Off Our Chests: No Secrets Left Behind Read More »

Campaigners challenge NHS England’s latest plan to share patient data

Remember the Care.data debacle? Now, a new move by NHS England to move the records of 55 million patients into a database that will be accessible by third-party companies is under fire by privacy campaigners, who claim it could be unlawful.  The new General Practice Data for Planning and Research (GPDPR) service was unveiled earlier …

Campaigners challenge NHS England’s latest plan to share patient data Read More »

Moderna will file COVID-19 jab for teens after trial shows 100% protection

Moderna’s COVID-19 vaccine has joined the Pfizer/BioNTech jab in showing efficacy in younger patients in clinical trials, setting up an emergency use filing early next month. The results of the phase 2/3 TeenCOVE study in more than 3,700 adolescents aged 12 to 17 revealed no cases of COVID-19 after two doses of the mRNA-1273 shot, …

Moderna will file COVID-19 jab for teens after trial shows 100% protection Read More »

Safety of mRNA COVID-19 jabs backed, despite myocarditis cases

As US and EU health regulators review cases of heart inflammation seen in young people administered mRNA-based COVID-19 vaccines from Pfizer/BioNTech and Moderna, cardiologists have come out in favour of the jabs. The American Heart Association (AHA) and American Stroke Association (ASA) have issued a statement saying that the benefits of the vaccines “enormously outweigh …

Safety of mRNA COVID-19 jabs backed, despite myocarditis cases Read More »

UK says Pfizer, AZ COVID-19 vaccines work against Indian variant

People who have received two doses of the AstraZeneca or Pfizer/BioNTech COVID-19 vaccines have good protection against the Indian variant of SARS-CoV-2 , according to new UK data. The Pfizer/BioNTech shot provided 88% protection against the B.1.617.2 variant first identified in India and currently gaining ground across the UK and other countries around the world, …

UK says Pfizer, AZ COVID-19 vaccines work against Indian variant Read More »

UK booster trial will test value of third COVID jab dose

All seven COVID-19 vaccines ordered by the UK government will be tested in a new trial that will see whether they can be used as a third booster dose to protect against new variants.  The Cov-Boost trial is thought to be the first in the world to try to generate data on the value of …

UK booster trial will test value of third COVID jab dose Read More »

UK highlights life sciences’ key role in post-COVID recovery

The UK government used the Queen’s Speech to set out its ambition to make the country a leader in life sciences, garnering a warm response from industry groups.  The speech – an opportunity for Boris Johnson’s government to set out its plans for the year ahead after consolidating its position in last week’s local elections …

UK highlights life sciences’ key role in post-COVID recovery Read More »

How a lack of mental health diagnosis is affecting young men

As lockdown gradually eases, things are starting to look up but the lasting impact COVID-19 has had on our wellbeing remains. During Mental Health Awareness Month we look at the mental health stigma amongst men. To say we’re in the midst of a mental health crisis is not an exaggeration. Mental health concerns have been …

How a lack of mental health diagnosis is affecting young men Read More »

EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine

A review of side effects reported with coronavirus vaccines by the EMA’s safety committee has uncovered cases of inflammation of the heart in people receiving the Pfizer/BioNTech Comirnaty shot.  The Pharmacovigilance Risk Assessment Committee (PRAC) says it is aware of cases of myocarditis and pericarditis – inflammation of the heart muscle and membrane around the …

EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine Read More »

Why relationships are key in rare disease patient engagement

Real-world data is a vital part of rare disease drug development, but to get a true picture of patients’ unmet needs pharma should take a broader view of their lived experiences, says Xperiome’s Jeremy Edwards. It is difficult to get data on rare diseases and the people who live with them by their very nature. …

Why relationships are key in rare disease patient engagement Read More »

UK ‘planning to widen AstraZeneca COVID jab restrictions’

Reports are emerging that the UK may join other countries in imposing restrictions on the use of AstraZeneca’s COVID-19 vaccine in younger people, after a fresh look at the risks and benefits of the shot.  The Joint Committee on Vaccination and Immunisation (JCVI) said last month that it is preferable for adults aged under 30 …

UK ‘planning to widen AstraZeneca COVID jab restrictions’ Read More »

Not just COVID-19 vaccines: 5 things that cause blood clots

Reports of COVID-19 vaccinations causing blood clots has caused alarm in the general population. However due to the rarity of incidences from vaccination, myGP explores the most common causes of blood clots and how we can prevent them. Over 11 million doses of COVID-19 vaccines have been given across the UK, with blood clotting observed …

Not just COVID-19 vaccines: 5 things that cause blood clots Read More »

3 Considerations for Pharma Brand Strategy Success

Change is coming in the digital marketing world whether you’re ready or not. New challenges are presented for marketers as privacy measures tighten and we say goodbye to cookies, yet this impending farewell also presents an invaluable opportunity to rejuvenate your pharma brand strategy. As healthcare marketers prepare for the switch to flip, one thing is …

3 Considerations for Pharma Brand Strategy Success Read More »

Growing up different and not knowing why: My experience of rare vascular disorder KTS

Protracted diagnostic odysseys don’t only block access to rare disease treatments, they also leave people facing emotional turmoil all alone. Growing up in Glasgow, Linsey Brady “felt like a freak” and did everything she could to hide what she was told was a vascular deformation on her leg from the rest of the world. She …

Growing up different and not knowing why: My experience of rare vascular disorder KTS Read More »

AbbVie’s Humira (adalimumab) Receives Health Canada’s Approval for Pediatric Patients with Active Ulcerative Colitis

Shots: The approval is based on P-III ENVISION I study that involves assessing the efficacy, safety, and PK of Humira (SC) in pediatric patients aged 4-17yrs. with mod. to sev. UC The study met its co-1EPs of clinical remission @8wks, patients who responded @8wks, achieved clinical remission @52wks., no new safety signals were identified Humira …

AbbVie’s Humira (adalimumab) Receives Health Canada’s Approval for Pediatric Patients with Active Ulcerative Colitis Read More »

Roche Receives the US FDA’s Approval for First CDx to Identify Endometrial Cancer Patients Eligible for Immunotherapy

Shots: The US FDA has approved Ventana MMR RxDx panel to identify endometrial cancer patients who are eligible for treatment with GSK’s Jemperli (monothx.) that has received the US FDA’s approval on Apr 22, 2021 The CDx provides clinicians with a standardized testing option that uses a comprehensive panel of DNA mismatch repair (MMR) biomarkers …

Roche Receives the US FDA’s Approval for First CDx to Identify Endometrial Cancer Patients Eligible for Immunotherapy Read More »

Jazz Presents Results of Xywav (Oral Solution) in P-III Withdrawal Study for Adult Patients with Idiopathic Hypersomnia at AAN2021

Shots: The P-III withdrawal study involves assessing the efficacy and safety of Xywav (oral solution) vs PBO in a ratio (1:1) in adult patients with idiopathic hypersomnia. The study includes a titration and optimization period of up to 14wks. followed by a 2wks. open-label, SDP The study demonstrated a change in ESS score within 2wks., …

Jazz Presents Results of Xywav (Oral Solution) in P-III Withdrawal Study for Adult Patients with Idiopathic Hypersomnia at AAN2021 Read More »

Janssen’s Darzalex (daratumumab, SC) Combination Regimen Receives Health Canada’s Approval for Patients with Newly Diagnosed Light Chain Amyloidosis

Shots: The approval is based on results from the P-III ANDROMEDA (AMY3001) study involves assessing the safety and efficacy of Darzalex (1800mg, SC, qw) + bortezomib, cyclophosphamide, and dexamethasone (VCd) vs VCd alone in 388 patients with newly diagnosed AL amyloidosis The study showed higher hematologic response rate in ITT population (53% vs 18%), patients …

Janssen’s Darzalex (daratumumab, SC) Combination Regimen Receives Health Canada’s Approval for Patients with Newly Diagnosed Light Chain Amyloidosis Read More »

Biogen and Eisai Report Results of Lecanemab (BAN2401) in P-IIb Study 201 for Patients with Early Alzheimer Disease

Shots: The P-IIb POC Study 201 involves assessing lecanemab in patients with early AD Results: @18mos, prespecified analysis showed a consistent reduction of clinical decline across several clinical and biomarker EPs at highest doses and reduction in brain Aβ & clinical decline. The results are published in a peer-reviewed journal In March, the companies have …

Biogen and Eisai Report Results of Lecanemab (BAN2401) in P-IIb Study 201 for Patients with Early Alzheimer Disease Read More »

Alnylam Presents Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy at AAN 2021

Shots: The P-III HELIOS-A study assessing Vutrisiran (25mg, SC, once every 3mos.) vs patisiran (0.3 mg/kg, IV, q3w) in 164 patients in a ratio (3:1) with hATTR amyloidosis with polyneuropathy The study met its 1EPs & 2EPs i.e. change from baseline in mNIS+7 @9mos. & improvement in QoL assessed by Norfolk QoL-DN and gait speed …

Alnylam Presents Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy at AAN 2021 Read More »

Zogenix Presents Results of Fintepla’s (fenfluramine) Study Highlighting the Impact of Treatment on Dravet Syndrome Patients, Caregivers, and Families at AAN 2021

Shots: The P-III study is designed to assess caregivers’ perspectives on the long-term seizure & non-seizure-related benefits of Fintepla on patients with Dravet syndrome and on their caregivers and families Results: seizure-related benefits noted by caregivers include a reduction in frequency, seizure activity, and shorter recovery time while non-seizure benefits include improvements in executive functions …

Zogenix Presents Results of Fintepla’s (fenfluramine) Study Highlighting the Impact of Treatment on Dravet Syndrome Patients, Caregivers, and Families at AAN 2021 Read More »

World Orphan Drug Congress USA Virtual 2021

On Wednesday, April 28th, the World Orphan Drug Congress USA is being held online for free! The conference brings together pharma, biotechs, government, payers, investors and patient/patient advocates in the rare disease space to discuss the latest developments that will lead to the future of orphan drug development. We are thrilled to announce some amazing speakers …

World Orphan Drug Congress USA Virtual 2021 Read More »

Omada Health Launches the First Virtual Cardiometabolic Clinic for Patients with Diabetes and Hypertension

Shots: The company has launched the first virtual clinic to guide patients with chronic conditions and helps to improve health and behavior via tracking tools & informational guides for weight management, daily activity levels and more Omada’s platform uses AI to analyze movements and range of motion via video and offers physical therapy sessions, wearable …

Omada Health Launches the First Virtual Cardiometabolic Clinic for Patients with Diabetes and Hypertension Read More »

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive EC’s Approval for 1L Treatment of Advanced Renal Cell Carcinoma

Shots: The approval is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC Results: @median follow-up of 10.6 mos.; m-PFS (16.6 vs 8.3mos.), ORR (55.7% vs 27.1%); CR (9.3% vs 4.3%); OS (40% reduction in risk of death), Grade 3+ AEs …

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive EC’s Approval for 1L Treatment of Advanced Renal Cell Carcinoma Read More »

The Pain Is In Your Brain: Your Knees Know Next to Nothing

By HANS DUVEFELT A “frozen shoulder” can be manipulated to move freely again under general anesthesia. The medications we use to put patients to sleep for such procedures work on the brain and don’t concentrate in the shoulder joints at all. An ingrown toenail can be removed or an arthritic knee can be replaced by …

The Pain Is In Your Brain: Your Knees Know Next to Nothing Read More »

AstraZeneca’s Tagrisso (osimertinib) Receives the NMPA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Shots: The approval is based on results from the P-III ADAURA trial assessing Tagrisso (80mg, qd) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated for three years or until disease recurrence Results: Improvement in DFS in all population, 83% reduction in the …

AstraZeneca’s Tagrisso (osimertinib) Receives the NMPA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer Read More »

US seeks halt on J&J COVID vaccine rollout as clot concerns spread

US health authorities have recommended pausing dosing with Johnson & Johnson’s COVID-19 vaccine as they investigate cases of blood clots also observed in some people taking the AstraZeneca shot.  The FDA said there had been reports of six cases of cerebral venous sinus thrombosis (CVST) associated with low blood platelet counts (thrombocytopenia) out of more …

US seeks halt on J&J COVID vaccine rollout as clot concerns spread Read More »

Cytisinicline – the solution to stop smoking?

Whether present in electronic or combustible cigarettes, nicotine is a highly addictive substance. Dr Cindy Jacobs, chief medical officer of Achieve Life Sciences discusses the potential of cytisinicline therapy for smoking cessation.  Although e-cigarettes are considered a less dangerous alternative to combustible cigarettes, they can still result in, or sustain, nicotine addiction, for which the …

Cytisinicline – the solution to stop smoking? Read More »

The power of communication: engaging diverse groups in healthcare

Humans are diverse and communications to engage us need to be inclusive. It’s no longer about talking to a group, a cohort or an imagined section of society – especially in healthcare. Page & Page’s Lisa Jane Lishman outlines why communication and the strategies behind it need to be more personal to ensure that people …

The power of communication: engaging diverse groups in healthcare Read More »

UK will offer under-30s alternative to AZ’s COVID jab

The UK drugs regulator has said people aged under 30 should be offered an alternative to the AstraZeneca COVID-19 vaccine, because of evidence linking it to rare blood clots.  Updated figures from the Medicines and Healthcare products Regulatory Agency (MHRA) reveal 79 people experienced blood clots after receiving a dose of Vaxzevria (AZD1222), with 19 …

UK will offer under-30s alternative to AZ’s COVID jab Read More »

Paediatric trial of AZ COVID jab ‘halted as a precaution’

Oxford University has suspended a clinical trial of its AstraZeneca-partnered COVID-19 vaccine in children and adolescents while a possible link to rare cases of blood clotting is investigated by the UK drugs regulator.  Around 300 volunteers have been enrolled into the trial, but investigators have decided to pause dosing with the Oxford/AZ vaccine while they …

Paediatric trial of AZ COVID jab ‘halted as a precaution’ Read More »

Exelixis Reports the US FDA’s Acceptance of IND for XB002 in Patients with Advanced Solid Tumors

Shots: The US FDA has accepted IND to assess the safety, tolerability, PK, and preliminary antitumor activity of XB002 in patients with advanced solid tumors. The P-I trial is expected to initiate in Q2’21 The preclinical data demonstrated that XB002 binds to tissue factors without affecting the coagulation cascade, in contrast with prior therapies in …

Exelixis Reports the US FDA’s Acceptance of IND for XB002 in Patients with Advanced Solid Tumors Read More »

Could Moderna shot save UK’s under-50s COVID vaccination push?

People in the UK will start receiving doses of Moderna’s COVID-19 vaccine in around two weeks’ time, according to vaccines minister Nadhim Zahawi. The roll-out of the third coronavirus shot will come as the UK exits its second lockdown round, and in time to offset an anticipated dip in supply of the Oxford University/AstraZeneca AZD1222 …

Could Moderna shot save UK’s under-50s COVID vaccination push? Read More »

Ultragenyx Collaborates with n-Lorem Foundation to Advance Personalized Medicines Treatment for Patients with Ultra-Rare Diseases

Shots: The companies collaborated to develop the personalized medicines for patients with ultra-rare diseases. The collaboration involves additional resources, financial contribution, and experience from both the company The alliance strengthens n-Lorem’s mission to bring immediate hope and rapid treatment to ultra-rare disease patients in need n-Lorem Foundation provides a free and lifetime supply of ASO …

Ultragenyx Collaborates with n-Lorem Foundation to Advance Personalized Medicines Treatment for Patients with Ultra-Rare Diseases Read More »

Lilly’s Taltz (ixekizumab) Receives Health Canada’s Approval for Pediatric Patients with Moderate to Severe Plaque Psoriasis

Shots: The approval is based on P-III study involves assessing Taltz (20mg for <25kg/40mg for 25-50kg/80 mg for >50 kg @12wks., with 40/80/160mg starting doses, respectively) vs PBO in 171 patients aged 6-<18 yrs. with mod. to sev. PsO Results: @ 12wks., patients achieving PASI 75 (89% vs 25%); patients achieving sPGA 0,1 (81% vs …

Lilly’s Taltz (ixekizumab) Receives Health Canada’s Approval for Pediatric Patients with Moderate to Severe Plaque Psoriasis Read More »

Janssen and SpringWorks Reports Dosing of First Patient in P-Ib trial for Nirogacestat + Teclistamab to Treat Relapsed or Refractory Multiple Myeloma

Shots: The first patient has been dosed in P-Ib trial evaluating SpringWorks’ Nirogacestat (GSI) + Janssen’s Teclistamab (Ab targeting BCMA and CD3) in patients with r/r MM. Janssen assumes all costs of study & other expenses related to the supply of nirogacestat In preclinical models, Nirogacestat increased the cell surface density of BCMA, reduced the …

Janssen and SpringWorks Reports Dosing of First Patient in P-Ib trial for Nirogacestat + Teclistamab to Treat Relapsed or Refractory Multiple Myeloma Read More »

Kite Reports Submission of sBLA to the US FDA for Tecartus in Adult Patients with R/R Acute Lymphoblastic Leukemia

Shots: The sBLA is based on data from the P- I/II ZUMA-3 trial in adult patients age ≥18 years old for the treatment of adult patients with r/r B-cell ALL The focus of the study is to evaluate the safety and efficacy in adult patients with r/r ALL If approved, Tecartus will be the 1st …

Kite Reports Submission of sBLA to the US FDA for Tecartus in Adult Patients with R/R Acute Lymphoblastic Leukemia Read More »

EMA backs safety of AZ COVID-19 jab in all age groups

The head of the EMA has reiterated that there is no evidence to limit the use of AstraZeneca’s COVID-19 vaccine in any age group, after Germany and Canada imposed restrictions in younger patients.  “Our position has not changed” from a safety update two weeks ago, said Emer Cooke at an EMA press conference today. “According …

EMA backs safety of AZ COVID-19 jab in all age groups Read More »

Novartis’ Kesimpta (ofatumumab) Receives the EC’s Approval for Adult Patients with Relapsing Multiple Sclerosis

Shots: The approval is based on P-III ASCLEPIOS I and II studies that involve assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, PO, qd) in 1,882 adults aged 18-55yrs. with a confirmed diagnosis of RMS The study demonstrated a reduction of annual relapses by over 50% and achieved >30% relative risk reduction of 3mos. confirmed …

Novartis’ Kesimpta (ofatumumab) Receives the EC’s Approval for Adult Patients with Relapsing Multiple Sclerosis Read More »

UK government launches new office to “level up” nation’s health

The government has continued its shake-up of UK health authorities with the creation of the Office of Health Promotion (OHP), which will focus on issues like obesity, mental and sexual health, and promoting physical activity.  The OHP will take over the health improvement remit currently the responsibility of Public Health England (PHE), and will “lead …

UK government launches new office to “level up” nation’s health Read More »

BMS Report Results of Relatlimab + Opdivo (nivolumab) in P-II/III RELATIVITY-047 Study in Patients with Previously Untreated Metastatic or Unresectable Melanoma

Shots: The P-II/III RELATIVITY-047 (CA224-047) study involves assessing the FD combination of relatlimab (160 mg) + Opdivo (480mg) vs Opdivo (480mg, IV, q4w) alone in 714 patients in a ratio (1:1) with previously untreated metastatic or unresectable melanoma The study met its 1EPs of the PFS while the follow-up for 2EPs of OS and ORR …

BMS Report Results of Relatlimab + Opdivo (nivolumab) in P-II/III RELATIVITY-047 Study in Patients with Previously Untreated Metastatic or Unresectable Melanoma Read More »

J&J Visions’ Acuvue Theravision with Ketotifen Receives MHLW’s Approval for Vision Correction and Allergic Eye Itch

Shots: The MHLW has approved Acuvue Theravision with Ketotifen as the first combination contact lens that provides vision correction and an antihistamine drug to relieve symptoms for people experiencing itchy allergy eyes Data demonstrated that 8 out of 10 contact lens wearers feel frustrated when their eye allergies interfere with normal contact lens wear. The …

J&J Visions’ Acuvue Theravision with Ketotifen Receives MHLW’s Approval for Vision Correction and Allergic Eye Itch Read More »

MHRA launches patient involvement pilot for drug applications

The UK drugs regulator is now asking that all applications for new medicines or indications detail the efforts made to involve patients in the drug development process.  The voluntary scheme by the Medicines and Healthcare products Regulatory Agency (MHRA) aims to inject a dose of “patient centricity” into medicines development – something that has been …

MHRA launches patient involvement pilot for drug applications Read More »

The hidden danger of isolated congenital asplenia

TEAM 4 Travis is an advocacy group with one objective – to ensure it doesn’t take an autopsy to diagnose isolated congenital asplenia. As part of our Patient Insights series, founder Allison Bones tells us why she is determined to stop history repeating itself. When Travis Bones died just days after his fourth birthday, his …

The hidden danger of isolated congenital asplenia Read More »

Making a big impact in small patient populations

Approximately 85% of rare diseases are genetic, offering significant opportunities to develop better treatments as our understanding of the human genome improves1. Advances in next-generation sequencing have shown that sequencing the whole genomes of large numbers of individuals in a standardized way can improve the diagnosis and treatment of patients with rare diseases. Scientists have …

Making a big impact in small patient populations Read More »

Making a big impact in small patient populations

Approximately 85% of rare diseases are genetic, offering significant opportunities to develop better treatments as our understanding of the human genome improves1. Advances in next-generation sequencing have shown that sequencing the whole genomes of large numbers of individuals in a standardized way can improve the diagnosis and treatment of patients with rare diseases. Scientists have …

Making a big impact in small patient populations Read More »

Continuity of Care in a Pandemic: Reflecting on the Rise of Telehealth

March 2021 comes with mixed emotions, as people across the United States reflect on one year of life in the era of COVID-19. From a rollercoaster of lockdown restrictions, isolation, mask-wearing and socially distancing, to finally experiencing a glimmer of hope with increasing vaccine distribution – it’s safe to say the past 12 months have …

Continuity of Care in a Pandemic: Reflecting on the Rise of Telehealth Read More »

Continuity of Care in a Pandemic: Reflecting on the Rise of Telehealth

March 2021 comes with mixed emotions, as people across the United States reflect on one year of life in the era of COVID-19. From a rollercoaster of lockdown restrictions, isolation, mask-wearing and socially distancing, to finally experiencing a glimmer of hope with increasing vaccine distribution – it’s safe to say the past 12 months have …

Continuity of Care in a Pandemic: Reflecting on the Rise of Telehealth Read More »

Merck Reports the US FDA’s Acceptance of NDA for Priority Review of Belzutifan (MK-6482) to Treat Patients with Von Hippel-Lindau Disease Associated RCC

Shots: The NDA is based on P-II study-004 trial involves assessing Belzutifan (120 mg, PO, qd) in 61 patients with VHL disease who had at least one measurable solid tumor localized to the kidney and did not require immediate surgery Results: It showed ORR of 36.1% while the 2EPs include DCR, DoR, time to response, …

Merck Reports the US FDA’s Acceptance of NDA for Priority Review of Belzutifan (MK-6482) to Treat Patients with Von Hippel-Lindau Disease Associated RCC Read More »

States halting AZ jab a ‘disaster’ for EU’s COVID vaccination programme

The decision by around a dozen EU countries to suspend dosing with AstraZeneca’s COVID-19 vaccine is facing criticism, amid fears that it could undermine the response to the pandemic in Europe.  Germany, France, Italy and Spain are among the member states that have announced a suspension of dosing with AZD1222 in the last 24 hours …

States halting AZ jab a ‘disaster’ for EU’s COVID vaccination programme Read More »

Patient involvement in trial design: looking to the future

COVID-19 has transformed the way we think about patient participation in trial design – but there are still many barriers to overcome in improving engagement. Speakers at the NIHR’s recent virtual event for the pharma industry discussed best practices for bringing patient insights into research. The pandemic has forced the industry to embrace virtual patient …

Patient involvement in trial design: looking to the future Read More »

EU regulators probe safety of AstraZeneca vaccine batch after blood clot reports

European safety regulators have launched an investigation into the safety of a batch of the Oxford University/AstraZeneca COVID-19 vaccine, as countries including Denmark suspended its use as a precaution following reports of blood clots. Initial findings showed no issue with the shots suspended by Austrian authorities after a person was diagnosed with severe blood clotting …

EU regulators probe safety of AstraZeneca vaccine batch after blood clot reports Read More »

Roche’s Actemra/RoActemra (tocilizumab) + Veklury Fail to Meet its Primary Endpoints in P-III REMDACTA Study for Patients with Severe COVID-19 Pneumonia

Shots: The P-III REMDACTA study involves assessing Actemra/RoActemra (tocilizumab) + Veklury (remdesivir) vs PBO + Veklury in hospitalized patients with severe COVID-19 pneumonia receiving SOC The study did not meet its 1EPs i.e. improvement in time to hospital discharge up to day28 and failed to meet its 2EPs compared to Veklury alone. The findings will …

Roche’s Actemra/RoActemra (tocilizumab) + Veklury Fail to Meet its Primary Endpoints in P-III REMDACTA Study for Patients with Severe COVID-19 Pneumonia Read More »

Getting the 340B program back on track in 2021

As our nation continues to fight a global pandemic, the need for access to affordable and quality health care feels even more pressing. This is especially true for vulnerable patients who have been disproportionately impacted by COVID-19. That’s why it has never been more important for policymakers to ensure federal programs, like the 340B program, …

Getting the 340B program back on track in 2021 Read More »

Lymphoma Action – championing the patient voice in cell therapy

Lymphoma Action is the only UK health charity dedicated to people affected by lymphoma. Chief Executive Ropinder Gill and Director of Operations and External Affairs Stephen Scowcroft believe it is essential to champion the patient voice in cell therapy. This thought leadership series has been paid for and developed with Kite, A Gilead Company. Lymphoma …

Lymphoma Action – championing the patient voice in cell therapy Read More »

How accidental advocacy is amplifying the GM1 voice

Rare disease families need to stand up and be counted if they want things to change said mum and advocate Christine Waggoner. She spoke to pharmaphorum as part of our Patients Insights series. Like many “rare disease mums”, Christine is an accidental advocate. After her daughter, Iris, was diagnosed with a rare disease at five, …

How accidental advocacy is amplifying the GM1 voice Read More »

NIH abandons convalescent plasma trial in mild COVID

Another trial of convalescent plasma in people with COVID-19 has missed the mark, this time in mild to moderate disease, further dashing hopes that the therapy could have an impact on the infection.  Convalescent plasma taken from recovered COVID-19 patients is laden with antibodies against SARS-CoV-2, and the hope was this could be used to …

NIH abandons convalescent plasma trial in mild COVID Read More »

Providers look to predictive modeling to help rebuild finances in 2021

After a challenging 2020, health systems are looking to deploy strategies for recovery, especially to bolster financial health. One strategy health executives are considering is investing in predictive modeling technology that can help them manage patient demand and outcomes in the coming year.

Roche introduces 15-minute nasal COVID test in UK

Roche Diagnostics has launched a 15-minute nasal antigen test for COVID-19 in the UK, and says it has millions of the kits available straight away to help the country recover from the pandemic.   The speedy test can turn around results within 15 minutes, without the need for processing swabs in a lab, and only …

Roche introduces 15-minute nasal COVID test in UK Read More »

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive CHMP’s Positive Opinion as 1L Treatment for Advanced Renal Cell Carcinoma

Shots: The CHMP recommendation is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC The P-III result showed improvements in PFS, OS and ORR with consistent efficacy benefits observed across key subgroups of patients and was well tolerated, with a low …

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive CHMP’s Positive Opinion as 1L Treatment for Advanced Renal Cell Carcinoma Read More »

BridgeBio and Origin’s Nulibry (fosdenopterin) Receives the US FDA’s Approval as the First Therapy to Reduce the Risk of Mortality in Patients with MoCD Type A

Shots: The FDA has approved Nulibry based on three clinical trials compared to data from a natural history study in patients with MoCD Type A The results from three clinical trials showed improvement in overall survival and an 82% reduction in the risk of death, @3yrs. probability of survival in rcPMP-treated patients (84% vs 55%), …

BridgeBio and Origin’s Nulibry (fosdenopterin) Receives the US FDA’s Approval as the First Therapy to Reduce the Risk of Mortality in Patients with MoCD Type A Read More »

Health at every size – making medicine weight inclusive

UK-based doctor, Dr Natasha Larmie is on a mission to make medicine weight inclusive. Inspired by the Health at Every Size movement, Natasha is campaigning to take the weighing scales out of general practice and focus instead on health promoting behaviours. Last year, as the pandemic escalated worldwide, UK GP Dr Natasha Larmie embarked on …

Health at every size – making medicine weight inclusive Read More »

Daiichi Sankyo Collaborates with LYSA-LYSARC-CALYM for Valemetostat in Patients with R/R B-Cell Lymphoma

Shots: LYSA-LYSARC to conduct a P-II study to evaluate the safety and efficacy of valemetostat in six cohorts of patients with r/r B-cell lymphoma. The study will include ~140 patients at 22 sites in France and Belgium and is anticipated to be initiated in 2021 The collaboration brings together Daiichi Sankyo’s science and the multidisciplinary …

Daiichi Sankyo Collaborates with LYSA-LYSARC-CALYM for Valemetostat in Patients with R/R B-Cell Lymphoma Read More »

Building a better future for people with rare diseases in all four UK nations

How has rare disease care changed over the last few years? And what might we expect from the next five? We attended the Rare Disease Day Virtual Parliamentary Event to find out. The rare disease community has a golden opportunity to transform the way care is delivered across all four UK nations – that’s according …

Building a better future for people with rare diseases in all four UK nations Read More »

Limited access to cancer biomarker testing in Europe, report finds

There is limited access to biomarker testing for cancer in Europe, despite the huge potential of the technology to improve outcomes, according to a new report. The report from European Federation of Pharmaceutical Industries and Associations (EFPIA) shows the results of research conducted in 2020 to assess the availability, quality and reimbursement of biomarker tests …

Limited access to cancer biomarker testing in Europe, report finds Read More »

AZ COVID jab efficacy debate is hindering EU’s vaccine drive

The spat between the EU and AstraZeneca over access to the company’s COVID-19 shot led to scathing remarks about its efficacy that now threaten to undermine the EU’s vaccination targets.  The European Commission approved AZ’s AZD1222 vaccine for use in the EU in all adults aged over 18 at the end of January, more than …

AZ COVID jab efficacy debate is hindering EU’s vaccine drive Read More »

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receive the US FDA’s Approval as 1L Treatment for Advanced NSCLC

Shots: The approval is based on the P-III EMPOWER-Lung 1 trial assessing Libtayo (350mg, q3w) monothx. vs platinum doublet CT in 710 patients for the 1L treatment with advanced NSCLC who tested positive for PD-L1 in ≥50% of tumor cells and without EGFR, ALK or ROS1 aberrations The study showed a 32% reduction in the …

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receive the US FDA’s Approval as 1L Treatment for Advanced NSCLC Read More »

Common but not normal: It’s time to talk about maternal mental health

As part of our Patients Insights series, the founder and CEO of Motherhood Understood shares her experience of postpartum depression, talks about the power of peer support, and explains what the wider healthcare community could do to play their part. Within days of giving birth to her first child, Jen Schwartz’s fairy tale view of …

Common but not normal: It’s time to talk about maternal mental health Read More »

Zynteglo halt re-ignites viral vector safety concerns; analysts

Bluebird Bio’s decision to hit pause on the launch of Zynteglo for beta thalassaemia after two cases of cancer were seen in a clinical trial could see fears over the safety of viral vectors used to deliver gene therapies resurface.  That’s the view of analysts at Jefferies, who suggest it could “re-ignite concerns over the …

Zynteglo halt re-ignites viral vector safety concerns; analysts Read More »

Scientists make case for one dose of Pfizer’s COVID jab to stretch supplies

Two researchers have suggested that the second dose of Pfizer and BioNTech’s COVID-19 vaccine could be delayed, as this would increase the number of people that can be protected while supplies are limited without compromising its efficacy.  The two Canadian researchers – Danuta Skowronski and Gaston De Serres – make the suggestion in a letter …

Scientists make case for one dose of Pfizer’s COVID jab to stretch supplies Read More »

UK will start first COVID-19 challenge study “within a month”

Sometime within the next few weeks, young and healthy volunteers will be deliberately exposed to the COVID-19 coronavirus in the UK in what looks set to be the first study of its type worldwide.  The human challenge study has just secured ethics committee approval and will recruit up to 90 volunteers aged 18-30 years, according …

UK will start first COVID-19 challenge study “within a month” Read More »

Relationship Advice: What Patients Want HCPs to Know About Satisfaction

What aspects of a patient’s treatment matter most? For many, healthcare providers (HCPs) make a significant impact on how a person feels about their overall care plan; a positive HCP-patient relationship can help a person feel in control of their health and more prepared for the journey ahead, while a less than ideal HCP-patient relationship …

Relationship Advice: What Patients Want HCPs to Know About Satisfaction Read More »

Building early relationships: a gamechanger for pioneering rare disease treatment

Advocacy groups play a crucial role in both driving access to innovative treatment and services and educating patients and caregivers on novel breakthroughs. On average, it takes more than four years to receive an accurate diagnosis of a rare disease.1 This diagnostic odyssey has pushed patients and caregivers online to self-diagnose and learn more about …

Building early relationships: a gamechanger for pioneering rare disease treatment Read More »

COVID-19 increased demands on carers’ wellbeing, study finds

COVID-19 has increased demands on informal carers and severely increased demands on their mental, physical and financial wellbeing, according to a global study. Embracing Carers is a global initiative led by Germany’s Merck KGaA and is focused on recognising and raising awareness about the role of informal carers. It intends to develop solutions with global …

COVID-19 increased demands on carers’ wellbeing, study finds Read More »

Roche and PatchAi partner on digital tool for cancer patients

Roche’s Italian subsidiary has joined forces with digital health startup PatchAi to roll out an app that aims to support people diagnosed with cancer. Roche and PatchAi have been working together on the Smart Health Companion (SHC), which was launched to oncology and haematology patients in July 2020, and will now step up their collaboration …

Roche and PatchAi partner on digital tool for cancer patients Read More »

BMS and Acceleron’s Reblozyl (Luspatercept) Receives Health Canada Approval for Adult Patients With Myelodysplastic Syndromes

Shots: The approval is based on P-III MEDALIST study involves assessing ReblozyL vs PBO in a ratio (2:1) in adult patients with very low- to intermediate-risk MDS-RS requiring regular RBC transfusions (>2 RBC units/ 8 wks) The results showed transfusion independence for 8 wks or longer during the first 24 wks (38% vs. 13%) Reblozyl …

BMS and Acceleron’s Reblozyl (Luspatercept) Receives Health Canada Approval for Adult Patients With Myelodysplastic Syndromes Read More »

Exelixis Report Results of Cabometyx (cabozantinib) in P-II PAPMET Study for Patients with Metastatic Papillary Renal Cell Carcinoma

Shots: The P-II SWOG S1500/PAPMET trial involves assessing cabometyx (60 mg, qd with dose reductions to 40 & 20mg ), crizotinib, and savolitinib vs sunitinib in a ratio (1:1:1:1) for patients with advanced or metastatic PRCC The results demonstrated significant improvement in PFS. The trial met its 1EP’s shows mPFS (9.0 mos. vs 5.6 mos.); …

Exelixis Report Results of Cabometyx (cabozantinib) in P-II PAPMET Study for Patients with Metastatic Papillary Renal Cell Carcinoma Read More »

Guinea declares Ebola epidemic following first deaths since 2016

Guinea has officially declared it is dealing with an Ebola epidemic, after at least three people died from the virus. The BBC reported that these first deaths from Ebola since 2016 were linked to the burial of a nurse, where four others fell ill with diarrhoea, vomiting and bleeding. Newly developed vaccines will be supplied …

Guinea declares Ebola epidemic following first deaths since 2016 Read More »

Takeda Report Results of TAK-620 (maribavir) in P-III SOLCTICE Trial for the Treatment of Post-Transplant Patients with Cytomegalovirus Infection

Shots: The P-III TAK-620-303 (SOLSTICE) trial involves assessing TAK-620 (400mg) vs conventional antiviral therapies (IAT) in HCT and SOT recipients in a ratio (2:1) with R/R CMV infection refractory with/ out resistance, to one or a combination of the conventional antiviral therapies The 1EPs study shows confirmed CMV viremia clearance @ 8wk; (55% vs 26.1% …

Takeda Report Results of TAK-620 (maribavir) in P-III SOLCTICE Trial for the Treatment of Post-Transplant Patients with Cytomegalovirus Infection Read More »

Ipsen’s John Chaddock on making neurotoxins a priority for healthcare systems

Injected neurotoxins can be incredibly potent in treating spasticity from neurological diseases, but the field doesn’t always get the attention it needs.  Ipsen’s John Chaddock tells us why the company is investing heavily in neurotoxin research and how he hopes to raise awareness among young scientists and the NHS. When the COVID-19 pandemic first hit, …

Ipsen’s John Chaddock on making neurotoxins a priority for healthcare systems Read More »

Regeneron’s Evkeeza (evinacumab-dgnb) Receives the US FDA’s Approval for Patients with Homozygous Familial Hypercholesterolemia

Shots: The approval is based on P-III ELIPSE trial that involves assessing Evkeeza (15 mg/kg, IV, q4w) + vs PBO in 65 patients aged ≥12yrs. with HoFH for 24wks. The study met 1EPs i.e. 49% reduction in LDL-C (47% vs 2%), patients also experienced a reduction in the level of ApoB, non-HDL-C. Reductions in LDL-C …

Regeneron’s Evkeeza (evinacumab-dgnb) Receives the US FDA’s Approval for Patients with Homozygous Familial Hypercholesterolemia Read More »

Galapagos and Gilead Discontinue the P-III Trials of Ziritaxestat (GLPG1690) for Idiopathic Pulmonary Fibrosis

Shots: The P-III program consists of two trials (ISABELA 1 & 2) assessing ziritaxesta (200/ 600mg, qd) + SOC vs PBO + SOC in ~1500 patients with IPF. The 1EPs of the study decline in forced vital capacity until 52wks. The termination of the study is based IDMC’s recommendation following a regular review of unblinded …

Galapagos and Gilead Discontinue the P-III Trials of Ziritaxestat (GLPG1690) for Idiopathic Pulmonary Fibrosis Read More »

A study to avoid chemotherapy in patients with early HER-2+ breast cancer

MEDSIR, a global company dedicated to independent clinical research in oncology, has initiated the PHERGain II clinical trial to demonstrate that in patients with HER2-positive early breast cancer with a good prognosis, a chemotherapy-free therapeutic approach can be as effective as the current standard of care, which involves the use of this generally more toxic …

A study to avoid chemotherapy in patients with early HER-2+ breast cancer Read More »

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receives US FDA’s Approval for Patients with Advanced Basal Cell Carcinoma

Shots: The FDA approval is based on P-II trial involves assessing Libtayo (350mg, q3w) in patients with locally advanced BCC & metastatic BCC (nodal or distant) Results: median follow-up (9.5 & 15.1mos.); ORR (21% & 29%); PR (21% & 23%); D0R @≥6mos. (100% & 79%); with longer follow up, 0RR with LA BCC (31%) as …

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receives US FDA’s Approval for Patients with Advanced Basal Cell Carcinoma Read More »

5 Ways to Make Your Pharma Marketing More Personal

Personalization in marketing–the practice of understanding and delivering content when and where people are ready to accept it–in any industry is key, but perhaps even more so in healthcare. If we’ve learned anything as marketers in 2020, this new landscape demands personalization to break through the noise and reach and engage with people during their …

5 Ways to Make Your Pharma Marketing More Personal Read More »

BMS’ Inrebic (fedratinib) Receives EC’s Approval for Patients with Newly Diagnosed and Previously Treated Myelofibrosis

Shots: The EC approval is based on JAKARTA and JAKARTA2 studies. The pivotal JAKARTA study involves assessing Inrebic (500mg) vs PBO in 289 patients with intermediate-2 or high-risk primary or secondary myelofibrosis with splenomegaly The P-II JAKARTA 2 study involves assessing of Inrebic (400mg, qd) in 97 patients with intermediate or high-risk primary or secondary …

BMS’ Inrebic (fedratinib) Receives EC’s Approval for Patients with Newly Diagnosed and Previously Treated Myelofibrosis Read More »

Why we need the human element of remote clinical trials

Over the last year, we’ve noticed that “connectivity” doesn’t always equate to “connected” – and that’s just as true in the realm of clinical trials as it is in our personal lives. Amanda Barrell reports from a panel at the Patients as Partners Europe conference on remote clinical trials. Decentralised trials have been growing in …

Why we need the human element of remote clinical trials Read More »

23andMe goes public using Richard Branson’s blank cheque company

DNA testing company 23andMe has signed a deal to merge with a ‘blank cheque’ company set up by Virgin billionaire Sir Richard Branson as a shortcut to a public listing. The agreement with Branson’s VG Acquisition Corp ties in with an emerging trend among life sciences companies to forego the usual initial public offering (IPO) …

23andMe goes public using Richard Branson’s blank cheque company Read More »

Daiichi Sankyo Initiates P-II Study of Patritumab Deruxtecan in Patients with EGFR-Mutated NSCLC

Shots: The P-II HERTHENA-Lung01 study involves assessing patritumab deruxtecan in 420 patients in a ratio (1:1) with EGFR-mutated m/ LA NSCLC prior treated with TKI and Pt-based CT. The first patient has been dosed in P-II study The 1EPs of P-II study include ORR and 2EPs include DoR, PFS, DCR, and time to response. Moreover, …

Daiichi Sankyo Initiates P-II Study of Patritumab Deruxtecan in Patients with EGFR-Mutated NSCLC Read More »

Merck KGaA’s Tepmetko (tepotinib) Receives the US FDA’s Approval for Patients with Metastatic NSCLC with METex14 Skipping Alterations

Shots: The approval is based on pivotal P- II VISION study that involves assessing of Tepmetko (450mg, qd) as monothx. in 152 patients with a median age of 73 years with advanced/ m-NSCLC with METex14 skipping alterations Results: treatment-naïve patients & previously treated patients, ORR (43% & 43%); mDoR (0.8 and 11.1mos.); DoR @6mos. (67% …

Merck KGaA’s Tepmetko (tepotinib) Receives the US FDA’s Approval for Patients with Metastatic NSCLC with METex14 Skipping Alterations Read More »

Gan & Lee Receives the US FDA’s Fast Track Designation for GLR2007 for the Treatment of Patients with Glioblastoma

Shots: The US FDA has granted FTD for GLR2007 for the treatment of patients with glioblastoma and application is eligible for Rolling Review and for Accelerated Approval and Priority Review The Designation evaluate to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need GLR2007 is …

Gan & Lee Receives the US FDA’s Fast Track Designation for GLR2007 for the Treatment of Patients with Glioblastoma Read More »

Merck’s Report Results of Keytruda (pembrolizumab) in Combination With Ipilimumab vs Keytruda Monotherapy in P-III KEYNOTE-598 for Metastatic Non-Small Cell Lung Cancer Patients

Shots: The P- III trial involves assessing of Keytruda in combination with ipilimumab vs Keytruda monothx in 568 patients in a ratio (1:1) as 1L treatment for metastatic NSCLC patients without EGFR or ALK genomic tumor aberrations and whose tumors express PD-L1 Results: @ median follow-up (20.6 mos.); mOS (21.4 vs 21.9 mos.); mPFS (8.2 …

Merck’s Report Results of Keytruda (pembrolizumab) in Combination With Ipilimumab vs Keytruda Monotherapy in P-III KEYNOTE-598 for Metastatic Non-Small Cell Lung Cancer Patients Read More »

Patients as Partners Europe: Are we doing patient centricity all wrong?

To be truly patient centric, do we need to turn the current model on its head and work within a more free-thinking, free-speaking framework? Amanda Barrell reports from Patients as Partners Europe. Despite huge progress over the last decade, patient involvement in research is still largely in the hands of the pharmaceutical companies. That is …

Patients as Partners Europe: Are we doing patient centricity all wrong? Read More »

Mistrust in medical research: a patient perspective

In medical research, trust has traditionally been hard-fought for. Terms like “lab rats” and “guinea pigs” are often used in conversations about clinical trials. For some communities, the historic unethical treatment of participants is also still a raw memory[1]. People tend to remember when things go wrong, and this casts doubt over procedures and leads …

Mistrust in medical research: a patient perspective Read More »

Unpacking rare diseases in the first edition of Delta magazine

Welcome to Delta – the new Fishawack Health magazine. We’ve chosen to focus our first edition of the magazine on a topic close to our hearts, rare diseases. Rare diseases represent an incredibly high unmet need, not only due to the lack of therapies and the practical difficulties in diagnosis, but also in patients’ desire …

Unpacking rare diseases in the first edition of Delta magazine Read More »

UK is first European country to see COVID-19 deaths pass 100,000

More than 100,000 people have died within 28 days of a positive COVID-19 test in the UK, the first European country to meet that grim milestone. The UK is only the fifth country after the US, Brazil, India and Mexico to pass that threshold, after a surge in cases following the holiday period around the …

UK is first European country to see COVID-19 deaths pass 100,000 Read More »

Real-world evidence: breaking boundaries in rare disease

The COVID-19 pandemic has added a new layer of complexity to the drug development process. Launch timelines have been delayed and clinical trials have been postponed or suspended. As a result, life sciences companies are turning to novel methods of collecting clinical data and innovative trial design. The generation of data to show the significant …

Real-world evidence: breaking boundaries in rare disease Read More »

Patient partnerships: putting relevance into relationships

There are perhaps two ways to look at 2020 – on the surface, it has been a year of pandemic health catastrophe, on a deeper level it has been a year where we finally acknowledged the fragility of health partnerships and the importance of good relationships between the pharmaceutical industry and the patients it serves. …

Patient partnerships: putting relevance into relationships Read More »

Incyte Reports Acceptance and Priority Review of BLA for Retifanlimab to Treat Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)

Shots: The BLA submission is based on P-II POD1UM-202 trial involves assessing of retifanlimab (500 mg, q4w) in 94 patients with locally advanced or metastatic SCAC who have progressed on or are intolerant of standard platinum-based CT The study demonstrates 14% ORR for retifanlimab monotherapy as determined by ICR using RECIST v1.1 and mDOR of …

Incyte Reports Acceptance and Priority Review of BLA for Retifanlimab to Treat Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) Read More »

Aurinia Lupkynis (voclosporin) Receives US FDA’s Approval to Treat Adult Patients with Active Lupus Nephritis

Shots: The approval is based on the pivotal AURORA P-III study and AURA-LV P-II study involves assessing of Lupkynis + SoC in 533 patients to treat adult patients with LN The study demonstrated significantly improved renal response rates vs SoC, improved response rates in all parameters across immunologically-active classes, 50 % reduction in UPCR twice …

Aurinia Lupkynis (voclosporin) Receives US FDA’s Approval to Treat Adult Patients with Active Lupus Nephritis Read More »

Exelixis Cabometyx (cabozantinib) + Opdivo (nivolumab) Receives US FDA’s Approval as a 1L Treatment for Patients with Advanced Renal Cell Carcinoma

Shots: The approval is based on results from CheckMate -9ER, P-III pivotal trial involves assessing of Cabometyx + Opdivo vs sunitinib in 651 patients previously untreated advanced or metastatic RCC. Results: @ median follow-up of 18.1 mos. patients treated with the combination achieved PFS of 16.6 mos vs 8.3 mos for Sutent arm. Opdivo + …

Exelixis Cabometyx (cabozantinib) + Opdivo (nivolumab) Receives US FDA’s Approval as a 1L Treatment for Patients with Advanced Renal Cell Carcinoma Read More »

Assessing physician practices and expectations in the post-COVID era

The ongoing COVID-19 pandemic has affected the routines of many practicing physicians, including an impact on their prescribing decisions. New research from CRA shows that for many physician practices, prescribing has shifted based on route of administration. These changes, initially presumed to be temporary, may continue beyond the pandemic. As several COVID-19 vaccine candidates progress …

Assessing physician practices and expectations in the post-COVID era Read More »

3 practical steps for improving patient support

Research Partnership’s Emilie Braund and Harrison Gaiger dig down into the top insights pharma companies can harness to make their patient support programmes as powerful as possible. The pandemic has undoubtedly disrupted the healthcare landscape and amplified the complex factors that influence and shape patient journeys. Findings from our recently published whitepaper ‘Free thinking: The …

3 practical steps for improving patient support Read More »

Health literacy needs support, now more than ever

The COVID-19 pandemic has brought healthcare guidelines and scientific advances front-of-mind on a global scale, in the process highlighting long-standing gaps in health literacy as well as an opportunity for pharma. It’s long been known that many people struggle to access, understand and use health information and services to make decisions about their health. As …

Health literacy needs support, now more than ever Read More »

Unlocking the potential in rare disease research with decentralised trials

A survey by rare disease patient network Raremark found that 86% of the community members asked were interested in taking part in clinical trials. CEO Jeremy Edwards looks at how decentralised trial models can solve some of the challenges for clinical trial recruitment in rare disease. With low and geographically dispersed patient populations in rare …

Unlocking the potential in rare disease research with decentralised trials Read More »

Allergic reactions prompt Moderna COVID vaccine pause in California

Public health authorities in California are seeking a halt on dosing of one lot of Moderna’s COVID-19 vaccine after reports of allergic reactions at one immunisation clinic. According to state epidemiologist Dr Erica Pan, there were a higher-than-expected number of suspected allergic reactions at a community clinic being used to administer the shot, with some …

Allergic reactions prompt Moderna COVID vaccine pause in California Read More »

A collaborative approach to greater diversity in clinical trials

The need for diversity in clinical trial populations has been a topic of discussion across regulators and the industry in general for decades. Despite the introduction of US policies, beginning with the 1993 National Institutes of Health (NIH) Revitalization Act which called for the inclusion of more women and communities of colour in clinical trials, …

A collaborative approach to greater diversity in clinical trials Read More »

Interstitial Lung Disease (ILD) Drug Development Summit

Network with over 50 other industry pioneers including Ionis Pharmaceuticals, Genentech, Vicore, and AnaMar to hear first-hand how the latest scientific research is innovating and upgrading ILD therapeutics at this trailblazing new meeting. The 1st Interstitial Lung Disease Drug Development Summit is a ground-breaking new conference dedicated to helping you drive forward the development of effective therapies for chronic …

Interstitial Lung Disease (ILD) Drug Development Summit Read More »

Enabling new models of care: pursuing pharma’s partnership potential

There is a huge, ongoing shift in how health and wellness is approached in the UK, and the changes will have important implications for NHS-industry partnerships. Transformative change is coming to the NHS and is set to radically alter how the UK’s health service cares for people at a population level. The NHS Long Term …

Enabling new models of care: pursuing pharma’s partnership potential Read More »

‘No going back’ for clinical trials after COVID

Trial sites have adapted swiftly to the restrictions of COVID-19, and patients have seen many knock-on benefits as a result. The next step is ensuring the industry does not regress to old ways of working once the pandemic is over, say Karen McIntyre and Allyson Small. COVID-19 has changed everything for clinical trials – but …

‘No going back’ for clinical trials after COVID Read More »

How patient insights are changing trial solutions

Patients have been asking for patient-centric trial solutions for years – the industry just hasn’t been listening. That’s according to Medidata’s Anthony Costello, who was bringing patient feedback into product design long before COVID-19. He tells us what insights pharma has been missing out on and how they can be harnessed to build better solutions. …

How patient insights are changing trial solutions Read More »

Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD

Shots: The first patient has been dosed in P-III CIFFREO study assessing PF-06939926 vs PBO in 99 ambulatory male patients aged 4-7yrs. with DMD across 55 sites in 15 countries. The first patient was dosed at a site in Barcelona, Spain on Dec 29, 2020. The 1EPs of the study is the change in NSAA …

Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD Read More »

IL-6 drugs do work in COVID-19, says UK, as it plans NHS use

New data means that IL-6 drugs from Roche and Sanofi that had been all-but written off as coronavirus therapies will now be offered routinely to COVID-19  patients in intensive care in the UK. The renaissance of the two therapies comes on the back of the REMAP-CAP trial, which found that the IL-6 inhibitors RoActemra (tocilizumab) …

IL-6 drugs do work in COVID-19, says UK, as it plans NHS use Read More »

True patient-focused research through decentralised and hybrid trials

How can pharma improve the patient-centricity of its trials during COVID-19 and beyond? Experts from across the sector give their thoughts on the key approaches and technologies that are driving patient engagement forward. With COVID-19 presenting new barriers to running and recruiting for clinical trials, making studies patient-centric is more important now than ever before. …

True patient-focused research through decentralised and hybrid trials Read More »

Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy

Shots: The P-III HELIOS-A study assessing vutrisiran (25mg, SC, once every 3mos.) vs patisiran (0.3 mg/kg, IV, q3w) in 164 patients in a ratio (3:1) with hATTR amyloidosis with polyneuropathy The study met its 1EPs & 2EPs i.e. change from baseline in the mNIS+7 @9mos. & changes in QoL assessed by Norfolk QoL-DN and gait …

Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy Read More »

Boosting the impact of patient services

New research from Accenture has revealed that adoption of patient support services hasn’t improved since 2015 despite increasing pharma investment. The company’s Jennifer Spada tells us how companies can boost awareness of their programmes to improve patient outcomes. As part of its drive towards patient centricity, the pharma industry has increasingly been building patient support …

Boosting the impact of patient services Read More »

Behind the scenes: How health systems, EHR vendors will give patients unprecedented access to their data

Health systems and EHR vendors have been working for months to comply with the ONC’s final rule on interoperability and information blocking that goes into effect in April and is expected to grant patients unprecedented access to their health information. Here is a look at some of the issues they contended with.

Regeneron’s Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen

Shots: The company reported encouraging initial data from an ongoing P-I/II/III trial of its casirivimab + imdevimab (8,000/2,400mg) in hospitalized COVID-19 patients requiring low-flow oxygen. The results passed the futility analysis as seronegative patients treated with the Ab cocktail had a lower risk of death or receiving mechanical ventilation In seronegative patients, the cocktail reduced …

Regeneron’s Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen Read More »

Vulnerable should all get COVID-19 shot before summer, says NHS chief

NHS England’s chief executive Sir Simon Stevens has said that all vulnerable people over the age of 50 will be offered a COVID-19 vaccine by “late spring” in a message to healthcare workers. The prediction comes after the NHS announced on Christmas Eve that more than half a million people had received the Pfizer/BioNTech shot …

Vulnerable should all get COVID-19 shot before summer, says NHS chief Read More »

Amgen hands off leprosy, TB candidate to Australian non-profit

Amgen has decided that a drug for leprosy and tuberculosis it inherited as part of its acquisition of Celgene’s psoriasis blockbuster Otezla last year would fare better in the hands of a non-profit company, dedicated to bringing affordable medicines to poorer countries. AMG 634 – a PDE4 inhibitor being investigated for TB and leprosy complication …

Amgen hands off leprosy, TB candidate to Australian non-profit Read More »

NHS leaders urge UK government to extend Brexit transition period

NHS leaders have written to the UK prime minister urging him to extend the Brexit transition period by a month to avoid plunging the healthcare service into chaos on 1 January. The letter, published today by the NHS Confederation – a membership organisation representing NHS leaders from all parts of the health service, outlines concerns …

NHS leaders urge UK government to extend Brexit transition period Read More »

3 Patient Lessons: What Cancer Patients Teach Me

By YASMIN ASVAT An estimated 1.8 million people in this country may face a cancer diagnosis this year, in what has already been a bleak year of isolation and loss.   While news of the COVID-19 vaccine rolling out across the U.S. offers hope in a year of 311,000 deaths,  11 million  people face the financial pressure of unemployment, and, approximately 43 percent of …

3 Patient Lessons: What Cancer Patients Teach Me Read More »

AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma

Shots: The P-III SOURCE study involves assessing Tezepelumab (210mg, q4w) vs PBO in 150 adult patients as add-on therapy with patients maintained on their currently prescribed ICS + LABA, with/ out other asthma controller therapy for 48wks. The trial did not meet its 1EPs i.e., reduction in the daily OCS dose, without loss of asthma …

AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma Read More »

2020 in review: COVID-19 and patient centric clinical trials

The trials and tribulations of 2020 have brought the vital role of research, pharma, and biotech into sharp focus. But how has the push to develop treatments and vaccines for SARS-CoV-2 affected the industry’s commitment to patient centricity? This time last year, researchers and industry players were working hard to embed patient centricity and engagement …

2020 in review: COVID-19 and patient centric clinical trials Read More »

Finding agility in unprecedented times

Nicole Farmer, general manager, UK & Ireland at Sanofi Genzyme, tells us how the company aimed for agile adaptation during COVID-19, and how these lessons are driving patient centricity going forward. 2020 has been a watershed year for every company in the industry – and for Nicole Farmer, general manager for the UK & Ireland …

Finding agility in unprecedented times Read More »

Health inequalities: A societal challenge that needs a cross-sector solution

COVID-19 has laid the UK’s health inequalities bare and created an imperative for the NHS to develop a step-change in how it cares for diverse and marginalised communities. Health inequality is the “greatest societal challenge of our time”, according to a briefing document calling for a system-wide solution. The report was published by the Association …

Health inequalities: A societal challenge that needs a cross-sector solution Read More »

Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases

Shots: The approval is based on trial assessing Riabni (375 mg/m2, IV) vs Rituxan once weekly for 4wks. followed by dosing @12wks. & 20wks. in 256 patients in a ratio (1:1) with grade 1, 2, or 3a follicular B-cell NHL & low tumor burden The WAC of Riabni will be 23.7% lower than the Rituxan …

Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases Read More »

Patient experiences are evolving. How can pharma keep up?

By listening to the people who are navigating this new landscape everyday.Integrating personal experiences and patient-reported data, Health Union recently hosted a one-day virtual event entitled The COVID-19 Effect: How Pharma Can Adapt to the Evolving Patient Experience, featuring real-time conversations between people living with chronic conditions and industry experts. The sessions focused on the …

Patient experiences are evolving. How can pharma keep up? Read More »

Patient journeys in the era of COVID-19

OPEN Health’s Richard Jones and Sumira Riaz assess the pandemic’s implications for understanding patients’ experiences and how the pharma industry can support them It’s impossible not to view healthcare in 2020 through the lens of the current global pandemic and COVID-19 is certainly set to cast a long shadow over patient needs and engagement. Even …

Patient journeys in the era of COVID-19 Read More »

Novartis’s Entresto Receives the US FDA’s Advisory Committee Recommendation to Treat Patients with HFpEF

Shots: The US FDA’s CRDAC voted 12 to 1 supporting the use of Entresto (sacubitril/valsartan) in the treatment of patients with HFpEF The decision was based on efficacy & safety analyses, including findings from a pre-specified subgroup analysis of PARAGON-HF (P-III study in HFpEF) and additional evidence from PARAMOUNT (P-II trial in HFpEF), as well …

Novartis’s Entresto Receives the US FDA’s Advisory Committee Recommendation to Treat Patients with HFpEF Read More »

How pharma needs to change for the era of digital health

Experts from Healthware Group explore how companies can rebuild their approach to digital from the ground up for the benefit of patients. Digital is not just a nice-to-have for pharma companies – it’s a necessity for ensuring that patients have the best possible outcomes in modern healthcare systems. With digital tools and techniques being able …

How pharma needs to change for the era of digital health Read More »

Pandemic has little impact on pharma’s reputation, says report

The pandemic has had very little positive impact on the public’s perceptions of pharma although the industry has fared much better than politicians, according to a report. According to the report from Takeda UK, only 17% of respondents said their impression of pharmaceutical companies had improved, based on how the industry had reacted to the …

Pandemic has little impact on pharma’s reputation, says report Read More »

Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer

Shots: Roche launches the cobas PIK3CA mutation test for patients with advanced/ m-BC in countries accepting the CE mark The IVT test is a real-time PCR test for the qualitative detection & identification of 17 mutations in exons 2, 5, 8, 10 & 21 in the gene encoding the catalytic subunit of PIK3CA in DNA …

Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer Read More »

Deep Dive: Patients and Partnerships

As this issue’s title suggests, patient centricity is about more than just talking points and marketing strategies – it requires companies to truly listen to, engage with and partner with the patients they serve, and in putting this month’s Deep Dive together it’s been great to see that so many pharma firms are now taking …

Deep Dive: Patients and Partnerships Read More »

CMS proposed rule requires payers to streamline prior authorizations

The rule would require payers in the Medicaid, CHIP and QHP programs to build and maintain application programing interfaces to improve data exchange and the prior authorization process. But the rule does not include Medicare Advantage plans, which the American Hospital Association called “disappointing.”

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing

Shots: Roche has launched Elecsys SARS-CoV-2 Ag test as an aid in the diagnosis of SARS-CoV-2 infections, in the markets accepting the CE Mark. Additionally, Roche has also filed a EUA to the US FDA The test showed 94.5% sensitivity across 200 PCR confirmed symptomatic individuals & 99.9% specificity across 2747 PCR negative symptomatic & …

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing Read More »

Does a lack of diversity in clinical trials reflect a lack of diversity among researchers?

Embedding diversity into clinical research does not start and end at trial recruitment – the community needs processes and institutions that reflect society and provide representation. Greater representation among study designers, research teams, and funding committees would lead to greater diversity among research participants and help to tackle health inequalities. Speakers at the virtual National …

Does a lack of diversity in clinical trials reflect a lack of diversity among researchers? Read More »

Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19

Shots: Health Canada has granted authorization under interim order for the emergency use of BNT162b2. The distribution of the vaccine in Canada will be prioritized according to the populations identified in guidance from the NACI BioNTech will hold the regulatory approval in Canada while Pfizer will have the commercialization rights. The approval is based on …

Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19 Read More »

What HCPs think about COVID-19’s impact on cancer

COVID-19’s knock-on effect on cancer patients is of concern by HCPs, with delayed or decreased diagnosis seen as a key worry. CREATION.co’s Lara Meyer explores why HCPs need more support. The COVID-19 pandemic has been mainstream headline news throughout 2020 and continues to have a profound impact on all our lives. A key concern that …

What HCPs think about COVID-19’s impact on cancer Read More »

Sharing experiences to level the healthcare playing field

Amanda Barrell speaks to Alfred Samuels on his experience of prostate cancer and diversifying clinical trials to include the Black, Asian and minority ethnic (BAME) community. Alfred Samuels’ stage 4 metastatic prostate cancer brought his 30-year career, which had seen him travel the world with the likes of Beyoncé, Oasis, and Bob Dylan, to a …

Sharing experiences to level the healthcare playing field Read More »

Survey Finds Telehealth Is Convenient Alternative, Will Likely Continue Beyond the Pandemic

A new Health Union survey reveals that people with chronic conditions feel that telehealth, despite its convenience and increased use throughout the COVID-19 pandemic, is generally less preferable than in-person visits, but can still serve as an occasionally suitable alternative. The survey is the fifth in Health Union’s ongoing COVID-19 Consumer Attitudes and Health Behaviors …

Survey Finds Telehealth Is Convenient Alternative, Will Likely Continue Beyond the Pandemic Read More »

PRISYM 360 Achieves SAP® Certification as Integrated with Cloud Solutions from SAP

PRISYM 360 Achieves SAP® Certification as Integrated with Cloud Solutions from SAP The latest version of the PRISYM 360 intelligent data import connector now has SAP-certified integration using SAP Cloud Platform Integration Suite Wokingham, United Kingdom — 7 December 2020 — PRISYM ID, a leading provider of regulated content and label management solutions for the life …

PRISYM 360 Achieves SAP® Certification as Integrated with Cloud Solutions from SAP Read More »

Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin lymphoma

Shots: The P-II ZUMA-5 study involves assessing Yescarta (axicabtagene ciloleucel) in patients with r/r iNHL after at least 2L of systemic therapy. After a single infusion of Yescarta, 92% of patients responded, including 76% of patients achieving a CR @median follow-up of 17.5 mos., results presented at ASH The data supports the US FDA’s acceptance …

Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin lymphoma Read More »

The urgent need for education and awareness about mitochondrial disease

Delayed diagnosis, misdiagnosis, and no cure or disease modifying treatments – children living with mitochondrial disease face all the issues often associated with rare diseases. It’s a problem that Michelle Bamber, whose two little girls both have the life-limiting condition, knows only too well. Lily was a happy, contented baby, and her parents had no …

The urgent need for education and awareness about mitochondrial disease Read More »

Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC

Shots: The P-III ATLANTIS study involves assessing Zepzelca (lurbinectedin, 2.0mg/m2) + doxorubicin vs topotecan/ CAV in 613 adult patients in a ratio (1:1) aged ≥18yrs. with SCLC whose disease progressed following one prior Pt.-containing line The study did not meet its 1EP of OS in the ITT population while there were no adverse effects on …

Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC Read More »

Social media erupts as anti-vaxxers respond to COVID-19 vaccine approval

In the midst of the jubilation about the UK’s emergency approval of Pfizer/BioNTech’s COVID-19 shot in the UK came the depressingly inevitable round of anti-vaccine social media activity and lobbying. The green light for BNT162b was swiftly followed by posts on Twitter likening the vaccine to thalidomide – the drug that notoriously resulted in thousands …

Social media erupts as anti-vaxxers respond to COVID-19 vaccine approval Read More »

Member of COVID R&D Alliance Report the First Patient Enrollment in COMMUNITY Study

Shots: Amgen, UCB, and Takeda reported that the first patient has been enrolled in the COMMUNITY trial. The study will test whether Amgen’s Otezla, Takeda’s lanadelumab, and UCB’s zilucoplan can reduce the severity of COVID-19 in hospitalized patients by moderating the immune system’s response to the disease The focus of the trial is to identify …

Member of COVID R&D Alliance Report the First Patient Enrollment in COMMUNITY Study Read More »

‘Knowledge is power’ for rare diseases and NAbs

Cure Rare Disease’s Rich Horgan discusses the importance of preclinical NAbs screening and helping rare disease patients better understand their eligibility for gene therapies. Neutralising antibodies (NAbs) present a unique challenge to researchers looking to treat patients with AAV treatment. As AAV is a virus derived from the common cold, the immune system can easily …

‘Knowledge is power’ for rare diseases and NAbs Read More »

How the rare disease community has developed fertile ground for progress

Amanda Barrell explores how a perfect storm of changing economics, advances in technology, and the increasing volume of the patient voice is stoking change in the rare disease space. New models of drug development are fuelling life-changing advantages in the rare disease space, previously an economic no-go area for pharma and biotech companies. That was …

How the rare disease community has developed fertile ground for progress Read More »

COVID-19 lessons for how pharma should support patient advocacy

Trio Health’s Neil McGregor-Paterson asks whether the healthcare industry has paid enough attention to the patient voice during COVID-19 and looks at the many ways pharma can improve the patient experience across the sector going forward. Never has the health and care voluntary sector (HCVS) played such a critical role in supporting our nation´s health …

COVID-19 lessons for how pharma should support patient advocacy Read More »

Alnylam’s Oxlumo (lumasiran) Receives the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients

Shots: The approval is based on P-III ILLUMINATE-A & -B trials. The studies demonstrating reductions in urinary oxalate and encourage safety and tolerability in pediatric and adult patients The ILLUMINATE-A showed that Oxlumo met its 1EP i.e. change in 24hrs. (65% vs 12%) compared to PBO, the study also achieved significant results for all 6 …

Alnylam’s Oxlumo (lumasiran) Receives the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients Read More »

The Art of Listening: Beyond the Chief Complaint

By HANS DUVEFELT A doctor’s schedule as typical EMR templates see it only has “Visit Types”: New Patient, 15 minute, 30 minute. But as clinicians we like to know more than that. One patient may have a brand new worrisome problem we must start evaluating from scratch, while another is just coming in for a …

The Art of Listening: Beyond the Chief Complaint Read More »

Healthcare’s COVID-19 backlog: how pharma can help

IQVIA’s Sarah Rickwood explores how pharma can help healthcare systems address treatment backlogs caused by the COVID-19 pandemic. As lockdowns started in the West during March 2020, there was, inevitably, much punditry on exit scenarios – for economies, populations, and healthcare systems. Considerable time was devoted to the discussion of V- , U- and L-shaped …

Healthcare’s COVID-19 backlog: how pharma can help Read More »

3 steps for comprehensive patient collaboration

Janssen’s Daniel de Schryver tells us why it’s time to give patients a permanent seat at the table and improve health outcomes through patient-pharma dialogue. I’m struck by just how much we thrive when we share a common purpose; when – as a society, a group or a family unit – we work together to …

3 steps for comprehensive patient collaboration Read More »

Regeneron’s Casirivimab and Imdevimab Receive the US FDA’s EUA as the First Combination Therapy for COVID-19

Shots: The US FDA has issued a EUA for casirivimab (1,200mg) + imdevimab (1,200mg) administered together for mild to mod. COVID-19 in adults and pediatric patients aged ≥12yrs. weighing at least 40kg [~88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 The EUA …

Regeneron’s Casirivimab and Imdevimab Receive the US FDA’s EUA as the First Combination Therapy for COVID-19 Read More »

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza

Shots: The approval is based on two P-III studies assessing the safety and efficacy of Supemtek (quadrivalent recombinant influenza vaccine) in 10,000 patients with influenza aged > 18yrs. Supemtek is 1st and only recombinant influenza vaccine approved in the EU The P-III efficacy study demonstrated improved protection against influenza compared to standard-dose influenza vaccine and …

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza Read More »

Bridging the gap between pharma and the NHS in MS

Janette Curlis is a Multiple Sclerosis Nurse Advisor (MSNA) at Biogen, helping to support the company’s Multiple Sclerosis (MS) field teams and developing patient and Healthcare Professional (HCP) materials. We spoke to her about being a bridge between pharma and the NHS and the challenges that are facing Multiple Sclerosis Nurses (MSNs) and patients today. …

Bridging the gap between pharma and the NHS in MS Read More »

Abbott Launches IonicRF Generator for Patients with Chronic Pain in the US

Shots: Abbott has launched the IonicRF Generator, which is used to deliver a non-surgical, minimally invasive treatment for the management of pain in the nervous system Radiofrequency ablation uses an electric current to heat up a small area of nerve tissue to stop it from sending pain signals. Studies showed that pain relief following a …

Abbott Launches IonicRF Generator for Patients with Chronic Pain in the US Read More »

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma

Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs pbo + SOC in adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with or without OCS Trial met its 1EPs i.e. reduction in AAER @52wks. in the overall …

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma Read More »

5 Things Patient Advocates Want Pharma and the Healthcare Industry to Know

The COVID-19 pandemic has presented many obstacles, yet the healthcare industry continues to march forward to meet the needs of patients. With physical distancing, new office protocols and the widespread use of telehealth, the patient experience is changing–particularly for people living with chronic conditions, who may require more regular access to care. To truly understand …

5 Things Patient Advocates Want Pharma and the Healthcare Industry to Know Read More »

Be in the room: Turning patient engagement to patient centricity

After three brushes with cancer, Robert Weker understands the patient journey more than many – and he is determined to put that experience to good use. The avid blogger and passionate advocate retired from his R&D role four years ago to focus on his own health, and now works full time on making sure the …

Be in the room: Turning patient engagement to patient centricity Read More »

Talking Medicines gets funding to expand AI-based “patient voice” platform

Talking Medicines has raised £1.1 million ($1.4 million) in funding that will be used to develop an artificial intelligence (AI) data platform that can be used by pharma companies to gain insights into how patients perceive them. The Glasgow-based company – which is behind the MedSmart app that helps patients keep a digital records of …

Talking Medicines gets funding to expand AI-based “patient voice” platform Read More »

Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis

Shots: The P-IIIb ULTIMATE study involves assessing Cosentyx (300/150mg) vs PBO weekly for a mos. with treatment starting @4wks., followed by a once-a-month dose for the next 11mos. in 166 biologic-naïve patients in a ratio (1:1) with active PsA The study reduction of synovitis @12wks. with an early improvement observed as 1wk., ACR20 (68% vs …

Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis Read More »

Boston Scientific’s Ranger DCB Receives the US FDA’s Approval for Peripheral Artery Disease in the SFA and PPA

Shots: The approval is based on the RANGER II SFA pivotal study assessing the Ranger DCB vs standard PTA for the treatment in patients with PAD in the SFA & PPA The study met its both 1EPs @12mos. i.e. MAE (94.1% vs 83.5%); lesion revascularization rate (5.5% vs 16.5%); Binary primary patency (82.9% vs 66.3%); …

Boston Scientific’s Ranger DCB Receives the US FDA’s Approval for Peripheral Artery Disease in the SFA and PPA Read More »

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasis

Shots: The P-III POETYK PSO-1 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (apremilast) in 666 patients with moderate to severe plaque psoriasis The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile of …

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasis Read More »

Ring 20: Could the rare disease get left behind by next-generation gene sequencing?

Ring Chromosome 20 Syndrome, or (R)20, is an ultra-rare form of epilepsy with a devastating impact – yet despite huge leaps forward in gene sequencing in recent years, diagnoses are going down instead of up. We spoke to Allison Watson, co-founder of Ring 20 Research and Support, about raising awareness, building the evidence base, and …

Ring 20: Could the rare disease get left behind by next-generation gene sequencing? Read More »

Fostering Confidence in Newly Diagnosed Autoimmune Patients

When a person is newly diagnosed with an autoimmune condition, such as psoriasis or rheumatoid arthritis, it’s not uncommon for us to hear from them in our online health communities discussing fear or uncertainty, and seeking connection or support. The myriad of difficult decisions they are making around treatment options may foster a sense of self-doubt, and …

Fostering Confidence in Newly Diagnosed Autoimmune Patients Read More »

Tetra Therapeutics Reports Positive Results of BPN14770 in P-II Study for Fragile X Syndrome

Shots: The P-II study is a two-way crossover study assessing BPN14770 (25mg, bid) vs PBO in 30 adult male patients aged 18-45yrs. with FXS due to >200 CGG repeats in the FMR1 gene The study demonstrated benefits in oral reading recognition (+2.80), picture vocabulary (+5.79), cognition crystallized composite score (+5.29), benefits were maintained up to …

Tetra Therapeutics Reports Positive Results of BPN14770 in P-II Study for Fragile X Syndrome Read More »

Regeneron Pauses Dosing of Garetosmab (REGN2477) in P-II LUMINA-1 Study for Fibrodysplasia Ossificans Progressiva

Shots: Regeneron pauses dosing of the garetosmab (REGN2477) in the ongoing P-II LUMINA-1 study in patients with FOP. The pause is due to fatal serious AEs in the study during the open-label extension during which all patients received active treatment Regeneron shared the update with the trial’s IDMC and regulatory authorities and will conduct a …

Regeneron Pauses Dosing of Garetosmab (REGN2477) in P-II LUMINA-1 Study for Fibrodysplasia Ossificans Progressiva Read More »

UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-to-Severe Psoriasis

Shots: The P-III BE SURE study involves assessing bimekizumab vs Humira (adalimumab) for 24wks. is followed until 56wks. in 478 adult patients with chronic PsO for at least 6 mos. before screening & with an affected body surface area of at least 10%, PASI of at least 12 & IGA score equal to or > …

UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-to-Severe Psoriasis Read More »

AbbVie Reports Results of SKYRIZI (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis

Shots: The P-III LIMMitless study is designed to evaluate the long-term safety & efficacy assessing risankizumab (150 mg q12wks.) continuous risankizumab with a loading dose in adults with moderate to severe plaque psoriasis. The analysis includes integrated data from five P-II & III studies (ultIMMa-1, ultIMMa-2, SustaIMM, IMMvent and NCT03255382) and the LIMMitless study Results: …

AbbVie Reports Results of SKYRIZI (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis Read More »

Takeda to partner on patient-centric data with Seqster

Takeda has partnered with patient data firm Seqster in a drive to improve care through better access and understanding of patient-level data. The partnership follows Takeda’s investment in the US startup earlier this year. The pharma firm said it wants to leverage the company’s technology across its business San Diego-based Seqster has developed a portal …

Takeda to partner on patient-centric data with Seqster Read More »