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 […]
patients
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
“Tell Me More”
By HANS DUVEFELT Words can be misleading. Medical terms work really well when shared between clinicians. But we can’t assume our patients speak the same […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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) + […]
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 […]
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) […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
Help Your Patient Be an RA Warrior
By Mary Schmalfeldt, BSN, RN Clinical Support Educator, VMS BioMarketing Recently, I had an opportunity to do something for a friend I wish I could […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
‘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 […]
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 […]
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 […]
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 […]
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 […]
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) […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Proposed HIPAA changes generally favorable, though new burdens may arise, experts say
The HHS has proposed changes to the HIPAA Privacy Rule — the biggest in seven years, a healthcare lawyer said. But while the changes aim […]
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 […]
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 […]
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, […]
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 […]
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, […]
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 […]
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 […]
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 […]
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) […]
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 […]
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 […]
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 […]
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. […]
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. […]
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 […]
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 […]
‘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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
Unite Us expands social determinants partnerships in Louisiana, West Virginia
The technology company is partnering with major insurers, including Aetna and Humana, as well as providers like Ochsner Health to expand access to its platform […]
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 […]
Technology boosts care delivery, population health efforts amid Covid-19 pandemic
As the Covid-19 crisis accelerates, healthcare organizations are turning to technology solutions to help them keep pace with patient care needs as well as population […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
HHS’ plans for health IT through 2025: 4 key goals
A recently released 50-page plan details the federal agency’s health IT-related objectives over the next five years and outlines the strategies it plans to use […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Why 72% of patients don’t feel listened to by pharma
Claus Møldrup explores research showing that patients want their voice to be heard more by pharma, and asks what a truly effective feedback loop for […]
Sanofi Presents Results of Olipudase Alfa in Two Clinical Studies at ASHG 2020
Shots: The P-II/III ASCEND trial involves assessing olipudase alfa 3 mg/kg (IV, q2w) vs PBO in 36 adult patients with ASMD type B to evaluate […]
Samsung Bioepis Reports Results of Renflexis (biosimilar, infliximab) from Two Studies in IBD Patients
Shots: The company reported results from two real-world studies of Renflexis (infliximab-abda) in patients with IBD registered in the US Veteran Affairs Healthcare System database. […]
Pharma 2030: Will payers fund more preventive care programmes?
Preventive care programmes are key to better health outcomes, but several factors are limiting their uptake. A new analysis looks at these barriers and asks […]
Foundation Medicine’s FoundationOne CDx Receives the US FDA’s Approval as a CDx for Vitrakvi (larotrectinib)
Shots: The US FDA approved FoundationOneCDx to be used as a CDx for Vitrakvi (larotrectinib) to identify patients with NTRK fusions across all solid tumors. […]
Toxic positivity and grief: The reality of living through cancer
Cancer doesn’t end when treatment stops – it’s a lifelong journey and people need support throughout, says patient advocate Megan-Claire Chase. No one gets through […]
Jazz Reports Results of Xywav (calcium, magnesium, potassium, and sodium oxybates) in P-III Study for Cataplexy or EDS in Patients with Narcolepsy
Shots: The P-III study involves assessing Xywav vs PBO in patients aged ≥ 7yrs. with cataplexy or EDS with narcolepsy Results: study met its 1EPs […]
What HCPs Think about schools reopening
In our latest article in the What HCPs Think series, CREATION.co’s Jamie Doggett analyses the social media activity of doctors to determine their views on […]
Sanofi’s Sarclisa (isatuximab) Receives NICE Recommendation for Patients with Multiple Myeloma
Shots: The NICE has issued FAD which is based on the P-III ICARIA-MM trial assessing isatuximab + pom-dex vs pom-dex in patients prior treated with […]
Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma
Shots: The approval is based on P-III KEYNOTE-204 study assessing Keytruda (200mg, IV, q3w vs BV (1.8 mg/kg, IV, q3w) in 304 patients in a […]
Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil
Shots: The P-II study will evaluate STI-5656 in ~400 patients hospitalized due to COVID-19 having mild, moderate, and severe symptoms. The P-II clinical trials of […]
Bayer Report Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma
Shots: The P-III CHRONOS-3 study involves assessing of Aliqopa + rituximab vs PBO + rituximab in 458 patients with relapsed indolent NHL who have received […]
NICE changes its mind on Novartis’ progressive MS drug Mayzent
UK cost-effectiveness agency NICE has backed Novartis’ Mayzent for secondary progressive multiple sclerosis (SPMS), after turning it down earlier this year in draft guidance. The […]
Flying the flag for research in Aarskog syndrome
Delayed diagnosis, lack of awareness, and a limited evidence base – Aarskog syndrome faces all the challenges of rare diseases everywhere. But a new study […]
How Can Patients Get Medical Records from a Closed Medical Practice?
By GRACE CORDOVANO, DEVEN McGRAW, and AARON MIRI The HIPAA Privacy Rule gives patients the right to copies of their medical records, with rare exceptions. […]
Roche working “around the clock” to tackle UK test supply problems
Supplies of swabs for coronavirus and other critical NHS tests for diseases like cancer, diabetes and heart disease have been threatened by a failure at […]
Roche working “around the clock” to tackle UK test supply problems
Supplies of swabs for coronavirus and other critical NHS tests for diseases like cancer, diabetes and heart disease have been threatened by a failure at […]
Retired NFL Linebacker Overcomes ADHD, Invests in Mental Health Platform Done
October is ADHD Awareness Month, and retired NFL linebacker J.T. Thomas wants people to know that it is okay to get help for the treatment […]
Retired NFL Linebacker Overcomes ADHD, Invests in Mental Health Platform Done
October is ADHD Awareness Month, and retired NFL linebacker J.T. Thomas wants people to know that it is okay to get help for the treatment […]
The COVID-19 Effect: How Pharma Can Adapt to the Evolving Patient Experience
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 […]
Pfizer Signs an Agreement with SpringWorks to Evaluate Nirogacestat + PF‐06863135 for R/R Multiple Myeloma
Shots: Pfizer to sponsor & conduct P-Ib/II study evaluating the safety, tolerability, and preliminary efficacy of dual regimen and will assume costs of study & […]
The value of good data to patients
Better patient care pathways and models of care can be leveraged from the use of data, and the ability to collate and assess this information […]
COVID-19 drives a new era of self-care
New research shows that the COVID-19 pandemic is encouraging people to take their health into their own hands, and experts say this trend towards self-care […]
Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout
Shots: The P-II COMPARE study assessing SEL-212 (once monthly) vs pegloticase (twice monthly) in 170 patients with chronic refractory gout SEL-212 showed a numerically higher […]
Industry group says FDA botched COVID-19 convalescent plasma guidance
Already under fire for what some view as a premature authorisation of convalescent plasma for COVID-19, the FDA is now being accused of a blunder […]
Chinese starts vaccinating key workers against COVID-19; report
China has already granted emergency use authorisation to multiple COVID-19 vaccines developed by domestic drugmakers and started dosing key workers, according to local media reports. […]
Sorrento Files IND for STI-1499 (COVI-GUARD) in Patients Hospitalized with COVID-19
Shots: Sorrento has filed an IND for STI-1499 in patients hospitalized with COVID-19. In preclinical studies, STI-1499 has demonstrated 100% neutralizing effect (in vitro) against […]
Government under fire over plan to scrap Public Health England
Health Secretary Matt Hancock is planning to dissolve Public Health England and replace it with a new agency dedicated to responding to pandemics, according to […]
UK medical journals spar over breast cancer screening study
Screening women for breast cancer in their 40s rather than their 50s could save lives, say the authors of a new Lancet Oncology study, although […]
Strata Oncology Collaborates with Mirati Therapeutics to Broaden Enrollment in Clinical Trial of MRTX849 for Patients with Advanced Solid Tumors
Shots: The multiple expansion cohort will assess the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in patients with advanced solid tumors […]
Novo Nordisk Resumes P-III Study of Concizumab for Patients with Hemophilia A and B
Shots: The company resumes the P-III program (explorer6, 7, and 8) of concizumab. The clinical trials are evaluating concizumab (SC) prophylaxis treatment in hemophilia A […]
Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH
Shots: The BLA is based on P-III study evaluating the efficacy and safety of evinacumab (15 mg/kg, IV, q4w) in 65 patients aged ≥12yrs. with […]
Roche Collaborates with Celleron Therapeutics for Emactuzumab to Treat Patients with Tenosynovial Giant Cell Tumor
Shots: Celleron will receive an exclusive global right for the clinical development, manufacturing, and commercialization of emactuzumab (formerly RG7155 and RO5509554). The companies expect the […]
Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis
Shots: In the HIBISCUS I induction study, in patients without prior anti-TNF treatment, etrolizumab met its 1EPs while in HIBISCUS II study in the same […]
Bad behaviour: why understanding human behaviour can improve outcomes
Why did I do that? A common question I often ask myself after opening the biscuit packet for the third time in an hour. Only […]
Roche’s Tecentriq (atezolizumab) + Paclitaxel Fail to Meet the Primary Endpoint in P-III IMpassion131 Study for Patients with Metastatic Triple-Negative Breast Cancer
Shots: The P-III IMpassion131 study involves assessing of Tecentriq + paclitaxel vs PBO + paclitaxel, in 651 people in a ratio (2:1) with previously untreated, […]
UCB’s Cimzia (certolizumab pegol) Receives the EMA’s Approval for a Reduced Maintenance Dose in Patients with Axial Spondyloarthritis Spectrum
Shots: The P-IIIb C-OPTIMISE study assessing Cimzia (200mg, q2w with a loading dose of 400mg @ 0, 2 & 4wks.) vs PBO during 48wks. open-label […]
Lundbeck Halts P-II Study of Lu AF11167 in Patients with Negative Symptoms of Schizophrenia
Shots: The company discontinues P-II proof POC study of Lu AF11167 in patients with schizophrenia, who are experiencing persistent negative symptoms (NCT03793712). The P-II study […]
Post-viral syndrome: Learning to live with COVID-19 on the NHS
Recent months have exacerbated many of the issues that were facing the NHS before anyone had ever heard the word COVID-19 – and the scars […]
Playing an Active Role in Treatment Yields More Confidence in Patients
When aiming to reach the people who will benefit most from a given medication or therapy, patients who play an active role in treatment decisions […]
Government warned over test and trace as UK schools prep to reopen
The current level of test and trace in the UK is inadequate to prevent a sharp increase in coronavirus infections when schools reopen in September […]
Tackling multimorbidity through collaboration
As populations age, multimorbidity becomes an increasingly pertinent issue for healthcare systems. A new action group from the ABPI seeks to bring the NHS, academia […]
Pharma’s rep soars on back of COVID-19, says FutureBrand
The perception of pharma and medical product companies has surged forward since the start of the COVID-19 pandemic, but they still lie mostly outside the […]
Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the Treatment of Patients with Multiple Myeloma
Shots: The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM, notably newly diagnosed, transplant-ineligible patients as […]
Lilly’s antibody for COVID-19 protection starts nursing home trial
While the world waits an effective coronavirus vaccine, Eli Lilly has started late-stage human testing an antibody drug as an alternative way to prevent viral […]
Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome
Shots: The BT designation is based on the final analysis of the Pevonedistat-2001 P-II study assessing pevonedistat + azacitidine vs azacitidine as monothx. in patients […]
