From Buy
Friday, August 6, 2021
Around 250 digital health apps are launching every day, says IQVIA
There was a dramatic increase in the launch of health-related mobile applications last year, taking the total number on offer in app stories to 350,000 – and while average quality is currently “middling” it is on the rise, according to a report from IQVIA.
The pandemic contributed to another 90,000 apps being introduced in 2020 – an average of 250 per day – and this coupled with rising number and functionality of wearable devices “provides evidence of digital health’s accelerating innovation,” according to the IQVIA Institute for Human Data Science’s 2021 trends report.
Many of the new apps being launched are geared towards consumers and are intended for general wellness or fitness, but there is an increasing trend towards tools intended to help patients with specific health conditions.
Among the latter group, apps for mental health, diabetes and cardiovascular disease applications are the most common, collectively accounting for around half of all disease-specific launches.
Disease management apps now account for 47% of the most widely used digital health apps in 2020, up from 28% in 2015.
There remains a consumer-oriented emphasis in the wearables market, with 55% of devices still focusing on activity and fitness, but a new generation of more sophisticated devices is allowing tools to be developed that offer “significant health impact,” says IQVIA.
“During the pandemic people self-monitored their oxygen saturations using pulse oximeters, and spikes in downloads of health apps tied to those devices occurred in waves around the globe, coinciding with peaks in virus cases and lockdowns,” it points out.
IQVIA also identified 438 feasibility studies looking at 933 distinct biomarkers last year, and 96 trials that used digital biomarkers as endpoints, as digital health tools continue to be inserted into the medicine development process.
There’s been an increase in the use of sensors and digital biomarkers in clinical trials of pharmaceuticals and medical devices that has allowed more studies to be carried out in a virtual or decentralised way.
Digital therapeutics (DTx) that set out to treat, prevent or manage specific diseases are also on the rise, with more than 250 identified and 150 already commercially available, helped by the introduction of approval pathways in national regulatory frameworks.
The commercial products are mostly tools aimed at clinical conditions like diabetes that can be personalised to patients and require involvement from healthcare providers or coaches, and a couple of dozen have been given marketing authorisation by regulators.
“We are finding evidence of a growing maturity of digital health tools in mainstream medicine,” said Murray Aitken, executive director of the IQVIA Institute for Human Data Science.
“While there has been a significant growth in apps and digital health tools since 2013, we are beginning to detect improved quality of the digital health tools in the management of health conditions,” he added.
That maturity is also reflected in the way digital health tools are being brought to market, with four business models emerging – direct to consumer, value-based contracting by payers or employers, and device- or drug-like reimbursement by health services.
There are still barriers to overcome however, including challenges in integrating the use of digital health tools into physicians’ workflows, and a lack of standards for DTx assessment, prescribing and reimbursement.
Nevertheless, the quality improvements seen in recent years have resulted in strong evidence for some tools on patient health, encouraging uptake in clinical practice, according to Aitken.
“The growing success of digital health is a testament to the value and sustained impact of its innovation that bodes well for further advances in medicine and healthcare moving forward,” he said.
The trends identified by IQVIA tie in with rising levels of investment in the digital health sector, with a record $14.7 billion injected into US digital health companies in the first half of this year, overtaking the entire amount raised in 2020 in just six months.
https://pharmaphorum.com/news/around-250-digital-health-apps-are-launching-per-day-says-iqvia/
Plinabulin blooms at last for Beyondspring
Beyondspring’s claim yesterday that its lead asset, plinabulin, succeeded in phase 3 could be seen as an unexpected victory for vascular disrupting agents, a class that has endured years of clinical failures, and which many had assumed to be dead and buried.
That said, the company now prefers to call plinabulin a “selective immunomodulating microtubule-binding agent”, and has played up its associated immune system effects to differentiate it from other failures. And whether the Dublin-3 lung cancer study, whose toplining prompted Beyondspring’s 176% surge yesterday, really was a resounding success remains open to debate.
Beyond the not especially convincing <0.04 p value for its primary overall survival endpoint, Dublin-3’s most glaring drawback is that it does not represent today’s real-world NSCLC setting, which comprises a PD-(L)1 inhibitor, largely in the front line.
85% checkpoint naive
Dublin-3, a second/third-line NSCLC trial, is to support a US filing next year. Yet only 15% of its 559 patients had failed PD-(L)1 blockade, Beyondspring admitted on an analyst call yesterday.
Thus, rather than demonstrating how plinabulin might perform after Keytruda, Dublin-3 had mostly shown its post-chemo effect, compared against patients switched from platinum to docetaxel chemo. 24-month OS was 22.1% for plinabulin plus docetaxel versus 12.5% for docetaxel alone, but Beyondspring did not provide any median OS data beyond a log rank p value of <0.04.
Defending the result, Beyondspring’s chief medical officer, Ramon Mohanlal, said: “Even if we have only a relatively small number of patients who had had a prior PD-(L)1 inhibitor the claim still holds that this is a treatment for second and third line generally, irrespective of what [patients] had before.”
Worryingly, Mr Mohanlal declined to call the OS effect clinically meaningful, simply saying the hazard ratio was “within expectations”.
The reason Dublin-3 fails to reflect the current treatment setting is because it had begun back in 2015, before any anti-PD-(L)1 therapy had been approved for front-line NSCLC. The trial was seen as something of a long shot, plinabulin having already underwhelmed in a phase 2/3 docetaxel combo trial in NSCLC, run by its originator, Nereus Pharmaceuticals.
In 2012 Nereus was sold to Triphase Accelerator, from which Beyondspring bought plinabulin. Beyondspring has largely played up plinabulin’s ability to boost neutrophils, and indeed the project is filed for chemotherapy-induced neutropenia, with a November 30 Pdufa date; however, 100% of 2026 sellside forecast $446m revenue is in NSCLC, Evaluate Pharma computes.
Demographics representative?
The FDA could additionally take issue with Dublin-3’s patient demographics: only 20% of subjects came from US hospitals, so the trial might not reflect a typical US population. But Beyondspring said the FDA was amenable to a US filing as long as pharmacokinetic data for US and eastern patients were similar.
The group called plinabulin a first-in-class selective immunomodulating microtubule-binding agent that induces antigen-presenting cells, distancing it from its earlier vascular disrupting agent (VDA) pharmacology.
Will any other VDA players now take note? Evaluate Pharma reveals only two such agents still in development, and even these can barely be called active; Bionomics’ BNC105 is in the clinic, but there are no company-sponsored trials ongoing, while Medicinova has deemed its MN-029 non-core, though it has not formally discontinued it.
Apart from that the VDA space is a graveyard whose most abject failure is perhaps Antisoma’s vadimezan. Given the numerous red flags around Beyondspring’s Dublin-3 study investors would be wise to remain cautious.
| Plinabulin, and the vascular disrupting agent graveyard | ||
|---|---|---|
| Project | Company | Note |
| Filed | ||
| Plinabulin | Beyondspring (ex Nereus) | Filed for chemotherapy-induced neutropenia (30 Nov 2021 Pdufa date); ph3 Dublin-3 trial to be used for US filing for 2/3L NSCLC in 2021 |
| Phase 2 | ||
| BNC105 | Bionomics | Ph1 (US) & ph2 (Australia) investigator-initiated studies ongoing |
| Phase 1 | ||
| MN-029/ denibulin | Medicinova (ex Angiogene) | Two ph1 trials showed safety, v limited efficacy; marked "non-core" in pipeline |
| Discontinued | ||
| Vadimezan | Antisoma/Novartis | Failed ph3 in NSCLC |
| Ombrabulin | Sanofi | Failed ph3 in soft tissue sarcoma |
| Fosbretabulin | Mateon | Ph3 thyroid cancer trial terminated for slow recruitment |
| ZD6126 | Angiogene (ex Astrazeneca) | Scrapped after ph2 by Astra, then by Angiogene |
| ABT-751 | Abbvie | Various ph1 & 2 studies completed or terminated |
| Verubulin | Myrexis/Epicept | Mixed ph2 glioblastoma data; Myrexis liquidated; Epicept acquired by Immune Pharmaceuticals, also liquidated |
| Crolibulin | Epicept | Epicept acquired by Immune Pharmaceuticals, liquidated |
| ICT01-2588 | Incanthera | Azademethylcolchicine formulation, part of "project EP0015", but no longer appears in pipeline, said to have been assigned to Ellipses Pharma |
| OS342/NX101 | Oncosynergy | No information |
| Source: Evaluate Pharma, clinicaltrials.gov & company announcements. https://www.evaluate.com/vantage/articles/news/trial-results/plinabulin-blooms-last-beyondspring | ||
J&J seeks emergency use nod for COVID-19 vaccine in India
Johnson & Johnson has applied for emergency use approval of its coronavirus vaccine in India, the U.S. pharmaceutical giant said on Friday, moving a step closer to supplying the first single-dose COVID-19 shot to the country.
The shot will be brought to India through a supply agreement with homegrown vaccine maker Biological E Ltd, J&J said in an emailed statement.
The company's application comes at a time when legal wrangles have held up U.S. vaccine donations to India, which has not met requests for granting foreign manufacturers indemnity from lawsuits.
J&J said it was in talks with the Indian government to accelerate the availability of its vaccine, without giving further details.
Indian health authorities have so far approved the use of vaccines developed by AstraZeneca, Bharat Biotech, Russia's Gamaleya Institute and Moderna.
The government and Moderna are still trying to sort out issues over imports of the vaccine and indemnity, a top executive at Indian drugmaker and Moderna's local distribution partner Cipla told Reuters in an interview on Friday.
Only about 495.3 million people from a population of more than 1.3 billion had received at least one dose of the vaccine as of Friday, according to the Indian health ministry data.
Johnson & Johnson is yet to request full approval for its shot with the U.S. Food and Drug Administration.
https://finance.yahoo.com/news/2-j-j-seeks-emergency-075802167.html
S.African Study Shows High COVID Protection From J&J Shot
Johnson & Johnson's COVID-19 vaccine is working well in South Africa, offering protection against severe disease and death, the co-head of a trial in the country said on Friday.
The J&J vaccine was administered to healthcare workers from mid-February in a research study, which was completed in May, with 477,234 health workers vaccinated, joint lead investigator Glenda Gray told a media briefing.
South Africa's health regulator approved the J&J shot in April, and it is being used in the national vaccine programme alongside Pfizer's.
Gray said the single-shot J&J vaccine offered 91% to 96.2% protection against death, while offering 67% efficacy against infection when the Beta coronavirus variant dominates and about 71% when the Delta variant dominates.
"Consistently after receiving the vaccine, there was very little death occurring in the vaccinated group as compared to the control group and showing a remarkable up-to 96.2% protection against death," Gray said.
"This was our primary endpoint and we are able to say this vaccine protected health workers against death," she added.
South Africa's vaccination campaign got off to a shaky start in February after the government paused AstraZeneca vaccinations because of a small trial showing the shot offered minimal protection against mild to moderate illness caused by the Beta variant, which was dominant in the country at the time.
Vaccinations have since ramped up, with over 8.3 million people vaccinated as of Thursday.
Newly appointed health minister Joe Phaahla told the same briefing that the government was planning to start using other vaccines approved by the regulator, including the Sinovac shot.
"It was approved ... also that the AstraZeneca vaccine, which has now been shown to be effective against the Delta variant, that we should also look at bringing it back into use," Phaahla said.
Early signs Covid-19 vaccines may not stop Delta transmission: UK
There are early signs that people who have been vaccinated against Covid-19 may be able to transmit the Delta variant of the virus as easily as those who have not, scientists at Public Health England (PHE) said on Friday.
The findings chime with those from the US Centers for Disease Control and Prevention, which last week raised concerns that vaccinated people infected with Delta could, unlike with other variants, readily transmit it.
The highly infectious Delta variant has become the dominant coronavirus type globally, sustaining a pandemic that has already killed more than 4.4 million people, including over 130,000 in Britain.
Vaccines have been shown to provide good protection against severe disease and death from Delta, especially with two doses, but there is less data on whether vaccinated people can still transmit it to others.
"Some initial findings ... indicate that levels of virus in those who become infected with Delta having already been vaccinated may be similar to levels found in unvaccinated people," PHE said in a statement.
"This may have implications for people's infectiousness, whether they have been vaccinated or not. However, this is early exploratory analysis and further targeted studies are needed to confirm whether this is the case."
PHE said that of confirmed Delta cases that had ended up hospitalised since July 19, 55.1% were unvaccinated, while 34.9% had received two doses of a Covid-19 vaccine.
Nearly 75% of the British population has had two vaccine doses, and PHE said that "as more of the population gets vaccinated, we will see a higher relative percentage of vaccinated people in hospital".
Separately, PHE said another variant, known as B.1.621, first detected in Colombia, had shown signs of evading the immune response triggered by either Covid-19 vaccines or previous infection.
PHE has labelled the variant "under investigation" but has not declared it a "variant of concern" - a designation that can trigger strong policy responses.
"There is preliminary laboratory evidence to suggest that vaccination and previous infection may be less effective at preventing infection with (B.1.621)," it said, adding there had been 37 confirmed cases of the variant in England.
"However, this data is very limited and more research is required. There is no evidence to suggest that (it) is more transmissible than the dominant Delta variant."
"This may have implications for people's infectiousness, whether they have been vaccinated or not. However, this is early exploratory analysis and further targeted studies are needed to confirm whether this is the case."
PHE said that of confirmed Delta cases that had ended up hospitalised since July 19, 55.1% were unvaccinated, while 34.9% had received two doses of a Covid-19 vaccine.
Nearly 75% of the British population has had two vaccine doses, and PHE said that "as more of the population gets vaccinated, we will see a higher relative percentage of vaccinated people in hospital".
Separately, PHE said another variant, known as B.1.621, first detected in Colombia, had shown signs of evading the immune response triggered by either Covid-19 vaccines or previous infection.
PHE has labelled the variant "under investigation" but has not declared it a "variant of concern" - a designation that can trigger strong policy responses.
"There is preliminary laboratory evidence to suggest that vaccination and previous infection may be less effective at preventing infection with (B.1.621)," it said, adding there had been 37 confirmed cases of the variant in England.
"However, this data is very limited and more research is required. There is no evidence to suggest that (it) is more transmissible than the dominant Delta variant."
No link found so far between menstrual disorders and COVID-19 vaccines: EU
No causal link between COVID-19 vaccines and menstrual disorders has been found so far, Europe's drugs regulator said on Friday, separately recommending that three new conditions be added as possible side-effects of J&J's coronavirus shot.
The European Medicines Agency said its safety committee had studied cases of menstrual disorders reported after vaccination, adding it had requested more data from vaccine developers to assess the issue.
Menstrual disorders can occur for various reasons, from stress and tiredness to underlying medical conditions such as fibroids and endometriosis.
Separately, the EMA on Friday recommended that immune thrombocytopenia, or low blood platelets, dizziness, and tinnitus, or ringing in the ear, be added to the labels of J&J's single-shot vaccine as potential adverse reactions.
The EMA stressed that benefits of J&J's vaccine still outweighed any risks, adding that it had analysed 1,183 cases of dizziness and more than 100 cases of tinnitus to reach its conclusion.
The company did not immediately respond to Reuters' request for comment.
The EMA last month listed a rare nerve-degenerating disorder, Guillain-Barré syndrome (GBS), as a possible rare side-effect from the J&J shot. The U.S.-based company has also struggled with supply in the European Union.
The EMA has also added GBS as a possible side-effect of AstraZeneca's COVID-19 vaccine, and said on Friday it was still monitoring such reports.
Both J&J and AstraZeneca vaccines use similar technology but with different versions of a cold virus to deliver immunity-building instructions to the body.
Subscribe to:
Comments (Atom)