2020

article thumbnail

MHRA looks to AI to hunt for COVID-19 vaccine side effects

pharmaphorum

The UK drugs regulator has awarded a £1.5 million tender to a software company for an artificial intelligence tool that will be used to process “the expected high volume of COVID-19 vaccine adverse drug reactions (ADRs).”. The tender awarded to Maidenhead, Berkshire-based GenPact UK aims to “ensure that no details from the ADRs…are missed” as the UK prepares to start rolling out COVID-19 vaccines – assuming their safety and efficacy is supported in late-stage trials.

Vaccines 145
article thumbnail

DNA analysis could pinpoint ‘long haulers’ among COVID-19 patients

Outsourcing Pharma

The analytical tool, developed via Bionano Genomics, maps structural variations in DNA that are known to cause disease and are tied to symptom severity.

145
145
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

10 indicted in $1.4B rural hospital fraudulent billing scheme: DOJ

Fierce Healthcare

10 indicted in $1.4B rural hospital fraudulent billing scheme: DOJ. pminemyer. Tue, 06/30/2020 - 10:14.

Hospitals 124
article thumbnail

First trial participant gets GSK's 5-in-1 meningitis jab

Pharma Times

The Phase III study is evaluating the safety, tolerability and immunogenicity of GSK’s MenABCWY vaccine candidate compared to Bexsero and Menveo

article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

article thumbnail

A history of the pharmaceutical industry

pharmaphorum

The 21st century pharmaceutical and biotech sector has come a long way from its roots in 19th century pharmacy. pharmaphorum looks at its evolution over the centuries. The roots of the pharmaceutical industry lie back with the apothecaries and pharmacies that offered traditional remedies as far back as the middle ages, offering a hit-and-miss range of treatments based on centuries of folk knowledge.

FDA 145
article thumbnail

Pharma’s digital transformation journey and the role of customer reference data

pharmaphorum

Better management of customer data could help pharmaceutical companies’ digital transformation, according to Veeva’s Rebecca Silver. pharmaphorum’s Richard Staines spoke to her about how the use of customer reference data can transform pharma companies, increase competitiveness, and benefit the bottom line during these challenging times. Precision medicine is emerging as a key approach for disease treatment and prevention, which makes it even more critical to get the right medicine to the

More Trending

article thumbnail

FDA launches Digital Health Center of Excellence

pharmaphorum

The FDA has launched its Digital Health Center of Excellence (DHCoE), as the agency continues with its commitment to advancing use of technology such as mobile health devices, software and wearables to create medical products. Housed within the agency’s Center for Devices and Radiological Health, the DHCoE is part of a wider strategy to encourage development of digital health products and therapeutics.

FDA 144
article thumbnail

Could a COVID-19 breath test help UK out of lockdown?

pharmaphorum

A potential COVID-19 breath test has been unveiled in the UK, as the country desperately searches for alternatives to crippling lockdown measures to prevent the disease from spreading. The breath test has been developed by Integumen in collaboration with Modern Water, Avacta and Aptamer Group, which had been working on test that identifies the SARS-CoV-2 coronavirus in waste water.

Vaccines 143
article thumbnail

Life science leaders sign new ‘Biotech Social Pact’ for Europe

pharmaphorum

The signatories of a new Biotech Social Pact with Europe and patients explain why healthcare calls for a new social contract, not a pharmaceutical strategy. As Europe continues its efforts to battle the Covid-19 pandemic, it is rightfully focusing its attention on the longer-term implications of this crisis. One common thread is clearly emerging from EU and national discussions: to reinforce Europe’s “strategic autonomy” and “technological sovereignty” in key industrial sectors.

141
141
article thumbnail

Novartis launches digital health hub in Canada

pharmaphorum

Novartis is opening a new digital health innovation hub in Canada to help develop “scalable, digital solutions” for patients and healthcare providers. The Canadian Biome Digital Innovation Hub will be based in Montreal at the artificial intelligence research institute, Mila. The institute formed a strategic alliance with Novartis in 2019. Canada is the latest country to join a global network of hubs opened by Novartis.

141
141
article thumbnail

Innovate UK funding for new precision cancer treatment technology

pharmaphorum

Sixfold Bioscience and Medicines Discovery Catapult awarded Innovate UK grant to pursue ground-breaking project. Sixfold Bioscience in partnership with Medicines Discovery Catapult, has been given the green light, through the award of an Innovate UK Smart Grant to test a pioneering system designed to deliver drugs directly to cancerous cells, without impacting the healthy cells around it.

141
141
article thumbnail

UK trials digital ‘health passport’ to help borders reopen

pharmaphorum

Regular fliers are used to long queues to clear security – but a rigorous COVID-19 testing regime could be added to pre-flight checks backed by a digital “health passport” to prove passengers are free from the coronavirus. The UK is the latest country to test the scheme that allows passengers to demonstrate their coronavirus status as part of a global framework for COVID-safe air travel.

Vaccines 140
article thumbnail

Vertical pharma: How sector convergence can erase digital health siloes

pharmaphorum

Life science companies must evolve and find new ways of working that erase the lines between industries and sub-sectors if they are to adapt to the digitalised world. That’s according to the team at Sweden’s Sahlgrenska Science Park, who are getting ready to host a virtual event looking at how the specialisation of digital expertise is driving a trend of sector convergence that pharma is only just cottoning on to.

Hospitals 140
article thumbnail

AI implementation for pharma and healthcare

pharmaphorum

Abid Rahman from Intouch Group tells pharmaphorum how AI-based technology is solving challenges across healthcare systems, pharmaceutical companies, and patient treatment. With AI already the key engine for a growing list of consumer devices, the trend has created exciting opportunities for pharma and healthcare. “We have now entered a new phase of AI implementation where AI-based technology is expected to be foundational and not just a novel technology,” Abid Rahman, vice president, innovation,

article thumbnail

Digital health player UpHealth swells with three-way merger

pharmaphorum

A merger involving two US digital health specialists and a blank cheque company has created a telemedicine player, called UpHealth, that is valued at more than $1.3 billion. The three-way deal combines UpHealth – which provides patient care management, telemedicine and digital pharmacy services and gives its name to the new group – with CloudBreak, which provides a video consultation platform for doctors and patients.

article thumbnail

Amazon bolsters Alexa’s health credentials with Sharecare deal

pharmaphorum

Amazon’s Alexa device can already field health and medical questions, but the library of responses has now been bulked up thanks to a partnership with digital health company Sharecare. The new deal adds more than 80,000 questions and answers to the repertoire of the Alexa virtual assistant, which provides information, entertainment and advice to users on voice command via devices such as Amazon’s Echo smart speakers.

article thumbnail

Toxic positivity and grief: The reality of living through cancer

pharmaphorum

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 cancer unscathed. People are usually left with a mixture of treatment aftereffects, toxic positivity, and lingering anger to deal with. Megan-Claire Chase , a fierce patient advocate who has been blogging about her experiences since she was diagnosed with breast cancer in 2015, said the disease never went away.

article thumbnail

iRhythm digital heart monitoring service backed by NICE

pharmaphorum

A heart monitor developed by iRhythm has become the first product to be endorsed by NICE in a pilot project covering digital health technologies. In new guidance, the health technology assessment (HTA) agency has recommended iRhythm’s Zio XT service for detecting abnormal heart rhythms – provided NHS organisations that deploy it collect evidence of its benefits.

Hospitals 136
article thumbnail

Sophia Genetics launches AI tool to find COVID-19 ‘unknowns’

pharmaphorum

Swiss medical data specialist Sophia Genetics has launched a platform that will sift through data generated at more than 1,000 hospitals around the world to try to work out how the COVID-19 pandemic will evolve in the coming months and years. The data mining tool will be used to try to unearth some of the many unknowns with the virus, using next-generation sequencing (NGS) to see how the genome of SARS-CoV-2 changes over time, along with patient genetic information, results of lung and CT scans,

Vaccines 136
article thumbnail

Regeneron’s antibody cocktail active against coronavirus, cuts symptoms

pharmaphorum

Regeneron’s antibody cocktail seems to reduce levels of coronavirus and improve symptoms in patients, according to early test results. This first data comes from a descriptive analysis from the seamless phase 1/2/3 trial that Regeneron hopes will hurry the medicine dubbed REGN-COV2 to market. The ongoing double-blind trial measures the effect of adding REGN-COV2 to usual standard of care, compared with usual standard of care.

article thumbnail

Vertex gets EU okay to treat younger cystic fibrosis patients

pharmaphorum

A new EMA approval has expanded the use of Vertex Pharma’s exon-skipping cystic fibrosis therapy Symkevi to children as young as six if they have specific gene mutations. The regulator has given a green light to use of Symkevi (tezacaftor/ivacaftor) with Vertex’ Kalydeco (ivacaftor) in patients ages six years and older who have two copies of the F508del mutation in the CFTR gene, or one F508del copy and one of 14 other so-called “minimal function” mutations in CFTR.

Labelling 134
article thumbnail

Careology teams up with private GP group on COVID-19 monitor

pharmaphorum

A digital tool that allows doctors to monitor patients with COVID-19 remotely in real time and intervene when treatment is needed has been launched in the UK. The mobile app – developed by digital heath specialist Careology – provides advice on COVID-19 symptoms and links patients with doctors at the London General Practice, a private GP group with around 50,000 people on its books, via online video consultations.

134
134
article thumbnail

MindMed aims for Nasdaq listing after Compass’ magic mushroom-fuelled IPO

pharmaphorum

Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5 million with its IPO on Friday and shares are still significantly above their launch price of $17.

FDA 134
article thumbnail

Cognoa preps FDA filing for digital autism diagnostic

pharmaphorum

An artificial intelligence-powered diagnostic for autism spectrum disorder (ASD), developed by Cognoa, has met all its objectives in a pivotal trial and will be filed for approval with the FDA. The ASD diagnostic app is designed to serve as a tool that can be used by paediatricians in primary care to detect autism traits early on and start treatment sooner.

FDA 134
article thumbnail

The value of good data to patients

pharmaphorum

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 will drive more sustainable models of care, whilst unlocking the value of ‘longitudinal, real-world data’ as a resource for healthcare organisations, research and academia, policy advisors and pharma. There is a societal shift that is required though, to educate patients on the value of this data and how it can be used to improve the outcome of patients gl

article thumbnail

Novel nasal spray reduces viral replication by up to 96%: according to COVID-19 challenge study

Outsourcing Pharma

Ena Respiratoryâs preventative nasal spray treatment could reach human trials within four months, following results from an animal study released today which showed the spray reduced COVID-19 replication by up to 96%.

133
133
article thumbnail

Non-vaccine nasal spray could protect against COVID-19

pharmaphorum

Two UK biotechs – Destiny Pharma and Sporegen – have joined forces to develop a nasal spray that they say could serve as a first line of defense against coronavirus infections. The nasal spray could provide protection from infection within a few days of administration, and would be easy to make in bulk at a low cost, say the partners. The programme is still in the early stages of development, but if it works in trials would provide another approach to prevent transmission of SARS-CoV-2, the viru

Vaccines 133
article thumbnail

How the rare disease community has developed fertile ground for progress

pharmaphorum

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 among the discussion points during Fighting Rare Diseases – The Science, Economics and the Patients , a webinar hosted by o2h Group.

132
132
article thumbnail

AI’s infiltration of pharma: How COVID-19 accelerated change

pharmaphorum

The pharmaceutical industry has sometimes been a laggard in terms of digital maturity, but the COVID-19 crisis has provided companies the impetus to rapidly implement the most cutting-edge technologies. At the heart of most of these digital advancements is AI and machine learning. With a collective sense of uncertainty, many are pinning their hopes on a vaccine and treatment, and sophisticated technology could help speed up the process of finding an effective medicine.

Vaccines 132
article thumbnail

The new pharma collaborations driving transformative research in oncology

pharmaphorum

The pharmaceutical industry is one of the most scientifically innovative and competitive industries, particularly in oncology. As of 2018, there were over 1,100 cancer therapies in development, and as of 2020, 362 of them were cell and gene therapies. As a result, there is a need for continued innovation and increased efficiency in terms of drug development to manage cost, complexity and speed to provide potentially transformative therapies for cancer patients.

article thumbnail

Potential HIV cure Phase I trial gets FDA green light

Outsourcing Pharma

American Gene Technologies has received the agencyâs approval to launch the first human trial for its lead HIV program, starting in Baltimore and DC.

FDA 145
article thumbnail

Accelerating the digital approval process

pharmaphorum

The boom in digital tech over COVID means that pharma can move faster than ever – but the industry’s traditional processes for asset approval are still holding timelines back. David Reily examines how pharma companies are responding to the increased burden of asset approval with new ways of working. The coronavirus pandemic has forced a traditionally risk-averse industry tied to legacy systems for regulation and compliance to fully embrace digital solutions in commercial and marketing functions.

article thumbnail

Pharma 2030: Will payers fund more preventive care programmes?

pharmaphorum

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 how they could be overcome. Over the past decade, many healthcare systems have worked to expand their focus on health maintenance and disease prevention as several studies have indicated that preventive care services can play a significant role in improving general health while helping reduce long term healthcare costs.

Vaccines 130
article thumbnail

3 ways pharma marketers can draw inspiration from digitally-native brands

pharmaphorum

As pharmaceutical marketers prepare their brands for the future, there are a number of important ways they can learn from digitally-native brands. Companies like prescription glasses firm Warby Parker, shoe brand Rothy’s and tele-dentistry’s SmileDirectClub have grown up in today’s digitally native environment and can offer some key pointers for pharma.

Vaccines 130
article thumbnail

WHO: remdesivir shows little effect on COVID-19

Outsourcing Pharma

The agencyâs Solidarity Therapeutics Trial examined a range of drugs repurposed for COVID-19 treatment, finding nearly no effect on patient mortality.

142
142
article thumbnail

Pharma improves HCP engagement during COVID-19 – report

pharmaphorum

Pharma companies have improved how they engage with healthcare providers as a result of COVID-19, according to a new survey of HCPs. This has resulted in pharma companies being more relevant and providing more value in closing the care gap, the report says. The Accenture survey of 720 general practitioners, oncologists, cardiologists and immunologists globally found that this is in turn helping HCPs better serve patients.