June, 2021

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BioNTech takes its first cancer vaccine into phase 2

pharmaphorum

It would be easy to forget that back in 2019, BioNTech was an early-stage biotech firmly focused on cancer vaccines, before being catapulted onto the world-stage with its COVID-19 shot. Now, the German company has issued a reminder of its original R&D mission with the start of the first phase 2 trial of BNT111 – the first of several cancer vaccine candidates – in patients with skin cancer.

Vaccines 145
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Novartis reports 'clinically relevant' survival data for Lutathera

Pharma Times

The radioligand therapy was linked with a significant increase in progression-free survival and a clinically relevant increase in overall survival in patients with midgut neuroendocrine tumours

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Phesi COVID-19 study indicates obesity a major complicating factor

Outsourcing Pharma

The virtual clinical development firmâs analysis of patient profiles reflects obesity is the most significant indicator for severity in those under 40.

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New patent expiration for Merck Sharp drug CLARINEX

Drug Patent Watch

Annual Drug Patent Expirations for CLARINEX Clarinex is a drug marketed by Merck Sharp Dohme and is included in five NDAs. It is available from two suppliers. There are four…. The post New patent expiration for Merck Sharp drug CLARINEX appeared first on DrugPatentWatch - Make Better Decisions.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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The Rise of Audio Social Networks – Where Pharma Can Make an Impact

Pharma Marketing Network

Anyone with a smart device has been feeling the grueling effects of social isolation and screen fatigue since the start of the COVID-19 outbreak. Recently, we have witnessed a flood of new “audio-social apps” and audio features on social media platforms, aiming to finds new ways to connect, curb loneliness and cut excessive screen exposure. What are some of these audio-focused platforms and where can pharma play a role?

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F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works

NY Times

Aducanumab is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some prominent experts say there’s not enough evidence it can address cognitive symptoms.

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NHS England announces extra funding for young people’s mental health services

Pharma Times

An extra £40m will go toward enhancing mental health services for children and young people

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FDA approves Biogen’s Alzheimer's drug, Aduhelm

Outsourcing Pharma

The US Food and Drug Administration (FDA) has approved Biogenâs Aduhelm (aducanumab) for the treatment of Alzheimerâs: making it the first new treatment approved for the disease since 2003.

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New patent for LUPIN drug SOLOSEC

Drug Patent Watch

Annual Drug Patent Expirations for SOLOSEC Solosec is a drug marketed by Lupin and is included in one NDA. It is available from one supplier. There are four patents protecting…. The post New patent for LUPIN drug SOLOSEC appeared first on DrugPatentWatch - Make Better Decisions.

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Digital fabric could be used to measure health data

pharmaphorum

Researchers in the US have developed a wearable fabric that can sense, store and analyse data that could be used to measure physiological functions or detect illness. The team from Massachusetts Institute of Technology (MIT) claim this is the first example of a fabric which can record data in a digital rather than in an analogue format, allowing it to be programmed like any other digital device.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Novo Nordisk crowns cell therapy pipeline with $598m Heartseed deal

pharmaphorum

Novo Nordisk is paying $55 million upfront to secure rights to a cell therapy for heart failure developed by Japanese startup Heartseed. The Danish drugmaker has acquired exclusive rights outside Japan to Heartseed’s HS-001 therapy based on heart muscle cells (cardiomyocytes) derived from human stem cells, and is due to start the phase 1/2 LAPiS trial in Japan later this year.

Immunity 138
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Artificial pancreas will be piloted in 1,000 diabetics, says NHS CEO

pharmaphorum

NHS England will provide artificial pancreas devices to 1,000 type 1 diabetes patients as part of a pilot study of the technology, according to chief executive Sir Simon Stevens. The diabetics will be offered the closed-loop systems, which continually monitor glucose levels in the blood and uses the data to automatically adjust the dose of insulin delivered by an externally worn pump, at around 25 specialist centres across England.

Diabetes 130
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Ensuring accessibility: Crossing the digital divide in healthcare

pharmaphorum

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

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Amicus' Pompe disease therapy joins early access scheme

Pharma Times

The MHRA has issued an EAMS scientific opinion opening the door to use of cipaglucosidase alfa with miglustat in eligible patients with Pompe disease

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Janssen’s myeloma CAR T therapy cilta-cel demonstrates ‘sustained efficacy’

Pharma Times

Updated study results showed an overall response rate of 98% with a longer-term follow-up at a median of 18 months

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AZ, Pfizer/BioNTech vaccines ‘highly effective’ against Delta variant

Pharma Times

New real world data from PHE shows vaccines can protect against hospitalisation caused by variant

Vaccines 152
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NICE recommends Tecentriq for first-line NSCLC

Pharma Times

Tecentriq is indicated for adults with metastatic NSCLC if their tumours have PD-L1 expression on at least 50% of tumour cells or 10% of tumour-infiltrating immune cells

Immunity 112
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'Indian' variant of coronavirus now dominant strain in the UK

Pharma Times

Officials warned that early evidence suggests there may be an increased risk of hospitalisation for Delta compared to the Alpha (Kent) strain

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Trial finds Orion digital therapeutic helps chronic pain sufferers

pharmaphorum

A digital therapeutic aimed at people with chronic lower back pain based on virtual reality (VR) has shown encouraging results in a clinical trial, helping patients manage the fear of movement that can reduce their activity and impede recovery. The therapy uses a VR headset to guide people with chronic pain through a series of cognitive behavioural therapy (CBT) exercises that are designed to help them overcome the fear of movement – also known as kinesiophobia.

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Transforming pharma R&D with a scientist-centric approach to AI & automation

pharmaphorum

As biopharmaceutical products have become increasingly complex, both in design and in regulatory requirements, we need a new way of working. Markus Gershater looks at how automation and artificial intelligence (AI) can transform pharma R&D. Due to increasing complexity in R&D, pharma teams are under pressure to drive down costs and speed up time to market whilst improving outcomes, and most recognise that incorporating automation and AI into their workflows will be game-changing.

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BioMarin resubmits haemophilia A gene therapy to the EMA

Pharma Times

Company initially withdrew a marketing authorisation application for the gene therapy last year

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Pandemic paves way for innovative hybrid healthcare

pharmaphorum

While the heroic abilities of the NHS have been on display throughout the COVID-19 pandemic, the last year has also exposed the longstanding limitations and frailties of our underfunded healthcare system, says Maya Ward. With an estimated 100,000 unfilled posts and staff turnover expected to increase due to emotional exhaustion, the health service’s workforce stands to be further stretched by an ageing population.

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Keeping clinical trial data safe – handling cybersecurity in a risky world

pharmaphorum

The development of vaccines for COVID-19 has been a masterclass in effective collaboration and applied digitisation in healthcare. However the increased complexity and involvement of different parties, exposes manufacturers to heightened threat levels. Abel Archundia discusses how COVID-19 has highlighted the importance of securing clinical trials against cyber threats.

Vaccines 108
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Opdivo, Yervoy combination approved to treat malignant pleural mesothelioma

Pharma Times

Combination immunotherapy treatment approved in the EU for first-line treatment of adults with unresectable MPM

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Zolgensma shows promise in presymptomatic SMA patients

Pharma Times

Children treated with gene therapy prior to symptom presentation achieved motor milestones not seen in the natural history of SMA

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Biogen’s ambitions in gene therapy hit by another failed pivotal trial

pharmaphorum

When Biogen acquired Nightstar Therapeutics in 2019, it added a pair inherited retinal disorder (IRD) gene therapies that it hoped would accelerate a push into the fast-evolving category. . Just over two years later, both of those candidates have failed late-stage clinical trials, leaving Biogen’s $800 million investment in Nightstar looking like a poor deal.

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ASCO21: Gilead sets up first FDA okay for adult ALL with Tecartus data

pharmaphorum

Novartis’ Kymriah has had the CAR-T therapy market for acute lymphoblastic leukaemia (ALL) to itself so far, but Gilead Sciences’ Kite subsidiary is now looming in the rear view mirror – armed with new data for its already-filed rival Tecartus. Results of the phase 1/2 ZUMA-3 trial of Tecartus (brexucabtagene autoleucel) reported at the ongoing ASCO conference revealed a 71% complete response rate with the CAR-T in heavily pre-treated adult patients with B-cell precursor ALL.

Labelling 104
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Country focus: China & APAC’s growing medical needs bring opportunities and challenges

pharmaphorum

Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharma companies, and gives tips for companies navigating this enormous market. Home to over 60% of the world’s population, Asia Pacific (APAC) is not a region the biopharma industry can afford to ignore. Dr Jay Mei, founder and CEO of Antengene, notes that the region has rich innovation resources but also urgent medical needs, leading to both opportunities and uncertainties for the industry.

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EC approves Sanofi’s Aubagio for paediatric MS patients

Pharma Times

Aubagio has been authorised for the treatment of paediatric patients aged ten to 17 years living with RRMS

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Researchers develop COVID-19 antibody test to detect new variants

Pharma Times

New antibody tests can detect if an individual has been exposed to COVID-19 variants, including Alpha and Delta variants

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What HCPs think about blood clots linked to COVID-19 vaccines

pharmaphorum

In the latest edition of What HCPs Think , CREATION.co’s Laura Marsh looks at what healthcare professionals are saying about blood clots linked to COVID-19 vaccines. The formation of blood clots is a necessary process in order for the body to repair damage caused by injury and to slow down bleeding. However, when blood clots form inappropriately, this limits blood flow through vessels and can pose a significant health risk.

Vaccines 102
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MHRA approves Venclyxto for newly diagnosed AML

Pharma Times

The approval is based on results from the Phase III VIALE-A study as well as the Phase Ib M14-358 clinical trial

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FDA approves Alkermes’ Lybalvi for schizophrenia and bipolar I disorder

Pharma Times

Alkermes said that it is expecting to make Lybalvi available for patients in the fourth quarter of 2021

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Vertex, CRISPR Therapeutics’ blood disorder gene therapy shows more promise

Pharma Times

CTX001 is being evaluated as a one-time treatment for transfusion dependent beta thalassemia and sickle cell disease

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Researchers identify new drug class with potential in BRCA-mutated tumours

Pharma Times

POLQ inhibitors could be used to kill PARP inhibitor-resistant cancer cells

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