Precision medicine and the role of pathologists in multidisciplinary bladder cancer care
How can the combined power of multidisciplinary teams and precision medicine be harnessed for people living with bladder cancer?
5 September 2024Top Content
Sustainable drug delivery devices: striking a balance between aspirations and current possibilities
Alex Fong and Olivia Houselander from Owen Mumford Pharmaceutical Services consider the action needed to make drug discovery processes more sustainable
17 July 2024
Exploring disease modification to change the future of epilepsy treatment
Konrad Werhahn from UCB discusses how disease-modifying solutions may introduce a new era in treatment for epilepsies
17 July 2024
The role of AI in patient support
Rajul Jain from ProPharma considers how AI can be used in patient support, especially considering how it can be used to streamline operations and supplement human expertise
17 July 2024
Pride month and LGBTQ+ healthcare
Betsy Goodfellow from Pharmafocus considers Pride month and the state of LGBTQ+ healthcare in the UK
4 June 2024
European Commission approves Pfizer’s Velsipity for ulcerative colitis treatment
Pfizer has announced that the EC has granted marketing authorisation for Velsipity (etrasimod) in the EU.
4 March 2024Industry Insights
Sustainable drug delivery devices: striking a balance between aspirations and current possibilities
Alex Fong and Olivia Houselander from Owen Mumford Pharmaceutical Services consider the action needed to make drug discovery processes more sustainable
17 July 2024Exploring disease modification to change the future of epilepsy treatment
Konrad Werhahn from UCB discusses how disease-modifying solutions may introduce a new era in treatment for epilepsies
17 July 2024The role of AI in patient support
Rajul Jain from ProPharma considers how AI can be used in patient support, especially considering how it can be used to streamline operations and supplement human expertise
17 July 2024
20 years of EGFR in NSCLC: how precision medicine helps navigate lung cancer challenges
Henar Hevia at Johnson & Johnson considers the progress that has been made in lung cancer treatment since the discovery of EGFR, including the evolving treatment paradigm, the role of precision medicine in treatment decision-making and quality of life for patients receiving targeted treatments
4 June 2024
Paediatric clinical trials for obesity treatment
Alan Baldridge and Heather Peterson from ICON consider the prevalence of paediatric obesity and assess clinical trials of its treatments
4 June 2024
Epilepsy and brain health: a call for global action and unity
Rafal Kaminski from Angelini Pharma tells Pharmafocus about the global challenge of epilepsy as well as how his company is striving to bridge the gaps in epilepsy treatment
28 April 2024UK News
CluePoints launches Medical & Safety Review (MSR) software
Risk-based quality management (RBQM) and data quality oversight software company Cluepoints launches its latest application, the medical & safety review (MSR), to simplify and streamline the medical analysis of study data through user-friendly dashboards, data manipulation and cleaning, query management and full transparency over the data history.
Next-generation sequencing partnership announced between ANGLE plc and NuProbe
Liquid biopsy company ANGLE plc has announced a partnership with NuProbe, a genomics and molecular diagnostics company, to utilise the latter’s pan-cancer next-generation sequencing (NGS) panel.
FDA approves first drug in 50 years for treatment of schizophrenia in adults
Earlier this September, the US Food and Drug Administration (FDA) granted approval for PureTech Health’s Karxt for the treatment of schizophrenia in adults, triggering royalty payments of $29m to PureTech. It will be the first approved mechanism by the FDAfor schizophrenia in over 50 years.
Research collaboration between FDA and Owlstone Medical set to see improvements in breath biopsies
Owlstone Medical has entered into a research collaboration with the US Food and Drug administration’s (FDA) centre for devices and radiological health to develop methods for the confident identification of individual chemicals in the composure of breath.
First nasal spray for treatment of anaphylaxis approved by FDA
Ars pharmaceuticals has been granted approval by the us food and drug administration (fda) for their epinephrine nasal spray, neffy, to be used as treatment of type 1 allergic reactions including anaphylaxis.
Novo Holdings invests in Oxford Nanopore Technologies
Leading life science investor novo holdings has announced a £50m investment in oxford nanopore technologies. Oxford nanopore technologies is a leading uk-listed company currently specialising in a new generation of molecular sensing technology based on nanopores.
Cresset collaborates with Enamine to enable the design of new targeted protein degraders
Drug discovery company Cresset has announced the extension of its global collaboration with chemical and biological contract research organisation (cro) Enamine.
First oral treatment for hormone-sensitive prostate cancer recommended by NICE
Accord healthcare have recently announced that NICE have recommended the first oral androgen deprivation therapy (adt) treatment for hormone-sensitive prostate cancer. Prostate cancer is the most common cancer in men across the uk.
Verisense announce opening of Digital Biobank
This month, Verisense have announced that their digital biobank, with data from over one million people, is open for business.
Positive results announced for Levicept’s moderate-to-severe osteoarthritis treatment
Biotechnology company Levicept has announced positive results from its phase 2 trial into levi-04 for the treatment of osteoarthritis.
Calliditas Therapeutics announces positive phase 2b data in Primary Biliary Cholangitis trial
Calliditas therapeutics ab has recently announced that the phase 2b transform trial met its primary endpoint. The trial showed statistically significant improvement in alkaline phosphatase (alp) for both doses tested versus placebo. the trial evaluated setanaxib, a nox enzyme inhibitor, in patients with primary biliary cholangitis (pbc) and elevated liver stiffness.
CHMP gives positive opinion for Merck’s KEYTRUDA for unresectable or metastatic urothelial carcinoma
Merck (known as MSDoutside of the US and Canada) has announced that its anti-pd-1 therapy, in combination with padcev (enfortuman vedotin-ejfv), has received a positive opinion from the European Medicines Agency (EMA)
Clinical trials for personalised cancer vaccine used to tackle aggressive brain tumours in young
Researchers at the UCLA Health jonsson comprehensive cancer center have announced that they are launching a first-of-its-kind clinical trial to evaluate the safety and effectiveness of a cancer vaccine. The vaccine targets h3 g34-mutant diffuse hemispheric glioma, an aggressive brain tumour typically found in adolescents and young people.
The National Institute for Health and Care Excellence announce technology appraisal guidance
The National Institute for Health and Care excellence (NICE) have recommended adult patients in England or Wales with moderately or severely active ulcerative colitis (uc) who have not responded well to or cannot tolerate conventional or biological therapy including a tumour necrosis factor (tnf) alpha inhibitor the option of skyrizi (risankizumab).
European Commission approves combination chemotherapy for treatment of advanced EGFR-mutated
This month, Janssen-Cilag international, part of johnson & johnson (j&j) has announced that the European Commission (EC) has approved a combined treatment of rybrevant (amivantamab) and chemotherapy (carboplatin and pemerexed) for the treatment of non-small cell lung cancer (nsclc) with an epidermal growth factor receptor (EGFR).
Eisai and EcoNaviSta enter dementia collaboration
Eisai and Econavista have announced that they have entered into a business alliance agreement, initiating their collaboration intended to build an ecosystem in the field of dementia.
Global News
NICE gives positive recommendation for Santen’s Roclanda
The National Institute for Health and Care Excellence (NICE) has given a positive recommendation for Santen’s Roclanda (netarsudil 0.02% and latanoprost 0.005%) as an option for patients suffering from primary open-angle glaucoma (poag) or ocular hypertension.
CHMP adopts positive opinion for new breast cancer drug, Kisquali, from Novartis
Last month, the Committee for Medicinal Products for Human Use (CHMP), which is part of the European Medicines Agency (EMA) announced that it has adopted a positive opinion for Novartis’ Kisquali (ribociclib) as an adjuvant in the treatment of adults with hormone receptor-positive/human epidermal growth factor 2negative (hr+/her2-) early breast cancer (ebc).
Eplontersen recommended for EU approval by CHMP for hereditary transthyretin-mediated amyloidosis
Wainzua (Eplotersen), produced by AstraZeneca and Ionis, has been recommended for approval in the EU by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP). The drug will be used as a treatment for hereditary transthyretin-mediated amyloidosis in adult patients who have stage 1 or 2 polyneuropathy (commonly referred to as hattr-pn or attrv-pn).
CytexOrtho receives FDA greenlight for clinical trials into joint repair technology
Clinical stage medical device company CytexOrtho has announced approval from the US Food and Drug Administration (FDA) for its planned phase 1 clinical trial into orthopaedic joint preservation and repair.
Survey from Roche finds worryingly low understandings about HPV and cervical cancer
Questioning almost 9,000 participants across 12 countries in Latin America and Europe, the research revealed significant knowledge gaps surrounding human papillomavirus (HPV) and highlighted several significant barriers preventing women from screening for it.
Best-in-class AI model from Bioptimus integrated into Proscia’s leading software platform
French start-up Bioptimus has announced that its H-optimus-o biology reference artificial intelligence (AI) foundation model has been wholly integrated into Proscia’s Concentriq Embeddings software platform, with the aim of enabling quicker and more efficient breakthroughs in AI development for therapeutic research.
HIV vaccine candidate successfully optimised for industrial production
Sumagen Canada Inc, a biotech company based in both South Korea and Canada has partnered with CDMO Naobios to industrialise Sumagen’s human immunodeficiency virus (HIV)-1 vaccine candidate (SAV0001) at bench scale.
Aravax successfully recruits for phase 3 peanut allergy treatment study
Clinical-stage biotech company Aravax has announced that it has completed phase 2 recruitment for its precision therapy (pvx108) study, which investigates treatment of peanut allergies.
Headlands Research opens new clinical trials site in El Paso, Texas, to serve Hispanic population
Headlands Research, a multinational network of clinical research sites, has launched a new clinical trials site in El Paso, Texas, US.
Biologic medicine Dupixent approved by FDA for COPD patients in the US
The US Food and Drug Administration has approved Sanofi’s Dupixent as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.
Tiziana Life Sciences awarded $4m grant by NIH to study anti-CD3 in Alzheimer’s disease
Tiziana Life Sciences, a biotechnology company developing immunomodulation therapies, announced that the National Institutes of Health (NIH),'s National Institute on Aging has awarded a $4m grant to Dr Howard Weiner as principal investigator at Brigham and Women’s Hospital to be the key research site to study nasal anti-cd3 for the treatment of alzheimer’s disease (ad).
European Commission approves Astellas Pharma’s GEJ adenocarcinoma treatment
The European Commission (EC) has approved Astellas Pharma’s vyloy (zolbetuximab) in combination with fluoropyrimidine and platinum-containing chemotherapy as a treatment for adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are claudin (CLDN) 18.2 positive.
Ministry of Health, Labour and Welfare of Japan approves new drug for early Alzheimer’s disease
The Ministry of Health, Labour and Welfare Japan has approved treatment for Eli Lilly’s KINSULA, indicated for adult patients with early symptomatic Alzheimer’s disease (AD). This also includes patients with mild dementia stage AD, and mild cognitive impairment.
New collaboration agreement announced between EMIH association and the MTIG
The European Microbiome Innovation for Health (EMIH) association and the Microbiome Therapeutics Innovation Group (MTIG) have announced a new collaborative agreement. The agreement seeks to advance microbiome drug development by improving collaboration between the two microbiome focused coalitions.
FDA approves first drug in 50 years for treatment of schizophrenia in adults
Earlier this September, the US Food and Drug Administration (FDA) granted approval for PureTech Health’s Karxt for the treatment of schizophrenia in adults, triggering royalty payments of $29m to PureTech. It will be the first approved mechanism by the FDAfor schizophrenia in over 50 years.
Third application for Orion’s prostate cancer drug submitted by partner Bayer
Finnish pharmaceutical company Orion has announced that its partner Bayer is applying for a third application of its prostate cancer drug, darolutamide, in the US.
European News
Survey from Roche finds worryingly low understandings about HPV and cervical cancer
Questioning almost 9,000 participants across 12 countries in Latin America and Europe, the research revealed significant knowledge gaps surrounding human papillomavirus (HPV) and highlighted several significant barriers preventing women from screening for it.
Best-in-class AI model from Bioptimus integrated into Proscia’s leading software platform
French start-up Bioptimus has announced that its H-optimus-o biology reference artificial intelligence (AI) foundation model has been wholly integrated into Proscia’s Concentriq embeddings software platform, with the aim of enabling quicker and more efficient breakthroughs in ai development for therapeutic research.
Almirall’s Immunoskin event returns for a third year, discussing medical dermatology advances
Hosted again in Barcelona, Spain, the Immunoskin conference ran from 26-27 October and brought together leading experts in dermatological conditions and treatments.
EcoVadis Platinum medal given to Liveo Research’s Singapore pharma packaging site
Liveo Research, a leading primary packaging manufacturer, has had the EcoVadis rating of its Singapore site increased from gold to platinum. This means that the pharma packaging site is now rated in the top 1% of the 100,000 companies evaluated by ecovadis in its annual global surveys.
HUTCHMED set to receive $20m in funding from Takeda for colorectal cancer drug sales
In late October, HUTCHMED’s partner Takeda will pay a milestone payment of $20m as the result of over $200m worth of sales for Fruzaqla (fruquintinib), which treats metastatic colorectal cancer (CRC).
Exhibitor numbers for CPHI India grow for third year in a row, with 50,000 attendees expected
Running from 26-28 November 2024, the largest pharma event in India is expected to have a record attendance of delegates from more than 150 countries, with over 2,000 exhibitors also expected.
PacBio announces update to sequencing system to bring down cost of genome sample to below $500
Announced by PacBio, known for developing sequencing solutions, SPRQ has the potential to significantly reduce the cost of sequencing genomes.
HIV vaccine candidate successfully optimised for industrial production
Sumagen Canada Inc, a biotech company based in both South Korea and Canada, has partnered with CDMO Naobios to industrialise Sumagen’s human immunodeficiency virus (HIV)-1 vaccine candidate (sav0001) at bench scale.
Bayer and Liveo Research pair to launch new sustainable blister packaging
The partnership between the two companies has resulted in the launching of a first-of-its-kind blister packaging, utilising polyethylene terephthalate (PET) instead of the more traditional poly vinyl chloride (PVC).
NRG Therapeutics secures funding for development of treatment for neurodegenerative disease
NRG Therapeutics has announced that its NRG5051 inhibitor has secured a $5m grant from the Michael J. Fox foundation for Parkinson’s research (MJFF).
PacBio announces update to sequencing system to bring down cost of genome sample to below $500
Announced by PacBio, known for developing sequencing solutions, SPRQ has the potential to significantly reduce the cost of sequencing genomes.
Bayer and Liveo Research pair to launch new sustainable blister packaging
The partnership between the two companies has resulted in the launching of a first-of-its-kind blister packaging, utilising polyethylene terephthalate (PET) instead of the more traditional poly vinyl chloride (PVC).
Aravax successfully recruits for phase 3 peanut allergy treatment study
Clinical-stage biotech company Aravax has announced that it has completed phase 2 recruitment for its precision therapy (pvx108) study, which investigates treatment of peanut allergies.
NRG Therapeutics secures funding for development of treatment for neurodegenerative disease
NRG Therapeutics has announced that its NRG5051 inhibitor has secured a $5m grant from the Michael J. Fox Foundation for Parkinson’s Research (MJFF).
Chiesi announces phase 3 results from enzyme-replacement study
Chiesi Global Rare Diseases has announced the results from its BRIGHT trial, which evaluates the efficacy of enzyme-replacement therapy drug ELFABRIO at twice the approved dose in patients who have been treated with agalsidase alfa or beta.
VALIANT phase 3 trial results highlight potential treatment for rare kidney diseases
SOBI and Apellis Pharmaceuticals have announced the results from the VALIANT trial, which highlight that systemic pegcetacoplan treatment could benefit patients with c3 glomerulopathy (c3g) and primary immune complex membranoproliferative glomerulonephritis (ic-mpgn).
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Welcome to the September 2024 issue of Pharmafocus! This issue covers the latest news including new FDA approval for primary biliary cholangitis, NICE recommendations for skyrizi (risankizumab), CHMP opinion on Merck’s KEYTRUDA, as well as articles on precision medicine and oral peptides PLUS what to look out for at this year's CPHI in Milan!
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Appointments
Darrin Schellin appointed new CEO at Pharma Tech Industries
Pharma Tech Industries, a pharmaceutical manufacturing and packaging solutions contractor for wellness products and medical devices, has announced the appointment of its new chief executive officer, Darrin T Schellin.
CluePoints appoint Richard Young as chief strategy officer
Cluepoints, a data quality oversight and and risk-based quality management software provider, has announced the appointment of Richard Young as its chief strategy officer.
Dr Souad Kechairi appointed chief medical officer at PLL Therapeutics
Dr Souad Kechairi has been appointed chief medical officer at PLL Therapeutics, a biopharmaceutical company specialising in polypeptides.
Shawn Cross appointed as chief financial officer for Pacira Biosciences
Pacira biosciences, specialist in non-opioid pain therapies, has appointed Shawn Cross as its chief financial officer. In this role, Mr Cross will take over all responsibility for the company’s financial operations.
Dr Souad Kechairi appointed chief medical officer at PLL Therapeutics
Dr Souad Kechairi has been appointed chief medical officer at PLL Therapeutics, a biopharmaceutical company specialising in polypeptides.
Prilenia appoints new staff to advance company’s development plans
Prilenia, a clinical stage biotech focusing on neurodegenerative and neurodevelopmental disorders, has announced the appointment of two new senior staff members ‒ Rob Lauzen as chief financial officer (CFO) and Jason Marks as chief legal officer (CLO).
Steriline’s founder ‘passes torch’ to children with CEO and CSO appointments
Aseptic packaging company Steriline’s founder Gerardo Fumagalli has ‘passed the torch’ to his children Illaria Fumagalli and Federico Fumagalli, who have been appointed to chief executive officer and chief sales officer, respectively. Gerardo will continue on as chairman of the board of directors.
Eli Lilly expands with two senior hires in Public Affairs and Communications team
Pharmaceutical company Eli Lilly has announced the appointment of two senior positions in its public affairs and communications team.
Dr Anada Gubbi appointed by SFA Therapeutics as director of Biostatistics
SFA Therapeutics, a clinical-stage biopharmaceutical company, has announced that it has appointed Dr Anada Gubbi as director of biostatistics. Dr Gubbi will be responsible for assisting SFA Therapeutics in effectively developing drug candidates for the treatment of inflammatory diseases.
Curve Therapeutics bolsters its leadership team with appointment of Simon Jones
With his 20 years of expertise and proven track record in biotech and pharmaceutical industries, Curve Therapeutics appoints Simon Jones as chief financial officer and chief operating officer.
Adam Rosenberg replaces Dr Carlo Incerti as new chair of the board at VectorY Therapeutics
Vectory Therapeutics has announced the appointment of Adam Rosenberg as chair of the board, replacin Dr Carlo Incerti.
Dr Jonathan Appleby appointed by Mogrify as chief scientific officer
Mogrify has announced the appointment of Dr Jonathan Appleby as chief scientific officer.
Professor yih-shing duh appointed as chief scientific advisor by H.E.L. Group
Professor Yih-Shing Duh appointed as chief scientific advisor by H.E.L. Group
Enhanc3D Genomics appoints Hazel Jones as CEO
Enhanc3D Genomics has announced the appointment of Hazel Jones as chief executive officer (CEO), following a successful six-month term as interim CEO and COO.
Closed Loop Medicine appoints Paul Johnson as non-executive director
Closed loop medicine has announced the appointment of Paul Johnson as an independent non-executive director.
Sphere Fluidics appoints Curtis Nicholson as director of sales EMEA
Sphere Fluidics has announced the appointment of Curtis Nicholson as director for sales for Europe, Middle East and Africa (EMEA).
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