The biggest news of 2023
Betsy Goodfellow from Pharmafocus looks back at 2023 and reviews some of the biggest pharma news of the year
24 November 2023Betsy Goodfellow from Pharmafocus looks back at 2023 and reviews some of the biggest pharma news of the year
24 November 2023Read on for five key facts about AMR.
24 November 2023Dr Harsha Rajasimha from Jeeva Informatics considers how digital innovations and decentralisation can improve clinical trials
24 November 2023Steve Brownett-Gale, marketing lead at Origin, considers how to combat counterfeiting in the pharma industry
24 November 2023Monika Lamba Saini, Greg Lever and Ashley Polhemus from IQVIA and Q2 Solutions explore digital health technologies and their use in clinical trials
24 November 2023Betsy Goodfellow from Pharmafocus reviews Gilead’s innovative new book, From the Margins. Described as ‘the most difficult book to read’, it highlights stories of hardship, stigmatisation, abuse and marginalisation
1 November 2023Betsy Goodfellow from Pharmafocus looks back at 2023 and reviews some of the biggest pharma news of the year
24 November 2023Dr Harsha Rajasimha from Jeeva Informatics considers how digital innovations and decentralisation can improve clinical trials
24 November 2023Steve Brownett-Gale, marketing lead at Origin, considers how to combat counterfeiting in the pharma industry
24 November 2023Monika Lamba Saini, Greg Lever and Ashley Polhemus from IQVIA and Q2 Solutions explore digital health technologies and their use in clinical trials
24 November 2023Betsy Goodfellow from Pharmafocus reviews Gilead’s innovative new book, From the Margins. Described as ‘the most difficult book to read’, it highlights stories of hardship, stigmatisation, abuse and marginalisation
1 November 2023Louisa Steinberg and Maureen Glynn from ICON consider the role of digital therapeutics in the treatment of central nervous system conditions and how they can be used to improve clinical trials
1 November 2023Virocell Biologics has announced that it can now manufacture and export viral vectors from Great Ormand Street Hospital’s (GOSH) state-of-the-art manufacturing facility, the Zayed Centre for Research, for use in clinical trials.
AbbVie has announced that the MHRA has granted a marketing authorisation for Aquipta (atogepant), for the prophylaxis of migraine in adult patients who have had at least four migraine days each month.
Amicus Therapeutics has announced that the MHRA in the UK has granted marketing authorisation to pombiliti (cipaglucosidase alfa) and opfolda (miglustat) for the treatment of adult patients with late-onset pompe disease.
Novo Nordisk has today announced that Wegovy (semaglutide injection) is now available in the UK through a controlled and limited launch. The drug is intended to provide new treatment options to patients living with obesity.
Ministers have opened a new vaccine research centre at the UKHSA Porton Down campus in Wiltshire, intended to prepare for 'disease x', the next possible pandemic pathogen.
Bristol Myers Squibb has announced that NICE has recommended Sotyktu (deucravacitinib) for use on the NHS in England as a new treatment option for adult patients with moderate-to-severe plaque psoriasis.
Figures from a team at the University of York, the London School of Economics and Political Science (LSE), and the London School of Hygiene and Tropical Medicine (LSHTM) have revealed that the total cost of prescription medicines to NHS England reached a new high of £17.2bn in 2021-22, and that since 2018, NHS spending on branded medicines have been increasing by over 5% annually.
UK-based trade union Unite were pushing for staff walkouts at several GSK manufacturing sites due to disputes regarding pay increases, however to date there have been no updates as to whether GSK have extended another offer.
NHS England has announced that pharmacists in England will be given wider prescribing powers to relieve pressure put on GPs.
Otsuka Pharmaceuticals has announced that the National Institute for Health and Care Excellence (NICE) has recommended Lupkynis (Voclosporin) in combination with Mycophenolate Mofetil (MMF) as a treatment option for adult patients with active lupus nephritis (LN).
The National Institute for Health and Care Excellence (NICE) has announced that it is recommending two personalised immunotherapy treatments to the Cancer Drugs Fund (CDF) for the treatment of aggressive forms of blood cancers.
NHS England has approved the use of AstraZeneca’s Lynparza (olaparib) for the treatment of patients with breast cancer and prostate cancer. This approval means men with advanced prostate cancer and women with her2-negative early breast cancer who are at high risk of the disease returning will be offered olaparib through the NHS in england. The decision has already received praise from charities and clinicians.
A new clinical trial is set to begin shortly, which will be a collaboration between the universities of Edinburgh, Aberdeen and Birmingham. The study will assess the efficacy of the drug dichloroacetate in managing pain for patients with endometriosis.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has been limited to approving medicines in Great Britain (England, Scotland and Wales) in the wake of Brexit, with the EMA still responsible for Northern Ireland. However, it is looking likely that a new deal with the EU will restore the agency’s authority over the whole of the United Kingdom.
A new state-of-the-art facility named the Clinical Biotechnology Centre (CBC) is opening in Bristol, UK. It cost approximately £10m to build, funded by the UK Government.
AstraZeneca has announced that it has signed an exclusive licence agreement (ELA) with KYM Biosciences for cmg901, which is an antibody drug conjugate (ADC) intended to treat gastric cancer.
Eisai and Biogen have announced that Eisai has shared new data for Leqembi (lecanemab-irmb) 100mg/ml injection for intravenous use at the 16th annual clinical trials on Alzheimer’s disease conference in Boston, US on 24-27 October 2023.
Boan Biotech has announced that the first patient has been enrolled in its phase 3 trial of its nivolumab injection (ba1104) in china.
Merck, known as MSD outside of the US, has announced that the FDA has approved Keytruda in combination with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of adult patients with locally advanced unresectable or metastatic her2-negative gastric or gastroesophageal junction adenocarcinoma.
Bristol Myers Squibb has announced that the FDA has approved Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ros1-positive non-small cell lung cancer.
Eli Lilly has announced that the FDA has approved Zepbound (tirzepatide) injection for chronic weight management, indicated for patients who are obese or overweight and have weight-related medical problems such as hypertension, dyslipidaemia, type 2 diabetes mellitus, obstructive sleep apnoea or cardiovascular disease.
Janssen Pharmaceuticals, a Johnson & Johnson company, has announced a development and commercialisation agreement with Sanofi for Janssen’s extraintestinal pathogenic escherichia coli investigational vaccine programme.
India-based pharma company Sun Pharmaceutical Industries has announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for deuruxolitinib for the treatment of adults with moderate-to-severe alopecia areata.
Regeneron Pharmaceuticals and Sanofi have announced that the US Food and Drug Administration (FDA) has accepted their supplemental biologics license application for Dupixent (dupilumab) for the treatment of children between one and 11 years old with eosinophilic oesophagitis (EOE).
Karuna Therapeutics has announced that it has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for Karxt (xanomeline-trospium) for the treatment of schizophrenia.
Genentech has announced positive topline long-term results from its global phase 3 BALATON and COMINO trials, which assessed extended treatment intervals with Vabysmo (faricimab-svoa) in macular oedema due to branch and central retinal vein occlusion (BRVO and CRVO).
Sanofi has shared new data for the long-term efficacy of Nexviazyme (avalglucosidease alfa) for the treatment of Pompe disease at the 28th annual congress of the world muscle society (WMS) in Charleston, South Carolina, US.
Biogen has announced that the FDA has approved Tofidence (tocilizumab-bavi) as an intravenous formulation, a biosimilar monoclonal antibody referencing actemra.
Eli Lilly and Boehringer Ingelheim have announced that the FDA has approved Jardiance (empagliflozin) 10mg tablets to reduce risk of sustained decline in estimated glomerular filtration rate (EGFR), end-stage kidney disease, cardiovascular death and hospitalisation in adults with chronic kidney disease (CKD).
Pfizer has announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended abrysvo, the company’s bivalent respiratory syncytial virus (RSV) vaccine, for maternal immunisation.
The World Health Organization (WHO) has announced that it has recommended a new vaccine, r21/matrix-m, for the prevention of malaria in children.
GSK has announced positive results from zoster-076 post-licence phase 4 efficacy trial for Shingrix recombinant zoster vaccine (RZV) in China.
GSK has announced that the CHMP of the EMA has given a positive recommendation to the company’s momelotinib for patients with myelofibrosis.
Daiichi Sankyo has announced that Vanflyta (quizartinib) has been approved in the EU for combination use with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy for adult patients with newly diagnosed acute myeloid leukaemia that is flt3-itd positive.
Roche has announced that the EC has approved the extension of Evrysdi’s marketing authorisation in the EU to include infants under two months with a clinical diagnosis of spinal muscular atrophy (SMA).
GSK has announced that ViiV healthcare has received a positive opinion from the EMA's CHMP, recommending marketing authorisation for cabotegravir long-acting (LA) injectable and tablets for HIV prevention.
The European Parliament has shared its recommendations for a ‘coordinated EU response to health threats posed by antimicrobial resistance,’ according to its press release.
The European Commission (EC) has again delayed the release of its new proposal for changes to Europe’s pharma legislation. The decision was previously expected on 29 March 2023, but has been announced to be “slightly later”.
Pharma giant AstraZeneca has been given a recommendation by the EU's Committee for Medicinal Products (CHMP) for marketing authorisation for ultomiris (ravulizumab), a treatment for adult patients with neuromyelitis optica spectrum disorder (NMSOD) who are anti-aquaporin-4 (AQP4) antibody positive (ab+).
AbbVie has announced that it has received positive feedback from the EMA's Committee for Medicinal Products for Human Use (CHMP) recommending the approval of upadacitinib (rinvoq) for the treatment of adult patients with moderate to severe crohn’s disease who have had an inadequate response, lost response or were intolerant to conventional therapies or biologic agents.
CSL, a biotech company, has announced that it has received conditional marketing authorisation (CMA) from the European Commission (EC) for its haemophilia b drug hemgenix.
Life sciences giant Merck & Co has announced that it will appeal the EU's committee for Medicinal Products for Human Use’s (CHMP) decision to not recommend approval for its COVID-19 drug lagevrio.
Following the increase in respiratory infections, the continuing cost of living crisis and the Russia-Ukraine conflict, Europe is planning countermeasures for further antibiotic shortages
AstraZeneca has announced plans to open a new facility in Ireland, previously planned for northwest England
Genoscience Pharma has received FDA ODD for its hepatocellular carcinoma drug
Regeneron Pharmaceuticals and Sanofi have announced that the European Commission (EC) has expanded the marketing authorisation for Dupixent® (dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
ServBlock, an Irish start-up, and Irish Manufacturing Research (IMR), have been given EU funding to build a data exchange system for outsourced pharmaceutical manufacturing.
Recently, AstraZeneca announced two drug approvals in the European Union (EU), the first being Imfinzi’s approval for the treatment of biliary tract cancer, and the latter being Lynparza for prostate cancer.
Welcome to the December 2023 issue of Pharmafocus!
Welcome to the November 2023 issue of Pharmafocus! This issue includes the latest news as well as fascinating articles.
Welcome to the October 2023 issue of Pharmafocus!
Welcome to Pharmafocus September 2023! This issue covers the latest news from GSK's new RSV vaccine to another contaminated cough syrup triggering a Medical Product Alert from WHO. The issue also includes insights from Sanofi, Phastar and Veeva.
Welcome to the July/August issue of Pharmafocus! This issue includes articles on the use of biomolecular condensates in diabetes treatment, the link between Alzheimer's disease and age-related macular degeneration, and the impact of the cost of living crisis on health, as well as all the latest pharma news!
Welcome to the June issue of Pharmafocus! This month's magazine includes the latest news, and fascinating insights from AstraZeneca, CytoReason, and Medidata!
Enhanc3D Genomics has announced the appointment of Hazel Jones as chief operating officer.
Oxolife has announced that it has appointed globally renowned fertility experts to its scientific advisory board.
IO Biotech has announced the appointment of Helen Collins MD to its board of directors.
NanoSyrinx has announced the appointment of Anthony Johnson MD to its board as non-executive director.
Closed Loop Medicine has announced the appointment of Konstantinos Vlassis as chief technology officer.
CEO and president of FUJIFILM Diosynth Biotechnologies Lars Petersen has appointed Maja Pedersen as chief quality officer, where she will serve as a member of the executive leadership team.
Invisius Limited has announced that it has appointed Professor Bernard Canaud to its clinical advisory board.
Pheon Therapeutics has announced hat it has appointed Arvin Yang MD PhD as chief medical officer.
Hansa Biopharma has announced the appointment of Dr Hitto Kaufmann as its new chief scientific officer effective 1 December 2023.
Clinical stage biotech company Destiny Pharma has announced the appointment of Chris Tovey as chief executive officer.
Bristol Myers Squibb announces appointment of Dr Monica Shaw
CN Bio has announced the appointment of Dr Tomasz Kostrzewski as chief scientific officer
The biotechnology company foghorn therapeutics has announced the addition of the new chief medical officer, Alfonso Quintás-Cardama, who will be replacing Sam Agresta after his retirement on 11 September 2023.
The Helmholtz Centre for Infection Research (HZI), Germany, has appointed professor Josef Penninger as scientific director.
Cytovation, a clinical stage immune-oncology company with a focus on targeted tumour membrane immunotherapies, has announced that it has appointed Olav Hellebø to its board of directors.
Reacta appoints Kevin Hawkins as new head of regulatory affairs