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 2023Top Content
Five facts about antimicrobial resistance
Read on for five key facts about AMR.
24 November 2023
Embracing technological advancements: revolutionising clinical trials through remote capabilities
Dr Harsha Rajasimha from Jeeva Informatics considers how digital innovations and decentralisation can improve clinical trials
24 November 2023
Anti-counterfeiting: the battle against fake pharmaceuticals
Steve Brownett-Gale, marketing lead at Origin, considers how to combat counterfeiting in the pharma industry
24 November 2023
Notable tech-enabled solutions advancing clinical trials with all stakeholders in mind
Monika Lamba Saini, Greg Lever and Ashley Polhemus from IQVIA and Q2 Solutions explore digital health technologies and their use in clinical trials
24 November 2023
From the Margins: a book review
Betsy 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 2023Industry Insights
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 2023Embracing technological advancements: revolutionising clinical trials through remote capabilities
Dr Harsha Rajasimha from Jeeva Informatics considers how digital innovations and decentralisation can improve clinical trials
24 November 2023Anti-counterfeiting: the battle against fake pharmaceuticals
Steve Brownett-Gale, marketing lead at Origin, considers how to combat counterfeiting in the pharma industry
24 November 2023Notable tech-enabled solutions advancing clinical trials with all stakeholders in mind
Monika Lamba Saini, Greg Lever and Ashley Polhemus from IQVIA and Q2 Solutions explore digital health technologies and their use in clinical trials
24 November 2023From the Margins: a book review
Betsy 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 2023
The role of digital therapeutics in central nervous system clinical trials
Louisa 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 2023UK News
ViroCell and Great Ormand Street Hospital receive MHRA manufacturing approval
Virocell 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.
MHRA grants marketing authorisation to AbbVie’s Aquipta for migraine prevention
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.
MHRA clears Amicus Therapeutics’ Pompe disease treatment for use in the UK
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’s Wegovy (semaglutide injection) made available in the UK
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.
UKHSA opens new vaccine research centre in Wiltshire to prepare for future pandemics
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’s Sotyktu recommended to treat adult patients with psoriasis on the NHS
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.
Report finds NHS may miss out on new drugs due to rising costs
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.
Trade union Unite calls for GSK staff walkouts over pay increase disputes
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.
Pharmacists in England given wider prescribing powers to relieve GP pressure
NHS England has announced that pharmacists in England will be given wider prescribing powers to relieve pressure put on GPs.
NICE recommends Otsuka’s Lupkynis (voclosporin) in combination treatment for active lupus nephritis
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).
NICE recommends two CAR T treatments for blood cancers to the Cancer Drugs Fund
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.
AstraZeneca’s Lynparza approved by NHS England
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.
New clinical trial aims to find new endometriosis treatment
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.
MHRA’s authority restored following Northern Ireland Brexit deal
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.
Biotech centre focusing on gene therapies opens in Bristol, UK
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 signs $63m agreement for gastric cancer treatment
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.
Global News
New data shared for Leqembi as Alzheimer’s treatment
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 enrols first patient for Nivolumab phase 3 trial in China
Boan Biotech has announced that the first patient has been enrolled in its phase 3 trial of its nivolumab injection (ba1104) in china.
Merck’s Keytruda approved by FDA for gastric cancer treatment
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.
BMS’s Augtyro approved by FDA for lung cancer treatment
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.
FDA approves Eli Lilly’s Zepbound for chronic weight management
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 and Sanofi partner for E. coli vaccine programme
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.
Sun Pharma’s NDA for deuruxolitinib accepted by FDA
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.
FDA accepts Regeneron and Sanofi’s sBLA for Dupixent for priority review
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’ NDA submitted to FDA for schizophrenia treatment
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 announces results from two phase 3 trials of retinal vein occlusion treatment
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 announces long-term efficacy data for Nexviazyme for Pompe disease treatment
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’s Tofidence biosimilar gains FDA approval
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’s Jardiance approved by FDA for chronic kidney disease treatment
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’s RSV vaccine provisionally recommended by CDC Advisory Committee
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.
New vaccine for prevention of malaria in paediatric patients recommended by WHO
The World Health Organization (WHO) has announced that it has recommended a new vaccine, r21/matrix-m, for the prevention of malaria in children.
Promising results announced from GSK’s shingles trial in China
GSK has announced positive results from zoster-076 post-licence phase 4 efficacy trial for Shingrix recombinant zoster vaccine (RZV) in China.
European News
CHMP shares positive opinion for GSK’s momelotinib for myelofibrosis treatment
GSK has announced that the CHMP of the EMA has given a positive recommendation to the company’s momelotinib for patients with myelofibrosis.
EC approves Daiichi Sankyo’s Vanflyta for acute myeloid leukaemia treatment
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’s Evrysdi approved by EC for babies under two months with spinal muscular atrophy
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).
CHMP grants positive opinion to ViiV Healthcare’s cabotegravir for HIV prevention
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.
European Parliament shares goal to tackle antimicrobial resistance
The European Parliament has shared its recommendations for a ‘coordinated EU response to health threats posed by antimicrobial resistance,’ according to its press release.
European Commission delays release of major changes to pharma legislation
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”.
AstraZeneca’s NMOSD treatment recommended marketing
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 gains positive CHMP opinion for upadacitinib for the treatment of Crohn’s disease
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 receives CMA from the European Commission for haemophilia B drug
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.
Merck to appeal EU rejection of COVID-19 drug
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.
Europe Plans Further Antibiotic Shortage Countermeasures
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 Moves Manufacturing To Ireland Due To Britain’s Tax Regime
AstraZeneca has announced plans to open a new facility in Ireland, previously planned for northwest England
Genoscience Pharma Received Orphan Drug Designation For Hepatocellular Carcinoma Drug
Genoscience Pharma has received FDA ODD for its hepatocellular carcinoma drug
European Commission Approves Dupixent® As The First And Only Targeted Medicine For Prurigo Nodularis
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 Secures EU Funding For Pharma Manufacturing Data Space
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.
Astrazeneca Shares Two New Drug Approvals In The EU
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.
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Appointments
Hazel Jones appointed as Enhanc3D Genomics’ chief operating officer
Enhanc3D Genomics has announced the appointment of Hazel Jones as chief operating officer.
International fertility experts appointed to Oxolife’s Scientific Advisory Board
Oxolife has announced that it has appointed globally renowned fertility experts to its scientific advisory board.
IO Biotech appoints Helen Collins to board of directors
IO Biotech has announced the appointment of Helen Collins MD to its board of directors.
NanoSyrinx appoints Anthony Johnson as non-executive director
NanoSyrinx has announced the appointment of Anthony Johnson MD to its board as non-executive director.
Konstantinos Vlassis appointed as Closed Loop Medicine’s chief technology officer
Closed Loop Medicine has announced the appointment of Konstantinos Vlassis as chief technology officer.
FUJIFILM Diosynth Biotechnologies appoints Maja Pedersen as chief quality 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.
Invizius appoints Bernard Canaud to clinical advisory board
Invisius Limited has announced that it has appointed Professor Bernard Canaud to its clinical advisory board.
Pheon appoints Arvin Yang as chief medical officer
Pheon Therapeutics has announced hat it has appointed Arvin Yang MD PhD as chief medical officer.
Hansa Biopharma appoints Dr Hitto Kaufmann as chief scientific officer
Hansa Biopharma has announced the appointment of Dr Hitto Kaufmann as its new chief scientific officer effective 1 December 2023.
Chris Tovey appointed as Destiny Pharma’s new CEO
Clinical stage biotech company Destiny Pharma has announced the appointment of Chris Tovey as chief executive officer.
Move of the month
Bristol Myers Squibb announces appointment of Dr Monica Shaw
Dr Tomasz Kostrzewski introduced as CN Bio’s new chief scientific officer
CN Bio has announced the appointment of Dr Tomasz Kostrzewski as chief scientific officer
Alfonso Quintás-Cardama to join Foghorn Therapeutics as new chief medical 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.
Helmholtz Centre for Infection Research appoints Josef Penninger to new scientific director
The Helmholtz Centre for Infection Research (HZI), Germany, has appointed professor Josef Penninger as scientific director.
Olav Hellebø to join Cytovation’s board of directors
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
Reacta appoints Kevin Hawkins as new head of regulatory affairs
Pharmafocus
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