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The risk of replicating social bias in synthetic patients – the need for human intelligence with AI

The risk of replicating social bias in synthetic patients – the need for human intelligence with AI

Paul Reed and Annabelle Gall at Research Partnership, an Inizio Advisory company, consider the benefits and drawbacks of AI, especially in terms of diversity and synthetic patients

 7 February 2024
2024: a tipping point for progress in rare diseases?

2024: a tipping point for progress in rare diseases?

Soraya Bekkali from Alexion, AstraZeneca Rare Disease, explains why the EU must act in 2024 to tackle the health equity crisis that people living with rare diseases face every day

 7 February 2024
Paediatrics in the review of the EU General Pharmaceutical Legislation

Paediatrics in the review of the EU General Pharmaceutical Legislation

Pauline Roudot from Novartis considers the path to approval for paediatric medications

 7 February 2024
Our Winter of Discontent: NHS strikes and missed targets

Our Winter of Discontent: NHS strikes and missed targets

Betsy Goodfellow from Pharmafocus considers the current state of the NHS amid ongoing strikes and ever-growing waiting lists, as well as the impact of the infectious illnesses circulating during the winter months

 7 February 2024
Ageing populations and geographical health disparities in the UK

Ageing populations and geographical health disparities in the UK

Betsy Goodfellow from Pharmafocus considers how the UK’s ageing population impacts general health trends, focusing on how a greater proportion of people’s lives are spent in ill health as more people are living much longer

 7 February 2024
Five facts about the NHS

Five facts about the NHS

Five key facts about the NHS

 7 February 2024

Industry Insights

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Don’t settle for black box: why only explainable AI is built for scientific discovery

Don’t settle for black box: why only explainable AI is built for scientific discovery

Lykke Pedersen from Abzu considers the benefits of AI and its different applications within the pharma industry

 7 February 2024
The risk of replicating social bias in synthetic patients – the need for human intelligence with AI

The risk of replicating social bias in synthetic patients – the need for human intelligence with AI

Paul Reed and Annabelle Gall at Research Partnership, an Inizio Advisory company, consider the benefits and drawbacks of AI, especially in terms of diversity and synthetic patients

 7 February 2024
2024: a tipping point for progress in rare diseases?

2024: a tipping point for progress in rare diseases?

Soraya Bekkali from Alexion, AstraZeneca Rare Disease, explains why the EU must act in 2024 to tackle the health equity crisis that people living with rare diseases face every day

 7 February 2024
The impact of climate change on respiratory health

The impact of climate change on respiratory health

With the first ever COP health event being held in December 2023, Shishir Patel from Chiesi UK and Ireland reflects on the need to align environmental and health strategies and shares his work building a clearer picture of how climate change can impact respiratory health

 7 February 2024
Paediatrics in the review of the EU General Pharmaceutical Legislation

Paediatrics in the review of the EU General Pharmaceutical Legislation

Pauline Roudot from Novartis considers the path to approval for paediatric medications

 7 February 2024
Our Winter of Discontent: NHS strikes and missed targets

Our Winter of Discontent: NHS strikes and missed targets

Betsy Goodfellow from Pharmafocus considers the current state of the NHS amid ongoing strikes and ever-growing waiting lists, as well as the impact of the infectious illnesses circulating during the winter months

 7 February 2024

UK News

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Measles outbreak possible, advises UKHSA

Measles outbreak possible, advises UKHSA

The UKHSA has warned that further outbreaks of measles could spread to other towns and cities unless uptake in the measles, mumps and rubella vaccination is increased in at-risk areas.

ViroCell and Great Ormand Street Hospital receive MHRA manufacturing approval

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

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

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’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

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’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

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

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

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

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

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

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

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

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

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.

Global News

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Merck’s Keytruda with chemoradiotherapy approved by FDA as treatment for cervical cancer

Merck’s Keytruda with chemoradiotherapy approved by FDA as treatment for cervical cancer

Merck has announced that the FDA has approved Keytruda (pembrolizumab) in combination with chemoradiotherapy for the treatment of figo (international federation of gynecology and obstetrics) 2014 stage iii-iva cervical cancer.

J&J’s Balversa approved by FDA for bladder cancer treatment

J&J’s Balversa approved by FDA for bladder cancer treatment

Johnson & Johnson (J&J) has announced that the FDA has approved a supplemental new drug application for Balversa (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma with susceptible fibroblast growth factor receptor 3 genetic alterations whose disease has progressed on or after one prior treatment.

AstraZeneca and Ionis’s Wainua approved by FDA

AstraZeneca and Ionis’s Wainua approved by FDA

AstraZeneca and Ionis have announced that the FDA has approved Wainua (eplontersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (haattr-pn or attrv-pn) in adult patients.

FDA approves Calliditas Therapeutics’ Tarpeyo to reduce loss of kidney function

FDA approves Calliditas Therapeutics’ Tarpeyo to reduce loss of kidney function

Calliditas Therapeutics has announced that the FDA has approved Tarpeyo (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobin a nephropathy at risk of disease progression.

New data shared for Leqembi as Alzheimer’s treatment

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 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’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

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

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 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

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

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’ 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 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 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’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.

European News

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CHMP shares positive opinion for GSK’s momelotinib for myelofibrosis treatment

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

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’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

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

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

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

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 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 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

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

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 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 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

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 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

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

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Dr Joerg Moeller appointed CEO of BenevolentAI

Dr Joerg Moeller appointed CEO of BenevolentAI

BenevolentAI has announced that it has appointed Dr Joerg Moeller MD PhD as its new chief executive officer and executive board member, the changes will be effective immediately.

Sosei Group appoints Toshihiro Maeda as COO

Sosei Group appoints Toshihiro Maeda as COO

Sosei Group corporation has announced the appointment of Toshihiro Maeda as chief operating officer (COO).

X-Chem announces new CEO and CSO

X-Chem announces new CEO and CSO

X-Chem has announced that it is making changes to its executive management team, with Karen Lackey, the current chief scientific officer (CSO), becoming chief executive officer (CEO) and Matthew Clark, the current CEO pivoting to the role of president and CSO.

Peter Crossley appointed COO of Cellular Origins

Peter Crossley appointed COO of Cellular Origins

Cellular Origins has announced that it has appointed Peter Crossley as chief operating officer (COO).

Hazel Jones appointed as Enhanc3D Genomics’ chief operating officer

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

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 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 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

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

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

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 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 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

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

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

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