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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
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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
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Pride month and LGBTQ+ healthcare

Betsy Goodfellow from Pharmafocus considers Pride month and the state of LGBTQ+ healthcare in the UK

 4 June 2024
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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 2024
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Rare disease clinical trials: the urgent need for patients to be heard

Ahead of clinical trials day, Soraya Bekkali, from Alexion, AstraZeneca Rare Disease, highlights the urgent need to elevate patients’ voices to accelerate rare disease innovation

 28 April 2024
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Psychedelic medicines and the treatment of neurological conditions

Rob Conley from Beckley Psytech tells Pharmafocus about the use of psychedelic medicine for the treatment of psychiatric and neurological conditions, and how this field could develop in the future

 28 April 2024

Industry Insights

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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
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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
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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 2024
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Rare disease clinical trials: the urgent need for patients to be heard

Ahead of clinical trials day, Soraya Bekkali, from Alexion, AstraZeneca Rare Disease, highlights the urgent need to elevate patients’ voices to accelerate rare disease innovation

 28 April 2024
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Psychedelic medicines and the treatment of neurological conditions

Rob Conley from Beckley Psytech tells Pharmafocus about the use of psychedelic medicine for the treatment of psychiatric and neurological conditions, and how this field could develop in the future

 28 April 2024
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Psychoactives in mental health treatment

Kabir Nath from Compass Pathways explores the need for new treatments in the mental health space, as well as assessing whether psychoactives could be the way forward

 28 April 2024

UK News

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MHRA approves Ascendis Pharma’s Yorvipath for hypoparathyroidism treatment

Ascendis Pharma has announced that the MHRA has granted marketing authorisation for Yorvipath (palopegteriparatide, developed as transcon pth) in Great Britain as a parathyroid hormone (pth) replacement therapy for the treatment of adult patients with chronic hypoparathyroidism.

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AbbVie’s migraine treatment recommended by NICE for NHS use

The National Institute for Health and Care Excellence (NICE) has shared draft guidance recommending AbbVie’s Aquipta (atogepant) as an option for preventing chronic and episodic migraines in adults who typically have at least four migraine days per month and where three previous preventative options have failed.

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Takeda’s Hyqvia gains MHRA marketing authorisation for CIDP treatment

Takeda has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation to Hyqvia as a maintenance therapy for patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) following stabilisation with an intravenous immunoglobin therapy (IVIG).

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AbbVie’s Tepkinly recommended by NICE for SC treatment of DLBCL

AbbVie has announced that the NICE has recommended Tepkinly (epcoritamab) as a treatment option for adults with diffuse large b-cell lymphoma (DLBCL) whose cancer has returned or not responded to two previous treatments.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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).

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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.

Global News

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FDA approves Pfizer’s Beqvez for treatment of haemophilia B

Pfizer has announced that the FDA has approved Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate-to-severe haemophilia B.

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Roche’s HPV self-collection screening option approved by FDA

Roche has announced that the FDA has approved its human papillomavirus (HPV) self-collection solution.

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Amgen’s Imdelltra approved by FDA for extensive-stage small cell lung cancer

Amgen has announced that the FDA has approved Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer who have had disease progression on or after platinum-based chemotherapy.

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Eko Health’s AI for heart failure detection approved by FDA

Eko Health has announced that the FDA has approved its low ejection fraction (low ef) detection artificial intelligence (AI).

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AstraZeneca & Daiichi Sankyo’s BLA for datopotamab deruxtecan accepted by FDA for breast cancer

AstraZeneca and Daiichi Sankyo have announced that their biologics license application (bla) for datopotamab deruxtecan (dato-dxd) has been accepted in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (hr)-positive, her2-negative breast cancer who have had prior systemic therapy for unresectable or metastatic disease.

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Candel Therapeutics’ pancreatic cancer treatment granted ODD by FDA

Candel Therapeutics has announced that the FDA has granted orphan drug designation (ODD) to can-2409, Candel’s immunotherapy candidate, for the treatment of pancreatic cancer.

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FDA accepts GSK’s meningococcal vaccine candidate BLA for review

GSK has announced that the FDA has accepted for review a biologics license application (BLA) for its 5-in-1 meningococcal abcwy (menabcwy) vaccine candidate.

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FDA approves Roche’s Alecensa lung cancer treatment

Roche has announced that the FDA has approved alecensa (alectinib) for the adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (alk)-positive non-small cell lung cancer (nsclc).

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ImmunityBio’s Anktiva bladder cancer treatment approved by FDA

ImmunityBio has announced that the FDA has approved Anktiva (n-803, or nogapendekin alfa inbakicept-pmln) plus bacillus calmette-guérin (bcg) for the treatment of patients with bcg-unresponsive non-muscle invasive bladder cancer (nmibc) with carcinoma in situ (cis), with or without papillary tumours.

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Rezdiffra approved by FDA as first treatment for liver scarring due to fatty liver disease

The FDA has announced that it has approved Rezdiffra (resmetirom) for the treatment of adult patients with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate-to-advanced liver scarring (fibrosis), for use alongside diet and exercise.

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FDA grants IND clearance to Spero Therapeutics’ bacterial infection treatment

Spero Therapeutics has announced that it has gained FDA clearance for the investigational new drug (IND) application to assess SPR206 in a phase 2 clinical study.

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J&J’s Opsynvi approved in US for PAH treatment

Johnson & Johnson (J&J) has announced that the FDA has approved Opsynvi (macitentan and tadalafil) for the chronic treatment of adults with pulmonary arterial hypertension (PAH).

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AstraZeneca’s Ultomiris approved by FDA for NMOSD treatment

AstraZeneca has announced that the FDA has approved Ultomiris (ravulizumab-cwvs) as the first and only long-acting c5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (aqp4) antibody-positive (ab+) neuromyelitis optica spectrum disorder (nmosd).

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FDA approves AstraZeneca’s Tagrisso for lung cancer treatment

AstraZeneca has announced that the FDA has approved Tagrisso for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.

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FDA grants Fast Track designation to GSK’s chronic hepatitis B treatment

GSK has announced that the FDA has granted fast track designation for bepirovirsen, an investigational antisense oligonucleotide for the treatment of chronic hepatitis b.

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FDA grants breakthrough therapy designation for J&J’s nipocalimab as HDFN treatment

Johnson & Johnson has announced that the FDA has granted breakthrough therapy designation for nipocalimab for the treatment of alloimmunised pregnant individuals at high risk of severe haemolytic disease of the foetus and newborn.

European News

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CHMP grants positive opinion for J&J’s Rybrevant for lung cancer treatment

Janssen, a Johnson & Johnson company, has announced that the CHMP of the EMA has recommended Rybrevant (amivantamab) in combination with chemotherapy.

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Pfizer’s Emblaveo approved in EU for multidrug-resistant infection treatment

Pfizer has announced that the EC has granted marketing authorisation for Emblaveo (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (ciai), hospital-acquired pneumonia (hap), including ventilator-associated pneumonia (vap) and complicated urinary tract infections (cuti), including pyelonephritis.

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EMA accepts two applications for datopotamab deruxtecan for oncology treatments

AstraZeneca has announced that the European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (dato-dxd) in the treatment of two cancers.

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Novo Nordisk’s Awiqli recommended by CHMP for diabetes treatment

Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Awiqli (once-daily basal insulin icodec) for the treatment of diabetes in adult patients.

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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.

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Vertex’s Casgevy for sickle cell disease treatment approved by European Commission

Vertex Pharmaceuticals has announced that the European Commission (EC) has granted conditional marketing authorisation to Casgevy (exagamglogene autotemcel), a crispr/cas9 gene-edited therapy.

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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.

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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.

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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).

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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.

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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.

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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”.

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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+).

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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.

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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.

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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.

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Appointments

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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.

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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.

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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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Dr Alison Evans appointed head of education and training at Drug Safety Research Unit

Drug Safety Research Unit appoints Dr Alison Evans as head of education and training.

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Margrethe Sørgaard appointed SVP clinical operations and pharmacovigilance at Calluna Pharma

Calluna Pharma has announced that it has appointed Margrethe Sørgaard as senior vice president of clinical operations and pharmacovigilance.

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Jaap Stuut appointed as president and general manager of Sakura Finetek Europe

Sakura Finetek Europe has announced the appointment of Jaap Stuut as president and general manager, effective immediately.

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Meenu Chhabra Karson appointed board chair of Harness Therapeutics

Harness Therapeutics has announced the appointment of Meenu Chhabra Karson as chair of its board of directors.

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Bob Kain joins Single Technologies as advisor

Single Technologies has announced that it has appointed Bob Kain as an advisor to support the commercialisation of its 3D sequencing system.

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Joseph Bertelsen appointed CCO of Nuclera

Nuclera has announced that it has appointed Joseph Bertelsen as chief commercial officer (CCO).

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Dr James Malone appointed CTO at BenevolentAI

BenevolentAI has announced that Dr Daniel Neil, current chief technology officer (CTO) is stepping down, to be succeeded by Dr James Malone, who joins the company in April.

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Vynamic appoints new head of life sciences Europe

Vynamic has announced the appointment of Gemma Pfister as head of life sciences Europe.

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Parexel announces new CEO

Parexel has announced that its CEO, Jamie MacDonald will retire, with the company’s current chief operating and growth officer Peyton Howell taking over as CEO, effective 15 May 2024.

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Amylyx Pharmaceuticals appoints Andrew Caldwell as General Manager UK and Ireland

Amylyx Pharmaceuticals has announced that it has appointed Andrew Caldwell to general manager UK and Ireland.

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Georges Rawadi appointed CEO of StromaCare

French biotech company StromaCare has announced the appointment of Georges Rawadi as chief executive officer (CEO).

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AdhereTech appoints Paul Sekhri to board of directors

AdhereTech has announced that it has appointed Paul Sekhri to its board of directors, having begun his new role on 7 February 2024.

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Cuttsy+Cuttsy announces appointment of Jon Hume as commercial director

Cuttsy+Cuttsy has announced the appointment of Jon Hume as commercial director, taking his new role from 1 March 2024.