Jonathan Bowen from Sanofi UK and Ireland explains how indication-based agreements can remove barriers to patient access to combination cancer therapies
Read on for five facts about rare diseases
Giles Partington, Lindsay Govan, Paddy O’Hara, Emily Foreman and Jennifer Visser-Rogers from Phastar consider how data can be used to improve research innovations in rare diseases
Veeva talks to Pharmafocus about the best ways that biopharma companies can boost their engagement
Betsy Goodfellow from Pharmafocus considers the importance of community pharmacies as part of primary care in the UK and the significance of their closure
GSK has announced that the MHRA has authorised its Arexvy respiratory syncytial virus (RSV) vaccine for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults over the age of 60.
Alexander Gebauer from Galimedix Therapeutics talks to Pharmafocus about the link between the two diseases and what the treatment landscape for both could look like in the future
Ameet Nathwani at Dewpoint Therapeutics considers the current treatment landscape for both type 1 and type 2 diabetes, as well as evaluating the use of biomolecular condensates as a potential treatment option
Betsy Goodfellow from Pharmafocus considers the importance of community pharmacies as part of primary care in the UK and the significance of their closure
Giles Partington, Lindsay Govan, Paddy O’Hara, Emily Foreman and Jennifer Visser-Rogers from Phastar consider how data can be used to improve research innovations in rare diseases
Jonathan Bowen from Sanofi UK and Ireland explains how indication-based agreements can remove barriers to patient access to combination cancer therapies
Veeva talks to Pharmafocus about the best ways that biopharma companies can boost their engagement
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.
Moda Living has announced a partnership with LloydsPharmacy to bring residents a ‘health concierge service’ through videogp.
Bristol Myers Squibb’s (BMS) immunotherapy drug opdivo (nivolumab) has become the first to be cleared for NHS use alongside chemotherapy as a pre-surgery (neoadjuvant) therapy for patients with resectable non-small cell lung cancer (NSCLC).
NICE has recommended eight new digital therapies to be used by the NHS for the treatment of mental health disorders
Eli Lilly and AbbVie both announce that they will leave VPAS, causing concern that NHS patients may not receive breakthrough drug treatments
The WHO has shared a medical product alert for an additional contaminated cough syrup medicine identified in Africa.
Astellas Pharma and Mitsui Fudosan have announced that Astellas plans to establish a tumour microenvironment (TME) open innovation hub, intended to open in October 2023.
GSK has announced that the FDA has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (DMMR) or microsatellite instability-high (MSI-H).
Japanese Eisai and US-based biotechnology company Biogen have announced that the FDA has given their Alzheimer’s disease drug Leqembi (lecanemab-irmb) full approval through the approval of a supplemental biologics license application.
FDA has announced that it has approved the Opill (norgestrel) tablet for non-prescription use to prevent pregnancy.
The FDA has announced that it has approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of adult patients with type 1 diabetes.
The US Food and Drug Administration (FDA) has announced that it has approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of adult patients with mild-to-moderate COVID-19 if they are at high risk for progression to severe COVID-19, including hospitalisation or death.
The US Food and Drug Administration (FDA) has released updated guidance for blood donation, which relaxes the rules for donations from men who have sex with men (MSM).
The US centers for disease control and prevention (CDC) have released updated data regarding contaminated eyedrops. As of may 2023, 81 patients in 18 states have tested positive for VIM-GES-CRPA, a rare strain of drug-resistant pseudomonas aeruginosa.
GSK has announced that the US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (SBLA) for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with mismatch repair deficient (DMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.
Global pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has approved its respiratory syncytial virus (RSV) vaccine for the prevention of lower respiratory tract disease (LRTD) caused by RSV in patients aged 60 years or older.
Global pharmaceutical company Bristol Myers Squibb (BMS) has announced that its new drug application (NDA) has been accepted by the US Food and Drug Administration (FDA) for its ros1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) treatment repotrectinib.
The US Food and Drug Administration (FDA) has announced that it has cleared the beta bionics ilet ace pump and the ilet dosing decision software for people over the age of six with type 1 diabetes.
Pfizer has announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) from the US Food and Drug Administration (FDA) has voted in favour of the company’s respiratory syncytial virus (RSV) vaccine for maternal immunisation.
The US Food and Drug Administration (FDA) has announced that it has approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of opioid overdose in adults and paediatric patients over the age of 12.
Abbott has announced that the US Food and Drug Administration (FDA) has granted its clearance for the assert-IQ insertable cardiac monitor (ICM), providing doctors with a new diagnostic option for the evaluation and long-term monitoring of people with irregular heartbeats.
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.
Europe, Feb 1, 2023
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.
Europe, Feb 1, 2023
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.
Europe, Feb 1, 2023
Polish clinical stage biotechnology company Molecure has announced its third quarter results for the period ending 30 September 2022. Its press release also mentions its plans for its R&D day in December, and its strategies and preparations for various phase 1 and 2 clinical trials.
Europe, Dec 1, 2022
Karyopharm Therapeutics and the Menarini Group’s Nexpovio (selinexor) has been granted orphan medicinal product designation by the European Commission (EC). The drug is intended to treat myelofibrosis (MF), a rare kind of bone marrow cancer.
Europe, Dec 1, 2022
AstraZeneca has announced that three of its drugs have been recommended for EU approval. The three drugs are: Imfinzi, Enhertu and Lynparza, all of which can be used to treat different cancers.
Europe, Dec 1, 2022
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!
Welcome to Pharmafocus May 2023! This issue covers the latest news from BMS collaborating with SpaceX to various pharma companies cutting insulin prices, as well as the usual exciting features!
Welcome to the April 2023 issue of Pharmafocus! This issue covers the latest news from new endometriosis clinical trials to MHRA's restored authority following a new Brexit agreement, as well as articles on compounded medication and the impacts of menopause.
Welcome to the March 2023 issue of Pharmafocus! This issue covers the latest pharma news, and features articles on CVD, supply chains and the importance of the patient voice.
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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
Simon Sinclair appointed as chief medical officer of Ondine Biomedical
Immodulon, a late-stage clinical company developing highly differentiated cancer immunotherapies to prime a patient’s own immune system, has announced that it has appointed Dr Josefine Roemmler-Zehrer as chief medical officer.
Sinaptica Therapeutics has announced the appointment of Ken Mariash Jr as chief executive office.
Swiss biotech Engimmune Therapeutics has announced that it has appointed Dr Annalisa D’Andrea to its board of directors as a non-executive director.
Oncology research organisation, Sarah Cannon Research Institute (SCRI) has announced that Ishwaria Subbiah MD MS, has been appointed to the role of executive director of cancer care equity and professional wellness.
LEON has announced the appointment of Dr Setu Kasera as its new chief scientific officer (CSO) effective 15 June 2023.
Private clinical-stage biotech, Aviceda Therapeutics has announced that it has appointed Patrick Johnson to its board of directors.
Clinical stage biopharmaceutical company, Fulcrum Therapeutics, has announced the appointment of Alex C Sapir as CEO and president effective 1 July 2023.
Optibrium has announced the appointment of Dr Hamed Tabatabaei Ghomi as head of research, this is the latest appointment in a series of senior level hires. Ghomi brings with him experience of strategic and industrial research in the bioinformatics space, as well as a positive academic record.
The Janssen pharmaceutical companies, part of Johnson & Johnson (J&J), has announced the appointment of Roz Bekker as the new managing director of Janssen UK and Ireland.
Ingenza has announced the appointment of Steve Jones as chief financial officer (CFO). Jones has over 25 years of industry experience, and has previously held senior financial roles across a range of business sectors.
Syncona ltd has announced the appointment of roel bulthuis as managing partner and head of investments. Bulthuis has over 20 years of experience in life sciences venture capital, business development and investment banking, that he brings with him to his new role.
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