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Five Facts on Clinical Trials in the UK

According to statistics from the Office for Life Sciences, interventional clinical trials in 2023-2024 featured 19,984 participants – a 9.2% reduction compared to the same time frame in 2022-2023.

 12 February 2025
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NDA in China receives priority review status for lung cancer treatment

HUTCHMED has announced that the China National Medical Products Administration (NMPA) have granted a priority review for a new drug application (NDA).

 12 February 2025
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NICE issues positive final guidance for treatment of Duchenne Muscular Dystrophy from Santhera

Santhera Pharmaceuticals has received positive final guidance from the National Institute for Care and Excellence (NICE) for AGAMREE (vamorolone) to be used as treatment of Duchenne Muscular Dystophy (DMD) in patients who are aged 4 or older in the UK.

 12 February 2025
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How digital researchers will transform drug discovery

Rob Brown at Sapio Sciences explores how technologies like natural language processing, generative artificial intelligence and AI agents are revolutionising drug discovery, transforming lab informatics tools like electronic lab notebooks and laboratory information management systems into virtual lab assistants

 12 February 2025
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Opportunities to reduce steroid toxicity and embrace new treatment options for autoimmune patients

John Stone at Steritas analyses the benefits that a quantifiable index system can have for researchers looking into steroid toxicity.

 12 February 2025

Industry Insights

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Solving common challenges in rare disease trials

Ruthie Davi and Elizabeth Lamont at Medidata AI discuss how adopting different approaches, such as synthetic control arms and remote monitoring, can aid researchers in investigating rare diseases.

 12 February 2025
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The future of pharma: how AI will reshape drug development and patient care in 2025

Vikas Jain at Tata Consultancy Services examines three key avenues for AI to be adopted by the pharma industry and the benefits that each adoption can have.

 12 February 2025
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Improving the patient experience: insights from Uganda, the UK and the US

Improving patient experience is increasingly recognised as essential to enhancing healthcare quality, satisfaction and health outcomes across the globe. By understanding the unique challenges and opportunities in different regions, healthcare systems can develop more effective, patient-centred care models.

 6 December 2024
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Sustainable drug delivery devices: striking a balance between aspirations and current possibilities

Alex Fong and Olivia Houselander from Owen Mumford Pharmaceutical Services consider the action needed to make drug discovery processes more sustainable

 17 July 2024
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Exploring disease modification to change the future of epilepsy treatment

Konrad Werhahn from UCB discusses how disease-modifying solutions may introduce a new era in treatment for epilepsies

 17 July 2024
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The role of AI in patient support

Rajul Jain from ProPharma considers how AI can be used in patient support, especially considering how it can be used to streamline operations and supplement human expertise

 17 July 2024

Mergers & Acquisitions

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CANDOR Bioscience acquired by Medix Biochemica

CANDOR Biosciences, a supplier in immunoassay solutions, has been acquired by Medix Biochemica, a supplier of raw materials for in vitro diagnostics (IVD). This will support the vision from Medix Biochemica to become the first-in-choice partner for raw materials in the IVD industry.

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Phillips Medisize closes acquisition of Vectura Group Ltd

Subsidiary of Molex, Phillips Medisize, has announced the successful acquisition of Vectura Group Ltd. The acquisition was completed through an affiliate.

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Stragen Services acquired by ProductLife Group

A division of European specialty generics platform Stragen Group, Stragen Services, has been acquired by ProductLife Group (PLG), a global consulting services specialising in areas around scientific, regulatory, compliance and digital transformation.

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Infrareal acquires former Takeda pharma and biotech site in Austria

Infrareal holding has announced that it has entered into a corresponding transfer agreement with Takeda to acquire the 24-hectare site in Orth, Lower Austria – subject to merger control approval from Austrian regulators.

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Double acquisition by Astoriom helps cement its UK and US presence

Global leader in R&D sample stability and biorepository storage Astoriom has announced the acquisition of both MTS Cryo stores and Cool Repair Scientific UK (both Nottingham, UK).

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Axol Bioscience acquires Phenocell

Earlier this year, Axol Bioscience announced the acquisition of Phenocell SAS with the goal of expanding cell models and services to include dermatology and ophthalmology.

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Stelis, Strides and Steriscience merge to form new CDMO

The CDMO launched earlier this year at the CPHI conference in Milan, Italy.

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University of Edinburgh spinout Kynos Therapeutics acquired by Dr. Falk Pharma

Kynos Therapeutics – a Scottish clinical stage biopharma company focusing on developing novel kynurenine 3-monooxygenase (kmo) inhibitors – has been acquired by Dr. Falk Pharma.

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EyeBio to be acquired by Merck for an upfront $1.3bn

Merck and EyeBiotech Limited, have announced that the two companies have entered into a definitive agreement under which Merck, through one of its subsidiaries, will acquire EyeBio.

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Chemaxon to be acquired by Certara for drug discovery

Certara and Chemaxon have announced that they have signed a definitive agreement under which Certara will acquire Chemaxon.

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Icon Group acquires Pharmaxo as part of strategic partnership

Pharmaxo has announced that it is joining Icon Group as part of a strategic partnership intended to establish a global compounding operator as well as to allow icon to enter the UK market.

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Human Immunology Biosciences to be aquired by Biogen for $1.15bn

Biogen and Human Immunology Biosciences (HI-Bio) have announced that they have entered into a definitive agreement for Biogen to acquire HI-Bio for $1.15bn upfront, alongside up to $650m in potential milestone payments.

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Mirus Bio to be acquired by Merck for $600m

Merck has announced that it has signed a definitive agreement to acquire Mirus Bio for $600m.

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Landos Biopharma to be acquired by AbbVie for approximately $137.5m

AbbVie and Landos Biopharma have announced that they have entered into a definitive agreement under which AbbVie will acquire Landos for an approximate $137.5m ‒ or $20.42 per share ‒ adding to its portfolio in inflammatory and autoimmune diseases.

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Alpine Immune Sciences to be acquired by Vertex for $4.9bn

Vertex Pharmaceuticals and Alpine Immune Sciences have announced that they have entered into a definitive agreement under which Vertex will acquire Alpine for $65 per share, totalling an approximate $4.9bn.

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Johnson & Johnson announces acquisition of Shockwave Medical for $13.1bn

Johnson & Johnson (J&J) and Shockwave Medical have announced that they have entered into a definitive agreement under which J&J will acquire all outstanding shares of Shockwave Medical for $335 per share, or a total value of $13.1bn.

Approvals

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Combination first-in-line treatment approved for patients with non-small cell lung cancer

Johnson & Johnson company Janssen-Cilag Interenational NV has announced news that the European Commission (EC) has approved a marketing authorisation for the combination of LASCLUZE (lazertinib) and RYBREVANT (amivantamab) for first-in-line treatment of adult patients with epidermal growth factor receptor (EGFR) mutations exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations in non-small cell lung cancer (NSCLC).

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MHRA grants marketing authorisation to ANDEMBRY for hereditary angioedema

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to ANDEMBRY (garadacimab) by CSL for the prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients over the age of 12.

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NICE issues positive final guidance for treatment of Duchenne Muscular Dystrophy from Santhera

Santhera Pharmaceuticals has received positive final guidance from the National Institute for Care and Excellence (NICE) for AGAMREE (vamorolone) to be used as treatment of Duchenne Muscular Dystophy (DMD) in patients who are aged 4 or older in the UK.

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Johnson & Johnson receives MHRA approval for BALVERSA

BALVERSA (erdafitinib) has been granted marketing approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of the most common type of bladder cancer, metastatic or unresectable urothelial carcinoma.

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Theramex receives recommendation for YSELTY in Scotland

Theramex, a dedicated women’s health company, has announced that the Scottish Medicines Consortium (SMC) has recommended YSELTY (linzagolix) for the treatment of moderate or severe symptoms of uterine fibroids (UFs) in adult women of reproductive age.

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MHRA greenlights adapted nuvaxovid JN.1 COVID-19 vaccine for ages 12 and up

Approval of an updated version of the Nuvaxovid COVID-19 vaccine, developed by Novavax, has been granted by the Medicines and Healthcare products Regulatory Agency (MHRA), to target the omicron JN.1 COVID-19 subvariant.

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J&J seeks approval for first drug to treat high-risk smouldering myeloma

Earlier in November, Johnson & Johnson Innovative Medicine have applied to the US Food and Drug Agency (FDA) and the European Medicines Agency (EMA) for the approval of a new indication for DARZALEX FASPRO (daratumumab and hyluronidase-fihj).

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NICE gives positive recommendation for Santen’s Roclanda

The National Institute for Health and Care Excellence (NICE) has given a positive recommendation for Santen’s Roclanda (netarsudil 0.02% and latanoprost 0.005%) as an option for patients suffering from primary open-angle glaucoma (poag) or ocular hypertension.

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CHMP adopts positive opinion for new breast cancer drug, Kisquali, from Novartis

Last month, the Committee for Medicinal Products for Human Use (CHMP), which is part of the European Medicines Agency (EMA) announced that it has adopted a positive opinion for Novartis’ Kisquali (ribociclib) as an adjuvant in the treatment of adults with hormone receptor-positive/human epidermal growth factor 2negative (hr+/her2-) early breast cancer (ebc).

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Eplontersen recommended for EU approval by CHMP for hereditary transthyretin-mediated amyloidosis

Wainzua (Eplotersen), produced by AstraZeneca and Ionis, has been recommended for approval in the EU by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP). The drug will be used as a treatment for hereditary transthyretin-mediated amyloidosis in adult patients who have stage 1 or 2 polyneuropathy (commonly referred to as hattr-pn or attrv-pn).

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CytexOrtho receives FDA greenlight for clinical trials into joint repair technology

Clinical stage medical device company CytexOrtho has announced approval from the US Food and Drug Administration (FDA) for its planned phase 1 clinical trial into orthopaedic joint preservation and repair.

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Headlands Research opens new clinical trials site in El Paso, Texas, to serve Hispanic population

Headlands Research, a multinational network of clinical research sites, has launched a new clinical trials site in El Paso, Texas, US.

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Biologic medicine Dupixent approved by FDA for COPD patients in the US

The US Food and Drug Administration has approved Sanofi’s Dupixent as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

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Tiziana Life Sciences awarded $4m grant by NIH to study anti-CD3 in Alzheimer’s disease

Tiziana Life Sciences, a biotechnology company developing immunomodulation therapies, announced that the National Institutes of Health (NIH),'s National Institute on Aging has awarded a $4m grant to Dr Howard Weiner as principal investigator at Brigham and Women’s Hospital to be the key research site to study nasal anti-cd3 for the treatment of alzheimer’s disease (ad).

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European Commission approves Astellas Pharma’s GEJ adenocarcinoma treatment

The European Commission (EC) has approved Astellas Pharma’s vyloy (zolbetuximab) in combination with fluoropyrimidine and platinum-containing chemotherapy as a treatment for adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are claudin (CLDN) 18.2 positive.

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Ministry of Health, Labour and Welfare of Japan approves new drug for early Alzheimer’s disease

The Ministry of Health, Labour and Welfare Japan has approved treatment for Eli Lilly’s KINSULA, indicated for adult patients with early symptomatic Alzheimer’s disease (AD). This also includes patients with mild dementia stage AD, and mild cognitive impairment.

General News

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Moderna named the largest industry sponsor of clinical trials in the UK from 2023-2024

Moderna, a US-based biopharmaceutical company with an expertise in messenger RNA (mRNA), has announced updates in the two years since it signed a ten-year partnership with the UK Government.

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Prenatal care could be revolutionised suggests studies from BrightHeart

Private medical device and artificial intelligence (AI)-led company, BrightHeart, has revealed two studies which show an improvement to pre-natal care through the use of AI technology which received clearance from the US Food and Drug Administration (FDA) in November 2024.

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University of Sheffield trial highlights immunotherapy-related improved survival rates

The University of Sheffield, UK, has announced study results for its trial into the survival rates of patients with operable bladder cancer, finding that those who have immunotherapy before and after the surgery have significantly improved rates of survival.

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European Commission launches new Biotech and Biomanufacturing Hub

The European Commission (EC) has announced the opening of a new Biotech and Biomanufacturing Hub, supporting start-ups and small-to medium-sized enterprises (SMEs) in bringing new innovations to the EU market.

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Alvogen issues voluntary US recall of fentanyl patch amid concerns over defective delivery system

US-based pharmaceutical company Alvogen has issued a voluntary recall of one batch of its Fentanyl Transdermal System 25mcg/h transdermal patches, amid concerns that patches could be multi-stacked in a single product pouch.

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NDA in China receives priority review status for lung cancer treatment

HUTCHMED has announced that the China National Medical Products Administration (NMPA) have granted a priority review for a new drug application (NDA).

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SolasCure partners with US Army for better wound care technology

SolasCure, a biotechnology company that is dedicated to working towards filling the current market gap in debridement – the removal of necrotic tissue to encourage healing – and healing solutions for chronic wounds has announced a partnership with the US Army’s Institute of Surgical Research (USAISR).

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Spinal cord stimulator with AI technology receives CE mark certification

The HFX iq, a personalised spinal cord stimulation (SCS) system developed by Nevro that leverages artificial intelligence technology to manage chronic pain, has received CE mark certification in Europe.

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Antibacterial peptides instrumental in efficiency against resistant bacteria

Earlier in November, the Chalmers University of Technology in Sweden published the results of a study demonstrating that resistant bacteria, when paired with material equipped with antibacterial peptides, can regain susceptibility to antibiotics.

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Cytomos raises £5m for scale-up process

Biotech company Cytomos has announced this month that it has raised £5m to scale up the production of its unique cell analysis technology.

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Revolutionary Alzheimer’s diagnostic blood test launches in the UK

Advance Tests, committed to enhancing diagnostic accessibility and advancing early disease detection, announced the exclusive UK launch of LucentAD complete.

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Survey from Roche finds worryingly low understandings about HPV and cervical cancer

Questioning almost 9,000 participants across 12 countries in Latin America and Europe, the research revealed significant knowledge gaps surrounding human papillomavirus (HPV) and highlighted several significant barriers preventing women from screening for it.

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Best-in-class AI model from Bioptimus integrated into Proscia’s leading software platform

French start-up Bioptimus has announced that its H-optimus-o biology reference artificial intelligence (AI) foundation model has been wholly integrated into Proscia’s Concentriq embeddings software platform, with the aim of enabling quicker and more efficient breakthroughs in ai development for therapeutic research.

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Almirall’s Immunoskin event returns for a third year, discussing medical dermatology advances

Hosted again in Barcelona, Spain, the Immunoskin conference ran from 26-27 October and brought together leading experts in dermatological conditions and treatments.

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EcoVadis Platinum medal given to Liveo Research’s Singapore pharma packaging site

Liveo Research, a leading primary packaging manufacturer, has had the EcoVadis rating of its Singapore site increased from gold to platinum. This means that the pharma packaging site is now rated in the top 1% of the 100,000 companies evaluated by ecovadis in its annual global surveys.

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HUTCHMED set to receive $20m in funding from Takeda for colorectal cancer drug sales

In late October, HUTCHMED’s partner Takeda will pay a milestone payment of $20m as the result of over $200m worth of sales for Fruzaqla (fruquintinib), which treats metastatic colorectal cancer (CRC).

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Appointments

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IDDI announces two new appointments to its leadership team

The International Drug Development Institute (IDDI) has announced changes to its executive leadership team to strengthen the company’s leadership and operational capabilities.

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David Loose appointed CEO of Essex Management

David Loose has been appointed as chief executive officer of Essex Management, part of contract research organisation Emmes Group.

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Jérôme Berger announced as strategy and finance executive at Vect-Horus

Vect-Horus, a private biotechnology company specialising in molecular development, has announced the appointment of Jérôme Berger to its board of directors.

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PrecisionLife appoints new leadership member, Bill Keating, as CCO

PrecisionLife has appointed seasoned executive Bill Keating as chief commercial officer of Diagnostics and Healthcare to drive commercial strategy for precision medicine.

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Dr Joerg Moeller appointed CEO of Antag Therapeutics

Novel obesity treatment-focused biopharmaceutical company Antag Therapeutics has announced the appointment of Joerg Moeller MD PhD as chief executive officer.

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Michael Garrett appointed as new chief executive officer at ExeVir Bio

Exevir Bio, a biotech company focused on developing heavy chain-only antibodies to target highly conserved epitopes for broad-spectrum protection against infectious diseases, has announced the appointment of Michael Garrett as its new CEO.

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Double hiring strengthens Biosynth upper management

Biosynth – known for supplying the life sciences industry with critical raw materials and services – has announced that Matt Gunnison has been appointed as its new CEO and Kieran Murphy has been appointed as chairman.

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Veronica Gambillara Fonck nominated as chair of MinervaX’s board of directors

Following the stepping down of the previous chair, Gerd Zettlmeissl, MinervaX has appointed Veronica Gambillara Fonck to lead the board of directors.

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Darrin Schellin appointed new CEO at Pharma Tech Industries

Pharma Tech Industries, a pharmaceutical manufacturing and packaging solutions contractor for wellness products and medical devices, has announced the appointment of its new chief executive officer, Darrin T Schellin.

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CluePoints appoint Richard Young as chief strategy officer

Cluepoints, a data quality oversight and and risk-based quality management software provider, has announced the appointment of Richard Young as its chief strategy officer.

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Dr Souad Kechairi appointed chief medical officer at PLL Therapeutics

Dr Souad Kechairi has been appointed chief medical officer at PLL Therapeutics, a biopharmaceutical company specialising in polypeptides.

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Shawn Cross appointed as chief financial officer for Pacira Biosciences

Pacira biosciences, specialist in non-opioid pain therapies, has appointed Shawn Cross as its chief financial officer. In this role, Mr Cross will take over all responsibility for the company’s financial operations.

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Prilenia appoints new staff to advance company’s development plans

Prilenia, a clinical stage biotech focusing on neurodegenerative and neurodevelopmental disorders, has announced the appointment of two new senior staff members ‒ Rob Lauzen as chief financial officer (CFO) and Jason Marks as chief legal officer (CLO).

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Steriline’s founder ‘passes torch’ to children with CEO and CSO appointments

Aseptic packaging company Steriline’s founder Gerardo Fumagalli has ‘passed the torch’ to his children Illaria Fumagalli and Federico Fumagalli, who have been appointed to chief executive officer and chief sales officer, respectively. Gerardo will continue on as chairman of the board of directors.

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Eli Lilly expands with two senior hires in Public Affairs and Communications team

Pharmaceutical company Eli Lilly has announced the appointment of two senior positions in its public affairs and communications team.

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Dr Anada Gubbi appointed by SFA Therapeutics as director of Biostatistics

SFA Therapeutics, a clinical-stage biopharmaceutical company, has announced that it has appointed Dr Anada Gubbi as director of biostatistics. Dr Gubbi will be responsible for assisting SFA Therapeutics in effectively developing drug candidates for the treatment of inflammatory diseases.