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Approvals

The latest approvals from the global pharmaceutical industry.

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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.

15 November 2024Approvals
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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).

15 November 2024Approvals
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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).

15 November 2024Approvals
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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.

15 November 2024Approvals
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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.

11 November 2024Approvals
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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.

11 November 2024Approvals
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HIV vaccine candidate successfully optimised for industrial production

Sumagen Canada Inc, a biotech company based in both South Korea and Canada has partnered with CDMO Naobios to industrialise Sumagen’s human immunodeficiency virus (HIV)-1 vaccine candidate (SAV0001) at bench scale.

11 November 2024Approvals
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Aravax successfully recruits for phase 3 peanut allergy treatment study

Clinical-stage biotech company Aravax has announced that it has completed phase 2 recruitment for its precision therapy (pvx108) study, which investigates treatment of peanut allergies.

11 November 2024General News
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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.

10 October 2024Approvals
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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.

10 October 2024Approvals
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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).

10 October 2024R & D
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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.

10 October 2024Approvals