Judge orders FDA to produce Pfizer safety data in eight months

January 7, 2022
Medical Communications

A federal judge has ordered the FDA to make public tens of thousands of more pages on the data it …

J&J COVID-19 vaccine shows protection against breakthrough infection for up to six months

January 7, 2022
Medical Communications

J&J have announced new results from the largest study to date on the durability of COVID-19 vaccines in the US. …

Neurimmune and AstraZeneca collaborate to develop human monoclonal antibody

January 7, 2022
Medical Communications

Neurimmune AG announced that it has entered into an exclusive global collaboration and license agreement with Alexion, AstraZeneca Rare Disease …

FDA grant Breakthrough Therapy Designation to telisotuzumab vedotin

January 6, 2022
Business Services

AbbVie’s investigational telisotuzumab vedotin has been granted Breakthrough Therapy Designation by the FDA for the treatment of patients with advanced …

Cyclenium Pharma and Vuja De Sciences collaborate on oncology drug discovery

January 6, 2022
Business Services

Cyclenium Pharma, an emerging pharmaceutical company, have announced a collaboration with Vuja De Sciences, to screen and optimise lead candidates …

FDA grants regenerative medicine advanced therapy designation to AlloVir’s posoleucel

January 6, 2022
Business Services

The FDA has granted AlloVir’s posoleucel Regenerative Medicine Advanced Therapy Designation (RMAT), for the treatment of adenovirus infections in adults …

Jazz Pharmeuticals announces Phase III data of idiopathic hypersomnia treatment

January 6, 2022
Business Services

Jazz Pharmaceuticals have announced that positive data, from the Phase III of Xywav oral solution for the treatment of adults …

Bharat Biotech receives approval to test nasal COVID-19 shot as booster

January 5, 2022
Research and Development

India’s drug regulator has granted approval to Bharat Biotech, for late stage trials of its nasal COVID-19 vaccine to be …

FDA grants breakthrough therapy designation to novel EGFR inhibitor

January 5, 2022
Research and Development

The FDA has granted a  breakthrough therapy designation to Cullian Oncology’s CLN-081, in certain patients with locally advanced or metastatic …

NaNotics and Mayo Clinic to collaborate on nanomedicine cancer treatment

January 5, 2022
Research and Development

Nanomedical company NaNotics have announced a research collaboration with Mayo Clinic, to develop a NaNot that targets the soluble form …

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NICE recommends PONVORY for the treatment of relapsing forms of multiple sclerosis

January 5, 2022
Research and Development

NICE has issued a positive Final Appraisal Document (FAD) recommending PONVORY® (ponesimod) as an option in England and Wales for …

Further evidence shows Omicron causes milder symptoms

January 4, 2022

A WHO official has said more evidence is emerging to support that the Omicron variant causes milder symptoms than previous …

Theranos founder Elizabeth Holmes found guilty of fraud

January 4, 2022
Manufacturing and Production

Elizabeth Holmes, founder of Theranos, has been found guilty on four of 11 charges of fraud, including one count of …

FDA expands Pfizer COVID-19 booster shot EUA for children aged 12-15

January 4, 2022
Manufacturing and Production

The FDA has bypassed its advisory panel and extended its Emergency Use Authorisation (EUA) for Pfizer BioNTech’s COVID-19 booster vaccine …

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Santhera enters exclusive license agreement with Sperogenix for Vamorolone in rare diseases

January 4, 2022
Manufacturing and Production

Santhera Pharmaceuticals has announced that it has entered into an exclusive license agreement with China-based company, Sperogenix Therapeutics, specialising in …

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NICE recommends combination treatment for patients with multiple myeloma

December 24, 2021
Medical Communications

NICE has recommended the use of Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) as induction and …

MHRA approves license extension for Novartis’ breast cancer targeted therapy

December 24, 2021
Medical Communications

The MHRA has approved the marketing authorisation to extend Novartis’ licence in Great Britain for Piqray (alpelisib), for use in …

Veklury demonstrates reduced risk of hospitalisation in high-risk patients with COVID-19

December 23, 2021
Business Services

Gilead Sciences have announced full results from a Phase III investigational study, evaluating the efficacy and safety of a three-day …

FDA approves Novartis’ Cosentyx for psoriatic arthritis patients

December 23, 2021

The FDA has approved Cosentyx (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in children four years and older, …

Avacta lateral flow test receives CE mark for consumer self-testing

December 22, 2021
Research and Development

Avacta Group plc, a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® …

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