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Cognixion receives FDA Breakthrough Device Designation for assisted communication device

May 5, 2023
Medical Communications Cognixion, FDA, Neurology, brain computer interface, breakthrough device designation, neuroscience

Cognixion, a developer of non-invasive Brain-Computer Interface (BCI) and Augmented Reality (AR) technology, has announced that the US Food and …

PureTech Health’s Founded Entity Akili announces positive data from adult ADHD trial

May 4, 2023
Medical Communications ADHD, Akili, Neurology, PureTech Health, clinical trials

Clinical-stage biotherapeutics company PureTech Health has reported that its Founded Entity Akili, a digital medicine company, has announced positive topline …

FDA approves world’s first RSV vaccine

May 4, 2023
Medical Communications FDA, RSV, Vaccine, Virology

The US Food and Drug Administration (FDA) has announced that it has approved the world’s first respiratory syncytial virus (RSV) …

Vicore announces initiation of proof-of-concept study for endothelial dysfunction treatments

May 4, 2023
Research and Development Cardiology, Vicore Pharma, clinical trials, endothelial dysfunction, organ damage

Vicore Pharma Holding AB has announced that it has dosed the first patient with C21 in its randomised, double-blind, placebo-controlled, …

NICE recommends Otsuka’s Lupkynis (voclosporin) in combination treatment for active lupus nephritis

May 4, 2023
Medical Communications MHRA, NICE, Nephrology, Otsuka Pharmaceuticals, lupus nephritis

Otsuka Pharmaceuticals has announced that the National Institutes for Health and Care Excellence (NICE) has recommended Lupkynis (voclosporin) in combination …

Maze Therapeutics and Sanofi sign exclusive worldwide license agreement for Pompe disease treatment

May 3, 2023
Sales and Marketing License Agreement, Pompe disease, Rare Diseases, Sanofi, maze therapeutics, treatment

Maze Therapeutics and Sanofi have announced that they have signed an exclusive worldwide license agreement for Maze’s gluogen synthase 1 …

Avadel Pharmaceuticals granted FDA final approval for narcolepsy drug

May 3, 2023
Medical Communications FDA, FDA Approval, Neurology, avadel pharmaceuticals, narcolepsy, new drug approvals

Irish biopharmaceutical company Avadel Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted final approval and …

Tempus receives FDA Premarket Approval for in vitro diagnostic scan

May 3, 2023
Medical Communications Diagnostics, FDA, Oncology, Tempus, in vitro

US-based artificial intelligence (AI) and precision medicine company Tempus has announced that the US Food and Drug Administration (FDA) has …

Eli Lilly shares positive analysis from phase 3 trial for lebrikizumab for atopic dermatitis

May 3, 2023
Research and Development Dermatology, Eli Lilly, Jenny Murase, atopic dermatitis, dermatology, lebrikizumab

Eli Lilly has announced new secondary analysis from its phase 3 clinical development programme for patients with atopic dermatitis (AD) …

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FDA approves Pfizer’s pneumococcal conjugate vaccine for infants and children

April 28, 2023
Market Access, Research and Development, Sales and Marketing Ear Nose & throat, FDA, Immunology, Pfizer, Vaccine, pneumococcal vaccine

Pfizer has announced that the US Food and Drug Administration (FDA) has approved its PREVNAR 20 (20-valent pneumococcal conjugate vaccine) …

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Boehringer Ingelheim invests €350m in Europe’s largest biotech development centre

April 28, 2023
Manufacturing and Production

Boehringer Ingelheim (BI) have announced that it will invest €350m in a state-of-the-art Biologicals Development Centre (BDC) in Germany. It …

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Daewoong Pharmaceutical and Vitalli Bio enter Global License Agreement for autoimmune disease candidate

April 28, 2023
Research and Development

South Korean Daewoong Pharmaceutical and US biotechnology company Vitalli Bio – a portfolio company of Aditum Bio – have announced …

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Eli Lilly’s tirzepatide achieves 15.7% weight loss in adult patients

April 28, 2023
Research and Development

Eli Lilly has announced that tirzepatide (10mg and 15mg) achieved significant and superior weight loss compared to a placebo over …

First Patient Dosed in the US in Avacta’s AVA6000 Phase 1 Clinical Study

April 27, 2023
Research and Development Avacta

Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics, announces that the …

Novartis Cosentyx® gains positive CHMP opinion for hidradenitis suppurativa

April 27, 2023
Business Services CHMP, Cosentyx, Dermatology, Novartis

Basel, April 26, 2023 â€” Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European …

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GSK’s RSV vaccine candidate gains positive EMA CHMP opinion

April 27, 2023
Medical Communications

GSK has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has shared a …

FDA approves first orally-administered faecal microbiota product for preventing serious gut infection

April 27, 2023
Medical Communications

The US Food and Drug Administration (FDA) has announced that it has approved the first orally-ingested faecal microbiota product for …

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National Institutes of Health awards grant for gammaCore clinical trial for patients with opioid use disorders

April 27, 2023
Research and Development

Bioelectronic medicine and wellness company electroCore have announced that the National Institute on Drug Abuse (NIDA) part of the National …

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NICE recommends two CAR T treatments for blood cancers to the Cancer Drugs Fund

April 27, 2023
Medical Communications

The National Institute for Health and Care Excellence (NICE) has announced that it is recommending two personalised immunotherapy treatments to …

Aldena Therapeutics and Empa Awarded InnoSuisse Funding to Advance STAR Particles as a Novel Drug Delivery Technology for Dermatology

April 26, 2023
Business Services

Boston, Massachusetts, April 26, 2023 – Aldena Therapeutics Inc. (Aldena), a private biotech company pioneering siRNA-based therapies for dermatological indications, …

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