Biogen Phase III choroideremia study did not meet primary endpoint

June 15, 2021
Manufacturing and Production Biogen, choroideremia, phase III

Biogen has announced that its investigational gene therapy study for the potential treatment of choroideremia did not meet its primary …

Bone regeneration stem cell “putty” sees positive results in trials

June 15, 2021
Manufacturing and Production Cell regeneration, Stem cells, bone, platform, technology

Belgian clinical stage company, Novadip Biosciences, has announced positive results from its Phase I trial of its autologous cell-based osteogenic …

Cognito Therapeutics initiates Down syndrome Alzheimer’s study

June 15, 2021
Manufacturing and Production

Cognito Therapeutics are going to run a second digital therapeutic study evaluating individuals who have the genetic rare disease, Down …

Janssen CLL treatment combination sees success in trials

June 14, 2021
Sales and Marketing CLL, Janssen

Janssen has announced positive data from its Phase III GLOW study, with the combination of imbruvica (ibrutinib) plus venetoclax (I+V) …

EMA official recommends avoiding AstraZeneca vaccine

June 14, 2021
Sales and Marketing

A senior executive at the EMA recommended abandoning the use of the AstraZeneca vaccine in the EU where alternatives are …

NICE recommends treatments for rare form of colorectal cancer

June 14, 2021
Sales and Marketing

NICE has recommended BMS’s nivolumab plus ipilimumab (also known as Opdivo and Yervoy) to treat people with a rare form …

Experimental COVID antibody treatment successful in trials

June 14, 2021
Sales and Marketing COVID-19, antibody therapy, celltrion, phase III

Celltrion has announced positive top-line data for its experimental antibody COVID-19 treatment, with Phase III trials finding it safe and …

Germany demands that J&J replace contaminated vaccine doses

June 14, 2021
Sales and Marketing

Germany’s health ministry has demanded that J&J must deliver 6.5 million COVID-19 vaccine doses to Germany in July to make …

Third FDA panel member quits over controversial Alzheimer’s drug approval

June 11, 2021
Medical Communications

The third FDA advisory panel member has quit over the approval of a controversial new Alzheimer’s drug. Biogen’s drug, aducanumab, …

“The future of pain care”: Virtual reality therapy proven to aid chronic pain

June 11, 2021
Medical Communications CBT, Virtual reality, chronic pain management, technology

A novel digital therapeutics software, DTxP, has shown statistically significant benefits for patients with chronic low back pain (CLBP) in …

G7: UK to donate 100 million surplus vaccine doses

June 11, 2021
Medical Communications Boris Johnson, COVID-19, G7, Joe Biden, UK, US, Vaccine

Boris Johnson has announced at the G7 meeting in Cornwall that the UK will donate over 100 million surplus doses …

Sutimlimab meets primary endpoint in treating cold agglutinin disease

June 11, 2021
Medical Communications

A Phase III study evaluating the safety and efficacy of sutimlimab in people with cold agglutinin disease (CAD) met its …

Pharmafile.com’s top 10 news stories of the week

June 11, 2021
Medical Communications

Among our ten most-read stories this week: AstraZeneca vs GSK: Cancer drug court battle could cost hundreds of millions; New …

Phase III breast cancer trial meets primary endpoint

June 10, 2021

Byondis has revealed positive Phase III results for (ADC) [vic-]trastuzumab duocarmazine (SYD985) in patients with HER2-positive unresectable locally advanced or …

Pharmafile.com’s weekly COVID-19 news round-up

June 10, 2021

The past week has seen lots of vaccine-related news, Pfizer-BioNTech has expanded its COVID-19 vaccine study in children under 12, …

NICE release new guidance on rheumatoid arthritis treatment

June 10, 2021
NICE, biosimilar, rheumatoid arthritis

NICE has today published final draft guidance for the treatment of moderate rheumatoid arthritis in patients who have not responded …

SMC approves nintedanib for patients with chronic lung disease

June 10, 2021

The Scottish Medicines Consortium (SMC) has approved nintedanib for NHSScotland for the treatment of adult patients with chronic fibrosing interstitial …

COVID chaos: Survey reveals global oncology trial disruptions

June 10, 2021
data, oncology

The pandemic has had a widespread impact across the healthcare industry and the world, however, a recent global survey from …

Pfizer to expand COVID vaccine study in children under 12

June 10, 2021
COVID-19, Pfizer, Vaccine

Pfizer has announced that it will begin large-scale testing of its COVID-19 vaccine after selecting a lower dose of the …

Phase III trial supports the potential use of Cabometyx for thyroid cancer

June 8, 2021
Manufacturing and Production

Ipsen and Exelixis have announced detailed results from the Phase III COSMIC-311 pivotal trial of Cabozantinib in patients with previously …

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