Margaret Keegan joins RQM+ as new CEO
March 29, 2022RQM+, a world leading provider of regulatory, clinical and quality solutions to the MedTech industry, announced the appointment of life …
Injecting real-world data into every day clinical trials – RWE and RWD
March 29, 2022The past two years have seen unprecedented pressure on healthcare systems, its workers, and clinical research as a whole. COVID-19 …
Preparation Preconditions: What measures are needed to combat another pandemic?
March 29, 2022Could we have foreseen the damage caused by the COVID-19 pandemic? This is a central question that has plagued biopharma …
CHMP recommends approval of Janssen’s first CAR-T therapy
March 29, 2022Manufacturing and Production
Johnson & Johnson have announced the CHMP recommendation of marketing authorisation of ciltacabtagene autoleucel (cilta-cel) for the treatment of adults …
Telix granted FDA orphan drug designation for bone marrow conditioning treatment
March 29, 2022Manufacturing and Production
The FDA has granted Orphan Drug Designation (ODD) for TLX66, for conditioning treatment prior to hematopoietic stem cell transplant (HSCT). …
Japan: drug approved for treatment of life-threatening bleeding
March 29, 2022Manufacturing and Production
AstraZeneca has announced that Ondexxya has become the first approved medicine in Japan to reverse the anticoagulant effect of Factor …
BIMZELX effective for moderate to severe plaque psoriasis treatment
March 29, 2022Manufacturing and Production
UCB has revealed results from its Phase III/IIIb trials of BIMZELX (bimekizumab) for the treatment of adults with moderate to …
NICE does not recommend icosapent ethyl for prevention of cardiovascular events
March 28, 2022Sales and Marketing
NICE has published further draft guidance for public consultation which does not recommend VAZKEPA (icosapent ethyl) for reducing the risk …
FDA approve oral solution for rare childhood epilepsy
March 28, 2022Sales and Marketing
UCB has announced that FINTEPLA® (fenfluramine) oral solution CIV has been approved by the FDA for the treatment of seizures …
EMA review first novel gene therapy candidate for haemophilia B
March 28, 2022Sales and Marketing
CSL Behring has today announced that the EMA has accepted the Marketing Authorising Application for etranacogene dezaparvovec (EtranaDez), under its …
Pregnant women to receive life-saving pre-eclampsia check on NHS
March 28, 2022Sales and Marketing
A life-saving blood test that can help diagnose suspected preterm pre-eclampsia has been recommended by NICE, and this is to …
After pressure from patients, ALS drug reviewed by FDA
March 25, 2022Medical Communications
The FDA is meeting next week to review a drug closely watched for ALS, also known as Lou Gehrig’s disease, …
Angle PLC announces identifying therapeutic targets in TNBC patients
March 25, 2022Medical Communications
A leading cancer research institute in Milan, Italy, Fondazione IRCCS Istituto Nazionale dei Tumori, has published results of a study …
FDA grant Breakthrough Therapy Designation for RSV vaccine candidate in older adults
March 25, 2022Medical Communications
Pfizer has announced that its respiratory syncytial virus (RSV) vaccine candidate has received Breakthrough Therapy Designation from the FDA, for …
ViiV Healthcare announces label update for long-acting HIV treatment
March 25, 2022Medical Communications
The FDA has approved a label update for Cabenuva (cabotegravir, rilpivirine), which makes the oral lead-in with cabotegravir and rilpivirine …
AstraZeneca cervical cancer treatment fails to meet endpoint in Phase III trial
March 24, 2022Business Services
AstraZeneca has shared that results from its Calla Phase III trial of Imfinzi for the treatment of locally advanced cervical …
Spot the Difference: A Common Cold, or COVID-19?
March 24, 2022Prior to the pandemic, if you got a runny nose and a sore throat, you would likely assume it was …
Novel therapy could revolutionise treatment for asthma, COPD, among others
March 24, 2022Business Services
A multicenter research team in Texas has developed the first drug to treat the uncontrolled secretion of mucins in the …
FDA approval for castration-resistant prostate cancer
March 24, 2022Business Services
The FDA has approved Novartis’ prostate cancer treatment, Pluvicto™, which is now expected to become available in a few weeks. …
Study finds COVID-19 may double severe complications in pregnancy
March 23, 2022Research and Development
A Kaiser Permanente analysis of pregnant patients who tested positive for COVID-19 found more than double the risk of severe …
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