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First patient dosed in Phase I clinical trial for coronavirus vaccine
A Phase I clinical trial to investigate mRNA-1273, a vaccine to prevent the spread of the coronavirus COVID-19, has begun in the US.
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Therapeutics
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EMA begins safety review of ifosfamide cancer medicines
The EMA has announced the results of its pharmacovigilance meeting for March, saying that it has started a review of medicines containing ifosfamide due to a higher risk of encephalopathy.
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EMA offers free advice to COVID-19 vaccine and therapeutic developers
The European Medicines Agency (EMA) announced it will provide free advice to those working on COVID-19 therapeutics and vaccines in the hopes of accelerating approval of a treatment.
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What pharma needs to know about commercial strategy
European Pharmaceutical Review explores commercial strategy with Dr Simone Seiter, Partner and expert at Simon-Kucher & Partner’s Life Sciences division.
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EC grants Orphan Drug Designation to FLT190, a Fabry Disease treatment
FLT190 gene therapy has been granted Orphan Drug Designation based on preliminary trial data and the positive opinion of an EMA committee.
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Distributing HIV drugs using mobile vans increases viral suppression, finds study
Researchers have shown that using mobile vans to deliver and dispense HIV drugs in South Africa and Uganda helps to combat the disease.
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MHRA issues Medicine Defect Information about Aripiprazole
The regulatory body has issued guidance based on a complaint that stated a precipitate formed in Aripiprazole 1mg/ml oral solution.
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Second patient cured of HIV using stem cell therapy
Researchers report that a patient who underwent stem-cell transplantation and a chemotherapy drug regimen has been cured of HIV.
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Hikma Pharmaceuticals extends Ketorolac Tromethamine recall in US
The FDA has announced that Hikma are now recalling certain lots of Ketorolac Tromethamine injections at the medical facility and retail levels.
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Almost 400 cell and gene therapies in US pipeline, finds report
New research has found that there are 362 cell and gene therapies in clinical pipelines in the US, an increase from 2018.
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New HIV PrEP drug could derail efforts to expand virus prevention coverage
US researchers have stated a newly approved HIV pre-exposure prophylaxis (PrEP) therapy does not have benefits that warrant its price tag and could deter generic competition.
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Ofev® (nintedanib) approved by FDA to treat interstitial lung diseases
The FDA has granted marketing authorisation for Ofev, as the first treatment for patients with chronic fibrosing interstitial lung diseases (ILDs).
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Ten drugs in pre-registration likely to be blockbusters by 2025, finds report
New research has found that of the drugs in the pre-registration phase, 10 are expected to become blockbusters over the next six years.
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Drug delivery method leads to sustained HIV antibody production in study
Using AAV-based technology to deliver mAbs in a Phase I trial, researchers report that participants successfully developed antibodies against HIV.
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FDA and FTC issue warning letters to companies selling fraudulent COVID-19 products
The US agencies have issued letters to seven companies, and removed online listings from others, whose products falsely claim to prevent or treat coronavirus.
