Investigational New Drug application approved for LINCL treatment
The FDA has granted Investigational New Drug application to PLX-200 to treat late infantile neuronal ceroid lipofuscinosis (LINCL).
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UK biotech records third highest year for investment, study finds
Research has revealed that the biotechnology industry was worth £1.3 billion in 2019, marking its third-highest year for investment.
Effectiveness of HPV vaccines Cervarix and Gardasil under question
Analysis of the designs of Phase II and III efficacy trials for HPV vaccines suggest they overstated their effectiveness against cervical cancer, according to researchers.
European Commission approves Sunosi® (solriamfetol)
EU marketing authorisation has been given to Sunosi (solriamfetol) for excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea.
Pharma to pay NHS Scotland £70m to fund new treatments
The ABPI has announced that the pharmaceutical industry will give the NHS Scotland £70 million, or £1 million a week, to fund new medicines.
Researchers develop vaccine formulation with long shelf life
A study has demonstrated in mice the success of a vaccine design which can be stored at room temperature for long periods of time.
New report shows impressive innovation in HIV first-in-class pipeline
A new report has shown a high level of novelty and diversity for the HIV first-in-class pipeline which targets drug resistance and latency reversal.
Patents for NLRP3 inflammasome-inhibiting compounds granted in US and Europe
Inflazome has announced that the US and EU will grant patents to their NLRP3 inflammasome inhibiting compounds.
Shortage of Accord’s phenytoin sodium expected until May
The UK DHSC has issued an alert that phenytoin sodium 100mg capsules made by Accord will be out of stock until May.
Blockchain will play a pivotal role in the healthcare industry, report predicts
A new report has predicted that, even though the healthcare sector has been slow on the uptake, blockchain will play a pivotal role, creating new ways for pharmaceutical stakeholders to exchange information.
Gilteritinib not recommended by NICE for AML treatment
NICE has said it will not recommend gilteritinib for treatment of acute myeloid leukaemia (AML) due to uncertainty around long-term survival expectancy and its cost-effectiveness.
EC approves Darzalex® in combination with VTd for multiple myeloma
The European Commission (EC) granted marketing authorisation for Darzalex in combination with bortezomib, thalidomide and dexamethasone (VTd) for multiple myeloma patients.
GSK halts Excedrin production due to manufacturing inconsistencies
GlaxoSmithKline has announced that it will not be manufacturing or distributing some of its Excedrin products after inconsistencies in ingredient transfer and weight.
Recommendations made by EMA to unlock big data potential
Ten priority actions have been recommended for the European medicines regulatory network to evolve its approach to data use.
FDA announces drug product recall due to lack of sterility assurance
FUSION IV Pharmaceuticals, Inc dba AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products to the user level as they do not adhere to federal guidelines.