Few CMOs equipped to manufacture cell and gene therapies, finds study
A report has said that with only 152 CMOs able to manufacture the 7,000 cell and gene therapies in the pipeline, production bottlenecks may occur.
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Impact of COVID-19 on clinical trials continuing, say researchers
An analysis of the impact of COVID-19 on clinical trials has shown this is increasing, with many sites unable to fully resume practice.
Imfinzi approved in EU to treat extensive-stage small cell lung cancer
Imfinzi (durvalumab) has been approved by the European Commission as a first-line treatment for extensive-stage small cell lung cancer, with chemotherapy.
Russia to supply Mexico with 32 million doses of Sputnik V
The Russian Direct Investment Fund (RDIF) said the supply of the COVID-19 vaccine should enable 25 percent of the population to be vaccinated.
$65 million expansion to HPAPI manufacturing facility
The expansion will be specifically designed to manufacture high-potency active pharmaceutical ingredients (HPAPIs) and complex antibody-drug conjugates (ADCs).
Pfizer and BioNTech may supply EU with 200 million doses of COVID-19 vaccine
The companies and European Commission will soon enter contract negotiations for the supply of their investigational COVID-19 vaccine candidate BNT162b2.
COVID-19 vaccine tablet induces systemic and mucosal immune responses
The researchers suggest inducing a mucosal immune response may be crucial to protect against SARS-CoV-2 infection and that the tablet formulation could overcome several major challenges associated with injectable vaccines.
Biopharma pledges to uphold scientific integrity in COVID-19 vaccine development
Nine biopharma CEOs pledged to make the integrity of the scientific process and sufficient supply priorities in the development of COVID-19 vaccines.
Dexamethasone Taw application to treat COVID-19 to be evaluated by EMA
Dexamethasone Taw will be examined by the EMA on an accelerated assessment timetable, to assess whether it should be given to patients with COVID-19.
British pharma industry responds to new Brexit guidance from MHRA
The ABPI has responded to new guidance, intended to prepare pharma companies for the end of the Brexit transition period, from the MHRA.
EMA safety committee recommends withdrawal of ulipristal acetate marketing authorisation
The EMA's PRAC has recommended the revocation of the marketing authorisation for ulipristal acetate, after a review confirmed liver injury caused by the medicine.
Russia’s Sputnik V COVID-19 vaccine safely elicits an antibody response, reports paper
Preliminary data from Phase I/II trails evaluating the vaccine reveal 100 percent of participants had a humoral and cellular response, with no serious adverse events reported.
Sanofi and GSK initiate Phase I/II trial of COVID-19 vaccine candidate
The trial will evaluate the safety, tolerability and immunogenicity of the duo’s COVID-19 recombinant protein-based vaccine candidate in 440 healthy US participants.
UK to invest £500 million in next generation COVID-19 testing
Matt Hancock has announced that the £500 million investment will go towards new COVID-19 testing technologies and increased testing capacity.
MHRA issues positive opinion to avelumab for Early Access to Medicines Scheme
The UK MHRA has given a positive scientific opinion for Merck and Pfizer's avelumab on the Early Access to Medicines Scheme (EAMS).
