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Cantex secures license to develop small molecule-drug for inflammatory lung diseases

pharmaphorum

Clinical stage pharmaceutical company Cantex Pharmaceuticals has obtained a global licence from Harvard University’s Office of Technology Development to develop the small-molecule drug azeliragon into a treatment for inflammatory lung diseases, including COVID-19. said Cantex CEO Stephen Marcus.

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Lantheus on POINT in radio-oncology with $2bn licensing deal

pharmaphorum

Lantheus’ pipeline-building drive in radiopharma has continued with a $260 million upfront deal to license rights to two oncology candidates from POINT Biopharma. Under the terms of the agreement, POINT will complete the study and, if positive, Lantheus will take responsibility for submitting the drug for approval.

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Sobi bolsters blood division via $435m ADC licensing deal

pharmaphorum

Swedish rare disease specialist Sobi is paying $55 million upfront to license rights to ADC Therapeutics’ lymphoma therapy Zynlonta – approved in the US last year – in Europe and other international markets. In the EU, loncastuximab tesirine has orphan drug designation for the treatment of DLBCL, a form of non-Hodgkin lymphoma (NHL).

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FDA Orphan Drug Designation awarded to rare disease therapies

Drug Discovery World

UK-based biotech SynaptixBio has secured a second Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA). Earlier last year the biotech successfully led a second round of investment, taking the total up to £13.2m ($16.7m), which will take it up to the start of in-human clinical trials later this year.

Drugs 52
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Novavax Vaccine Becomes First FDA-Authorized Protein Vaccine for COVID-19

XTalks

The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) to Novavax’s COVID-19 vaccine, making it the fourth authorized vaccine in the US against COVID-19. Safety data came from about 26,000 clinical trial participants who were administered the vaccine and 25,000 who received placebo. The vaccine was 78.6

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Sourcing Blockbuster Oncology Products for Clinical Trial Supply

XTalks

Oncology products monopolise the list of best-selling drugs. This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. Several oncology products now have “blockbuster” status where sales exceed $1 billion annually.

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FDA accepts to review ImmunityBio’s BLA for bladder cancer treatment

Pharmaceutical Technology

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

Trials 264