UCB and Ferring Pharmaceuticals Inc. today announced they have entered into a co-promotion agreement to commercialize the prefilled syringe formulation of CIMZIA®(certolizumab pegol) in the United States, specifically for the treatment of Crohn's disease (CD). Ferring will take over marketing, sales promotion, and field medical affairs activities. UCB will continue to be responsible for all product-related activities, including revenue recognition. CIMZIA is an injectable biologic treatment option for adults with moderate to severe Crohn's disease with inadequate response to conventional therapy. UCB will continue to promote and to commercialize the lyophilized formulation of CIMZIA for all indications as well as the prefilled syringe formulation for CIMZIA's rheumatology and dermatology indications.
Crohn's disease is an inflammatory bowel disease causing chronic inflammation of the gastrointestinal (GI) tract.2
Read more: https://prn.to/38Dd6vS

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Melbourne-based Affinity Biosciences Pty Ltd (Affinity), a privately held company focused on antibody discovery for cancer therapeutics, today announces the discovery of potent antibodies with therapeutic potential against COVID-19.
In March, Affinity commenced screening its proprietary library of one hundred billion human antibodies to discover those that might neutralise SARS-CoV-2, the virus that causes COVID-19. After discovering a number of candidate antibodies that block the virus spike protein from binding to its human receptor, Affinity engaged The Peter Doherty Institute for Infection and Immunity (Doherty Institute) in April to conduct testing using the virus in the laboratory. The Doherty Institute has confirmed that Affinity's antibodies can completely neutralise the infectivity of SARS-CoV-2 at a single digit microgram/ml concentration in a five-day virus neutralisation assay. The antibodies have high affinity for the SARS-CoV-2 spike protein at around 20 picomolar, driven by an exceptionally slow off-rate, a measure of how long the antibody remains bound to its target.
"Our antibodies latch onto the virus spike protein and block its activity," said Affinity CEO, Dr Peter Smith. "These antibodies may be protective in humans by preventing the virus from gaining a foothold in healthy people exposed to the virus, and may be useful in arresting the progress of the virus in an infected person by blocking its ability to infect new cells and replicate."
Read more: https://prn.to/2NQtYpr

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Novo Nordisk’s oral GLP-1 agonist Rybelsus – a key part of plans to inject growth into its diabetes franchise – has been approved for marketing in Japan.
The green light from the Japanese Ministry of Health, Labour and Welfare (MHLW) follows an FDA approval for Rybelsus (semaglutide) last October, and a recommendation for approval in the EU in February.
Rybelsus is the first and so far only oral alternative to injectable GLP-1 agonists such as Eli Lilly’s Trulicity (dulaglutide) and Novo Nordisk’s Ozempic (semaglutide) and Victoza (liraglutide), and has been tipped as a future blockbuster brand.
Novo Nordisk has a lot riding on the new drug, as the company’s diabetes franchise has been hit by competition from Trulicity as well as downwards pressure on pricing in the US from payers.
Read more: http://www.pmlive.com/pharma_news/novo_nordisk_gets_another_ok_for_oral_glp-1_drug_rybelsus_1343323

Carmine Therapeutics announced today that it has signed a research collaboration agreement with Takeda Pharmaceutical Company Limited ("Takeda") to discover, develop and commercialize transformative non-viral gene therapies for two rare disease targets using Carmine's REGENT(TM) technology, based on red blood cell extracellular vesicles. In addition, Takeda has committed a $5M convertible loan in support of the development of Carmine's novel REGENT(TM) platform.
Under the terms of the agreement, Carmine will receive an upfront payment, research funding support and is eligible for over $900M in total milestone payments plus tiered royalties. Takeda has an option to license the programs following the completion of pre-clinical proof of concept studies and would be responsible for clinical development and commercialization.
Read more: https://prn.to/2CYWCCV

Vertex has won a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its triple combination cystic fibrosis therapy, alongside a host of other recommendations announced in the Committee’s June meeting.
The CHMP has recommended granting a conditional marketing authorisation for the triple therapy, comprised of elexacaftor/tezacaftor/ivacaftor, under the brand name Kaftrio. It is the first triple combination therapy for the treatment of CF in patients aged 12 years and older with one F508del mutation and one minimal function mutation and in patients with two F508del mutations.
The triple therapy was approved by the US Food and Drug Administration (FDA) in October last year, and scored that approval only a few months after filing the combination treatment with the agency. In the US, the drug was approved under the brand name Trikafta, and priced at $311,000 for a year of treatment.
The treatment provides a new treatment option for many CF patients, including for those with certain mutations where no treatment is currently available in the EU.
Read more: http://www.pmlive.com/pharma_news/vertexs_triple_cf_therapy_scores_recommendation_from_chmp_1343261

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