These are last month’s pharma news and developments brought to you by Congress Bookers, a reliable accommodation partner for lead pharma companies worldwide.
FDA approved Brineura for a specific form of Batten disease
The U.S. Food and Drug Administration approved Brineura as a treatment for a specific form of Batten disease. Being an enzyme replacement therapy, Brineura’s active ingredient (cerliponase alfa) is a recombinant form of human TPP1, the enzyme deficient in patients with CLN2 disease.
Brineura is set to slow loss of walking ability in pediatric patients aged 3 and older suffering from late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase-1 (TPP1) deficiency.
The FDA granted approval of Brineura to BioMarin Pharmaceutical Inc.
Novartis entered clinical trial agreement with Allergan
Novartis entered into a clinical trial agreement with Allergan to use its FXR agonist and Allergan’s cenicriviroc (CVC) for the treatment of non-alcoholic steatohepatitis (NASH) as part of a Phase IIb study.
NASH is known to be one of the biggest triggers of liver diseases leading to liver transplants worldwide. At the moment, there aren’t any approved treatments for NASH.
As part of the agreement, Novartis and Allergan will conduct a Phase IIb clinical trial to assess the safety, efficacy and tolerability of their combines therapies for NASH.
Bristol-Myers Squibb enters into separate agreements with Biogen & Roche
Bristol-Myers Squibb entered into two separate agreements with Biogen and Roche to License anti-eTau and anti-myostatin compounds.
Under the agreements, Bristol- Myers Squibb plans to license BMS-986168, an anti-eTau compound in development for Progressive Supranuclear Palsy (PSP), to Biogen, and BMS-986089, an anti-myostatin adnectin in development for Duchenne Muscular Dystrophy, to Roche.
Roche’s Tecentriq won FDA OK
Genentech, a unit of Swiss drugmaker Roche Holding AG, got approval from the FDA for its already approved immunotherapy drug, Tecentriq, to treat advanced bladder cancer. The FDA granted Tecentriq an accelerated approval as an initial treatment for patients with advanced bladder cancer who are not eligible for standard cisplatin chemotherapy.
Tecentriq belongs to PD-1 inhibitors drug class. The latter helps the immune system fight cancer by blocking a mechanism used by tumors to escape attack.
GlaxoSmithKline’s malaria vaccine Mosquirix to undergo pilot studies in Ghana, Kenya and Malawi
GlaxoSmithKline’s Mosquirix is set to undergo real-world pilot studies in Ghana, Kenya and Malawi, 3 African countries selected by the World Health Organization, starting next year.
The pilots will enroll babies aged between 5 to 17 months. Besides testing the vaccine’s efficacy, the study will also focus upon whether it’s possible or not to deliver 4 doses in the sub-Saharan areas.
World Health Organization selected the three African countries because of their high malaria rates despite broad use of insecticidal bed nets and well-functioning immunization programs.
Takeda partners Harrington Discovery Institute for rare disease therapeutics development
Pharma company Takeda has partnered with Harrington Discovery Institute at University Hospitals in Cleveland, Ohio, to advance breakthrough therapeutic discoveries in rare diseases.
Under the agreement, Takeda will leverage Harrington Discovery Institute’s established operating model to set up a new programme to advance the development of medicines for rare diseases.
The Harrington programme will assist US MD and PhD researchers to carry out disruptive and transformative research, that may lead to the development of new treatments.
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