// Biotech and Pharma Therapeutics

Roche CEO Schwan Puts 3-Time Alzheimer’s Loser Gantenerumab Back In The Spotlight As FDA’s Controversial Aduhelm OK Inspires Blockbuster Forecasts
July 22, 2021 Biotech / Antibody Drug Conjugate Delivery Four years after Roche opted to resurrect its late-stage effort on their Alzheimer’s program for gantenerumab following a clear failure, Roche CEO Severin Schwan is signaling some fresh enthusiasm for its blockbuster prospects in the wake of the controversial Aduhelm OK. Read Full Article on Endpoints News >>
Industry Taking Notice of Araris Biotech’s Linker Technology for ADC Delivery
July 21, 2021 Biotech / Linker Swiss pharma company Araris Biotech AG is attracting attention based on ongoing research with its linker technology for antibody drug conjugate delivery. The company’s technology is designed to attach any off-the-shelf antibody with any payload without the need for modification. Read Full Article on Biospace >>
Bayer’s Billion-dollar Parkinson’s Disease Bet Snags FDA Fast-track Tag
July 20, 2021 Neurology / Parkinson’s / Gene Therapy The German pharma picked up the treatment, DA01, by buying Versant Ventures out of their regenerative medicine joint venture BlueRock Therapeutics in a deal worth about $1 billion. DA01 is a pluripotent stem cell-derived dopaminergic neuron therapy. Translation? The company takes donor cells that can develop into any cell type in the body and engineers them to become neurons that produce the neurotransmitter dopamine. Those neurons are then transplanted into a part of the brain called the putamen. Read Full Article on Fierce Biotech >>
Ardelyx Latest Biotech Surprised by Unexpected FDA Criticism of Drug Application
July 20, 2021 Diabetes / Chronic Kidney Disease – CKD Ardelyx developed its drug, called tenapanor, as a way for people with chronic kidney disease to control their phosphorus levels. The biotech reported success in multiple Phase 3 trials, but said the FDA took issue with the “size of the treatment effect” observed in testing and “its clinical relevance,” putting the treatment’s future in doubt for that indication. Ardelyx disclosed late Monday the Food and Drug Administration found “deficiencies” with the company’s application to approve its lead drug for patients with kidney disease, a surprise announcement that sent shares falling more than 70%. Read Full Article on BIOPHARMA DIVE >>