More than two weeks ahead of its expected PDUFA date, PTC Therapeutics Inc.’s spinal muscular atrophy (SM) drug, risdiplam, gained FDA approval, making it the first at-home, oral treatment intended for use in adults and children 2 months and older.
On-demand mental health company Ginger.io scooped up $50 million in a series D round that was led by Advance Venture Partners and Bessemer Venture Partners. Participants also included Cigna Ventures and existing investors such as Jeff Weiner, executive chairman of Linkedin, and Kaiser Permanente Venture.
Keeping you up to date on recent developments in neurology, including: Brain computer improves function in paralyzed patient; Blood test could diagnose brain damage hours after birth; Power-saving, wireless neural implant developed; After injury, astrocytes can make interneurons.
News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz, especially as the companies noted in their press release that the FDA “if possible, plans to act early” on the anti-amyloid beta (a-beta) monoclonal antibody. Regulators’ decision came about 30 days after they took receipt of the submission; they could have waited 60.
Biogen Inc., one the world's top neurological disease specialists, is committing to invest more than $1 billion in cash and equity in Denali Therapeutics Inc. for rights to co-develop and co-commercialize a potential therapy for Parkinson's disease (PD) and options to secure up to four more neurodegenerative disease programs from its new partner.
Bold up-fronts and even bigger milestones defined ambitious neurology deals Abbvie Inc. struck with Voyager Therapeutics Inc. in 2018 and 2019. With vectorized antibodies, they planned to target multiple indications tied to excess aggregations of tau and tragic synucleinopathies. Considerable progress was made, said Omar Khwaja, Voyager's chief medical officer. But despite millions of dollars invested in the programs, Abbvie has now decided to quit the venture, leaving Voyager to either go it alone or find a new partner in its work on the challenging indications.
Medtronic plc has won U.S. FDA approval of its Interstim Micro rechargeable sacral nerve stimulator and Interstim Surescan MRI leads for the treatment of urinary and bowel dysfunctions. The new products make Medtronic the only company to offer a choice between rechargeable and recharge-free sacral neuromodulation (SNM) systems, allowing patients to align their treatment with personal lifestyle preferences.
The U.S. FDA expanded the indications for Stryker Corp.’s Neuroform Atlas stent system to include use in the posterior circulation or back of the brain, making the device the only adjunctive stent approved for aneurysms in this challenging location. The Kalamazoo, Mich.-based company’s intracranial coil-assist stent gained its initial indication for the more common aneurysms in the anterior circulation of the neurovasculature in May 2019.
Keeping you up to date on recent developments in neurology, including: Quanterix biomarker technology used to measure neuronal injury in COVID-19 patients; AI could speed up and improve Alzheimer's diagnosis; Mental fatigue of MS linked to inefficient recruitment of neural resources.
Sangamo Therapeutics Inc. continued its collaboration spree, signing up its sixth big pharma/biotech partner: Novartis AG. The three-target deal will use Sangamo's zinc finger protein transcription factors to up-regulate undisclosed genes to treat autism spectrum disorder and other neurodevelopmental disorders.