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FDA approves 3rd drug for spinal muscular atrophy
The FDA has cleared Genentech's Evrysdi drug for spinal muscular atrophy in adults and children 2 months of age and older, according to an Aug. 10 announcement. -
Biologic Association enrolls 6,000+ members
More than 6,000 members have joined the Biologic Association within the first six months of its website launch. -
Bioventus, Cerapedics & more: 8 orthobiologic companies making waves in 2020
Since the beginning of the year, Becker's Spine Review has reported on eight orthobiologic and regenerative medicine companies that have launched new products, received FDA clearances and demonstrated favorable outcomes in clinical trials: -
Cerapedics reduces number of patients for TLIF bone graft clinical trial
Orthobiologics company Cerapedics received FDA approval to reduce the number of patients required for its P-15L bone graft clinical trial. -
Spine Wave introduces new allograft
Spinal implant developer Spine Wave has launched its Tempest Allograft Bone Matrix, according to a July 14 news release. -
Bioventus invests $15M in CartiHeal with option for acquisition
Orthobiologics company Bioventus said July 16 that it has invested $15 million in CartiHeal and agreed on an option structure to acquire the company pending approval of its Agili-C implant. -
Baxter bone graft gets green light for spine surgery
Orthobiologics company Baxter has received FDA clearance July 9 for its Altapore Shape Bioactive Bone Graft for spine surgery, according to Biospace. -
Aziyo Biologics launches bone matrix for orthopedic surgery
Regenerative medicine company Aziyo Biologics on June 29 launched OsteoGro V, a viable cell bone matrix to assist with bone repair. -
Bioventus launches new-look bone graft for complex spine surgery
Orthobiologics company Bioventus on June 25 launched its Signafuse bioactive bone graft in a strip format. -
4 recent advancements in spinal biologics
Here are four key developments in spinal biologics in the last month: -
$3.4M raised by biomaterials startup for scaffolds to treat spinal cord injuries
Biomaterials startup Spiderwort has closed a $3.4 million seed financing round one year after it secured $500,000 in a friends and family funding round, Betakit reports. -
SpineOvations' DiscSeal trial shows positive signs for reducing lumbar pain
Minimally invasive spine therapy company SpineOvations reported favorable results at the midpoint of its DiscSeal clinical trial. -
$2.1M spinal muscular atrophy drug gains European approval
The European Commission recently approved Zolgensma, Novartis' $2.1 million gene therapy drug for spinal muscular atrophy, for infants and children up to 46 pounds. -
The Spine Journal: Cerapedics' bone graft achieves higher fusion rate than allograft in lumbar fusion trial
Orthobiologics company Cerapedics published data from a clinical trial examining the fusion rate of its i-Factor bone graft in noninstrumented lumbar fusion. -
Alume Biosciences to begin nerve imaging clinical trial for spine surgery
The FDA on May 4 granted biotechnology company Alume Biosciences permission to investigate the use of a nerve imaging drug during spine surgery, Biospace reports. -
Carmell Therapeutics biologic for accelerated bone healing gains expedited review
The FDA granted Carmell Therapeutics Fast Track designation on April 27 for its debut product, a bone healing accelerant, OA Online reports. -
Bone Therapeutics hires new chief business officer
Stefanos Theoharis, PhD, was appointed chief business officer of Bone Therapeutics on March 26. -
$2.5B in sales projected for Novartis' spinal muscular atrophy drug by 2025
Zolgensma, Novartis' gene therapy drug for spinal muscular atrophy, recently demonstrated significant therapeutic benefits for patients in various extended clinical trials, reports Pharmaceutical Technology. -
Novartis' $2.1M gene therapy drug gains Japanese approval, seeking approval in 30+ countries
The Japanese Ministry of Health, Labour and Welfare recently approved Zolgensma, Novartis' gene therapy drug for the treatment of spinal muscular atrophy, for infants under the age of 2, according to Medical Dialogues. -
Anika Therapeutics' vision of a biologics-led future
Regenerative medicine therapies hold much potential in the orthopedic space, despite the lack of comprehensive knowledge around the therapies. Here, Anika Therapeutics interim CEO Cheryl Blanchard, PhD, explains how the company plans to approach the biologics market.
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