Notizia – Recent Pharma, Healthcare and Biotech Happenings

Biogen’s AMD Biosimilar Gets Approval; SmartLabs Series B Funding; BARDA, Partner Therapeutics in Sepsis Space; Synlogic to Explore Sepsis Market Domain

Win-win for Biogen as its Biosimilar Gets Approval for AMD  Samsung Bioepis and Biogen’s biosimilar drug, Byooviz, received USFDA approval for the treatment of vision loss, Age-related macular degeneration and has become the first biosimilar to Lucentis in the AMD market. The Lucentis copycat had also managed to score regulatory approval in the United Kingdom …

Biogen’s AMD Biosimilar Gets Approval; SmartLabs Series B Funding; BARDA, Partner Therapeutics in Sepsis Space; Synlogic to Explore Sepsis Market Domain Read More »

Series of FDA’s Approvals in ALS Drdeservesymphoma Space; Roche, Temedica Forges Digital Companionship, Shares of Sage Therapeutics Rises

FDA’s Go-Ahead to Amylyx New Drug Application for ALS Drug  Amylyx Pharmaceuticals has announced its plan to submit a New Drug Application (NDA) to the U.S. FDA for its drug, AMX0035 (sodium phenylbutyrate (PB) and Taurursodiol (TURSO)), for the treatment of Amyotrophic lateral sclerosis (ALS).  A few months ago, the company had decided to file …

Series of FDA’s Approvals in ALS Drdeservesymphoma Space; Roche, Temedica Forges Digital Companionship, Shares of Sage Therapeutics Rises Read More »

ADARx Raises $75M Series B; Fast Track Designation for Vor Biopharma’s drug; Ixaka’s cell therapy clears phase 3; Breakthrough Device Designation to NovoTTF-200T™ System

ADARx bags USD 75 Million to advance its RNA tech pipeline ADARx Pharmaceuticals, a biotechnology company developing RNA targeting therapeutics, announced the completion of a USD 75 million Series B financing to progress its drug development pipeline. SR One Capital Management and OrbiMed Advisors co-led Series B. Sirona Capital united this financing as well as …

ADARx Raises $75M Series B; Fast Track Designation for Vor Biopharma’s drug; Ixaka’s cell therapy clears phase 3; Breakthrough Device Designation to NovoTTF-200T™ System Read More »

Roche inks $3B deal; Owlstone raises $58M; FDA approves OCS heart system; Google, Mayo Clinic build brain-mapping AI algorithm

Roche’s Genentech taps Adaptimmune for T-Cell Therapy Collaboration for USD 3 Billion A collaboration valued more than USD 3 billion, Genentech, a member of the Roche Group, declared it will collaborate with Adaptimmune for developing and commercializing allogeneic T-cell therapies to treat multiple cancer indications.  Under their deal Genentech will work with Adaptimmune to develop …

Roche inks $3B deal; Owlstone raises $58M; FDA approves OCS heart system; Google, Mayo Clinic build brain-mapping AI algorithm Read More »

Pfizer’s RSV Vaccine; Forte Biosciences’ Atopic Dermatitis Asset; Bone Therapeutics’ Osteoarthritis Programme; JandJ’s HIV Vaccine Trial; Versanis Bio $70 M Series A Financing; AC Immune’s Alzheimer’s Antibody Drug

Pfizer’s RSV Vaccine enters in the late-stage of clinical trials  As the battle to get an effective Respiratory Syncytial Virus (RSV) vaccine on the market heats up, Pfizer is launching a critical late-stage study of its experimental vaccine against a severe version of a cold virus that may cause pneumonia and death in the young …

Pfizer’s RSV Vaccine; Forte Biosciences’ Atopic Dermatitis Asset; Bone Therapeutics’ Osteoarthritis Programme; JandJ’s HIV Vaccine Trial; Versanis Bio $70 M Series A Financing; AC Immune’s Alzheimer’s Antibody Drug Read More »

Abiomed’s Impella ECP; Helius’s PoNS Device; Smart Meter’s iGlucose BGM; XACT’s CT-Guided Percutaneous Procedures; BD’s Veritor At-Home COVID-19 Test; Delfi’s Liquid Biopsy

FDA awards Breakthrough Device Designation to Impella ECP  On August 18, 2021, Abiomed received breakthrough device designation from the United States Food and Drug Administration (FDA) for its Impella ECP expandable percutaneous heart pump, the world’s smallest heart pump and the first to be compatible with small-bore access and closure techniques.   This designation was based …

Abiomed’s Impella ECP; Helius’s PoNS Device; Smart Meter’s iGlucose BGM; XACT’s CT-Guided Percutaneous Procedures; BD’s Veritor At-Home COVID-19 Test; Delfi’s Liquid Biopsy Read More »

Ascendis’s SKYTROFA; MicroTransponder’s VNS System (Vivistim); BioMarin’s Voxzogo; Zimmer-Canary’s Smart Knee Implant; COVID-19 impact on Solid Organ Transplants

FDA’s Green Flag to Ascendis’s Once-Weekly SKYTROFA for Treatment of Pediatric Growth Hormone Deficiency For the treatment of growth failure due to deficiency of growth hormones, the USFDA approved Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd) for children of one year and older suffering from an improper secretion of endogenous growth hormone (GH). Growth Hormone Deficiency, commonly known …

Ascendis’s SKYTROFA; MicroTransponder’s VNS System (Vivistim); BioMarin’s Voxzogo; Zimmer-Canary’s Smart Knee Implant; COVID-19 impact on Solid Organ Transplants Read More »

BlueRock secures FDA fast track; Omniscient rakes in $29M; Neuspera’s nerve implant gets a $65M boost Rivus’ therapy nabs $35M

BlueRock Therapeutics secures FDA fast track for Parkinson’s disease cell therapy BlueRock, a Bayer subsidiary, is currently assessing the pluripotent stem cell-derived dopaminergic neuron therapy in a phase 1 study. This early-stage trial is set to enroll ten patients across the US and Canada, with its primary aim to evaluate the safety and tolerability of …

BlueRock secures FDA fast track; Omniscient rakes in $29M; Neuspera’s nerve implant gets a $65M boost Rivus’ therapy nabs $35M Read More »

MedTech Wrap Up

Neuros Medical Receives FDA Breakthrough Device Designation for its Novel Altius® High-Frequency Nerve Block System On June 29, 2021, the US Food and Drug Administration (FDA) granted Neuros Medical, Inc. Breakthrough Device Designation for the use of their unique Altius High-Frequency Nerve Block device in the management of chronic intractable pain of the lower limb in …

MedTech Wrap Up Read More »