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Pfizer tightens DMD trial criteria over safety concerns; Kytopen raises $30M; Eli Lilly taps Reify’s Care Access; Vensana Capital raises $325M

Pfizer tightens DMD patient criteria after serious adverse events in phase 3 gene therapy trial Pfizer is tightening up the criteria for Duchenne muscular dystrophy patients to partake in phase 3 clinical trials of its experimental gene therapy after three severe events were cropping up in ongoing studies. Th...

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UNION Therapeutics-Innovent’s collaboration; Delix Therapeutics bags $ 70 M; Biohaven’s Verdiperstat clinical trial result; Intra-Cellular’s CAPLYTA Phase III study

Innovent, UNION Therapeutics Set to Advance Dermatology Market in China  Innovent Biologics and UNION therapeutics have announced a strategic and licensing collaboration to develop and commercialize Orismilast, a next-generation PDE4 inhibitor for inflammatory dermatology conditions in China. Orismilast ...

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Boston Scientific pays $336M; Boehringer Ingelheim acquires Abexxa Biologics; Oncology, RNA biotech 858 Therapeutics inks $60M Series A; Novartis acquires Arctos Medical

Boston Scientific pays USD 336 Million to acquire blood clot medical device firm Boston Scientific Corp. is shelling out as much as USD 336 million to take over the rest of medical device firm Devoro Medical, which it has held a stake in since 2019. The payment comprises USD 269 million paid upfront for the 8...

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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 manag...

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FDA’s New Drug Application to ALS Drug; Approval to BeiGene’s Brukinsa; 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 f...

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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 ...

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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 indic...

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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 ...

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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 s...

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Shape Therapeutics-Roche’s Deal; AllStripes Raises $50M; Datavant-Real Chemistry’s Partnership; BlueWillow’s Nasal Vaccine

Shape Therapeutics inks gene therapy deal with Roche worth up to USD 3 Billion Seattle biotech firm Shape Therapeutics has signed a deal potentially exceeding USD 3 billion with pharma giant Roche to bolster the development of gene therapies for Alzheimer’s and Parkinson’s disease. Shape’s RNA editing technol...

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