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- Biotech & Pharma Updates | July 30 - 31, 2024
Biotech & Pharma Updates | July 30 - 31, 2024
J&J lands FDA approval for "foundational" multiple myeloma combo, Eisai drops more Leqembi data in support of long term use, Umoja cleared to dose first patients with their in situ CAR-T, AIRNA raises $60M Series A, Sanofi sues Sarepta over their DMD gene therapy, and EuroAPI is having a tough "transition year"
Sanofi sues Sarepta Therapeutics over alleged patent infringement related to Sarepta’s DMD gene therapy. | Gif: basketsfx on Giphy
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⬇️ The Good News ⬇️
THE GOOD
Approvals & Labels
Johnson & Johnson lands FDA approval for multiple myeloma quadruplet combo therapy
Monoclonal antibody, combo therapy, multiple myeloma, cancer - Read more
SanBio’s chronic motor paralysis stem cell-derived therapy nabs Japan approval
Somatic stem cell-processed product, chronic motor paralysis, traumatic brain injury - Read more
THE GOOD
Business Development
CastleVax lands $31M BARDA award to continue developing intranasal COVID-19 vaccine
COVID-19 vaccine, intranasal delivery - Read more
Chugai Pharmaceuticals buys licensing rights in Japan for Roche’s investigational breast cancer med
Small molecule, breast cancer - Read more
THE GOOD
Clinical Trials
Eisai drop more Leqembi data, making the case for long term use benefits
Monoclonal antibody, Alzheimer’s disease - Read more
AC Immune hopes they have an Alzheimer’s ace up their sleeve with their “morADCs”
Small molecule, antibody-drug conjugates, neurodegeneration, Alzheimer’s disease - Read more
Umoja Biopharma in vivo (in situ) CAR-T IND gets FDA clearance, first patient dosing EOY 2024 expected
In vivo/in situ CAR-T cell therapy, hematologic malignancies, cancer - Read more
Myeloid Therapeutics initiates Ph1 for their second in vivo CAR therapy
In vivo mRNA CAR therapy, liver cancer - Read more
ALX Oncology reports positive Ph2 topline data for gastric cancer fusion protein combo therapy
Fusion protein, combo therapy, gastric cancer - Read more
THE GOOD
Earnings & Finances
Teva Pharmaceuticals shows strong growth in Q2, raises guidance for the rest of 2024 - Read more
Daiichi Sankyo goes in further on ADCs, raises R&D spend by 30% YoY
Antibody-drug conjugate, cancer - Read more (PDF page six under "Core Operating Profit")
Takeda Pharmaceuticals’ Entyvio stands IBD ground against AbbVie’s blockbuster hopeful Skyrizi
Monoclonal antibody, ulcerative colitis, Crohn’s disease - Read more
THE GOOD
Fundraises
AIRNA $60M Series A
RNA editing therapy, Alpha-1 antitrypsin deficiency - Read more
iotaSciences equity raise (amount undisclosed)
Single-cell biology handling, single-cell cloning - Read more
Antag Therapeutics closing in on DKK 377M ($53.7M) fundraise
Obesity, weight loss - Read more [Paywall]
THE GOOD
Partnerships
AbCellera and Eli Lilly expand antibody development partnership
Therapeutic antibody, immunology, cardiovascular, neuroscience - Read more
THE GOOD
Product Launches
inFormed Consent, trifermed launch program that allows researchers to gain clinical trial participant informed consent remotely
Clinical trial, informed consent - Read more
THE GOOD
Research
IRA drug prices reducing biopharma innovation? Not the case argues one study
Inflation reduction act, drug pricing - Read more
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⬇️ The Bad News ⬇️
THE BAD
Approvals & Labels
Zevra Therapeutics faces FDA doubts ahead of adcomm
Small molecule, Niemann-Pick disease type C - Read more [Paywall]
THE BAD
Clinical Trials
PepGen announces “positive” data; analysts are wholly unimpressed
Oligonucleotide, Duchenne muscular dystrophy (DMD) - Read more
THE BAD
Company Shutdown
Tracon Pharmaceuticals calls it quits after Ph2 flunk
Monoclonal antibody, pleomorphic sarcoma, myxofibrosarcoma, cancer - Read more
THE BAD
Earnings & Finances
EuroAPI is going through a tough “transition year”, 10% net sales slide in H1 2024
CDMO, active pharmaceutical ingredient (API) - Read more
Takeda Pharmaceuticals takes $143M impairment charge related to Ovid Therapeutics acquired epilepsy med that flunked in Ph3
Small molecule, epilepsy - Read more
Sangamo Therapeutics needs more than just a Pfizer hemophilia A gene therapy win to stay alive
Gene therapy, hemophilia A - Read more
THE BAD
Lawsuits
Sanofi goes after Sarepta Therapeutics over alleged Elevidys patent infringement
Gene therapy, Duchenne muscular dystropy (DMD) - Read more
THE BAD
Layoffs
FibroGen lead asset failure in Ph2/3 results in 75% US headcount reduction
Monoclonal antibody, pancreatic cancer - Read more
HilleVax lead asset stumble in Ph2b means 40% workforce reduction
Vaccine, norovirus - Read more
Resolve Biosciences shutters San Jose site
Spatial analysis, transcriptome - Read more [LinkedIn post source]
THE BAD
Partnerships
Lundbeck nears end of 17 year depression drug collab with Takeda Pharmaceuticals
Small molecule, antidepressant - Read more
THE BAD
Politics & Policy
Biosecure Act turns attention towards clinical trials run in Chinese military associated sites
Biosecure Act, clinical trial - Read more [Paywall]
THE BAD
Strategic Plans
GSK drops Ph2 HPV vaccine candidate due to lack of “best-in-class potential”
Adjuvanted recombinant protein vaccine, human papillomavirus - Read more
⬇️ The Ugly News ⬇️
THE UGLY
Clinical Trials
MacroGenics halts Ph2 trial over safety concerns
Antibody-drug conjugate, prostrate cancer - Read more
You’re all caught up on the latest Pharma & Biotech News!
Gif: giphystudios2021 on Giphy
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