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THE GOOD
Approvals & Labels

Eli Lilly’s Kisunla scores Japan MHLW approval
Monoclonal antibody, Alzheimer’s disease - Read more

HutchMed lands Japan MHLW approval for Fruzaqla
Small molecule, colorectal cancer - Read more

Aurinia Pharmaceuticals’ Japan MHLW approval for Lupkynis
Peptide, lupus nephritis - Read more

Catalyst Pharmaceuticals, DyDo Pharma land Japan MHLW approval for Firdapse
Small molecule, autoimmune, Lambert-Eaton myasthenic syndrome - Read more

Capricor Therapeutics stock skyrockets after announcing FDA BLA filing intention for deramiocel in DMD
Cell therapy, Duchenne muscular dystrophy cardiomyopathy - Read more

Roche’s dual-stain cytology test for cervical cancer prevention get’s WHO endorsement
Cancer screening, cytology, cervical cancer - Read more

THE GOOD
Business Development

Surrozen scores $10M milestone payment as Boehringer Ingelheim prepares SZN-413 for clinical testing
Bispecific antibody, retinal vascular disease - Read more

THE GOOD
Clinical Trials

Wave Life Sciences stock jumps on positive interim Ph2 data for WVE-N531 in DMD
Oligonucleotide, Duchenne’s muscular dystrophy - Read more

Biogen, UCB’s lupus trials vindicated after nearly two decades, positive Ph3 results for dapirolizumab pegol
Fab fragment, lupus - Read more

Metsera showcases enticing Ph1 data for ultra-long lasting GLP-1 agonist MET-09
GLP-1, obesity - Read more

THE GOOD
Company Launches

Aptadir Therapeutics launches with $1.6M Pre-seed and a new class of RNA-inhibitors
Small molecule, myelodysplastic syndrome - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Fundraises

Constructive Bio $58M Series A
Cellular biofactories, manufacturing - Read more

LIfT Biosciences £10M ($18M) Series A
Cell therapy, allogeneic, cancer - Read more

VerImmune $4.5M Pre-Series A first close
Virus-inspired particles, cancer - Read more

Bio-Sourcing €2.5M ($2.8M) in grants and €10M ($11.2M) in equity from the Europe’s EIC Accelerator for goat-based biomanufacturing
Monoclonal antibody, biomanufacturings, goats - Read more

ResVita Bio $2M NIH grant
Protein therapy, Netherton Syndrome - Read more

THE GOOD
Investments

PCI Pharma Services plans US and EU expansions to the tune of $365M
CDMO, contract manufacturing, site expansion - Read more

THE GOOD
Lawsuits

Amgen notches legal win against Regeneron in Pavblu (Eylea biosimilar) row
Fusion protein, macular degeneration, biosimilar - Read more

THE GOOD
Mergers & Acquisitions

Minaris Regenerative Medicine to be acquired by investment firm Altaris
CDMO, cell therapy, contract manufacturing - Read more

THE GOOD
Opinions

Physician survey suggests reasons for why AbbVie’s Humira is still holding on despite increased biosimilar pressure
Monoclonal antibody, autoimmune, biosimilar - Read more

THE GOOD
Partnerships

Novartis makes “multi-target collaboration” with Flagship Pioneering’s Generate:Biomedicines, $65M upfront (includes $15M equity purchase) & $1B+ in biobucks
Protein, drug discovery, AI - Read more

Adaptimmune Therapeutics finalizes collaboration termination settlement with Genentech, Roche
Cell therapy, allogeneic T-cell, cancer - Read more

Lonza, Vertex Pharmaceuticals sign supply agreement for Casgevy
Gene-edited cell therapy, CRISPR, CDMO, manufacturing - Read more

Legend Biotech, Multiply Labs partner on enabling robotics-driven cell therapy manufacturing
Cell therapy manufacturing, robotics, automated manufacturing - Read more

Nona Biosciences, Alkyon Therapeutics sign immunotherapy discovery and development collaboration
Monoclonal antibody, drug development, drug discovery, solid tumor, cancer - Read more

Ribo Life Science, Ribocure Pharmaceuticals sign RNA drug discovery, development partnership with Pheiron
RNA, drug discovery, drug development - Read more

THE GOOD
Politics & Policy

US reauthorizes FDA’s rare pediatric priority review voucher program
Rare pediatric disease priority review voucher - Read more [Paywall]

Sen. Bernie Sanders assures Novo Nordisk that they won’t be penalized by PBMs for lowering GLP-1 prices
GLP-1, obesity, drug pricing, pharmacy benefit manager - Read more [Paywall]

US lawmakers push for “march-in” rights to allow generic versions of GLP-1 drugs to enter US market, promote competition and lower prices
GLP-1, obesity, drug pricing, drug patent - Read more

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THE BAD
Layoffs

bluebird bio goes through restructuring again, lays off another 25% of workforce
Gene therapy - Read more

AGC Biologics mothballs Colorado CGT manufacturing facility, lays off 68 employees
CDMO, cell and gene therapy manufacturing, contract manufacturing - Read more

THE BAD
Mergers & Acquisitions

Revance Therapeutics acquisition by Crown Laboratories hits speed pump due to Teoxane dispute
Recombinant protein, neurotoxin, glabellar lines, cervical dystonia - Read moreRead more

THE BAD
Politics & Policy

Novo Nordisk’s CEO ain’t buying PBM no-penalization promise if GLP-1 blockbuster prices drop
GLP-1, obesity, drug pricing - Read more [Paywall]

THE BAD
Regulatory

FDA considers narrowing PD-1 inhibitor labels in stomach cancer, could affect Bristol Myer Squibb’s Opdivo, Merck & Co.’s Keytruda and BeiGene’s Tevimbra
Monoclonal antibody, stomach cancer - Read more

THE UGLY
Lawsuits

Baltimore sues Biogen over alleged PBM “bribes” to favour their Tecfidera MS drug over generics
Small molecule, multiple sclerosis, generic, pharmacy benefit manager - Read more [Paywall]

THE UGLY
Public Health

SIGA Technologies fires their CMO after pandemic-era parties disclosed in secret recordings
Covid-19, pandemic - Read more [Paywall]

You’re all caught up on the latest Pharma & Biotech News!

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