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THE GOOD
Approvals & Labels

Vertex Pharmaceuticals’ Casgevy nabs Health Canada approval
Gene-edited cell therapy, CRISPR/Cas-9, sickle cell disease, beta thalassemia - Read more

Amgen’s Tepezza lands Japan MHLW approval
Monoclonal antibody, thyroid eye disease - Read more

Japan’s MHLW doesn’t sleep on Nxera Pharma’s insomnia med Quviviq, grants approval
Small molecule, insomnia - Read more

Junshi Biosciences scores Europrean EC approval for Loqtorzi in two solid tumor indications
Monoclonal antibody, asopharyngeal carcinoma, oesophageal squamous cell carcinoma, cancer - Read more

IntraBio scores FDA approvals for Aqneursa in Niemann-Pick disease type C (NPC) approval, second ever approval for NPC rapidly following last week’s Miplyffa (Zevra Therapeutics) approval
Small molecule, Niemann-Pick disease type C - Read more

THE GOOD
Business Development

Emergent BioSolutions raking in the infectious disease millions, confirms $400M worth of contracts related to vaccinia, smallpox, mpox vaccines
Vaccine, infectious disease, smallpox, monkeypox (mpox) - Read more

THE GOOD
Clinical Trials

Amgen notches “wins” in both atopic dermatitis (rocatinlimab) and generalized myasthenia gravis (Uplizna); investor reaction mixed
Monoclonal antibody, atopic dermatitis, generalized myasthenia gravis - Read more

More wind in Windtree Therapeutics’ sales as istaroxime notches Ph2 win in addressing low blood pressure caused by cardiogenic shock
Small molecule, cardiogenic shock - Read more

Shield Therapeutics’ iron deficiency med hits pediatric Ph3 main goal
Small molecule, iron deficiency - Read more

Arcutis Biotherapeutics touts “consistent improvement[s]” with Zoryve cream in atopic dermatitis, according to new pooled subgroup analysis Ph3 analysis
Small molecule, atopic dermatitis - Read more

GEN Pharmaceuticals showcases positive Ph2 data for GN-037 in plaque psoriasis
Small molecule, plaque psoriasis - Read more

Silexion Therapeutics “significant” Ph2 data using Loder in pancreatic cancer
RNA, pancreatic cancer - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Fundraises

Genespire $52M Series B
Gene therapy, methylmalonic acidemia, pediatric disease - Read more

Wave Life Sciences’ $200M public offering
Oligonucleotide, RNA, Duchenne's muscular dystrophy, alpha-1 antitrypsin deficiency, Huntington’s disease - Read more

Fzata up to $7M NIH grant
Biologic, chronic visceral pain associated with inflammatory bowel syndrome - Read more

LongBio Series B2 raise, undisclosed amount
Monoclonal antibody, allergy, paroxysmal nocturnal hemoglobinuria - Read more

THE GOOD
Investments

Eurofins CDMO to build new biologics manufacturing site in Mississauga, Canada, $64.1M project ($22.4M from Canada’s Strategic Innovation Fund)
CDMO, biologics manufacturing, contract manufacturing - Read more

THE GOOD
IPOs

BioAge Labs puts numbers to IPO ambitions, $198M projected gross proceeds
Small molecule, obesity, metabolic disease - Read more

THE GOOD
Mergers & Acquisitions

OncoC4’s all-stock merger of AcroImmune
Bispecific antibody, cancer - Read more 

THE GOOD
Partnerships

AskBio (Bayer) gene therapy collab with Belief BioMed
Gene therapy, drug discovery - Read more

Orion, Aitia to leverage AI-enabled oncology “digital twins” in drug discovery collab
AI-enabled drug discovery, drug development, cancer - Read more

I-Mab (TJ Biopharma) collab with Sanofi for uliledlimab development and commercialization
Monoclonal antibody, lung cancer, drug development, commercialization - Read more [Original press release in Chinese]

Coegin Pharma, Scandinavian Biolabs partner on FOL005 portfolio development
Peptide, hair growth, drug development - Read more

THE GOOD
Product Launches

PicnicHealth launches Virtual Site, tool to enable virtual observational studies
Clinical trial design, decentralized clinical trials - Read more 

THE GOOD
Research

Semaglutide use linked to reduced hidradenitis suppurativa (chronic skin condition) flares and improved quality of life in obese patients
GLP-1, obesity, hidradenitis suppurativa - Read more

Semaglutide use also linked to lowered overdose rates in type 2 diabetes patients with opioid use disorder
GLP-1, type 2 diabetes, opioid use disorder - Read more [Paywall]

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THE BAD
Clinical Trials

2seventy bio, Bristol Myers Squibb shutter Abecma multiple myeloma trial
Cell therapy, multiple myeloma, cancer - Read more

Merck & Co. Keytruda + favezelimab colorectal cancer combo misses in Ph3
Monoclonal antibody, colorectal cancer - Read more

Despite Celldex Therapeutics’ positive barzolvolimab Ph2 data in chronic hives, elevated rate of patient discontinuations spook investors
Monoclonal antibody, chronic hives - Read more [Paywall]

THE BAD
Layoffs

Johnson & Johnson allegedly shuttering cardiovascular and metabolic drug units
Cardiovascular diseases, metabolic disease - Read more [Paywall]

Fulcrum Therapeutics cuts 29 staffers (36% reduction)
Small molecule, sickle cell disease - Read more

THE UGLY
Clinical Trials

A Moderna trial site enticed kids with candy…I mean $2000 to participate in COVID-19 clinical trial, drawing UK’s PMCPA ire
Vaccine, COVID-19 booster - Read more

THE UGLY
Withdrawals & Recalls

Pfizer initiates global withdrawal of Oxbryta after patient deaths
Small molecule, sickle cell disease - Read more

Gilead recalls single lot of COVID-19 antiviral Veklury due to glass particulates in vials
Small molecule, COVID-19, antiviral - Read more

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

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