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THE GOOD
Approvals & Labels

GSK’s Jemperli expanded endometrial cancer label from the FDA means it’s duel-time with Merck & Co.’s Keytruda
Monoclonal antibody, endometrial cancer - Read more

Adaptimmune makes history with first the USA’s first FDA (accelerated) approval for an engineered cell therapy targeting solid tumors
Engineered cell therapy, synovial sarcoma, cancer - Read more

Bayer submits NDA to FDA for menopause-associated hot flash med
Small molecule, menopause, vasomotor symptoms, hot flash - Read more

THE GOOD
Business Development

Instil Bio pays $50M upfront & near-term, $2B biobucks to ImmuneOnco Biopharmaceuticals for ex-China rights to pair of bispecifics
Bispecific antibody, lung cancer - Read more

Passage Bio out-licences 3 pediatric gene therapy assets to newly-formed GEMMA Biotherapeutics
Gene therapy, GM1 gangliosidosis, Krabbe disease, metachromatic leukodystrophy - Read more

THE GOOD
Clinical Trials

Eli Lilly’s Zepbound (tirzepatide) associated with reduced heart failure risk in Ph3 trial
GLP-1, heart failure - Read more

As part of earning report, Aurinia Pharma announces resurrection of and Ph1 ascending dose study of autoimmune asset AUR200
Fusion protein, autoimmune - Read more

THE GOOD
Company Launches

Gene therapy legend James Wilson leaves the UPenn ivory tower to launch two companies, GEMMA Biotherapeutics and Franklin Biolabs
Gene therapy, AAV, clinical research organization (CRO) - Read more

THE GOOD
Earnings & Finances

Biogen beats expectations with Q2 earnings, bolstered by larger than expected Leqembi sales
Monoclonal antibody, Alzheimer’s disease - Read more

Blueprint Medicines raises guidance on blockbuster hopeful Ayvakit/Ayvakyt (avapritinib)
Small molecule, indolent systemic mastocytosis, cancer - Read more

BD enjoys the GLP-1 hype as demand for pre-filled syringes skyrockets
GLP-1, drug delivery, pre-filled syringes - Read more

Regeneron’s wet AMD med continues sales climb over Q2
Recombinant fusion protein, wet age-related macular degeneration (AMD) - Read more

THE GOOD
Fundraises

venBio closes their fifth life sciences fund, $528M
Venture capital, life science investment - Read more

Outpace Bio $144M Series B
T cell therapy, AI drug development, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer - Read more

Healx $47M Series C
Small molecule, AI drug development, neurofibromatosis, cancer - Read more

THE GOOD
Investments

Sanofi commits €1.3B ($1.4B) for new insulin manufacturing facility
Drug manufacturing, insulin - Read more

Novo Holdings invests £50M ($64M) in Oxford NanoPore
Instrumentation, DNA/RNA sequencing, molecular analysis - Read more

THE GOOD
IPOs

OS Therapies refiles IPO, aiming for $6M total raise
Antibody-drug conjugate, immunotherapy, breast cancer - Read more

THE GOOD
Mergers & Acquisitions

Otsuka Pharmaceuticals acquires Jnana Therapeutics for $800M cash
Small molecule, autoimmune, phenylketonuria, “chemoproteomics” - Read more

AbbVie completes $8.7B Cerevel Therapeutics acquisition
Small molecule, antipsychotic, schizophrenia, Parkinson’s disease - Read more

MilliporeSigma (Merck KGaA) completes $600M (€550M) acquisition of Mirus Bio
CDMO, viral vector manufacturing, bioprocess - Read more

THE GOOD
Partnerships

Valneva, LimmaTech form strategic alliance around latter’s shigella vaccine asset; €10M ($10.8M) upfront to LimmaTech + undisclosed biobucks and future royalties
Vaccine, shigella vaccine, shigellosis - Read more

SymBiosis and HealthTech Arkansas launch biotherapeutics innovation accelerator
Oncology, cancer, immunology, cardiometabolic - Read more

THE GOOD
Strategic Plans

Biogen’s CEO ready to spice things up with riskier, higher potential early-stage medicine acquisitions - Read more

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THE BAD
Clinical Trials

Sage Therapeutics changes Huntington’s trial endpoint ahead of readout
Small molecule, Huntington’s disease - Read more [Paywall]

Ionis Pharmaceuticals cuts Roche-partnered geographic atrophy asset after Ph2 data disappointment
Antisense oligonucleotide, geographic atrophy - Read more

Agios Pharmaceuticals’ pediatric rare disease small molecule misses Ph3 primary endpoint
Small molecule, pyruvate kinase deficiency - Read more 

THE BAD
Earnings & Finances

Merck KGaA’s bladder cancer med Bavencio faces stiff competition from Pfizer, Merck & Co., Astellas’ Padcev/Keytruda combo
Monoclonal antibody, antibody-drug conjugate, bladder cancer - Read more [Paywall]

Moderna cuts full year guidance on plummeting COVID-19 vaccine sale and the recently shrunken RSV vaccine market
Vaccine, COVID-19, respiratory syncytial virus - Read more

THE BAD
Lawsuits

Novo Nordisk’s IRA suit gets rejected, vows to appeal
Inflation reduction act - Read more

THE BAD
Layoffs

uniQure cuts a whopping 65% of workforce (300 jobs)
Gene therapy, Huntington’s disease, temporal lobe epilepsy - Read more

Bayer to cut 70 staffers at New Jersey HQ - Read more

Arbutus Biopharma to cut 40% of staff
RNAi, hepatitis B - Read more

Kyowa Kirin plans “significant reduction” in small molecule R&D division
Small molecule, research & development, drug discovery - Read more

Vir Biotechnology lays off 25% of workforce (140 employees) & cuts multiple clinical programs
siRNA, hepatitis B, T cell-based viral vector platform, COVID-19, influenza - Read more 

THE BAD
Partnerships

Biogen hands back license to amyloid beta tech from Denali Therapeutics
Small molecule, antibody transport vehicle, Alzheimer’s disease - Read more 

THE BAD
Strategic Plans

Takeda, after multiple layoffs, defends Alzheimer’s direction and pact with AC Immune
Liposome vaccine, Alzheimer’s disease - Read more [Paywall]

PBM Cigna promises “aggressive” defence as the PR storm and bad press continues
Pharmacy benefit manager - Read more

THE UGLY
Lawsuits

Novartis isn’t giving up on blocking an Entresto generic, files suit against the FDA
Small molecule, heart failure - Read more

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

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