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MINOR HOUSEKEEPING
How these updates are formatted

The newsletter is split into three main sections:

• THE GOOD - good news (eg. fundraises, product approvals)

• THE BAD - negative news (eg. clinical trial failures, layoffs)

• THE UGLY - negative but atypical news (lawsuits, product recalls, scandals)

Within each of the three above parts, there are additional sections for easier navigation:

• Eg. There will be multiple “The Good” sections covering things like Fundraises, Approvals, Partnerships etc.

• There will be also additional tags within these sections (Eg. fundraises may mention Stage, product approvals may mention drug name and disease area.)

See something you want to get into further? Click the Read More (goes out to either a news article or a press release).

One last thing; I know paywalls can be annoying, so there’s a [Paywall] tag for any news stories behind one.

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THE GOOD
Approvals & Labels

AstraZeneca nabs FDA approval for endometrial cancer
Monoclonal antibody, endometrial cancer - Read more

Not to be outdone, Merck’s Keytruda also lands FDA label expansion for endometrial cancer - it’s 3rd indication for this kind of cancer (and 40th indication overall)
Monoclonal antibody, endometrial cancer - Read more

Amgen’s leukemia med gets FDA approval to go after residual cancers cells
Bispecific T-cell engager, consolidation treatment, leukemia, cancer - Read more

Merck lands FDA approval for world’s first adult pneumococcal disease vaccine
Vaccine, pneumococcal pneumonia - Read more

J&J’s medtech division (DePuy Synthes) surgical robot gets FDA go perform partial knee replacements
Medical technology, robot-assisted surgey, knee replacement - Read more

Siemens Healthineers lands European approval for MS relapse risk-assessing blood test
Diagnostics, blood test, multiple sclerosis - Read more

THE GOOD
Business Development

Y-Biologics, IMBiologics and HK inno. N signs out-licensing deal with Navigator Medicines
$20M upfront, $940M biobucks
Dual-antibody, autoimmune - Read more

THE GOOD
Clinical Trials

Disc Medicine touts positive data across their portfolio at EHA
Monoclonal antibody, erythropoietic protoporphyria, myelofibrosis - Read more

AstraZeneca has positive Ph3 lymphoma data
Small molecule, lymphoma, cancer - Read more

Nurix Therapeutics’ has positive Ph1a/b leukemia data
Small molecule, leukemia, cancer - Read more

J&J smells the flowers with positive Ph2 autoimmune data
Monoclonal antibody, Sjögren's disease, autoimmune - Read more

Mirum Pharmaceuticals’ dual positive Ph2B interim cholangitis data
Small molecule, primary biliary cholangitis, primary sclerosing cholangitis - Read more

THE GOOD
Fundraises

Elion Therapeutics $81M Series B
Polyene antifungal, invasive fungal infections - Read more

Decheng Capital targets a $700M life science fund, its fifth
Venture capital, biotech investing - Read more [paywall]

THE GOOD
Investments

J&J commits €580M ($622M) over five years towards Italy-based pharmaceutical manufacturing infrastructure
Manufacturing, drug supply - Read more

THE GOOD
IPOs

Tempus AI has stellar IPO, raises $400M+
Clinical data linking, diagnostic tests, AI - Read more

THE GOOD
Mergers & Acquisitions

Two became one; Spur Therapeutics emerges from combining FreeLine Therapeutics and SwanBio Therapeutics
Gene therapy, CNS disorders, adrenomyeloneuropathy, Gaucher disease - Read more

THE GOOD
Product Development

Leuko is developing a way to monitor chemotherapy patient’s health - without blood tests
Non-invasive monitoring, chemotherapy, cancer - Read more

THE GOOD
Research

How often do animals studies accurately translate into approved therapies? Not often, but more than you’d expect.
Animal studies, medicine approvals - Read more

THE GOOD
Strategic Plans

argenx to host an R&D day next month, showcase their 2030 vision
Future plans, sweeping antibody, autoimmune - Read more

GSK has £3B ($3.8B) Blenrep dreams
Antibody-drug conjugate, myeloma, cancer - Read more

THE BAD
Clinical Trials

Takeda’s $200M bet from 2021 ends up flunking in Ph3
Small molecule, epilepsy, Dravet syndrome, Lennox-Gastaut syndrome - Read more

Double ouch - Marinus Pharmaceuticals faces a failed Ph3 and an investor lawsuit
Small molecule, epilepsy, refractory status epilepticus - Read more

Aerovate Therapeutics suffer a catastrophic drop in blood pressure after Ph2 failure
Small molecule, pulmonary arterial hypertension, blood pressure - Read more

THE BAD
Layoffs

After their DMD failure, Pfizer likely to cut 200 jobs at Sanford site
Gene therapy, manufacturing, Duchenne muscular dystrophy - Read more

THE UGLY
Lawsuits

J&J goes for the appeal over guilty verdict (and $150M in damages) in HIV off-label marketing case
Small molecule, HIV, antiviral - Read more 

THE UGLY
Politics & Policy

Novo Nordisk’s CEO set to testify before Senate committee on GLP-1 drug pricing
GLP-1, drug pricing - Read more 

Republicans call for NIH reorganization
Health agency, reorganization - Read more

THE UGLY
Regulatory

BioNTech, MediLink Therapeutics cancer ADC hit with FDA partial hold, citing “unreasonable and significant risk of illness or injuries”
Antibody drug conjugate, breast cancer, lung cancer - Read more

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

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