Welcome to the TLDR Biotech newsletter!

TLDR Biotech aims to be your one-stop source for biotech and pharma updates - all with one daily email.

I’m always looking to make these news compilations more informative, impactful, and easy to navigate.

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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

Bayer & BlueRock Therapeutics’ Parkinson’s therapy gains FDA RMAT (Regenerative Medicine Advanced Therapy) designation
Cell therapy, Parkinson’s - Read more

Bristol Myers Squibb expands Breyanzi label to cover new lymphoma indication
Cell therapy, CAR-T, cancer - Read more

With PDUFA date approaching, Verona’s COPD treatment could give Sanofi and Regeneron a run for their money
Small molecule, chronic obstructive pulmonary disorder - Read more

THE GOOD
Business Development

Compugen hits clinical milestone, to receive $5M from AstraZeneca
Bispecific antibody, lung cancer - Read more

Nxera Pharma hits clinical milestone, to receive $4.6M from Centessa Pharmaceuticals
Small molecule, narcolepsy, hypersomnia - Read more

THE GOOD
Clinical Trials

Summit Therapeutics beats Merck at it’s own game, Keytruda out-performed in head-to-head Ph3
Bispecific antibody, lung cancer - Read more

Ultragenyx stores sweet Ph3 gene therapy win
Gene therapy, AAV, glycogen storage diseases - Read more

BridgeBio whips out more positive Ph3 data
Small molecule, transthyretin amyloid cardiomyopathy - Read more

Soterios Pharma grows some hair on positive Ph2 data
Topical steroid, alopecia areata - Read more

Strand Therapeutics STX their initial landing with first patient dosed in Ph1 trial
mRNA, cancer - Read more

THE GOOD
Company Incubation

BioTools Innovator announces 2024 cohort, 20 Startups
Life science tools, diagnostics - Read more

MedTech Innovator announces 2024 cohort, 65 Startups
Medtech, medical devices - Read more

THE GOOD
Company Launches

Otsuka goes against the grain and launches a digital health company
Digital health, digital therapeutics - Read more

THE GOOD
Fundraises

Matter Bio $7M Seed raise
Genome integrity, lifespan extension - Read more

Weave Bio $10M Seed raise
Regulatory filing tech, AI - Read more

CinRx Pharma raises $73M
Biotech investment, hub-and-spoke - Read more

Natural Cycles $55M Series C
Birth control app - Read more

Celcuity aims for additional $62M in debt financing (and announces a Ph3 trial)
Small molecule, breast cancer - Read more

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THE GOOD
Investments

Novo Nordisk Foundation plans on plowing some GLP-1 spoils into regenerative medicine
GLP-1, regenerative medicine - Read more [Paywall]

THE GOOD
Lawsuits

Novo Nordisk goes after orgs selling allegedly impure semaglutide-containing products
GLP-1, semaglutide, compounding - Read more

Pfizer ducks some Chantix carcinogen claims after court ruling
Small molecule, smoking cessation - Read more

THE GOOD
Marketing

Having lymphoma = holding a huge boulder, at least according to Novartis’ market department - Read more

THE GOOD
Partnerships

Anocca, Shinobi Therapeutics cell therapy development partnership
Cell therapy, TCR-T cells, cancer - Read more

A public-private collaboration aims to understand ALS clinical trials and why they fail; deep dive
ALS, Lou Gehrig’s Disease - Read more

Nxera Pharma, PrecisionLife strategic R&D partnership
Auto-immune disorders, drug discovery - Read more

THE GOOD
Regulatory

Massive FDA reorganization to being in October this year
Organizational structure, inspections - Read more

THE GOOD
Research

Antibiotic selectively targets gram-negative bacteria, but spares healthy gut fauna; mouse models
Antibiotics, gut health, health bacteria - Read more

Retrospective study finds potential link between semaglutide use and curbing alcoholism
Semaglutide, GLP-1, alcohol use disorder - Read more

THE BAD
Clinical Trials

Immunovant postpones Ph3 trial readout as pipeline gets reshuffled
Antibody, myasthenia gravis - Read more

Novartis drops lung cancer med in Ph3 due to “increasing option available”
Small molecule, lung cancer - Read more [Paywall]

THE BAD
Patient Access

UK’s NHS plays “wait-and-see” on Grail cancer screening, postpones 1M people/year order
Cancer screening, detection - Read more

THE UGLY
Lawsuits

Clinical lab trade group goes after FDA on new lab testing regulations
Lab-developed tests - Read more [Paywall]

THE UGLY
Marketing

Doctors on social media get paid for drugs endorsements, raising ethical concerns; government database - Read more

THE UGLY
Withdrawals & Recalls

Particulate concerns force Sagent to withdraw 2 lots of chemotherapy meds
Small molecule, cancer, drug shortages - Read more 

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

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