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.

So if you have any feedback on what you like (or don’t), I’d love to hear from you!

(You can also reach out to me on LinkedIn)

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 new [Paywall] tag for any news stories behind one.

THE GOOD
Approvals & Labels

NICE work; Pfizer lands NHS approval for rare cardiac disease drug
Small molecule, rare disease, cardiomyopathy - Read more

Regeneron, Sanofi score FDA priority review for new Dupixent indication
Antibody, chronic rhinosinusitis - Read more

Medtronic’s cardiac med device lands Japanese approval
Pulsed field ablation, atrial fibrillation, medical device - Read more

Guardant Health has FDA adcomm for colorectal cancer screening
Colorectal cancer, disease screening - Read more

THE GOOD
Business Development

Takeda secures licensing options for AC Immune’s Alzheimer’s initiatives
$100M upfront, $2.1B biobucks
Antibody, mAb, Alzheimer’s - Read more

Sanofi secures ex-US rights to Fulcrum’s muscular dystrophy treatment
$80M upfront, $975M biobucks + future royalties
Small molecule, facioscapulohumeral muscular dystrophy - Read more

THE GOOD
Clinical Trials

Cardurion nails Phase 2a primary endpoint
Small molecule, heart failure - Read more

Cytokinetics struts positive top-line Phase 3 data, though questions remain
Small molecule, heart failure - Read more

Novo Nordisk hits Phase 3a endpoints for hemophilia A treatment
Bispecific antibody, hemophilia A - Read more

Cytokinetics’ Ph3 data is so good, they’re already prepping their commercial launch
Small molecule, hypertrophic cardiomyopathy - Read more [Paywall]

THE GOOD
Earnings & Finances

Roche’s posts astronomical Vabysmo sales, eating away at Regeneron’s share
Global Vabysmo sales: $933 million, 108% YoY increase
Antibody, mAb, AMD, Edema - Read more

THE GOOD
Fundraises

NewVale Capital raises $165M fund (oversubscribed)
Life science services, CDMO, CRO, logistics - Read more

May Health $25M Series B
Medical device, PCOS-related infertility - Read more

CereVasc $70M Series B
Medical device, normal pressure hydrocephalus - Read more

Ajax Therapeutics $95M Series C
Small molecule, myeloproliferative neoplasms, cancer - Read more

Lycia Therapeutics $106.6M Series C
Small molecule, protein degraders, autoimmune, inflammatory - Read more

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THE GOOD
Investments

Sanofi, Pfizer, AstraZeneca all bolstering France-based operations
€1.87B ($2.03B) total investment
Manufacturing, R&D - Read more

THE GOOD
Market Reports

340B Drug Discount Program grow with no end in sight
340B sales in 2023: $124.1B (wholesale acquisition cost), 16.5% YoY
340B, discount drugs - Read more

THE GOOD
Mergers & Acquisitions

OnKure and Reneo proposed merger with a $65 million private investment in public equity
Small molecule, breast cancer - Read more

THE GOOD
Partnerships

After sluggish Humira biosimilar launch, Boehringer partners with Quallent Pharmaceuticals (Cigna subsidiary)
Antibody, biosimilar, autoimmune - Read more

Senseonics and Rimidi partner on remote patient monitoring
Medical device, diabetes - Read more

Abbvie and Gilgamesh partner on “neuroplastogens” R&D
$65M, $1.95B options + milestones
Psychedelics, small molecule, psychiatry - Read more

THE GOOD
Product Launches

ArcScan surgical device lands Chinese NMPA approval
Eyecare, myopia, ophthalmology - Read more 

THE GOOD
Strategic Plans

Pfizer makes direct-to-consumer move, registers trademark
Direct to consumer - Read more

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THE BAD
Clinical Trials

Merck & Co. drops Ph3 skin cancer trial due to adverse side effects
Antibody, melanoma - Read more [Paywall]

Bristol Myers Squibb’s Ph3 lung cancer trial misses endpoint
Antibody, lung cancer, chemoradiotherapy - Read more

Shionogi Covid-19 treatment misses Ph3 endpoint
Antiviral, Covid-19 - Read more

THE BAD
Layoffs

QuidelOrtho reduces workforce by 5%, 500 employees
Covid-19 testing, diagnostics - Read more

THE BAD
Mergers & Acquisitions

Johnson & Johnson says goodbye to Kenvue spin-off, cutting ties via “debt-for-equity” exchange worth $3.75B
Consumer healthcare - Read more

THE UGLY
Politics & Policy

WuXi AppTec refutes accusations as BIOSECURE saga continues
USA-China relations, biopharma manufacturing - Read more

WHO misses pandemic response agreement deadline, but vows to continue working
Pandemic response, international cooperation - Read more [Paywall]

THE UGLY
Recalls

Ouch! Megadyne recalls pediatric electrodes after burn reports
Medical device, pediatrics - Read more

Tandem Diabetes Care recalls insulin pump iPhone app over glitch
Insulin pump, medical device, diabetes - Read more

THE UGLY
Research

US CMS proposes health data access changes, some researchers not happy
Health data, medical research - Read more [Paywall maybe]

DEEP DIVES & HOT TAKES
Biosimilars time to shine 🤑

The Inflation Reduction Act (IRA) and a wave of pharma patent expiries are causing revenue panic amid big pharma.

One section that’s celebrating though? Biosimilars.

These and other factors are spelling a bright future ahead for expanded biosimilar adoption in the USA.

Read more here.

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

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