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

Ride Ph3 data, Innovent Biologics prepares application to NPMA (Chinese FDA)
Antibody, psoriasis - Read more

Pfizer lands priority review voucher for Paxlovid
Small molecule, Covid-19 - Read more

Sanofi lands FDA priority review for combination therapy
Antibody, small molecule, cancer, multiple myeloma - Read more

CamDiab gets FDA green light for smartphone app for Type 1 diabetic pregnant women
Digital health, type 1 diabetes, pregnancy - Read more

THE GOOD
Clinical Trials

Be Biopharma’s B cell therapy for Hemophilia B lands IND clearance
Cell therapy, hemophilia B - Read more 

Arrowhead Pharmaceuticals hits Ph2 bullseye
Oligonucleotide, cholesterol, hyperlipidemia - Read more

AstraZeneca, Daiichi-Sankyo ADC Ph3 reports survival improvement but “did not reach statistical significance”
Antibody-drug conjugate, lung cancer - Read more

ILiAD Biotechnologies avoids getting whooped in Ph2 pertussis trial, hits primary goal
Vaccine, pertussis, whooping cough - Read more

Insmed stock explodes on positive Ph3 results
Small molecule, bronchiectasis - Read more

Novartis’ Ph3 autoimmune kidney disease data ALIGNs well with future FDA submission
Small molecule, immunoglobulin A nephropathy - Read more

Corcept Therapeutics is GRACEd with a hit endpoint in Ph3 trial
Small molecule, hypercortisolism (Cushing’s Syndrome) - Read more

THE GOOD
Earnings & Finances

This is a thing now; OZEM ETF, focused on GLP-1 & weight loss
Stock market, ETF, GLP-1, weight loss, obesity - Read more

THE GOOD
Fundraises

Amplitude Ventures $263M CAD ($192M) second fund
Precision medicine, life sciences & healthcare VC - Read more

CARGO Therapeutics $110M private placement
Cell therapy, cancer - Read more

Spectrum.Life €17M ($18.5M) fundraise
Digital health, mental health - Read more

Riding Ph3 wave, Insmed proposes $500M common stock public offering
Small molecule, bronchiectasis - Read more

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THE GOOD
Mergers & Acquisitions

Asahi Kasei offers to buy Calliditas Therapeutics
$1.1B, stock purchase, 83% premium
Small molecule, immunoglobulin A nephropathy, rare disease - Read more

J&J buys Yellow Jersey Therapeutics (Numab Therapeutics subsidiary)
$1.25B, all-cash
Bispecific antibody, atopic dermatitis - Read more

Palleos Healthcare & OCT Global merger
CRO, contract research - Read more

Merck & Co. nears deal closure to buy EyeBio
$1.3B, all-cash, $1.7B biobucks
Antibody, ophthalmology - Read more

THE GOOD
Partnerships

Abbvie signs deal flow partnership with biotech incubator BaseLaunch
Incubator, early stage investment - Read more

BioNTech forges ADC partnership with MediLink
$25M upfront, $1.8B biobucks
Antibody-drug conjugate, cancer - Read more

Gilead Sciences collabs with Cartography Bioscience
$25M upfront, undisclosed milestones
Drug discovery, computational platform, cancer - Read more

HanALL Biopharma licensing partnership with Turn Biotechnologies
$300M biobucks structure
mRNA, LNP, ophthalmic and otic diseases - Read more

THE GOOD
Regulatory

FDA reveals draft document for platform technologies
Platform technology - Read more

THE GOOD
Research

CAR-T therapy shows promise in curing asthma; mice study
Cell therapy, CAR-T, asthma - Read more

“Trojan Horse” GLP-1 may induce neuroplasticity, increase weight-loss; mice study
GLP-1, obesity, weight-loss - Read more

THE BAD
Clinical Trials

NS Pharma DMD trials RACEs towards Ph3 miss
Oligonucleotide, Duchenne’s - Read more

NIH-funded trials may fall short of diversity targets; study
Clinical diversity, underrepresented groups - Read more

THE BAD
Layoffs

Takeda plans 600+ personnel cuts in Massachusetts - Read more

THE UGLY
Politics & Policy

Louisiana reclassifies mifepristone and misoprostol as schedule IV drugs
Abortion access - Read more [Paywall]

NIH under investigation for allegedly skirting FIOA (Freedom of Information Act) rules during pandemic
Public transparency, Covid-19 - Read more

THE UGLY
Warning Letters & Form 483s

Laurus Synthesis handed “untitled” Form 483 follow-up
Quality control, CDMO - Read more

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

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