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

In win for consumers, Ipsen’s citizen petition rejected by FDA
Small molecule, acromegaly, cancer - Read more [Paywall]

In world first, Cuorips readies iPSC (induced human pluripotent stem cells)-based therapy approval bid in Japan
iPSC, iPS cells, cardiac tissue - Read more

THE GOOD
Clinical Trials*

*With ASCO abstracts out, this is a biiiig section today!

Nimbus Therapeutics positive Ph I/II solid cancer data
Small molecule, cancer, solid tumors - Read more

Pfizer rationalizes Ph1 → Ph3 jump with data
Antibody-drug conjugate, lung cancer - Read more [Paywall]

Merck, Kelun-Biotech show-off positive Ph3 data
Antibody-drug conjugate, breast cancer - Read more [Paywall]

Bristol Myers Squibb & Iovance report clinical data, with the latter claiming “paradigm-changing”
Antibody, cancer - Read more

AffyImmune claims "first documented complete response” for solid tumor treated with CAR-T
CAR-T, cell therapy, cancer, solid tumors - Read more

What CAN’T it do? Novo Nordisk trial demonstrates kidney protection from Semaglutide use
GLP-1, kidney disease, diabetes, obesity - Read more

Merus’ Ph2 data drop sends stock soaring +36%
Bispecific antibody, head & neck cancer - Read more

HI-Bio spills the (clinical data) beans; here’s the data that convinced Biogen to buy them
Antibody, IgA nephropathy - Read more 

Nuvation Bio presents some ROS1y Ph2 data
Small molecule, cancer - Read more [Paywall]

THE GOOD
Earnings & Finances

Medtronic beats estimates and unveils new Hugo surgical trials
Robot-assisted surgery, medical device - Read more

THE GOOD
Fundraises

StrokeDx $5M Seed Funding
Medical device, stroke detection - Read more

Atropos Health $33M Series B
Data, AI, clinical intelligence - Read more

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THE GOOD
Investments

Eli Lilly continues manufacturing expansion, $5B this time
GLP-1, obesity, diabetes - Read more

THE GOOD
IPOs

Actuate Therapeutics actuate-ly files $50M IPO
Small molecule, pancreatic cancer - Read more

THE GOOD
Lawsuits

GSK, Boehringer Ingelheim emerge victorious in first Zantac trial
Small molecule, heartburn, cancer - Read more

THE GOOD
Regulatory

FDA’s Peter Marks wants speedier rare disease GT approvals
Gene therapy, rare disease, Duchenne’s - Read more

THE GOOD
Research

“The pill for dudes” search continues; promising animal studies
Small molecule, male contraceptive - Read more

Diabetic patient is insulin-free for 33 months after cell therapy; world-first
Diabetes, cell therapy - Read more

THE BAD
Approvals & Labels

FDA advisory panel gives a 7-4 thumbs down to Novo Nordisk’s weekly insulin injection
Type 1 diabetes, insulin - Read more

THE BAD
Clinical Trials

Zealand holds out hope for weight-loss competitor despite lackluster results
GLP-1/GLP-2, obesity, weight-loss - Read more

Regeneron’s Ph1/2 clinical data miss
Bispecific antibody, colorectal cancer, solid tumor - Read more 

After two flops, Eli Lilly turns up the radio(ligand) on prostate cancer
Prostate cancer, radiopharma, small molecule - Read more

Verastem reports positive Ph1/2 data, but safety profile seriously spooks investors
Small molecule, pancreatic cancer, solid tumor - Read more

Merck KGaA and Pfizer kidney cancer drug combo takes Ph3 L
Small molecule, monoclonal antibody, kidney cancer - Read more

THE BAD
Opinions

With CAR-T, oncologists are “feeling a little left behind“; survey
CAR-T, cell therapy, cancer, physician opinions - Read more

THE UGLY
Clinical Trials

J&J reports four patient deaths in Ph1 trial
Radiopharma, prostate cancer - Read more

THE UGLY
Lawsuits

FDA sued by consumer advocacy group on SSRI sexual side effect labelling
SSRI, small molecule, side effects, depression - Read more [Paywall]

THE UGLY
Research

Some menopause treatments may raise ovarian cancer risk; study
Menopause, ovarian cancer, hormone therapy - Read more

THE UGLY
Politics & Policy

Canadian’s were promised made-in-canada Covid vaccines - 4 years & $130M+ later, no vials to show for is
Vaccine, Covid-19 - Read more

THE UGLY
Withdrawals & Recalls

FDA issues Class 1 recall for Hologic’s implantable breast cancer surgery marker
Safety warning, breast cancer, surgery - Read more

Pfizer’s Hospira issues sterile injectable recall, 5 drug lots
Small molecule, sterile injectables, blood pressure, pain management - Read more

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

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