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.

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THE GOOD
Approvals & Labels

Atara Biotherapeutics makes history by submitting the first ever BLA to the FDA for an allogeneic T-cell therapy
Cell therapy, allogeneic, cancer, autoimmune - Read more

Europe Commission decides not to revoke PTC Therapeutics’ DMD therapy approval
Small molecule, duchenne muscular dystrophy - Read more

FDA hands our first two approvals for Eylea biosimilars; one to Biocon and Samsung Bioepis, the other to Biogen
Fusion protein, edema, AMD - Read more

Implicity - lands FDA 510(k) clearance for heart failure algorithm
Algorithm, pacemaker, hart failure - Read more

THE GOOD
Clinical Trials

Gilead’s $4.3B CymaBay acquisition yields positive Ph3 data
Small molecule, primary biliary cholangitis, liver - Read more

Dyne Therapeutics dual Ph1/2 DMD and DM1 clinical data skyrockets stock price
Fusion protein, myotonic dystrophy type 1, Duchenne muscular dystrophy - Read more (Paywall)

Amgen, AstraZeneca’s COPD Ph2a didn’t meet endpoint, but still helped a patient subpopulation
Monoclonal antibody, chronic obstructive pulmonary disorder - Read more

…while COPD competitors Sanofi, Regeneron show positive Ph3 data for the same condition
Monoclonal antibody, chronic obstructive pulmonary disease - Read more

Endeavor BioMedicines and Vicore Pharma both present promising IPF trial data
Small molecule, idiopathic pulmonary fibrosis - Read more

J&J posts positive Ph3 UC data as predecessor blockbuster Stelara nears patent cliff
Monoclonal antibody, ulcerative colitis - Read more

Boston Scientific achieves harmony from discordant cardiac rhythms, aiming for 2025 approval
Medical device, discordant cardiac rhythms - Read more

Arrowhead Pharmaceuticals hits bullseye with Phase 1/2 data
RNAi, inflammatory lung disease, asthma - Read more

APRINOIA Therapeutics jumps on the FDA Fast Track highway
Small molecule, PET scan tracer, progressive supranuclear palsy - Read more

THE GOOD
Earnings & Finances

The King gives up; Shah Capital quits Novavax proxy fight after Sanofi licensing agreement
Covid-19 vaccine - Read more

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THE GOOD
Fundraises

Amplexd Therapeutics $2M raise
Suppository, photodynamic therapy, cervical intraepithelial neoplasia - Read more

Progentos Therapeutics $65M Series A
Small molecule, multiple sclerosis - Read more

Foghorn Therapeutics approx. $110M stock sale
Small molecule, cancer - Read more

THE GOOD
Investments

Singapore gets an end-to-end ADC manufacturing facility, thanks to AstraZeneca and a cool $1.5B
Antibody-drug conjugate, manufacturing - Read more

THE GOOD
IPOs

Rapport Therapeutics builds rapport around their IPO
Small molecule, focal epilepsy, bipolar disorder - Read more [Paywall]

THE GOOD
Lawsuits

"Good” for Pfizer, as AstraZeneca ordered to pay $107.5M in patent infringement case
Small molecule, cancer - Read more

THE BAD
Approvals & Labels

Helsinn’s accelerated approval pulled by FDA
Small molecule, bile duct cancer - Read more [Paywall]

THE BAD
Layoffs

BIO lobbying groups hits restructuring and staff cuts
Lobbying, industry group - Read more

THE UGLY
Politics & Policy

In a situation that will totally 100% not cause any conflicts of interest, some Members of Congress are trading stocks that could benefit from the BIOSECURE Act passing - Read more [Paywall]

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

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