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  • Biotech & Pharma Updates | May 28 - 29, 2024

Biotech & Pharma Updates | May 28 - 29, 2024

FDA approvals for Amgen and Tris Pharma, BMS' $80M global licensing spend, BioNTech continues Africa push with $145M, and Novo Nordisk blames the American Healthcare System

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.

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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 News ⬇️

THE GOOD
Approvals & Labels

Amgen lands interchangeable biosimilar approval from FDA 
Biosimilar, antibody, paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome - Read more

Eli Lilly scores FDA accelerated approval for thyroid cancer med
Small molecule, thyroid cancer, pediatric cancer - Read more

Tris Pharma gains FDA approval for ADHD med
Small molecule, ADHD - Read more

THE GOOD
Business Development

Bristol Myers Squibb purchased global license for Prothena asset
$80M upfront, $617.5M biobucks + additional royalties
Modality and indication not disclosed, neurodegenerative disease - Read more

Bio-Thera and STADA commercialization and licence deal
$10M upfront, $147.5M biobucks
Biosimilar, antibody, cancer - Read more

THE GOOD
Clinical Trials

Arcturus Therapeutics showcases positive Ph1/1b data, stock jumps +20%
mRNA, cystic fibrosis - Read more

Wake-up! J&J posts not-so-depressing Ph3 results
Small molecule, depression, insomnia - Read more

AstraZeneca’s Ph1 shows promising cholesterol-lowering results
Small molecule, dyslipidaemia - Read more

THE GOOD
Earnings & Finances

Among the gloomy CDMO landscape, Almac posts cheery earnings news
Year ending Sept 30, revenue +14% YoY to £958M ($1.2 billion)
CDMO, manufacturing - Read more

THE GOOD
Fundraises

Lucy Therapeutics $12.5M fundraise
Small molecule, mitochondrial dysfunction - Read more

LambdaVision Seed round (amount undisclosed)
Protein-based artificial retina, macular degeneration, retinitis pigmentosa - Read more

ExpressionEdits $13M Seed funding
Protein expression, intronization technology - Read more

Adcendo €16M ($17.3M) Series A extension
Antibody-drug conjugates, cancer - Read more

Gameto $33M Series B
IVF, Fertility Treatments - Read more

Merus public offering of common stock, $300M expected raise
Bispecific/trispecific antibody, cancer - Read more

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⬇️ The Good News (Cont.)⬇️

THE GOOD
IPOs

No Way! WayStar files nearly $1B IPO on $3.83B valuation
Healthcare payments software - Read more

THE GOOD
Mergers & Acquisitions

Nordson acquires Atrion
$800M all-stock, 15% premium
Medical device, medication infusion valves - Read more

Virtual Therapeutics acquires Akili Therapeutics
Digital Therapeutics, ADHD - Read more

THE GOOD
Patient Access

BioNTech continues Africa push with further $145M investment
mRNA vaccine, manufacturing site - Read more

Dollar General ends brief foray into mobile health clinics
Mobile clinic, healthcare services - Read more [Paywall]

THE GOOD
Product Launches

Ori Biotech and Cytiva (separately) launch next-gen CAR-T manufacturing platforms
CAR-T, cell therapy manufacturing - Read more [Paywall]

Ro launches tracker to help patients source GLP-1 meds
GLP-1, diabetes, obesity, weight loss - Read more

⬇️ The Bad News ⬇️

THE BAD
Clinical Trials

Biohaven stock drops after Ph1 miss
Small molecule, rheumatoid arthritis, myasthenia gravis - Read more

THE BAD
Earnings & Finance

Agilent Technologies misses revenue and cuts forecast as life sciences sector continues slow recovery
Life science instrumentation, diagnostics, research equipment - Read more

THE BAD
Layoffs

Ikena Oncology halves headcount
Small molecule, cancer - Read more

AEON Biopharma also chops headcount in half
Botulinum toxin, migraines - Read more

THE BAD
Opinions

Cell therapy at a cross-road; they’ve “lost [their] luster”
Cell therapy, cancer, autoimmune - Read more

⬇️ The Ugly News ⬇️

THE UGLY
Criminal Acts

Cencora victor of data breach, cyberattack
Patient data, prescription data - Read more

THE UGLY
Politics & Policy

In response to Sen. Bernie Sanders, Novo Nordisk blames high GLP-1 costs on the American Healthcare System
GLP-1, drug pricing - Read more

THE UGLY
Regulatory

Accelerated approvals again under scrutiny, this time for using “surrogate markers”; study
Accelerated approvals, surrogate markers, proxies - Read more

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

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