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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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