• TLDR Biotech
  • Posts
  • Biotech & Pharma Updates | July 24 - 25, 2024

Biotech & Pharma Updates | July 24 - 25, 2024

Pfizer lands EU approval for their hemophilia B gene therapy, a bunch of big pharmas report earnings, Chevron Doctrine might be resurrected, Ipsen buys pediatric cancer ex-US rights from Day One Biopharmaceuticals, while Roche, AbbVie, and Sanofi all clear out some of their clinical assets

Full House Thumbs Up GIF by Sound FX

Pfizer follows up their hemophilia A gene therapy Ph3 win with an EU approval for their hemophilia B gene therapy. | Gif: Sound_FX on Giphy

All the top Biotech & Pharma news in one daily newsletter.

What to understand how these updates are formatted? Check-out the FAQ.

Have any feedback? I’d love to hear from you!📣

(You can also reach out to me on LinkedIn)

Last thing - if you find the content useful and think a colleague would too, please share TLDR Biotech with them! ♻️

⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

Pfizer’s hemophilia B gene therapy lands EU approval
AAV gene therapy, hemophilia A - Read more

Pfizer, BioNTech updated COVID-19 vaccine gets UK MHRA pass
Covid-19 vaccine - Read more

BioMarin lands expanded label from FDA for enzyme replacement therapy for pediatric neurological condition
Enzyme replacement therapy, neuronal ceroid lipofuscinosis type 2 - Read more

EU’s adcomm CHMP gives thumbs up to Novo Nordisk’s Wegovy for preventing major adverse CV events
GLP-1, obesity, diabetes, cardiovascular events - Read more

Boehringer Ingelheim gets UK NICE recommendation for its stroke treatment
Recombinant protein, acute ischaemic stroke - Read more

THE GOOD
Business Development

Ipsen buys ex-US rights to Day One Biopharmaceuticals pediatric cancer small molecule for $111M upfront + $350M biobucks
Small molecule, pediatric low-grade glioma, cancer - Read more

Elixirgen Scientific, Mitsubishi Tanabe Pharma America iPSC-derived neuron and glial cell supply agreement
Induced pluripotent stem cells - Read more

Immunome buys rights to tumor-targeting antibodies from Nectin Therapeutics, terms not disclosed
Antibody-drug conjugate, cancer - Read more

Cartherics signs TLA with UniQuest and The University of Sydney for iPSC cell line
Technology license agreement, induced pluripotent stem cell-derived cardiomyocytes, cardiovascular disease, cell therapy - Read more

THE GOOD
Clinical Trials

Viking Therapeutics charges ahead with Ph3 obesity trial after Ph2 success
GLP-1/GIP, obesity, weight loss - Read more 

OS Therapies positive Ph1 data for breast cancer vaccine
Cancer vaccine, breast cancer - Read more

Galderma publishes full Ph3 atopic dermatitis results in The Lancet
Monoclonal antibody, atopic dermatitis - Read more

THE GOOD
Earnings & Finances

AbbVie beats expectations despite Humira sales drop, primarily due to strong Skyrizi (+45% YoY) and Rinvoq (+56% YoY) sales - Read more

Roche reports strong earnings, but the wolves (Regeneron & Bayer) are circling their Vabysmo eye disease blockbuster - Read more

argenx still has stamina against myasthenia gravis rival AstraZeneca 
Protein, myasthenia gravis - Read more

Specialty pharma Indivior stock gaps higher after reporting better-than-expected earnings and a $100M stock buyback
Small molecule, addiction, opioid use disorder - Read more

THE GOOD
Fundraises

Google co-founder Sergey Brin looks to commit $15M of a $25M raise for Soneira Bio
Small molecule, ibogaine, psychedelics - Read more [Paywall]

Sunflower Therapeutics signs $2M SAFE with SK bioscience
Simple agreement for future equity, protein manufacturing, drug development - Read more

4D Medicine £3.4M ($4.4M) Series A
Medical device, 3D printing, surgical implants - Read more

THE GOOD
Mergers & Acquisitions

Edwards Lifesciences buys JenaValve and Endotronix for $1.6B
Medical device, transcatheter valve, blood pressure, heart failure - Read more

THE GOOD
Partnerships

Autobahn Labs (not to be confused with Autobahn Therapeutics) signs academic research translational partnership with Charles River Laboratories
Academic spin-out, commercialization, company generation - Read more

M8 Pharmaceuticals, LG Chem sign LATAM commercialization partnership
Small molecule - Read more

THE GOOD
Politics & Policy

Democrats want to resurrect Chevron Doctrine
Stop Corporate Capture Act, Chevron Doctrine, regulatory agency deference - Read more

THE GOOD
Strategic Plans

Sanofi’s convinced they have a winner, push forward with capacity upgrades in support of RSV drug blockbuster hopes
Monoclonal antibody, respiratory syncytial virus - Read more

argenx has big autoimmune plans with their flagship drug Vyvgart
Protein, myasthenia gravis - Read more [Paywall]

AstraZeneca is betting big on combo therapies with their obesity push
Small molecule, obesity, weight loss - Read more [Paywall maybe]

Not to be outdone, Roche has obesity plans of their own, stemming from their $2.7B acquisition of Carmot Therapeutics
GLP-1/GIP, small molecule, obesity, weight loss - Read more

ENJOYING THESE NEWSLETTERS?
Consider an optional paid subscription.

It’s a lot of work to put together a daily newsletter, and it’s currently just me writing these things (+ one part-time contractor - no fancy editing team!).

If you’re getting value out of these daily compilations, please consider a paid subscription (only $5/month) to support my continued work on this project.

⬇️ The Bad News ⬇️

THE BAD
Clinical Trials

AbbVie discontinues Alzheimer’s med after Ph2 interim analysis
Monoclonal antibody, Alzheimer’s disease - Read more

Roche cuts multiple clinical programs, including a Pompe disease gene therapy, a non-Hodgkin lymphoma bispecific, and a pair of NSCLC combo therapies
Gene therapy, Pompe disease, lymphoma, bispecific antibody, monoclonal antibody, combo therapy, non-small cell lung cancer - Read more 

Sanofi clears rare disease house, axes multiple clinical programs
Monoclonal antibody, achondroplasia (dwarfism), osteogenesis imperfecta, gene therapy, phenylketonuria - Read more

Chemomab Therapeutics tries spinning Ph2 results in a positive light, but investors didn’t buy it
Monoclonal antibody, primary sclerosing cholangitis - Read more

THE BAD
Earnings & Finances

AstraZeneca, Daichii Sankyo use American football analogy to describe less-than-stellar Enhertu sales increase
Antibody-drug conjugate, breast cancer - Read more

THE BAD
Lawsuits

Drug or no drug? Ipsen loses to FDA in appeal, blockbuster classified as drug (not biologic)
Small molecule, generic - Read more [Paywall]

THE BAD
Layoffs

GlycoMimetics slashes 80% of staff after Ph3 leukaemia miss
Small molecule, acute myeloid leukaemia, cancer - Read more

THE BAD
Regulatory

FDA’s oncology drug adcomm calls for revamp of perioperative lung cancer trials, spurred by AstraZeneca’s “frustrat[ing]” Imfinzi trial design
Monoclonal antibody, lung cancer - Read more

⬇️ The Ugly News ⬇️

THE UGLY
Earnings & Finances

AstraZeneca (among other big pharma) continue fighting Medicare drug pricing negotiations despite multi-billion dollar quarterly revenues
Drug pricing, medicare/medicaid - Read more

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

Good Vibes Dancing GIF by Hello All

Gif: helloall on Giphy

TLDR Biotech wants to hear from you! 📣

Have comments/questions/complaints about this newsletter?
Send me an email - I want your brutally honest feedback. 📝

Want to sponsor this newsletter and reach an audience of 650+ biotech and pharma professionals? Reach us here. 👍

Disclaimer: Content, news, research, tools, and mention of stock or tradeable securities are for educational and illustrative purposes only and do not imply a recommendation or solicitation to buy or sell a particular security or to engage in any particular investment strategy. Read the full terms & conditions here.