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!

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.

Keep Reading