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  • Biotech & Pharma Updates | August 11 - 12, 2024

Biotech & Pharma Updates | August 11 - 12, 2024

J&J's talc lawsuit saga may be ending, Sandoz biosimilar approval signals fourth Eylea (Regenron) competitor, Pfizer lands immunocompromised RSV Ph3 win, Halda Therapeutics $126M Series B, $924M botox industry M&A, FibroGen to layoff 127 SF-based staffers, and there's a new "largest protein" in town

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⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

Ascendis Pharma’s rare endocrine disorder med lands FDA approval
Peptide, hormone replacement therapy, hypoparathyroidism - Read more

Sandoz’s Eylea biosimilar (Regeneron) nabs FDA approval
Recombinant fusion protein, biosimilar, wet age-related macular degeneration - Read more

scPharmaceuticals gains FDA label expansion for heart failure med
Small molecule, heart failure, congestion due to fluid overload - Read more 

THE GOOD
Business Development

Guangzhou Lupeng Pharmaceutical, Hansoh Pharmaceutical licensing arrangement within China
Small molecule, autoimmune - Read more

THE GOOD
Clinical Trials

Pfizer reels in Ph3 win for RSV vaccine in immunocompromised individuals, gunning for label expansion
Vaccine, respiratory syncytial virus (RSV) - Read more

Locus Biosciences ELIMINATES some doubt about their bacteriophage med with Ph2 (part 1) positive results
CRISPR-Cas3, engineered bacteriophage therapy, uncomplicated urinary tract infection, antimicrobial-resistant, multi-drug-resistant - Read more

Tonix Pharmaceuticals presents RESILIENT-ly positive Ph3 data for their fibromyalgia med
Small molecule, fibromyalgia, nociplastic syndrome - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Fundraises

Halda Therapeutics $126M Series B
Small molecule, prostate cancer - Read more

Tenax Therapeutics closes $100M private placement
Small molecule, pulmonary hypertension, heart failure - Read more

MeiraGTx $50M ordinary share offering, led by Sanofi with $30M investment
Gene therapy, X-Linked Retinitis Pigmentosa, Parkinson’s disease - Read more

scPharmaceuticals proposed public offering
Small molecule, heart failure, congestion due to fluid overload - Read more

THE GOOD
Investments

Despite Biosecure murmurs, Legend Biotech continues with cell therapy factory build
CAR-T cell therapy, multiple myeloma, cancer - Read more [Paywall]

THE GOOD
Lawsuits

J&J’s talc saga may be ending, as 75% of claimants vote in favor of a proposed $6.5B settlement
Talc, mineral, ovarian cancer - Read more

THE GOOD
Mergers & Acquisitions

Crown Laboratories buys Revance Therapeutics for $924M, competing with botox rival AbbVie 
Recombinant protein, neurotoxin, glabellar lines, cervical dystonia - Read more

Stryker strykes deal to acquire care.ai
Medical device, remote patient monitoring, smart hospital system - Read more

THE GOOD
Partnerships

Absci, Memorial Sloan Kettering Cancer Center (MSK) gen-AI driven oncology drug discovery pact
Generative AI, drug discovery & development, cancer - Read more

THE GOOD
Politics & Policy

Democrats call on administration to finalize rules regarding “march-in rights” to combat high drug prices
Drug pricing, march-in rights, drug patent - Read more

THE GOOD
Product Launches

Microsoft, Paige unveil 2nd gen image-based cancer diagnosis AI model
AI, cancer diagnosis - Read more 

THE GOOD
Research

Largest protein so far (aptly named PKZILLA) discovered in marine algae
Protein discovery, marine algae, toxin - Read more

THE GOOD
Strategic Plans

Despite initial rejection, Novo Nordisk pushes ahead with once-weekly insulin/semaglutide combination bid
GLP-1, insulin, type 2 diabetes - Read more

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⬇️ The Bad News ⬇️

THE BAD
Approvals & Labels

Humacyte’s BLA decision delayed, FDA requires additional time
Bioengineered human tissue, acellular tissue engineered vessel, arterial replacement and repair - Read more

THE BAD
Clinical Trals

Actinogen Medical depression hopeful misses Ph2 primary endpoint
Small molecule, cognitive dysfunction, major depressive disorder - Read more

THE BAD
Layoffs

FibroGen to lay off 127 staffers at San Francisco location
Monoclonal antibody, small molecule, cancer, chemotherapy-induced anemia - Read more

THE BAD
Politics & Policy

Biopharma industry keeping tabs on growing anti-China legislation, mentioned in multiple SEC filings
Biosecure act - Read more [Paywall]

THE BAD
Strategic Plans

As BiVictriX Therapeutics war chest dwindles, they decide their fortunes favour going private to bring their asset to clinical trials
Antibody-drug conjugate, leukemia, cancer - Read more

⬇️ The Ugly News ⬇️

THE UGLY
No Ugly News Today!

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

Happy International Lefthanders Day to all my leftie besties. | Gif: The Princess Bride

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