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  • Biotech & Pharma Updates | October 9 - 10, 2024

Biotech & Pharma Updates | October 9 - 10, 2024

Roche’s Itovebi nabs breast cancer approval from FDA, Pfizer’s small molecule prostrate cancer combo posts positive Ph3 data, Novartis antirust investigation by Swiss authorities dropped, Cytovale’s $100M Series D for rapid sepsis risk testing, Nona Biosciences & OverT Bio collab on cell therapies for solid tumors, Gritstone bio declares bankruptcy, CDMOs hearing client concerns over China raw material origins, bluebird bio’s Skysona causes blood cancer in 7 pediatric patients

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⬇️ The Good News ⬇️

THE GOOD
Accidents & Natural Disasters

B. Braun’s Daytona Beach, Florida site “not seriously impacted" by Milton, IV solution supply chain catches break after Baxter plant shut down causes widespread shortages
IV solutions, manufacturing, hurricane - Read more 

THE GOOD
Approvals & Labels

Roche nabs FDA approval for Itovebi as part of triple-med combo breast cancer treatment
Small molecule, breast cancer - Read more

THE GOOD
Clinical Trials

Pfizer’s Talzenna, Xtandi combo notches Ph3 win in effort to expand prostrate cancer label
Small molecule, prostrate cancer - Read more

Vanqua Bio touts positive Ph1 safety data for VQ-101, targeting Parkinson’s and related disorders
Small molecule, Parkinson’s disease - Read more

Vico Therapeutics’ positive Ph1/2a interim data for VO659 in Huntington’s disease
Antisense oligonucleotide, Huntington’s disease - Read more

Johnson & Johnson’s posts positive subgroup analysis of Ph3 Tremfya data in Crohn's disease and ulcerative colitis, bolstering recent FDA approval
Monoclonal antibody, Crohn's disease, ulcerative colitis - Read more

Immatics showcases updated IMA203 Ph1b data “affirm[ing IMA203’s] therapeutic potential” in metastatic melanoma and potentially other solid tumors
Cell therapy, metastatic melanoma, solid tumor, cancer, autologous TCR - Read more

THE GOOD
Criminal Acts

Novartis off the antitrust hook as Switzerland’s Competition Commission (COMCO) drops investigation, finds that “Novartis’ actions…were common practice”
Monoclonal antibody, psoriasis, patent law, antitrust - Read more 

THE GOOD
Fundraises

Holobiome Seed raise (undisclosed)
Microbiome therapeutic, depression - Read more

Booster Therapeutics $15M Seed raise
Small molecule, Parkinson’s disease, Alzheimer’s disease - Read more

MiLaboratories Series A (undisclosed)
Computational biology, bioinformatics - Read more

Lymphatica Medtech €17.9M ($19.6M) Series B
Medical device, lymphedema, implant - Read more

Cytovale $100M Series D
Diagnostic, sepsis, rapid test - Read more

Glooko $100M Series F
Digital health, diabetes - Read more

Immatics $150M public offering
Cell therapy, solid tumor, cancer, autologous TCR, bispecifics - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Market Reports

Vertex Pharmaceuticals commissions report on “The State of Pain in America” as FDA decision looms for their non-opioid pain med hopeful suzetrigine
Small molecule, pain relief, analgesic - Read more

THE GOOD
Partnerships

Eli Lilly, KeyBioscience expand obesity med development partnership, undisclosed upfront + $1.4B biobucks
Peptide, obesity, osteoarthritis, drug development - Read more

Nona Biosciences, OverT Bio collab on cell therapy development for solid tumors
Cell therapy, solid tumor, cancer, allogeneic gamma delta T cell, drug development - Read more

Roche, Tempest Therapeutics sign clinical partnership to advance Ph3 first-line trial for combination amezalpat (TPST-1120), Tecentriq, bevacizumab in hepatocellular carcinoma
Small molecule, hepatocellular carcinoma, liver cancer, clinical development - Read more

Ono Pharmaceutical, LigaChem Biosciences sign licensing + drug discovery agreement for novel ADCs
Antibody-drug conjugate, solid tumor, cancer - Read more

THE GOOD
Patient Access

US HHS proposes list of 101 generics that could be available to those on Medicare for <$2 per month
Drug pricing, generic - Read more 

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⬇️ The Bad News ⬇️

THE BAD
Earnings & Finances

Gritstone Bio declares bankruptcy as coffers dwindle and Granite cancer vaccine data disappoints
Cancer vaccine, colorectal cancer - Read more

THE BAD
Layoffs

Leo Pharma transformation plan to result in up to 250 job cuts
Monoclonal antibody, small molecule, dermatology - Read more

THE BAD
Mergers & Acquisitions

US Sen. Elizabeth Warren urges FTC to probe upcoming Novo Nordisk acquisition of Catalent, citing potential unfair advantages in ballooning obesity & diabetes drug markets
GLP-1, obesity, diabetes, manufacturing, antitrust - Read more [Paywall]

THE BAD
Strategic Plans

CDMO’s facing increased client scrutiny over China-based raw material dependence
CDMO, supply chain, Biosecure Act - Read more [Paywall]

⬇️ The Ugly News ⬇️

THE UGLY
Adverse Events

7 pediatric recipients of bluebird bio’s Skysona gene therapy developed blood cancers
Gene therapy, cerebral adrenoleukodystrophy, cancer - Read more

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

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