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  • Biotech & Pharma Updates | October 2 - 3, 2024

Biotech & Pharma Updates | October 2 - 3, 2024

Wuxi Biologics & WuXi AppTec consider selling some non-China asset, BMS’ Opdivo nabs expanded label, Grifols subsidiary nabs up to $135.2M BARDA biothreat contract, Kurma Partners closes new $155M biotech fund, Legend Biotech unveils plans for new cell therapy R&D Facility, Caliway Biopharmaceuticals rakes in $206M in Taiwan IPO, Flagship signs extensive collaboration with Singapore’s A*STAR, Eli Lilly’s Zepbound & Mounjaro no longer facing US shortages, no reopen date yet for Baxter facility hit by hurricane Helene

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⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

Bristol Myers Squibb’s Opdivo nabs FDA expanded label
Monoclonal antibody, lung cancer - Read more

Siemens Healthineers nabs FDA approval for speedy 3D mammography platform
Cancer diagnostics, breast cancer - Read more

THE GOOD
Business Development

BioCryst nabs $69M HHS supply contract for Rapivab flu antiviral
Small molecule, influenza, antiviral - Read more

Excellos lands opportunity to decentrally manufacture Galapagos CAR-T clinical assets
Cell therapy, lymphoma, cancer, decentralized manufacturing - Read more

Eton Pharmaceuticals buys Increlex insulin-like growth factor from Ipsen
Recombinant protein, severe primary insulin-like growth factor 1 deficiency - Read more

GigaGen (Grifols subsidiary) lands up to $135.2M 6 year biothreat contract from US BARDA
Recombinant polyclonal antibody, botulinum neurotoxin, biothreat - Read more

Blue Shield of California works around PBMs to get Humira biosimilar directly from the source (Fresenius in this case) at a steep discount
Monoclonal antibody, autoimmune, biosimilar, drug pricing - Read more

THE GOOD
Clinical Trials

Avidity Biosciences’ clinical hold lifted by FDA, Ph1/2 using delpacibart etedesiran (formerly AOC 1001)
Antibody oligonucleotide conjugate, myotonic dystrophy type 1 - Read more

Kiromic BioPharma touts “favourable” 10-month follow-up data for Deltacel in lung cancer
Cell therapy, lung cancer, allogeneic - Read more

THE GOOD
Company Launches

Franklin Biolabs officially launches
CRO, contract research, immunology - Read more

EnFuego Therapeutics comes out of stealth
RNA, cancer - Read more

THE GOOD
Fundraises

Kurma Partners closes new €140M ($155M) biotech fund
Venture capital, biotech investing - Read more

Resolution Therapeutics £63.5M ($83.2M) Series B
Cell therapy, liver disease, autologous macrophage - Read more

Enara Bio $32.5M Series B
T-cell receptor (TCR)-based therapies, cancer, dark antigen - Read more

Resilience $17.5M US federal funding
Domestic manufacturing, essential medicines, starting materials, APIs - Read more

Mithradote Bio $1M Seed raise
Small molecule, date-rape drug antidote - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Investments

Legend Biotech unveils plans for new cell therapy R&D facility in Philadelphia
Cell therapy, research & development - Read more

ReciPharm announces sweeping investments across multiple sites worldwide
CDMO, manufacturing, oral solid dose, fill-finish - Read more

Ferring Pharmaceuticals new gene therapy manufacturing hub in Finland, anticipating increased demand for Adstiladrin bladder cancer gene therapy
Gene therapy, bladder cancer, supply chain - Read more

THE GOOD
IPOs

Caliway Biopharmaceuticals scores NT$6.4B ($206M) in proceeds from Taiwan-based IPO
Small molecule, aesthetic medicine - Read more

Pentixapharm nabs €20M ($22M) in proceeds from IPO
Radiopharm, lymphoma, cancer - Read more

Septerna shoots for $100M IPO
Small molecule, hypoparathyroidism - Read more

Orum Therapeutics aims for up to KRW 108B ($80M) proceeds from IPO
Degrader-antibody conjugates, cancer, solid tumor - Read more

THE GOOD
Marketing

Eliem Therapeutics rebrands to Climb Bio
Monoclonal antibody, systemic lupus erythematosus, immune thrombocytopenia, membranous nephropathy - Read more

THE GOOD
Partnerships

Flagship Pioneering signs R&D and company nurture collab with Singapore’s A*STAR
Research & development, technology development, talent development - Read more

AstraZeneca, Arcus Biosciences sign clinical trial collab for casdatifan + volrustomig in renal cell carcinoma
Bispecific antibody, small molecule, renal cell carcinoma, cancer - Read more

Teva, mAbxience expand oncology biosimilar development collab, additional undisclosed candidate
Biologic, cancer, biosimilar, drug development - Read more

Halozyme Therapeutics, argenx expand drug delivery collab, Enhanze drug delivery technology
Antibody fragment, myasthenia gravis, drug development, drug delivery - Read more

Gingko Bioworks, Virica Biotech partner on accelerating AAV gene therapy manufacturing
Gene therapy, manufacturing innovation, AAV - Read more

Liquidia, Pharmosa Biopharm expand drug delivery collab, sustained release inhaled treprostinil
Small molecule, pulmonary arterial hypertension, pulmonary hypertension, interstitial lung disease - Read more

THE GOOD
Patient Access

Eli Lilly’s Zepbound, Mounjaro US shortages end according to FDA
GLP-1, obesity, diabetes, drug shortages - Read more

CSL Behring lands positive reimbursement nob from Spain for Hemgenix
Gene therapy, hemophilia B, reimbursement - Read more

UK’s NHS plans for phased roll-out of Eli Lilly’s Mounjaro, starting first with obese patients with “at least three weight-related health conditions“
GLP-1, obesity - Read more [Paywall maybe]

THE GOOD
Regulatory

FDA’s CDER officially launches the Quantitative Medicine Center of Excellence
Modelling & simulation, product review, policy development - Read more

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⬇️ The Bad News ⬇️

THE BAD
Accidents & Natural Disaster

No open date for North Carolina Baxter facility hit by hurricane Helene
Manufacturing, dialysis, IV solutions - Read more

THE BAD
Layoffs

Relay Therapeutics cutting 10% of workforce to work towards $50M in annual savings
Small molecule, cancer, solid tumor - Read more

THE BAD
Strategic Plans

WuXi AppTec, WuXi Biologics both considering offloading certain non-China assets as Biosecure Act looms
Biosecure Act - Read more

⬇️ The Ugly News ⬇️

THE UGLY
No Ugly Stories today!

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

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