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  • Biotech & Pharma Updates | September 26 - 29, 2024

Biotech & Pharma Updates | September 26 - 29, 2024

Regeneron, Sanofi’s Dupixent gets FDA ok for label expansion, Bavarian Nordic lands another mpox vaccine contract, BlueRock, Bayer showcase 24 month safety data for Parkinson’s disease cell therapy, Cassava’s $40M SEC settlement, Travere halts Ph3 due to drug substance issue, J&J gets final warning letter from HRSA to halt 340B rebate program

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⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

Regeneron, Sanofi’s COPD med Dupixent, after delay, get’s FDA approval for expanded label
Monoclonal antibody, chronic obstructive pulmonary disease - Read more

China also approves Regeneron, Sanofi’s Dupixent for COPD
Monoclonal antibody, chronic obstructive pulmonary disease - Read more

THE GOOD
Business Development

Bavarian Nordic lands another mpox vaccine contract, this time with UNICEF for 1 million doses
Vaccine, monkeypox (mpox) - Read more 

THE GOOD
Clinical Trials

Johnson & Johnson touts new data from Talevy, Tecvayli combo in multiple myelkoma, though side effects may be cause for concern
Bispecific antibody, multiple myeloma, cancer - Read more

Poseida Therapeutics showcases interim Ph1 data for allogeneic CAR-T P-BCMA-ALLO1 in multiple myeloma
Cell therapy, multiple myeloma, cancer, allogeneic CAR-T - Read more

BlueRock Therapeutics, Bayer present 24 month Ph1 safety profile data for cell therapy Bemdaneprocel in Parkinson’s disease
Cell therapy, Parkinson’s disease, stem-cell derived - Read more

IASO Bio presents Ph2 data for CAR-T Fucaso in multiple myeloma
Cell therapy, multiple myeloma, cancer, CAR-T - Read more

UCB touts two-year Ph3 data for bimekizumab-bkzx in hidradenitis duppurativa
Monoclonal antibody, hidradenitis suppurativa - Read more

THE GOOD
Criminal Acts

Cassava Sciences settles with US SEC, $40M penalty, related to “negligence-based disclosure charges” for simufilam Ph2b trial
Small molecule, Alzheimer’s disease - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Fundraises

Mendaera $73M raise
Medical device, handheld robotics - Read more

C2N $7.025M raise
Diagnostics, blood test, Alzheimer’s disease - Read more

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⬇️ The Bad News ⬇️

THE BAD
Clinical Trials

Travere Therapeutics halts Ph3 pegtibatinase trail enrolment due to drug substance manufacturing scale-up issue
Recombinant protein, classical homocystinuria, manufacturing - Read more

THE BAD
Patient Access

Novo Nordisk pares down some insulin pen manufacturing, transitioning to needle + vial supply
Insulin, diabetes, drug delivery - Read more [Paywall]

THE BAD
Politics & Policy

US Health Resources and Services Administration calls Johnson & Johnson by their full name, issues last warning to halt their proposed 340B rebate model
340b drug pricing, drug rebate program - Read more

⬇️ The Ugly News ⬇️

THE UGLY
Criminal Acts

Former FDA medical device chief called out by two House Democrats, who are urging HHS to investigate potential past conflicts of interest
Medical device, conflict of interest - Read more

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

Today in Canada - September 30th marks National Day for Truth and Reconciliation. | Source

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