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- Biotech & Pharma Updates | September 25 - 26, 2024
Biotech & Pharma Updates | September 25 - 26, 2024
BMS’s historic schizophrenia FDA approval, ARCH Venture Partners $3B 13th fund, Genentech touts positive Ph3 Gazyva lupus data, CSL Seqirus nabs another BARDA bird flu contract, Mirai Bio launches as Flagship’s newest endeavour, Novo Nordisk & Evotec partner to develop off-the-shelf stem-cell derived cell therapies, Inventiva’s coffers are weeks from running dry, Biogen and Sage discontinue essential tremor partnership, FDA adcomm advises narrower PD-1 inhibitor approvals, top NIH neuroscientist conducted alleged widespread Parkinson’s & Alzheimer's research misconduct
All the top Biotech & Pharma news in one daily newsletter.
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⬇️ The Good News ⬇️
THE GOOD
Approvals & Labels
Bristol Myers Squibb’s Cobenfy approval by the FDA ushers in the first new schizophrenia drug in more than two decades
Small molecule, schizophrenia - Read more
AstraZeneca scores FDA ok for expanded Tagrisso label
Small molecule, lung cancer - Read more
THE GOOD
Business Development
CSL Seqirus lands 5th avian flu pademic preparedness contract from BARDA, $121.4M
Vaccine, bird flu (avian flu), pandemic preparedness - Read more
Repair Technologies in-licenses Genevant’s LNP tech for $107M total upfront + biobucks
mRNA, lipid nanoparticle (LNP), atherosclerosis, cholesterol - Read more
Merck & Co. signs options and licensing deal with Evaxion Biotech for their preclinical gonorrhoea, infectious disease vaccines, up to $592M biobucks per asset
Vaccine, gonorrhoea, infectious disease - Read more
THE GOOD
Clinical Trials
Genentech (Roche) posts positive Ph3 for lupus med Gazyva
Monoclonal antibody, lupus nephritis - Read more
enGene posts promising first set of Ph3 data for detalimogene in bladder cancer
Non-viral gene therapy, bladder cancer - Read more
AbbVie’s tavapadon scores second Ph3 victory in Parkinson’s disease
Small molecule, Parkinson’s disease - Read more
AbbVie touts positive ad-hoc Ph3 analysis data for Rinvoq in atopic dermatitis
Small molecule, atopic dermatitis - Read more
Enanta Pharmaceuticals’ RSV antiviral EDP-323 meets Ph2a challenge
Small molecule, respiratory syncytial virus, antiviral - Read more
UNION Therapeutics showcases promising Ph2b data for orismilast in atopic dermatitis
Small molecule, atopic dermatitis - Read more
Biomea Fusion’s BMF-219 clinical hold lifted by FDA
Small molecule, type 2 diabetes, type 1 diabetes - Read more
THE GOOD
Company Launches
Mirai Bio is Flagship Pioneering’s newest endeavour, looking to solve key drug delivery challenges for genetic medicines
Cell & gene therapy, drug delivery, AI - Read more
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⬇️ The Good News (Cont’d) ⬇️
THE GOOD
Fundraises
ARCH Venture Partners announces a cool $3B for their 13th fund
Venture capital, biotech investment - Read more
Asabys Partners closes new €180M ($201M) fund
Venture capital, biotech investment - Read more
858 Therapeutics $50M Series B
Small molecule, solid tumor - Read more
ReSync Bio undisclosed raise
Scientific software, drug discovery - Read more
Eradivir closes $10.25M Series A
Small molecule bispecific antibody fusion, influenza, infectious disease - Read more
THE GOOD
Mergers & Acquisitions
Dotmatics acquires Virscidian
Scientific software, laboratory workflow automation, R&D workflows - Read more
Undisclosed PE firm makes $16B+ bid for Sanofi’s consumer health business
Consumer health, corporate spin-out - Read more
THE GOOD
Partnerships
Novo Nordisk, Evotec partner on developing off-the-shelf, stem-cell based cell therapies
Cell therapy, drug development, Parkinson’s disease, diabetes - Read more
AstraZeneca, Immunai expand AI-powered oncology drug development partnership
Antibody, oncology, drug development - Read more
Lundbeck, Iambic Therapeutics partner on AI-powered drug discovery
Small molecule, migraine, drug discovery - Read more
Biocon, Tabuk Pharmaceuticals partner on commercializing GLP-1 products in the Middle East
GLP-1, obesity, diabetes - Read more
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⬇️ The Bad News ⬇️
THE BAD
Earnings & Finances
Inventiva struggles to stay afloat as cash runway extends to mid-October 2024
Small molecule, metabolic dysfunction-associated steatohepatitis, non-alcoholic steatohepatitis - Read more
THE BAD
IPOs
Better luck next year? Insilico Medicine’s Hong Kong IPO ambitions look to be naught
AI-enabled drug discovery - Read more [Paywall]
THE BAD
Partnerships
Biogen discontinues Sage Therapeutics SAGE-324 partnership after disappointing Ph2 data earlier this year
Small molecule, essential tremor - Read more
THE BAD
Regulatory
FDA’s oncology adcomm favours narrowing PD-1 inhibitor approvals in 10-2 vote; Bristol Myer Squibb’s Opdivo, Merck & Co.’s Keytruda and BeiGene’s Tevimbra in the crosshairs
Monoclonal antibody, stomach cancer - Read more
THE BAD
Research
Retrospective study indicates “[no] significantly slower progression of disability“ for MS patients using Roche’s Ocrevus or Roche & Biogen’s Rituxan
Monoclonal antibody, multiple sclerosis - Read more
⬇️ The Ugly News ⬇️
THE UGLY
Criminal Acts
NIH neuroscience top dog whose work underpins several Parkinson’s and Alzheimer’s clinical assets committed alleged widespread research misconduct, according to NIH investigation
Academic misconduct, Parkinson’s, Alzheimer’s - Read more
THE UGLY
Marketing
Novo Nordisk draws UK’s PMCPA ire over alleged Saxenda (older GLP-1 drug) and pharmacy chain promotion
GLP-1, drug marketing - Read more
You’re all caught up on the latest Pharma & Biotech News!
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