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- Biotech & Pharma Updates | July 24 - 25, 2024
Biotech & Pharma Updates | July 24 - 25, 2024
Pfizer lands EU approval for their hemophilia B gene therapy, a bunch of big pharmas report earnings, Chevron Doctrine might be resurrected, Ipsen buys pediatric cancer ex-US rights from Day One Biopharmaceuticals, while Roche, AbbVie, and Sanofi all clear out some of their clinical assets
Pfizer follows up their hemophilia A gene therapy Ph3 win with an EU approval for their hemophilia B gene therapy. | Gif: Sound_FX on Giphy
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⬇️ The Good News ⬇️
THE GOOD
Approvals & Labels
Pfizer’s hemophilia B gene therapy lands EU approval
AAV gene therapy, hemophilia A - Read more
Pfizer, BioNTech updated COVID-19 vaccine gets UK MHRA pass
Covid-19 vaccine - Read more
BioMarin lands expanded label from FDA for enzyme replacement therapy for pediatric neurological condition
Enzyme replacement therapy, neuronal ceroid lipofuscinosis type 2 - Read more
EU’s adcomm CHMP gives thumbs up to Novo Nordisk’s Wegovy for preventing major adverse CV events
GLP-1, obesity, diabetes, cardiovascular events - Read more
Boehringer Ingelheim gets UK NICE recommendation for its stroke treatment
Recombinant protein, acute ischaemic stroke - Read more
THE GOOD
Business Development
Ipsen buys ex-US rights to Day One Biopharmaceuticals pediatric cancer small molecule for $111M upfront + $350M biobucks
Small molecule, pediatric low-grade glioma, cancer - Read more
Elixirgen Scientific, Mitsubishi Tanabe Pharma America iPSC-derived neuron and glial cell supply agreement
Induced pluripotent stem cells - Read more
Immunome buys rights to tumor-targeting antibodies from Nectin Therapeutics, terms not disclosed
Antibody-drug conjugate, cancer - Read more
Cartherics signs TLA with UniQuest and The University of Sydney for iPSC cell line
Technology license agreement, induced pluripotent stem cell-derived cardiomyocytes, cardiovascular disease, cell therapy - Read more
THE GOOD
Clinical Trials
Viking Therapeutics charges ahead with Ph3 obesity trial after Ph2 success
GLP-1/GIP, obesity, weight loss - Read more
OS Therapies positive Ph1 data for breast cancer vaccine
Cancer vaccine, breast cancer - Read more
Galderma publishes full Ph3 atopic dermatitis results in The Lancet
Monoclonal antibody, atopic dermatitis - Read more
THE GOOD
Earnings & Finances
AbbVie beats expectations despite Humira sales drop, primarily due to strong Skyrizi (+45% YoY) and Rinvoq (+56% YoY) sales - Read more
Roche reports strong earnings, but the wolves (Regeneron & Bayer) are circling their Vabysmo eye disease blockbuster - Read more
argenx still has stamina against myasthenia gravis rival AstraZeneca
Protein, myasthenia gravis - Read more
Specialty pharma Indivior stock gaps higher after reporting better-than-expected earnings and a $100M stock buyback
Small molecule, addiction, opioid use disorder - Read more
THE GOOD
Fundraises
Google co-founder Sergey Brin looks to commit $15M of a $25M raise for Soneira Bio
Small molecule, ibogaine, psychedelics - Read more [Paywall]
Sunflower Therapeutics signs $2M SAFE with SK bioscience
Simple agreement for future equity, protein manufacturing, drug development - Read more
4D Medicine £3.4M ($4.4M) Series A
Medical device, 3D printing, surgical implants - Read more
THE GOOD
Mergers & Acquisitions
Edwards Lifesciences buys JenaValve and Endotronix for $1.6B
Medical device, transcatheter valve, blood pressure, heart failure - Read more
THE GOOD
Partnerships
Autobahn Labs (not to be confused with Autobahn Therapeutics) signs academic research translational partnership with Charles River Laboratories
Academic spin-out, commercialization, company generation - Read more
M8 Pharmaceuticals, LG Chem sign LATAM commercialization partnership
Small molecule - Read more
THE GOOD
Politics & Policy
Democrats want to resurrect Chevron Doctrine
Stop Corporate Capture Act, Chevron Doctrine, regulatory agency deference - Read more
THE GOOD
Strategic Plans
Sanofi’s convinced they have a winner, push forward with capacity upgrades in support of RSV drug blockbuster hopes
Monoclonal antibody, respiratory syncytial virus - Read more
argenx has big autoimmune plans with their flagship drug Vyvgart
Protein, myasthenia gravis - Read more [Paywall]
AstraZeneca is betting big on combo therapies with their obesity push
Small molecule, obesity, weight loss - Read more [Paywall maybe]
Not to be outdone, Roche has obesity plans of their own, stemming from their $2.7B acquisition of Carmot Therapeutics
GLP-1/GIP, small molecule, obesity, weight loss - Read more
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⬇️ The Bad News ⬇️
THE BAD
Clinical Trials
AbbVie discontinues Alzheimer’s med after Ph2 interim analysis
Monoclonal antibody, Alzheimer’s disease - Read more
Roche cuts multiple clinical programs, including a Pompe disease gene therapy, a non-Hodgkin lymphoma bispecific, and a pair of NSCLC combo therapies
Gene therapy, Pompe disease, lymphoma, bispecific antibody, monoclonal antibody, combo therapy, non-small cell lung cancer - Read more
Sanofi clears rare disease house, axes multiple clinical programs
Monoclonal antibody, achondroplasia (dwarfism), osteogenesis imperfecta, gene therapy, phenylketonuria - Read more
Chemomab Therapeutics tries spinning Ph2 results in a positive light, but investors didn’t buy it
Monoclonal antibody, primary sclerosing cholangitis - Read more
THE BAD
Earnings & Finances
AstraZeneca, Daichii Sankyo use American football analogy to describe less-than-stellar Enhertu sales increase
Antibody-drug conjugate, breast cancer - Read more
THE BAD
Lawsuits
Drug or no drug? Ipsen loses to FDA in appeal, blockbuster classified as drug (not biologic)
Small molecule, generic - Read more [Paywall]
THE BAD
Layoffs
GlycoMimetics slashes 80% of staff after Ph3 leukaemia miss
Small molecule, acute myeloid leukaemia, cancer - Read more
THE BAD
Regulatory
FDA’s oncology drug adcomm calls for revamp of perioperative lung cancer trials, spurred by AstraZeneca’s “frustrat[ing]” Imfinzi trial design
Monoclonal antibody, lung cancer - Read more
⬇️ The Ugly News ⬇️
THE UGLY
Earnings & Finances
AstraZeneca (among other big pharma) continue fighting Medicare drug pricing negotiations despite multi-billion dollar quarterly revenues
Drug pricing, medicare/medicaid - Read more
You’re all caught up on the latest Pharma & Biotech News!
Gif: helloall on Giphy
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