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- Biotech & Pharma Updates | May 30 - June 2, 2024
Biotech & Pharma Updates | May 30 - June 2, 2024
GSK's ADC comeback story, Sanofi & Regeneron receive mixed signals, Moderna gets RSV vaccine approval, and an MDMA treatment lands FDA scrutiny.
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MINOR HOUSEKEEPING
How these updates are formatted
The newsletter is split into three main sections:
THE GOOD - good news (eg. fundraises, product approvals)
THE BAD - negative news (eg. clinical trial failures, layoffs)
THE UGLY - negative but atypical news (lawsuits, product recalls, scandals)
Within each of the three above parts, there are additional sections for easier navigation:
Eg. There will be multiple “The Good” sections covering things like Fundraises, Approvals, Partnerships etc.
There will be also additional tags within these sections (Eg. fundraises may mention Stage, product approvals may mention drug name and disease area.)
See something you want to get into further? Click the Read More (goes out to either a news article or a press release).
One last thing; I know paywalls can be annoying, so there’s a [Paywall] tag for any news stories behind one.
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⬇️ The Good News ⬇️
THE GOOD
Approvals & Labels
Sanofi & Regeneron have good news in Europe (thumbs up from Committee for Medicinal Products for Human Use), but bad news in the USA (FDA delays approval decision)
Monoclonal antibody, chronic obstructive pulmonary disorder (COPD) - Read more
Moderna RSV vaccine scores FDA approval - joins Pfizer and GSK
Vaccine, respiratory syncytial virus - Read more
Europe’s Committee for Medicinal Products for Human Use gave approval recommendations to 14 meds last week
Advisory committee - Read more
Astellas goes for round 2, re-applies BLA for cancer immunotherapy
Monoclonal antibody, cancer, adenocarcinoma - Read more
Biogen’s rare form of ALS treatment lands EU approval
Oligonucleotide, amyotrophic lateral sclerosis - Read more
THE GOOD
Business Development
As avian flu concerns mount, CSL Seqirus lands another US government vaccine contract
Vaccine, avian flu, pandemic preparedness - Read more
THE GOOD
Clinical Trials
Ionis Pharmaceuticals gives deeper glimpse into previously announced Ph3 win
Antisense oligonucleotide, hereditary angioedema - Read more
GSK’s Blenrep comeback story with a Ph3 win
Antibody-drug conjugate, cancer, multiple myeloma - Read more
AstraZeneca, Daiichi-Sankyo’s Enhertu aims to be ahead of chemo in breast cancer treatment, and they have the data to back it up
Antibody-drug conjugate, breast cancer - Read more
Novartis struts Ph3 leukaemia treatment data, beating out standard of care
Small molecule, cancer, chronic myeloid leukaemia - Read more
Novartis also shows-off 52-week safety data for CSU treatment
Small molecule, chronic spontaneous urticaria - Read more
Gilead, Arcus Ph1b/2 demonstrates death risk reduction in colorectal cancer
Small molecule, monoclonal antibody, combination therapy, cancer - Read more
Precision Neuroscience sets record, place precisely 4,096 electrodes (temporarily) on a live human brain
Brain-computer interface, medical device - Read more
THE GOOD
Fundraises
Valar Labs $22M Series A
Histology, cancer treatment screening, AI - Read more
Day One Biopharmaceuticals $108M raise via PRV sale (undisclosed buyer)
Small molecule, cancer, priority review voucher - Read more
Radiomer Therapeutics Pre-seed (amount undisclosed)
Radiopharmaceuticals, radioligands - Read more
DataHow Series A (amount undisclosed)
Bioprocessing, biomanufacturing, AI - Read more
ChromaTan $2M Phase IIB NIH Grant
Bioprocessing, biomanufacturing, AAV - Read more
THE GOOD
Investments
Sanofi opens doors of $800M CAD ($586 million) vaccine manufacturing plant - the largest in Canada
Vaccine, manufacturing - Read more
THE GOOD
Partnerships
Galapagos and Adaptimmune sign clinical POC partnerships; deal upwards of $665M in biobucks
Cell therapy, TCR T-cell, cancer - Read more
ConcertAI and Nvidia team up on clinical simulations
Clinical trials, AI - Read more
THE GOOD
Research
Genetic factors can determine what kind of breast cancer you might get, and how aggressive it will be
Inherited cancer risk, breast cancer, genetics - Read more
Caristo Diagnostics’ AI may predict cardiac events years in advance
AI, coronary computed tomography angiography, coronary inflammation - Read more
⬇️ The Bad News ⬇️
THE BAD
Approvals & Labels
Pharming Group’s APDS treatment hits CMC delay from EMA
Small molecule, activated phosphoinositide 3-kinase delta syndrome - Read more
Lykos Therapeutics faces FDA scrutiny in MDMA therapy application
MDMA, psychedelic, PTSD - Read more
THE BAD
Clinical Trials
Gilead urothelial cancer ADC slips in Ph3, misses primary endpoint
Antibody-drug conjugate, cancer - Read more
THE BAD
Earnings & Finances
Keytruda makes up half of Merck & Co’s revenue, which is “not a repeatable model”
Antibody, cancer, blockbusters - Read more [Paywall]
⬇️ The Ugly News ⬇️
THE UGLY
Lawsuits
Novartis goes after the State of Maryland on drug discount law
Compound pharmacy, 340B - Read more
THE UGLY
Politics & Policy
GenScript could be next in Biosecure Act’s crosshairs
Geopolitics, national security, Biosecure Act - Read more
THE UGLY
Public Health
Avian flu infects third patient, this time with respiratory symptoms
Bird flu, avian flu outbreak - Read more
You’re all caught up on the latest Pharma & Biotech News!
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