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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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