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  • Biotech & Pharma Updates | June 27 - 30, 2024

Biotech & Pharma Updates | June 27 - 30, 2024

Abbvie, Regeneron, Merck & Co. all land CHMP panel recommendations (while Apellis and PTC both get thumbs down), Lantheus buys radiophama assets, Ensho Therapeutics launches with Eisai assets, and former Cassava Sciences scientific advisor gets indicted

Merck’s FDA-approved pneumococcal vaccine gets CDC recommendation for 65+ adults (and younger adults with certain medical conditions) | Gif: TheOldManFX on Giphy

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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.

⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

AstraZeneca, Sanofi’s infant RSV vaccine gets thumbs-up from German vaccine advisory panel
Monoclonal antibody, respiratory syncytial virus vaccine - Read more

Merck’s FDA-approved pneumococcal vaccine gets CDC recommendation for 65+ adults and younger adults with certain health conditions
Vaccine, pneumococcal infection - Read more

Abbvie & Regeneron both land CHMP advisory panels thumbs up
Bispecific antibody, lymphoma, cancer - Read more

Merck & Co. also lands CHMP recommendation
Fusion protein, pulmonary arterial hypertension - Read more

THE GOOD
Business Development

Lantheus purchases two radiopharmaceutical assets from Life Molecular Imaging
$35M upfront + biobucks (amount undisclosed)
Radiopharma, prostate cancer, breast cancer - Read more

THE GOOD
Clinical Trials

J&J touts stellar Ph3 myasthenia gravis results
Monoclonal antibody, generalized myasthenia gravis - Read more

Ethris’ promising interim Ph1 safety data
mRNA, viral infection prevention, uncontrolled asthma - Read more

THE GOOD
Company Launches

Ensho Therapeutics launches with assets acquired from Eisai
Small molecule, inflammatory bowel disease, ulcerative colitis - Read more

THE GOOD
Fundraises

Savara $100M underwritten offering
Recombinant protein, nebulizer, pulmonary alveolar proteinosis - Read more

RareCyte $20M Financing
Precision biology, instrumentation, spatial biology - Read more

VenoStent $20M Series A + $4M Investment
Medical device, perivascular wrap, chronic kidney disease - Read more

THE GOOD
Lawsuits

Daiichi-Sankyo comes out on-top in Seagen (Pfizer) patent dispute
Antibody-drug conjugate, drug patent infringement - Read more

THE GOOD
Market Reports

Analyst’s predict a change in the Osteoporosis market winds; Amgen punching air - Read more

THE GOOD
Patient Access

CMS provides more details on cell & gene therapy access pilot
Outcome-based agreements, cell therapy, gene therapy - Read more [Paywall]

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⬇️ The Bad News ⬇️

THE BAD
Approvals & Labels

Rocket Pharmaceuticals handed FDA rejection, need more CMC info
Lentiviral gene therapy, severe leukocyte adhesion deficiency-I (LAD-I) - Read more

Apellis Pharmaceuticals’ thumbs down from CHMP
Polypeptide, geographic atrophy, age-related macular degeneration - Read more

PTC Therapeutics also handed negative CHMP opinion
Small molecule, duchenne muscular dystropy - Read more

THE BAD
Clinical Trials

GeNeuro long COVID med fails in Ph2, lay offs imminent
Monoclonal antibody, long COVID - Read more

THE BAD
IPOs

Alumis has a less-than-stellar IPO, stock sinks 20%
Small molecule, immune-related diseases - Read more

THE BAD
Layoffs

Ginkgo Bioworks layoffs continue, 400 employees
Genetic engineering, synthetic biology - Read more 

Astellas Gene Therapies San Francisco site to shutter by EOY
Gene therapy, rare disease - Read more [Paywall]

THE BAD
Patient Access

ICER also doesn’t agree with Lykos Therapeutics MDMA therapy
Drug pricing, MDMA, post-traumatic stress disorder (PTSD) - Read more

⬇️ The Ugly News ⬇️

THE UGLY
Criminal Acts

Former Cassava Sciences scientific advisor indicted on fraud
Small molecule, Alzheimer’s, research fraud - Read more

THE UGLY
Regulatory

Supreme Court overturns Chevron doctrine, potential ramifications for FDA and other federal agencies - Read more

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

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