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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
Approvals & Labels

The Sky(rizi)’s the limit for Abbvie as their Humira successor bags another approval
Monoclonal antibody, ulcerative colitis - Read more

Sarepta’s DMD gene therapy leaves Pfizer in the dust, lands key FDA label expansion
Gene therapy, Duchenne muscular dystrophy - Read more

Akili’s land FDA clearance for ADHD-treating video game
Digital therapeutic, attention-deficit/hyperactivity disorder - Read more

Swedish Orphan Biovitrum’s (Sobi) once-weekly hemophilia A therapy lands EU approval
Recombinant protein, hemophilia A - Read more

Dizal Pharmaceutical’s nabs Chinese NMPA approval for lymphoma therapeutic
Small molecule, T-cell lymphoma, cancer - Read more

C3i lands Health Canada approval to commercially produce cell therapies
CDMO, manufacturing, cell therapy - Read more

THE GOOD
Business Development

Biophytis and Blanver sign licensing agreement
Biophytis to receive up to €108 ($116M) upfront + biobucks
Small molecule, obesity, respiratory infections, sarcopenia, Duchenne Muscular Dystrophy (DMD) - Read more

Sun Pharma signs non-exclusive licensing agreement with Takeda
Small molecule, gastroesophageal reflux disease - Read more

Biopharma deal-making continues it’s 2024 ascent; report - Read more

THE GOOD
Clinical Trials

Silence Therapeutics doesn’t keep quiet about longer-term Ph2 results
siRNA, atherosclerotic cardiovascular disease - Read more

Gilead’s twice-yearly HIV prevention med scores 100% efficacy in Ph3
Small molecule, human immunodeficiency virus - Read more

Just a month after going private, Vaxxinity publishes promising Parkinson’s Ph1 data
Synthetic peptide, Parkinson’s disease - Read more

NIH reports positive Ph1b/2 data from a 5-cancer drug cocktail
Monoclonal antibody, small molecule, B-cell lymphoma, cancer - Read more

Zealand Pharmaceuticals flaunts positive Ph1 obesity treatment data
Amylin analogues, weight management, obesity - Read more

J&J gets under the skin with positive Ph3 Crohn’s data
Monoclonal antibody, Crohn’s disease - Read more

Aphaia Pharma presents positive Ph2 prediabetes treatment data
Oral glucose formulation, prediabetes treatment - Read more

THE GOOD
Company Launches

Yellowstone Biosciences erupts out of stealth with £16.5 ($20.9M)
Bispecific monoclonal antibody, T-cell receptor, cancer - Read more

THE GOOD
Fundraises

iOnctura $86M Series B
Small molecule, myelofibrosis, lung cancer - Read more

āshibio $40M Seed + Series A
Monoclonal antibody, fibrodysplasia ossificans progressiva (FOP) - Read more

Insightec $150M fundraise
Ultrasound, tremors, Parkinson’s disease - Read more

Forbion closes BioEconomy Fund I, €75M ($80M)
Life science, biotechnology, sustainable development - Read more

Gavi, the Vaccine Alliance seeks $9B in new pledges for developing world vaccine access
Patient access, vaccines, developing nations - Read more [Paywall]

THE GOOD
Investments

Takeda plans $230 plasma-derived facility expansion
Plasma-derived therapeutic, manufacturing - Read more [Paywall]

ThermoFisher throws down $58M for clinical research lab expansion
CMC, clinical development, laboratory services - Read more

THE GOOD
Market Reports

Clinical trial sites are a hot investment among PE firms and CROs
Private equity investment, contract research organization - Read more

THE GOOD
Mergers & Acquisitions

Bora Therapeutics acquire sterile manufacturing site from Emergent BioSolutions
Sterile injectables, sterile manufacturing - Read more

Vanda Pharmaceuticals keeps suitors at bay, says offer are "substantially undervalue[d]"
Small molecule, schizophrenia - Read more

Sidekick Health acquires PINK!
Digital therapeutics, women’s health, breast cancer - Read more

THE GOOD
Partnerships

Sumsung Biologics signs reworked manufacturing partnership with Baxter
Samsung receives upwards of $223M
Drug manufacturing - Read more

Macomics testing partnership with Institute of Oncology Research (IOR)
Macrophage targeting antibody, prostate cancer, mouse models - Read more

THE GOOD
Patient Access

Amazon expands access to generic drug savings program
Generics, drug subscription, online pharmacy - Read more

THE GOOD
Regulatory

CBER head says we we need a rare disease hub
Rare disease hub, communication - Read more [Paywall]

FDA updates draft guidance on gaining biosimilar interchangeability status
Biosimilar interchangeability - Read more

PTC Therapeutics cleared by FDA to continue Phase 2 Huntington’s trial Small molecule, Huntington’s disease - Read more

THE GOOD
Research

Blood test + AI could spot Parkinson’s disease years in advance
Blood test, screening, AI, Parkinson’s disease - Read more

Enlarged prostate med might find use preventing dementia with Lewy bodies
Small molecule, dementia, benign prostatic hyperplasia - Read more

A Colombia family’s genes may hold vital Alzheimer’s clues
Genetics, Alzheimer’s - Read more

THE BAD
Clinical Trials

Jazz Pharmaceuticals hits a sour note with a Ph2 failure
Small molecule, essential tremor - Read more

THE BAD
IPOs

Cinclus Pharma has a not-so-great trading debut
Small molecule, gastric acid related diseases - Read more [Paywall]

THE BAD
Layoffs

Cara Therapeutics cuts 70% of staff after clinical trial miss
Synthetic peptide, nocturnal pruritus - Read more

THE UGLY
Accidents & Natural Disasters

Novo Nordisk has another fire - Read more

THE UGLY
Cybersecurity

Change Healthcare begins sending out “compromised info” notices
Data breach, patient data - Read more [Paywall]

THE UGLY
Lawsuits

Eli Lilly brings the heat, goes after unauthorized compounded GLP-1/GIPs
GLP-1, GIP, obesity, compounding - Read more

Providence Therapeutics goes after Emergent BioSolutions in Canada for a Covid-19 vaccine manufacturing contract that never appeared
Covid-19 vaccine, manufacturing - Read more

THE UGLY
Regulatory

FDA condemns studies conduced by India-based CRO Synapse
Contract research organization - Read more [Paywall]

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

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