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THE GOOD
Approvals & Labels

Pfizer ends a rough week with FDA approval for Hympavzi in hemophilia A and B
Monoclonal antibody, hemophilia - Read more

Stealth BioTherapeutics lands surprise recommendation (10-6) from FDA adcom for elamipretide in ultra-rare Barth syndrome
Small molecule, Barth syndrome, peptide - Read more

Dong-A’s Imuldosa biosimilar (Stelara, Johnson & Johnson) nabs FDA approval
Monoclonal antibody, plaque psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, biosimilar - Read more

THE GOOD
Business Development

Sanofi may have found consumer health buyer in PE firm Clayton Dubilier & Rice, negotiating 50% controlling stake sale (terms undisclosed)
Consumer health, division sale - Read more

THE GOOD
Clinical Trials

Capricor Therapeutics touts positive 3-year data from deramiocel Ph2 in DMD
Cell therapy, Duchenne muscular dystrophy, allogeneic cell therapy - Read more

Allakos posts Ph1 bioavailability & safety data for mast cell-inhibiting mAb AK007
Monoclonal antibody, chronic spontaneous urticaria, food allergy, asthma - Read more

Cantargia showcases positive Ph1 biomarker & safety data for autoimmune/inflammatory-targeting mAb CAN10
Monoclonal antibody, psoriasis, hidradenitis suppurativa, systemic sclerosis - Read more

THE GOOD
Criminal Acts

Teva Pharmaceuticals’ agrees to $450M settlement involving two kickback schemes; investigation by US DOJ
Small molecule, multiple sclerosis, kickbacks - Read more

THE GOOD
Fundraise

SciFounders files plans for $35M second fund
Venture capital - Read more [Paywall]

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Investments

Eli Lilly further bolsters manufacturing capacity with planned $200M expansion to Suzhou manufacturing site
Manufacturing, site expansion - Read more

THE GOOD
Marketing

Pharma ads aren’t all that bad, even downright helpful, according to 2,000 surveyed patients & physicians
Pharmaceutical advertising - Read more

THE GOOD
Partnerships

Janssen Biotech, Ailux Biologics (XtalPi) sign AI-powered biologics discovery and engineering pact
Monoclonal antibody, drug discovery, AI - Read more

Eurofins Discovery, Dompé farmaceutici renew AI-powered drug discovery partnership
Small molecule, drug discovery, AI - Read more

THE GOOD
Patient Access

After fervor from compound lobby and patients, FDA grants temporary allowance for compounding pharmacies to continue making generic Mounjara, Zepbound (Eli Lilly)
GLP-1, obesity, diabetes - Read more

THE GOOD
Strategic Plans

Valneva aims for “sustained profitability“ by 2027 for Lyme disease vaccine VLA15, assuming successfully approved & commercialized by partner Pfizer
Vaccine, Lyme disease - Read more

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THE BAD
Clinical Trials

Sanofi, Denali Therapeutics’ oditrasertib in MS misses endpoints in Ph2, trial discontinued
Small molecule, multiple sclerosis - Read more

Perspective Therapeutics’ decision to lower dosing in further Ph1/2a cohorts spooked investors, stock sinks nearly 20%
Radiopharma, radionucleotide, melanoma, cancer - Read more

THE BAD
Earnings & Finances

Indivior stock drops nearly 20% on reduced full year guidance for long-acting opioid use disorder med Sublocade
Small molecule, opioid use disorder - Read more

Drug price hikes a potential outcome as geopolitical tensions drives European drug maker reshoring efforts
Geopolitics, drug pricing - Read more [Paywall]

THE BAD
Layoffs

Turnstone Biologics turns away 60% of their staff from employment as part of a runway extension endeavor
Cell therapy, colorectal cancer, head and neck cancer, uveal melanoma, TIL cell therapy - Read more

THE BAD
Partnerships

Gilead MASHes the eject button in liver disease collaboration with Yuhan
Small molecule, metabolic dysfunction-associated steatohepatitis - Read more

Alaunos Therapeutics gives up licensing rights to Precigen’s personalized T-cell platform as part of severed partnership
Cell therapy, solid tumor, cancer, TCR-T cell - Read more

THE BAD
Politics & Policy

Pharma lobby PhRMa goes after US federal government over 340B rebate program response
Drug pricing, 340B - Read more [Paywall]

THE UGLY
Shortages

FDA officially declares IV solutions shortage after Baxter plant forced to close by Hurricane Helene
Drug shortages, IV solution - Read more

THE UGLY
Warning Letters, Form 483s

Thermo Fisher’s Patheon subsidiary plant in North Carolina flagged for contamination, air bubble in syringe issues by FDA
CDMO, manufacturing, sterile injectables - Read more

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

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