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THE GOOD
Approvals & Labels

Eli Lilly nabs full FDA approval for selpercatinib in thyroid cancer
Small molecule, thyroid cancer - Read more

Fresenius Kabi, Formycon’s Otulfi (Stelara biosimilar, Johson & Johnson) receives FDA approval
Monoclonal antibody, Crohn’s disease, ulcerative colitis, plaque psoriasis, arthritis, biosimilar - Read more

Pharming Group’s Jeonja nabs UK MHRA approval to treat rare immune disorder PI3Kδ syndrome
Small molecule, PI3Kδ syndrome - Read more

Vertex Pharmaceuticals’ cystic fibrosis med gains Mexico COEFPRIS approval
Small molecule, cystic fibrosis - Read more

Remedee Labs nabs European approval for fibromyalgia pain-treating wristband
Medical device, fibromyalgia - Read more

THE GOOD
Business Development

Roche ponies up $850M for pair of experimental breast cancer meds from Regor Pharmaceuticals
Small molecule, breast cancer - Read more

Nanoscope Therapeutics licenses CatCh technology from Max Planck Innovation
Gene therapy, inherited retinal diseases, macular degeneration - Read more

JMT-Bio Technology (CSPC Pharmaceutical Group subsidiary) in-licenses mainlaid China rights to bispecific ADC JSKN003 from Jiangsu Alphamab Biopharmaceuticals (Alphamab Oncology subsidiary), up to RMB 3.08B ($438M) deal value
Bispecific antibody-drug conjugate, solid tumor, breast cancer - Read more

THE GOOD
Clinical Trials

Johnson & Johnson has double-win day, posts positive Ph3 results for both Carvykti and Darzalex Faspro in multiple myeloma
Cell therapy, monoclonal antibody, multiple myeloma - Read more

BridgeBio Pharma touts post-hoc Ph3 analysis of acoramidis in treating transthyretin amyloid cardiomyopathy, attempting to recover ground from a dismal early Ph3 readout
Small molecule, transthyretin amyloid cardiomyopathy - Read more

Rivus Pharmaceuticals showcases muscle-sparing weight-loss drug HU6 in Ph2a trial, obese patients with heart failure
Small molecule, obesity, heart failure - Read more

Novartis’ radiopharma hopeful Lutathera delivers a solid Ph2 win in treating meningioma
Radiopharma, meningioma brain tumors, cancer - Read more

Windtree Therapeutics’ positive topline Ph2 data for istaroxime in heart failure patients in early cardiogenic shock
Small molecule, heart failure, cardiogenic shock - Read more

Cereno Scientific’s pulmonary arterial hypertension med CS1 delivers stellar Ph2 results
Small molecule, pulmonary arterial hypertension - Read more 

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Fundraises

DCVC Bio closes oversubscribed $400M fund
Venture capital, biotech investing - Read more

BD²: Breakthrough Discoveries for thriving with Bipolar Disorder awarding $18M in grants for bipolar disorder R&D
Grants, bipolar disorder - Read more

Aktis Oncology $175M Series B
Radiopharma, cancer - Read more

Sequentia Biotech €10M ($11M) Series A
Bioinformatics, omics - Read more

Celaid Therapeutics’ up $19M grant from Japanese Agency for Medical Research and Development
Cell therapy, pediatric genetic disorders, stem cells - Read more

RadioNano Therapeutics ¥450M ($3.1M) raise
Inorganic nanoparticles, cancer - Read more

THE GOOD
IPOs

Visen Pharmaceuticals files IPO on Hong Kong Stock Exchange
Small molecule, pe­di­atric growth hor­mone de­fi­cien­cy - Read more

THE GOOD
Lawsuits

Dragged out Bristol Myers Squibb, Celgene shareholder suit dismissed by New York federal judge
Cell therapy, cancer, CAR-T, biobucks - Read more

THE GOOD
Market Reports

CDMO industry vibe upbeat going into 2025, CPHI Milan survey
CDMO, contract manufacturing - Read more

THE GOOD
Mergers & Acquisitions

Valerio Therapeutics acquires Emglev Therapeutics
Single domain antibody, drug discovery - Read more

THE GOOD
Partnerships

Prime Medicine, Bristol Myers Squibb sign up to $3.5B drug development and manufacturing pact, while the former also shaves pipeline from 18 down to 3 genetic disease areas
Cell therapy, genetic disease, drug development, gene editing - Read more 

Tampa’s Moffitt Cancer Center, Japanese CRO CMIC forge global cancer trial alliance
CRO, global clinical trials, cancer - Read more

THE GOOD
Regulatory

Johnson & Johnson succumbs to US HRSA pressure, pauses “controversial” 340B rebate program roll-out
340B drug pricing program - Read more

In regulatory win and blow to sketchy “stem cell” clinics in the USA, Ninth Circuit Court of Appeals rules that stromal vascular fractions are drugs and thus come under FDA purview
Stem cell, drug labelling, regulatory oversight - Read more

FDA commits to making adcomm changes a reality
Advisory committee - Read more [Paywall]

THE GOOD
Research

IMRT and proton bean therapy no different in prostrate cancer outcomes; head to head study
Radiation therapy, prostrate cancer, proton beam therapy, intensity-modulated radiation therapy - Read more

THE GOOD
Strategic Plans

Roche exudes confidence at annual pharma event, aims for 20 “transformative” drugs launches within the next decade
Corporate strategy, drug development - Read more

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THE BAD
Earnings & Finances

Pfizer continues offloading Haleon stake
Consumer health - Read more

THE BAD
Layoffs

Ensoma closes Copenhagen site, eliminates “a very small number” of roles
Cell therapy, in-vivo off-the-shelf, cancer - Read more [Paywall]

Inventprise lays off 7% of staff
Vaccine, infectious disease - Read more

THE BAD
Politics & Policy

PBM reform bill gets the boot in Calfornia, Gov. Newsom “not convinced“ that said reform would adequately address prescription drug pricing woes
Pharmacy benefit managers, drug pricing - Read more 

THE UGLY
Clinical Trials

Kezar Life Sciences halts Ph2b trial of zetomipzomib in lupus after four patient deaths (stock rallies nearly 50% anyway)
Small molecule, lupus nephritis - Read more

THE UGLY
Marketing

Otsuka in UK PMCPA hot water after Jinarc safety messaging oversight
Small molecule, kidney disease, drug marketing - Read more

Moderna also incurs UK PMCPA wrath over misleading conference presentation from 2022
Vaccine, COVID-19 - Read more

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

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