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THE GOOD
Approvals & Labels

Santhera Pharmaceuticals’ DMD therapy Agamree (targeting glucocorticoid and mineralocorticoid receptors) lands China NMPA approval
Small molecule, Duchenne muscular dystrophy - Read more

THE GOOD
Business Development

Vertex Pharmaceuticals and the Saudi Arabian Ministry of Industry and Mineral Resources and the Ministries of Investment and Health sign MOU focused on boosting gene therapy manufacturing in the region
Gene therapy, manufacturing - Read more

THE GOOD
Clinical Trials

Eli Lilly boasts positive Ph3 data for imlunestrant (estrogen receptor degrader) in breast cancer
Small molecule, breast cancer - Read more

Candel Therapeutics stock jumps on positive Ph3 data for CAN-2409 viral immunotherapy in prostate cancer
Viral immunotherapy, prostate cancer - Read more

Pharming Group touts positive topline Ph3 data for leniolisib (PI3Kδ inhibitor) in children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome
Small molecule, activated phosphoinositide 3-kinase delta syndrome - Read more

Arrowhead Pharmaceuticals showcases interim Ph1/2a data for ARO-CFB (targeting complement factor B) for complement mediated diseases
RNAi, complement mediated disease, kidney disease, immunoglobulin A nephropathy - Read more

Relay Therapeutics shares additional details on specific breast cancer sub-group from RLY-2608 (PI3Kα inhibitor) Ph2 trial
Small molecule, breast cancer - Read more

EsoBiotec begins world-first in vivo BCMA CAR-T clinical trial in multiple myeloma
Cell therapy, multiple myeloma, cancer, in vivo CAR-T - Read more

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⬇️ More Good News ⬇️

THE GOOD
Company Launches

Negev Labs launches with goals of harnessing neuroplastogens
Small molecule, neuroplastogen, psychedelics, psychiatric disorders, retinal degeneration - Read more

THE GOOD
Fundraises

Ambrosia Biosciences $25M Series A, small molecules for obesity and “other metabolic disorders”
Small molecule, obesity - Read more

Syncell $15M Series A, protein purification and spatial proteomics tech
Instrumentation, spatial proteomics, protein purification - Read more

Veradermics $75M Series B, small molecules for treating androgenetic alopecia
Small molecule, androgenetic alopecia, pattern hair loss - Read more

Noema Pharma undisclosed Series B extension (total Series B of $147M), neuroscience-based conditions with high unmet need
Small molecule, tuberous sclerosis complex, trigeminal neuralgia, Tourette syndrome - Read more

Angitia Biopharmaceuticals $120M Series C, musculoskeletal candidates
Biologic, degenerative disc disease, bispecific antibody, osteoporosis in postmenopausal women - Read more

Capstan Medical $110M Series C, robotic surgery for cardiac valve replacement
Robotic surgery, cardiac valve, mitral and tricuspid valve disease - Read more

Humanetics $5M raise from US DOD, medical countermeasures
Small molecule, acute radiation exposure, nanoparticle - Read more

RenaissThera undisclosed Seed raise, small molecules for obesity and diabetes (targeting GLP-1, GIP)
Small molecule, obesity, diabetes, GLP-1 - Read more

Rocket Pharmaceuticals $150M public offer of common stock
Gene therapy, Fanconi anemia, leukocyte adhesion deficiency-I, pyruvate kinase deficiency - Read more

ImmunityBio undisclosed public offering of common stock
Biologic, bladder cancer, cancer vaccine - Read more

CG Oncology public offering of 7.3M shares
Oncolytic immunotherapy, bladder cancer - Read more

THE GOOD
Investments

Daiichi Sankyo $152M ADC plant build in Shanghai, China
Antibody-drug conjugate, manufacturing, new site build - Read more 

THE GOOD
Mergers & Acquisitions

Chroma Medicine, Nvelop merger to create nChroma Bio, in vivo genetic medicines
Gene editing, epigenetic editors, non-viral delivery - Read more

Bayer buys Cara Care from partner Mahana Therapeutics
Digital therapeutics, irritable bowel syndrome - Read more

THE GOOD
Partnerships

Eli Lilly partners with telehealth platform Ro on providing vials (not injectable pens) of its blockbuster obesity med Zepbound
GLP-1, obesity, telehealth - Read more [Paywall]

TC BioPharm, CareDx partner on pharmacokinetic analyses of allogeneic gamma-delta T cell therapies
Cell therapy, acute myeloid leukemia, myelodysplastic syndrome, cancer, allogeneic gamma delta T cell therapy - Read more

PolyPid, ImmunoGenesis R&D collab on small molecule drug delivery tech
Small molecule, cancer, drug delivery - Read more

THE GOOD
Patients Access

Blood stem cell-based gene therapy still rely on difficult (sometimes unsafe) conditioning regimens; therapeutic developers seek alternatives
Gene therapy, conditioning regimen, stem cell-based therapies - Read more [Paywall]

A positive of the US pharma system - drugs are approved and made available faster compared to most of the EU; IQVIA report
Drug access, approval process - Read more [Paywall]

THE GOOD
Politics & Policy

Biopharma business development might have caught a break with President-elect Trump’s FTC pick
Biopharma business development, mergers & acquisitions, Federal Trade Commission - Read more

THE GOOD
Strategic Plans

Gilead plots path for sustained post-Biktarvy HIV dominance
Small molecule, human immunodeficiency virus infection - Read more

Eli Lilly’s has obesity meds on the “brain”
GLP-1, obesity, neurological conditions - Read more [Paywall]

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THE BAD
Business Development

SK Group may be looking to sell stake in Vietnam’s Imexpharm
Pharmaceutical manufacturing - Read more [Paywall]

THE BAD
Clinical Trials

Acelyrin’s izokibep (IL-17A inhibitor) flunks in non-infectious, non-anterior uveitis Ph2b/3 trial
Therapeutic protein, uveitis - Read more

Moberg Pharma’s MOB-015 (topical terbinafine) misses Ph3 endpoint in onychomycosis (nail fungus)
Small molecule, onychomycosis, nail fungus, topical - Read more

AnaptysBio atopic dermatitis hopeful ANB032 (targeting BTLA) misses all Ph2b endpoints
Monoclonal antibody, atopic dermatitis, eczema - Read more

Spruce Biosciences’ lone clinical asset, tildacerfont (corticotropin-releasing factor receptor-1 antagonist), fails in classic congenital adrenal hyperplasia Ph2 trial
Small molecule, classic congenital adrenal hyperplasia - Read more

SIGA Technologies’ tecovirimat (viral protein p37 inhibitor) NIH-run mpox trial halted due to lack of efficacy
Small molecule, mpox (monkeypox) infection, antiviral - Read more

Q32 Bio stock takes a massive beating (down 80%) after pair of bempikibart (IL-7Rα inhibitor) Ph2a trials disappoint; one trial in eczema misses endpoint, while other in alopecia has a clinical site excluded due to “marked protocol violations”
Monoclonal antibody, atopic dermatitis, eczema, alopecia - Read more

THE BAD
Layoffs

Cellectar lays off 60% of staff after FDA demands additional trial before considering an accelerated approval
Radiopharm, Waldenström macroglobulinemia, radiotherapy, bone marrow cancer - Read more

BenevolentAI’s “return to [techbio] roots” revamp to cost unspecified number of roles
Drug development, techbio, AI, drug discovery - Read more

THE BAD
Mergers & Acquisitions

Hepion and Pharma Two B call-off reverse merger
Small molecule, liver disease, Parkinson’s disease, cancer - Read more

THE BAD
Partnerships

Bayer ditches Moberg pact after Ph3 nail fungus topical failure
Small molecule, onychomycosis, nail fungus, topical - Read more [Paywall]

THE UGLY
Criminal Acts

Former CEO’s of CytoDyn and Amarex Clinical Research convicted in biotech fraud case by Maryland jury
Monoclonal antibody, COVID-19, human immunodeficiency virus, fraud, insider trading - Read more

THE UGLY
Public Health

Incoming HHS head RFK Jr. could rescind EUA’s for pediatric vaccines
Vaccine, infectious disease, COVID-19 - Read more [Paywall]

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

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