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THE GOOD
Business Development

Bayer buys Japan development, commercialization licensing rights to aficamten from Cytokinetics
Small molecule, hypertrophic cardiomyopathy - Read more

THE GOOD
Clinical Trials

Eli Lilly touts positive Ph2 data for lipoprotein inhibiting muvalaplin, genetic risk of heart disease
Small molecule, heart disease - Read more

Johnson & Johnson, Protagonist Therapeutics showcases positive Ph3 data for icotrokinra (IL-23 blocker) in plaque psoriasis
Peptide, plaque psoriasis - Read more

BridgeBio touts further Ph3 data from extension study for TTR stabilizer acoramidis in rare heart disease, as PDUFA date (November 29) approaches
Small molecule, transthyretin amyloid cardiomyopathy - Read more

Merck & Co. subcutaneous Keytruda formulation (utilizing Alteogen enzyme for better absorption, dispersion) comparable to SOC 30 minute infusion
Monoclonal antibody, lung cancer, formulation - Read more

Biogen, UCB’s dapirolizumab pegol (anti-CD40L Fab fragment) delivers positive Ph3 data in systemic lupus erythematosus
Fab fragment, systemic lupus erythematosus - Read more

GSK’s linerixibat (ileal bile acid transporter inhibitor) hits primary endpoint in Ph3 primary biliary cholangitis trial
Small molecule, primary biliary cholangitis - Read more

Brii Bio’s Ph2 trial data “clearly demonstrates” benefits of elebsiran (hepatitis B virus RNA transcripts degrading siRNA) + PEG-IFNα versus PEG-IFNα alone in chronic HBV infection
siRNA, chronic hepatitis B infection - Read more

Bristol Myers Squibb, Kyverna Therapeutics, Fate Therapeutics, Cabaletta Bio all showcase new CAR-T data in lupus
Cell therapy, lupus, CAR-T - Read more

Vir Biotechnology touts positive Ph3 data for tobevibart mAb (broadly neutralizing, + elebsiran siRNA) in chronic hepatitis D
Monoclonal antibody, hepatitis D, siRNA - Read more

Bluejay Therapeutics hepatitis D hopeful BJT-778 (targets hepatitis B virus surface antigen) delivers promising Ph3 data
Monoclonal antibody, hepatitis D - Read more

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⬇️ More Good News ⬇️

THE GOOD
Company Launches

“Fail fast” biotech venture foundry Jupiter Bioventures launches with $70M, aiming for supporting 8-10 startups in cancer or where “cancer biology provides insights”
Biotech investing, venture foundry, cancer - Read more

THE GOOD
Fundraises

Initiate Ventures $45M debut fund, investing in companies “at the intersection of healthcare, life sciences, and technology”
Venture capital, biotech investing, healthcare investing - Read more

Freya Biosciences $11.8M equity financing, microbial immunotherapies to treat bacterial vaginosis
Microbial immunotherapy, bacterial vaginosis - Read more

ATB Therapeutics €54M ($57M) Series A, novel cell-killing mechanism antibodies
Antibody, cancer, autoimmune - Read more

Synapticure $25M Series A, virtual care for neurodegenerative diseases
Digital health, neurodegenerative disease, virtual care - Read more

Spyre Therapeutics proposed $200M public offering
Antibody, inflammatory bowel disease - Read more

Tongrui Biopharma $100M Series A+, radionuclide drug conjugates
Radiopharm, radionuclide drug conjugate - Read more

Citizen Health $14.5M Seed raise, connecting drugmakers with consenting study participants
Health platform, AI, clinical trial participants - Read more

Cytomos £5M ($6.3M) raise, novel cell analysis system
Cell analysis technology, instrumentation - Read more

THE GOOD
Lawsuits

BeiGene (soon to BeOne Medicines) settles Brukinsa generic spat with MSN Pharmaceuticals
Small molecule, cancer - Read more

THE GOOD
Marketing

NeuroBo Pharmaceuticals rebrands to MetaVia
Small molecule, metabolic dysfunction-associated steatohepatitis (MASH), obesity - Read more

THE GOOD
Partnerships

LINDIS Biotech partners with Pharmanovia to launch catumaxomab (T-cell engager) in Europe
Bispecific antibody, epithelial cellular adhesion molecule (EpCAM)-positive carcinoma, cancer - Read more

Circio, Certest partner on new LNP formulations for tissue-specific DNA-vectors delivery
DNA, lipid nanoparticle, drug delivery - Read more

Xbrane Biopharma, Intas Pharmaceuticals global licensing, co-development agreement for nivolumab biosimilar (Opdivo, Bristol Myers Squibb), PD-1 inhibitor
Monoclonal antibody, cancer - Read more

THE GOOD
Politics & Policy

At least this guy’s a doctor; the Trump picks continue with Dr. Oz slated to lead Centers for Medicare and Medicaid Services
Medicare, medicaid - Read more

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THE BAD
Approvals & Labels

Astellas gets a CRL from the FDA for Izervay supplemental NDA, concerns around proposed labelling language
RNA aptamer, geographic atrophy (GA), age-related macular degeneration (AMD) - Read more

AstraZeneca, Daiichi Sankyo Enhertu ADC again rejected by UK’s NICE over a lack of “cost-effective pric[ing]”
Antibody-drug conjugate, breast cancer - Read more

AstraZeneca’s Andexxa (factor Xa inhibitor binder) FDA adcom chances not looking good after “major safety findings”
Recombinant coagulation factor, bleeding reversal - Read more

THE BAD
Clinical Trials

Incyte Pharmaceuticals halts INCB000262 (MRGPRX2 blocker) Ph2 recruitment following new (as yet undisclosed) animal toxicology studies
Small molecule, hives, urticaria - Read more

THE BAD
Opinions

BMO Capital Markets analyst says biopharma fears towards RFK Jr. are less important than the (currently unknown) incoming FDA commissioner
FDA commissioner, analyst opinion - Read more

THE BAD
Strategic Plans

Neurogene halts CLN5 Batten disease gene therapy NGN-101 development after FDA declines RMAT designation
Gene therapy, CLN5 Batten disease, Regenerative Medicine Advanced Therapy Designation - Read more

THE UGLY
Patient Access

Big pharma, despite progress, isn’t doing enough to provide equitable access to essential medicines
Essential medicines, low and middle-income country access - Read more

THE UGLY
Warning Letters, Form 483s

Tianjin Darentang Jingwanhong Pharmaceutical handed FDA warning letter after hindering inspection
Facility inspection, GMP violations - Read more

THE UGLY
Withdrawals & Recalls

Endo USA expands clonazepam recall due to package labelling error
Small molecule, panic disorder, labelling error - Read more

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

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