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THE GOOD
Approvals & Labels

Pfizer’s Hympavzi (anti-tissue factor pathway inhibitor) nabs haemophilia A, B approval from European Commission
Monoclonal antibody, haemophilia - Read more

UCB’s Bimzelx (IL-17F, IL17A inhibitor) lands fifth approved indication in hidradenitis suppurativa from FDA
Monoclonal antibody, hidradenitis suppurativa - Read more

Jazz Pharmaceuticals’ Ziihera (HER2 targeting) bispecific lands FDA approval in biliary tract cancer
Bispecific antibody, biliary tract cancer - Read more

Sandoz’s fludarabine phosphate gets FDA label updated under “Project Renewal”
Small molecule, leukemia, cancer - Read more

Medtronic’s smart insulin pen nabs FDA approval
Medical device, insulin pen, diabetes - Read more

THE GOOD
Business Development

Samsung Biologics lands $668M work of European manufacturing deals
CDMO, manufacturing - Read more

Asahi Kasei Pharma buys worldwide rights to Chiome Bioscience’s PFKR (anti-CX3CR1)
Monoclonal antibody, autoimune - Read more

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THE GOOD
Clinical Trials

Viking Therapeutics showcases final Ph2b results for VK2809 (thyroid hormone receptor-β agonist) in MASH
Small molecule, metabolic dysfunction associated steatohepatitis (MASH) - Read more

Novo Nordisk also touts positive MASH results, in Ph3 trial using semaglutide (GLP-1 agonist)
GLP-1, metabolic dysfunction associated steatohepatitis (MASH) - Read more

NewAmsterdam Pharma’s Ph3 trial for cholesterol-lowering obicetrapib (CEPT inhibitor, in combo with ezetimibe) hit endpoints, but analysts still not satisfied
Small molecule, high cholesterol - Read more

AmacaThera Ph1 data for AMT-143 “exceed[s] expectations” as non-opioid gel for post-operative pain relief
Small molecule, post-operative pain, gel - Read more

Melt Pharmaceuticals touts positive Ph3 topline data for MELT-300 non-opioid cataract surgery sedation pill
Small molecule, sedation, cataract surgery - Read more

THE GOOD
Company Launches

Valora Therapeutics emerges from stealth with $30M Seed raise, targeting glycans as a novel approach to cancer treatment
Antibody-lectin chimera, cancer - Read more 

THE GOOD
Earnings & Finances

Acurx Pharmaceuticals, Hoth Therapeutics, Enlivex Therapeutics all jump on the Bitcoin wagon with purchases of up to $1M worth of the decentralized currency
Bitcoin - Read more

THE GOOD
Fundraises

Venrock adds $500M to 10th investment fund
Biotech investing, healthcare investing, venture capital - Read more [Paywall]

NanoVation equity fundraise (amount undisclosed)
Lipid nanoparticle, drug delivery - Read more

Kookmin Bio KRW 3.4B ($2.4M) Series B
Microbiome - Read more [Press release in Korean]

Forte Biosciences $53M private placement
Monoclonal antibody, autoimmune - Read more

THE GOOD
Partnerships

Novartis, Vyriad partner on lentiviral-delivered CAR payloads to generate CAR-T cells in-vivo
Gene therapy, cell therapy, in-vivo CAR-T, delivery development - Read more

Pfizer to team up with Flagship Pioneering portfolio companies Montai Therapeutics and Ampersand Biomedicines on novel drug discovery
Small molecule, lung cancer, biologics, obesity, drug discovery - Read more

Sino Biopharmaceutical, Lixin Pharmaceutical strategic cooperation around LM-108 (CCR8 targeting) mAb and potential future bispecific, ADC candidates
Monoclonal antibody, solid tumor, cancer, bispecific antibody, antibody-drug conjugate - Read more [Press release in Chinese]

Laekna, Eli Lilly partner on LAE102 (activin receptor type 2 A antagonistic) mAb development for obesity
Monoclonal antibody, obesity, drug development - Read more

Alloy Therapeutics development partnership with Takeda on iPSC-derived CAR-T, CAR-NK cell therapies
Cell therapy, cancer, induced pluripotent stem cells, CAR-T/CAR-NK - Read more

23andMe (having exited drug discovery) looking to capitalize on patient data, signs collaboration and (de-identified) data sharing agreement with Mirador
Precision medicine development, target validation, immunology, inflammation - Read more

THE GOOD
Regulatory

FDA to hold adcom on generative AI, dubbed the “Digital Health Advisory Committee”
Medical device, AI, digital health - Read more [Paywall]

THE GOOD
Research

Squid ink (or how they release it) is the key to delivering oral meds more efficient and without needles
Drug delivery - Read more

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THE BAD
Clinical Trials

Sage Therapeutics’ SAGE-718 (NMDA receptor positive allosteric modulator) fails in Ph2, leaving the company with few options
Small molecule, Huntington’s disease - Read more

THE BAD
Lawsuits

Roche pulls out the litigation hammer against potential Evrysdi generic makers Natco Pharma and Zydus Lifesciences
Small molecule, spinal mulscular atrophy (SMA) - Read more

THE BAD
Layoffs

Johnson & Johnson and Merck & Co. both announce layoffs in China
Medtech, diabetes, HPV - Read more

THE BAD
Mergers & Acquisitions

Grifols says “no thanks, eh” to takeover bid from Canadian PE firm Brookfield
Plasma-based medicines, primary immunodeficiencies - Read more

THE UGLY
Opinions

52% of neurology patient groups consider pharma’s investment into nervous system disorders “inadequate”; PatientView report
Patient advocacy, nervous system disorders - Read more

THE UGLY
Politics & Policy

RFK Jr. wants to “blow [the FDA] up”, calls the regulatory body “corrupt”
Regulatory policy, regulatory overhaul - Read more [Paywall]

THE UGLY
Shortages

US nationwide IV fluid shortage continues, hospitals struggling and Baxter rationing
IV fluids, supply chain, manufacturing - Read more

THE UGLY
Warning Letters, Form 483s

Unexo Life Sciences handed FDA warning letter, citing “significant” problems
Medicated patch, pain relief - Read more

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

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