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THE GOOD
Approvals & Labels

Astellas' zolbetuximab (targeting CLDN18.2) nabs Chinese NMPA authorization, combined with chemotherapy for advanced HER2-negative gastric/gastroesophageal junction cancer treatment
Monoclonal antibody, gastric cancer - Read more

Amgen's tarlatamab (targeting DLL3, CD3) lands UK MHRA conditional marketing approval for treating extensive-stage small cell lung cancer after two prior therapies
Bispecific antibody, lung cancer - Read more

Nuvation Bio's taletrectinib (targeting ROS1) lands Chinese NMPA approval for ROS1 positive advanced non-small cell lung cancer
Small molecule, lung cancer - Read more

THE GOOD
Business Development

Merck & Co. acquires WuXi Biologics' Ireland vaccine facility for $500M
Vaccine, manufacturing, facility sale - Read more

LPOXY Therapeutics acquires rights to select Xeno Biosciences' clinical assets, in order to advance Clostridioides difficile infection prevention hopeful Sidiprev
Nonsystemic compound, clostridioides difficile infection - Read more

Southern XP lands commercial rights to HK inno.N’s K-CAB reflux medication in Australia and New Zealand
Small molecule, gastroesophageal reflux disease - Read more [Press release in Korean]

Santhera Pharmaceuticals and Clinigen sign supply and distribution agreement for Agamree for Duchenne muscular dystrophy patients in regions lacking direct commercial access
Small molecule, Duchenne muscular dystrophy - Read more

THE GOOD
Clinical Trials

Oculis's OCS-05, a neuroprotective therapy, shows positive Ph2 results for acute optic neuritis when administered with steroids
Small molecule, acute optic neuritis - Read more

Technoderma Medicines's TDM-180935 topical (JAK1, TYK2 inhibitor) delivers positive Ph2a results in atopic dermatitis
Small molecule, atopic dermatitis, eczema - Read more

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THE GOOD
Company Launches

Portage Biotech (re-)launches Cyncado Therapeutics, developing adenosine receptor antagonists as cancer treatments
Small molecule, cancer - Read more

THE GOOD
Fundraises

Aditum Bio closes $428M Fund III
Venture capital, biotech investing - Read more [Paywall]

Orbis Medicines €90M ($98M) Series A, developing oral macrocycle drugs dubbed “ⁿCycles”
Small molecule, drug discovery, macrocycle - Read more

PBS Biotech $17M growth capital, funding innovations in single-use bioreactors and bioprocess capabilities
Bioreactors, bioprocess, manufacturing - Read more

AEON Biopharma $20M public offering, developing botulinum toxin biosimilar (Botox, AbbVie) with “therapeutic uses”
Botulinum toxin complex, neurological disease - Read more

THE GOOD
Healthcare Equity

FDA releases guidance to improve pulse oximeter accuracy across skin tones, addressing concerns about inaccurate readings in darker-skinned patients
Medical device, pulse oximeter - Read more

THE GOOD
Investments

Basecamp Research expands with new CSO, Massachusetts lab, and UK-based AI computer cluster for genetic medicine development
Computational biology, drug discovery, AI, programmable genetic medicine - Read more

THE GOOD
IPOs

Anthem Biosciences, an Indian contract drugmaker, files for $397M IPO
CDMO, contract manufacturing - Read more

THE GOOD
Mergers & Acquisitions

Teoxane proposes to acquire Revance Therapeutics for $3.60 per share, leveraging existing partnership and 6.2% ownership stake
Medical aesthetics - Read more

Altaris completes Minaris Regenerative Medicine acquisition
CDMO, manufacturing, cell therapy - Read more

THE GOOD
Partnerships

JCR Pharmaceuticals, Modalis Therapeutics expand CNS gene therapy partnership using J-Brain Cargo delivery technology
Gene therapy, neuromuscular diseases, CNS diseases, cardiomyopathies, drug delivery - Read more

THE GOOD
Regulatory

FDA releases draft guidance for AI-enabled medical devices, covering safety and effectiveness throughout product lifecycle
Medical device, draft guidance, AI - Read more

FDA releases draft guidance to define when confirmatory trials are "underway" for accelerated drug approvals, aiming to clarify requirements
Accelerated approval, draft guidance, confirmatory clinical trial - Read more

THE GOOD
Research

Scientists discover new antibodies targeting unexplored parts of malaria parasites, showing promise for future prevention methods; mouse model
Antibody, malaria - Read more

Scientists use zebrafish protein Hmga1 to successfully repair damaged mouse hearts by activating dormant genes, potential to treat heart failure
Protein, heart repair, heart failure - Read more

Bioengineers create protein-based cellular circuits that can detect disease signals and trigger therapeutic responses, potential complex condition implications
Cellular circuitry, autoimmune, cancer - Read more

THE GOOD
Strategic Plans

I-Mab makes strategic pivot, focusing efforts on givastomig (targeting CLDN18.2, 4-1BB) bispecific
Bispecific antibody, cancer - Read more

Citius Oncology open to “all avenues” in hopes of commercializing FDA approved lymphoma med Lymphir (IL-2 receptor targeting)
Recombinant fusion protein, lymphoma, cancer - Read more

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THE BAD
Earnings & Finances

Moderna CEO admits to poor RSV vaccine sales, blames CDC's age restriction guidance limiting shots to those 75 and older + competition from incumbents GSK and Pfizer
Vaccine, respiratory syncytial virus - Read more

THE UGLY
Company Shutdown

Velia Therapeutics shuts down two years after $55M Series A
Microprotein, drug discovery - Read more [Paywall]

THE UGLY
Lawsuits

Aetna sues Pfizer, Novartis, and Teva Pharmaceuticals (among others) for allegedly fixing prices of 111 generic drugs through secret market-sharing agreements since 2012
Drug pricing, price fixing, generic - Read more

THE UGLY
Public Health

First U.S. death from H5N1 bird flu reported in Louisiana; elderly patient contracted virus from backyard and wild birds
Infectious disease, bird flu - Read more

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

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