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THE GOOD
Approvals & Labels

European Commission approves Bristol Myers Squibb's Opdivo (targeting PD-1) plus Yervoy (targeting CTLA-4) for first-line treatment of unresectable or advanced hepatocellular carcinoma in adults
Monoclonal antibody, hepatocellular carcinoma, cancer - Read more

Vertex's Alyftrek (targeting CFTR) nabs UK MHRA approval
Small molecule, cystic fibrosis - Read more

Celltrion's Omlyclo (targeting IgE) approved by FDA as the first interchangeable Xolair biosimilar (Novartis, Genentech)
Monoclonal antibody, biosimilar, asthma, chronic rhinosinusitis with nasal polyps, food allergy, chronic spontaneous urticaria - Read more

THE GOOD
Business Development

Kancera and Recardio sign letter of intent related to former out-licensing fractalkine program, including KAND567 and KAND145, to latter
Small molecule, inflammatory disease, cancer - Read more

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THE GOOD
Clinical Trials

AstraZeneca's Imfinzi (PD-L1 inhibitor) shows improved event-free survival in Ph3 trial for stage II-IVA gastric and gastroesophageal junction cancers
Small molecule, stomach cancer - Read more

Biocon Biologics' Yesintek (targeting IL-12, IL23; ustekinumab biosimilar, Janssen) delivers positive Ph3 trial data for moderate to severe chronic plaque psoriasis
Monoclonal antibody, plaque psoriasis, biosimilar - Read more

Novartis' remibrutinib (BTK inhibitor) improves sleep in Ph3 trial for chronic spontaneous urticaria patients
Small molecule, chronic spontaneous urticaria - Read more

UCB's Bimzelx (IL-17A/F inhibitor)shows sustained benefits in psoriasis and hidradenitis suppurativa with five-year efficacy data from Ph3 trial
Monoclonal antibody, psoriasis, hidradenitis suppurativa - Read more

Bristol Myers Squibb's Sotyktu (TYK2 inhibitor) delivers positive Ph3 results in psoriatic arthritis
Small molecule, psoriatic arthritis - Read more

Alumis' ESK-001 (TYK2 inhibitor) delivers sustained efficacy in Ph2 study for moderate-to-severe plaque psoriasis
Small molecule, plaque psoriasis - Read more

Johnson & Johnson's icotrokinra (IL-23 receptor blocker), outperformed Bristol Myers Squibb's Sotyktu (TYK2 inhibitor) in Ph3 trials for moderate-to-severe plaque psoriasis.
Synthetic peptide, plaque psoriasis - Read more

Kardigan unveil a Phase 2 trial for tonlamarsen (targeting AGT), an Ionis acquired hypertension drug, with $300M funding
Pipeline strategy, antisense oligonucleotide, hypertension - Read more

THE GOOD
Fundraises

4C Medical $175M Series D, pivotal trials of transcatheter mitral valve replacement device
Medical device, heart disease - Read more

FemtoVox $4.5M Seed, developing ultrafast laser surgery technology with 10x accuracy and reduced tissue damage
Laser surgery technology, medical device - Read more

THE GOOD
Investments

Roche launches Boston Innovation Center at Harvard, focusing on cardiovascular health, AI, and data science for drug development
New facility, technology and innovation site, AI, data science - Read more

THE GOOD
Lawsuits

Court blocks compounders from producing unauthorized tirzepatide versions, affirming that Eli Lilly's FDA-approved blockbusters aren’t in shortage
GLP-1, obesity, compounding - Read more

THE GOOD
Market Reports

January saw more generic drug prices decrease than increase, though some major price hikes occurred for specific medications
Generic, drug Pricing - Read more [Paywall]

THE GOOD
Mergers & Acquisition

Oklo acquires Atomic Alchemy, expanding into radioisotope production for healthcare, research, and defense industries
Isotope manufacturing - Read more

THE GOOD
Opinions

Arcturus confident BARDA funding for H5N1 mRNA vaccine trial will continue, despite reports of Moderna losing similar support
Biomedical Advanced Research and Development Authority (BARDA), pandemic preparedness, bird flu (H5N1/Avian flu), mRNA, vaccine - Read more

THE GOOD
Patient Access

Optum Rx adds Vertex Pharmaceuticals' new non-opioid pain drug Journavx (targeting Na_v1.8 sodium channel) to commercial formularies, despite price concerns compared to cheaper opioids
Health insurance, pharmacy benefit managers, drug pricing - Read more

THE GOOD
Product Launches

Nona Biosciences launches Hu-mAtrIx, an AI platform integrating with Harbour Mice technology to accelerate monoclonal antibody discovery
Monoclonal antibody, drug discovery, AI - Read more

THE GOOD
Regulatory

NIH centralizes peer review at Center for Scientific Review to “improve efficiency”, purported savings at $65 million annually
National Institute of Health (NIH), peer review - Read more

THE GOOD
Strategic Plans

Novo Nordisk aims to become rare disease leader with new launches, including sickle cell disease candidate, and external opportunities
Pipeline strategy, sickle cell disease, rare disease - Read more

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THE BAD
Clinical Trials

Johnson & Johnson halts testing of aticaprant (targeting KOR) for major depressive disorder with anhedonia, citing insufficient efficacy despite good safety profile
Pipeline strategy, small molecule, major depressive disorder - Read more

CytomX and Amgen discontinue CX-904 (targeting EGFR/CD3) in Ph1 trial for solid tumors, citing clinical observations and pipeline priorities
Pipeline strategy, bispecific T-cell engager, cancer, solid tumor - Read more

THE BAD
Earnings & Finances

Bayer informed analysts a day early about plans to issue shares, causing stock to drop 6.5% when formally announced
Big pharma strategy, share sale - Read more

THE BAD
Layoffs

Atea cuts staff by 25%
Small molecule, antiviral, hepatitis C - Read more

THE BAD
Mergers & Acquisitions

FTC blocks GTCR's $627M acquisition of Surmodics to prevent market concentration in hydrophilic coatings industry
Federal Trade Comission (FTC), antitrust, private equity acquisition - Read more

THE BAD
Partnerships

Molecular Partners, Novartis end three-year radiopharmaceutical drug development partnership
Radiopharm, drug development, cancer - Read more

THE BAD
Politics & Policy

FDA nominee Makary distances from agency disruptions, supports vaccines committee, but won't commit to rescheduling canceled flu meeting
Advisory committee, vaccine - Read more

THE BAD
Strategic Plans

Novo Nordisk clarifies it has no plans for new GLP-1 addiction trials beyond ongoing semaglutide studies on liver damage and alcohol use
Pipeline strategy, GLP-1, addiction - Read more

Theriva Biologics pauses development of SYN-004 (β-lactamase enzyme) in GvHD, at least until suitable “grant funding, or…a licensee or partner” appears
Pipeline strategy, enzyme, graft versus host disease (GvHD) - Read more

THE UGLY
Politics & Policy

NIH cancels millions in research grants nationwide, defying court orders
Federal research funding, National Institute of Health (NIH) - Read more [Paywall]

NIH patent filings and licensing applications came to a screeching halt 5 weeks ago and haven’t budged since
National Institute of Health (NIH), patent applications - Read more [Paywall]

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

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