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  • Biotech & Pharma Updates | January 30 - February 2, 2025

Biotech & Pharma Updates | January 30 - February 2, 2025

Novartis has big spending plans for bolt-on acquisitions in 2025, FDA approves Celltrion's Avtozma (Actemra biosimilar), AbbVie raises 2027 sales forecast as Skyrizi and Rinvoq continue to perform, AstraZeneca cancels planned £450M ($559M) Liverpool vaccine facility due to reduced UK government funding, CDC removes youth survey data on sexual orientation and gender identity following federal directive + 34 more stories

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⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

Sanofi's Sarclisa (anti-CD38) plus VRd regimen approved in China for newly diagnosed multiple myeloma patients ineligible for stem cell transplant
Monoclonal antibody, multiple myeloma, cancer - Read more

FDA approves Celltrion's Avtozma (IL-6 inhibitor; Actemra biosimilar, Genentech/Roche) for rheumatoid arthritis, giant cell arteritis, juvenile arthritis and COVID-19
Monoclonal antibody, rheumatoid arthritis, giant cell arteritis, juvenile arthritis and COVID-19 - Read more

Merck's Capvaxive vaccine receives EU CHMP recommendation for prevention of Streptococcus pneumoniae disease and pneumonia in adults
Vaccine, streptococcus pneumoniae - Read more

Bavarian Nordic's Vimkunya, a virus-like particle vaccine for chikungunya virus prevention, receives positive CHMP opinion for ages 12+
Vaccine, chikungunya virus, virus-like particle - Read more

Daiichi Sankyo, AstraZeneca's Dato-DXd (targeting TROP2) lands positive CHMP recommendation for EU approval in hormone receptor positive breast cancer
Antibody-drug conjugate, breast cancer - Read more

Bristol Myers Squibb's Opdivo (targeting PD-1) plus Yervoy (targeting CTLA-4) receives CHMP recommendation for first-line treatment of advanced liver cancer
Monoclonal antibody, liver cancer - Read more

Bristol Myers Squibb's Breyanzi (targeting CD19 receives CHMP recommendation for relapsed/refractory follicular lymphoma after two therapies
Cell therapy, follicular lymphoma, CAR-T - Read more

THE GOOD
Business Development

US Department of Defense signs $32.8M contract with Valneva for Japanese encephalitis vaccine Ixiaro supply over one year
Vaccine, Japanese encephalitis, Department of Defense - Read more

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⬇️ More Good News ⬇️

THE GOOD
Clinical Trials

Novadip Biosciences' NVD003 deliver Ph1b/2a trial for congenital pseudarthrosis of the Tibia bone condition
Cell therapy, congenital pseudarthrosis, adipose stem cell - Read more

Cognition Therapeutics touts positive Ph2 data for zervimesine (targeting sigma-2 receptors) in dementia with Lewy bodies
Small molecule oligomer, dementia with Lewy bodies - Read more

Creative Medical Technology's showcases “positive initial” Ph1/2 data for CELZ-201-DDT in treating chronic back pain from degenerative disc disease
Cell therapy, chronic back pain, degenerative disc disease, stem cell - Read more

THE GOOD
Earnings & Finances

AbbVie raises 2027 sales forecast for Skyrizi (targeting IL-23) and Rinvoq (JAK inhibitor) to $31B, with Skyrizi capturing 40% of psoriasis market
Monoclonal antibody, small molecule, psoriasis, atopic dermatitis, ulcerative colitis - Read more

Novartis reports strong 2024 performance and optimistic 2025 outlook, despite upcoming generic competition to key drugs including Entresto
Small molecule, heart failure - Read more

Novartis’ Kisqali (kinase inhibitor) shows strong growth after broader FDA approval, with 65% sales increase and rapid adoption in early breast cancer treatment
Small molecule, breast cancer - Read more

THE GOOD
Fundraises

Lieberman lands undisclosed investment from Lead Capital Partners, marketing research firm serving pharma and healthcare clients
Market research - Read more [Paywall]

Age Labs & LIPUM AB receive €1.9M ($2.0M) grant to develop biomarkers for rheumatoid arthritis treatment
Biomarker, diagnostics, rheumatoid arthritis, precision medicine - Read more

THE GOOD
Investments

GE HealthCare invests $138M in Irish facility to boost contrast media production by 25 million doses annually by 2027
Radiopharm, facility investment, contract media manufacturing - Read more

THE GOOD
IPOs

Biotech company Metsera prices IPO at $18 per share, aims to raise $275M for fuel obesity ambitions
GLP-1, obesity - Read more

Maze Therapeutics prices IPO at $16 per share, upsizing offer by 1M shares to raise $140 million
Small molecule, APOL1 kidney disease, chronic kidney disease, phenylketonuria - Read more

THE GOOD
Marketing

Bayer scores a marketing W as UK’s advertising watchdog PMCPA take their side against Roche in misleading marketing claims involving competiting eye disease products Eylea and Vabysmo
Bispecific antibody, fusion protein, neovascular age-related macular degeneration (wet AMD), diabetic macular edema - Read more

THE GOOD
Mergers & Acquisition

Novartis CEO plans more bolt-on acquisitions in 2025, following 30 deals in 2024, to support long-term growth beyond 2030
Big pharma M&A strategy - Read more

Kadimastem shareholders approve merger with NLS Pharmaceutics for Nasdaq listing, following failed IM Cannabis deal last year
Cell therapy, amyotrophic lateral sclerosis (ALS), allogeneic cell therapy - Read more

THE GOOD
Partnerships

OpenAI, US National Laboratories partner to advance disease research, allowing 15,000 National Laboratories scientist access to OpenAI's o1 series
Research & development, AI - Read more

PHAXIAM Therapeutics, Technophage partner to expand GMP phage portfolio and improve antimicrobial resistance treatment access in Europe
Bacteriophage therapy, antimicrobial resistance, antibiotic resistant infection, drug access - Read more

Orion, Invenra partner to discover bispecific antibodies for cancer using Invenra's B-Body platform technology
Bispecific antibody, cancer, drug discovery - Read more

THE GOOD
Patient Access

NICE approves Vertex Pharmaceuticals' £1.65M CRISPR gene therapy Casgevy for sickle cell disease treatment on England's NHS
Gene-editing, gene therapy, sickle cell disease, CRISPR, Cas9 - Read more

THE GOOD
Research

Sugar from soil bacteria shows promise in treating vitiligo by slowing pigment loss in mice, study finds
Bacteria-based therapy, vitiligo - Read more

THE GOOD
Strategic Plans

Celltrion explores US manufacturing options and inventory buildup to counter potential Trump-era pharmaceutical tariffs on foreign drug imports
Manufacturing site, drug access, tariffs - Read more

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⬇️ The Bad News ⬇️

THE BAD
Approvals & Labels

Eisai, Biogen's Leqembi (targeting beta-amyloid) application faces additional safety scrutiny as EC asks CHMP to review new data, despite initial recommendation
Read more

THE BAD
Clinical Trials

Novartis discontinues development of iscalimab (anti-CD40) for Sjögren's syndrome due to unfavorable benefit-risk profile following promising Ph2
Monoclonal antibody, Sjögren's syndrome - Read more

THE BAD
Investments

AstraZeneca cancels planned £450M ($559M) Liverpool vaccine facility due to reduced UK government funding, despite last-minute increased offer
New facility, vaccine manufacturing, research & development - Read more

THE BAD
Lawsuits

Genentech sues HHS, claiming “supposed STD clinics” wrongfully receive 340B discounts while not meeting eligibility requirements
Department of Health and Human Services, 340B Drug Pricing Program, sexually trasmitted disease (STD) - Read more

THE BAD
Layoffs

Fractyl Health cuts 22 jobs, instead shifts focus to GLP-1 “off-ramp” AAV gene therapy Rejuva
Gene therapy, obesity, AAV - Read more

ImmunityBio cuts 10 more California jobs in March 2025, following earlier layoffs that reduced workforce to approximately 630 employees
Fusion protein, lung cancer - Read more

THE BAD
Politics & Policy

Trump and HHS nominee Kennedy affirm commitment to lowering drug prices, though specifics on IRA support remain unclear
Drug pricing, Inflation Reduction Act - Read more [Paywall]

THE BAD
Strategic Plans

AbbVie reels in emraclidine (targeting M4 muscarinic acetylcholine) ambitions, shifts to adjunct therapy role with approved schizophrenia meds
Small molecule, schizophrenia, adjunct therapy - Read more

⬇️ The Ugly News ⬇️

THE UGLY
Politics & Policy

RFK Jr. dodges Senate committee questions about vaccines causing autism while seeking HHS secretary position
Vaccines, anti-vax, autism - Read more

NSF payment system shutdown disrupts researchers' lives as federal funding freeze threatens salary payments, despite court block (since restored)
Research & development, federal funding, funding freeze - Read more [Paywall]

CDC removes youth survey data on sexual orientation and gender identity, along with HIV pages, following federal directive
Sexual orientation, gender identity, human immunodeficiency virus (HIV) - Read more [Paywall]

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

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