Deals:
Novo Nordisk is licensing a drug called LX9851 from Lexicon Pharmaceuticals for up to $75 million in upfront and near-term payments, if the latter meets certain development goals. Lexicon is eligible to earn up to $1 billion from later R&D, regulatory and sales milestones.
A rival group is seeking to buy cell therapy biotech Bluebird Bio, in an effort to outbid a private equity offer by Carlyle and SK Capital.
Merck KGaA is spending $85 million to get global commercialization rights to pimicotinib, a candidate for non-malignant tumors that it licensed from Abbisko Therapeutics.
Eli Lilly is expanding its direct-to-consumer capabilities through the weight-loss app Noom.
Tang Capital’s shell company Concentra Biosciences acquired Allakos.
Fingerpaint Group, a 2024 MM+M Agency 100 honoree, announced that it is adding BlackPoint Consulting Group, a New York-based specialized advisory firm servicing healthcare and life sciences companies, to its portfolio.
Princeton10, a strategic healthcare marketing communications firm, acquired Persephone Digital, a boutique health and technology agency specializing in social media.
CareCloud acquired RevNu Medical Management.
CDMO Artis BioSolutions emerged from stealth and bought cell and gene therapy manufacturer Landmark Bio for an undisclosed amount.
Pentec Health expanded into digital therapeutic services through a partnership with Luminopia.
Eton Pharmaceuticals announced the out-licensing of commercial rights to Increlex in territories outside of the U.S. to Esteve Pharmaceuticals.
Hartford HealthCare reached an agreement with UnitedHealthcare for patients to have uninterrupted access to its physicians, hospitals and services.
CareCloud acquired RevNu Medical Management.
Revive Therapeutics entered into an asset purchase agreement with DiagnaMed Holdings Corp.
Abbott Laboratories consolidated its media work with Publicis Media’s Spark Foundry.
FDA:
Novavax said it hasn’t yet received an official decision from the FDA regarding the company’s BLA seeking the approval of its COVID-19 vaccine.
Milestone Pharmaceuticals said the FDA rejected its application seeking approval for an inhaled drug to treat adults with certain types of abnormal heart rhythm due to manufacturing deficiencies.
The FDA accepted Novo’s application for a label extension for Rybelsus to reduce the risk of major adverse cardiovascular events in adults with Type 2 diabetes who also have atherosclerotic cardiovascular disease or chronic kidney disease.
The agency granted marketing authorization to Visby Medical for the Visby Medical Women’s Sexual Health Test.
FDA approved Novartis’ radioligand therapy Pluvicto for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer.
The agency approved Sanofi’s novel treatment for hemophilia A or B, with or without factor inhibitors.
AstraZeneca’s Imfinzi was approved as a perioperative immunotherapy for patients with muscle-invasive bladder cancer.
A federal judge struck down the FDA’s plan to regulate lab-developed tests, ruling in favor of lab trade groups that said the agency was overstepping its bounds.
Novartis receives FDA accelerated approval for Vanrafia (atrasentan), a selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy.
Sanofi’s rilzabrutinib was granted orphan drug designation in the U.S. for two rare diseases with no approved medicines.
The FDA approved Amgen’s Uplizna for treating adults living with Immunoglobulin G4-related disease.
Layoffs:
Carisma Therapeutics is laying off 95% of its staff.
Tenaya Therapeutics terminated 30% to 40% of its staff.
BioAtla is laying off “over” 30% of staff.
Funding rounds:
Sandoz issued new bonds to repay spin-off term loans and signed a $2 billion revolving credit facility.
Google– and Alphabet-backed Isomorphic Labs raised a $600 million funding round.
MoonLake Immunotherapeutics secured up to $500 million in non-dilutive financing from Hercules Capital.
AIRNA announced its oversubscribed $155 million Series B raise.
Atsena Therapeutics raised $150 million in a Series C funding round.
Israeli biotech Polyrizon closed a $17 million private placement.
GRI Bio closed a $5 million public offering.
Citius Pharmaceuticals announced a $2 million registered direct offering of common stock.
Industry news:
Eli Lilly’s experimental drug, lepodisiran, showed promise in lowering levels of Lp(a) by 94% in patients at risk of heart attacks and stroke, according to recently released data.
BioNTech has highly encouraging survival data for its bispecific antibody combining checkpoint blockade with VEGF-A inhibition as a first-line treatment for a serious form of lung cancer.
Merck’s Winrevair slashed mortality-morbidity risk by 76%.
Democratic-led states sued to block President Donald Trump from an $11 billion health funding cut.
Axsome Therapeutics said it will narrow the focus of a late-stage study of its depression drug after an initial run of the trial showed improvement only in a small subgroup of patients.
Inizio Medical launched iON.AI.
An investigation by Democratic staff of the Senate Finance Committee concluded that Pfizer funneled profits through offshore subsidiaries in tax havens like Puerto Rico and Ireland thanks to loopholes created by a 2017 tax law.
Utah became the first state to ban fluoride in public drinking water.
Bayer said it was preparing market launches this year of two new drugs that could each have annual peak sales of at least $1 billion.
Eversana joined Veeva AI’s Partner program.
Tizianal Life Sciences launched its Phase 2 trial evaluating intranasal foralumab for the treatment of non-active secondary progressive multiple sclerosis.
Novo’s earnings nearly doubled in 2024.
Greenwich LifeSciences announced positive immune response data from Phase 3 trial evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences.
A recent study from Dreem Health revealed that 22% of Americans are hesitant to seek treatment for sleep related issues because they are uncertain about treatment options.
The University of Utah Huntsman Mental Health Institute opened a crisis care center in Salt Lake City to combat high suicide rates in the state.
Hims and Hers expanded its weight loss offering on their telehealth platform, adding Lilly’s Zepbound to the platform.
Lilly also sued two compounders over copies of its weight loss drug Zepbound and Mounjaro.
The Supreme Court backed the Food and Drug Administration in a lawsuit from two e-cigarette companies that claimed the agency acted unlawfully in refusing them to sell flavored vape products.
A federal judge ordered HHS and other agencies to ‘undo’ probationary worker firings.
The Supreme Court seemed to back Planned Parenthood in a patient’s rights case in South Carolina.
Compass Therapeutics’ Tovecimig met its primary endpoint in the randomized phase 2/3 study in patients with biliary tract cancer.
