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THE GOOD
Approvals & Labels

Mirum Pharmaceuticals' Ctexli approved by FDA as first treatment for cerebrotendinous xanthomatosis, a genetic cholesterol processing disorder
Small molecule, cerebrotendinous xanthomatosis - Read more

Gilead's Livdelzi (PPAR-delta agonist) lands EC approval for primary biliary cholangitis, following positive Ph3 trial results
Small molecule, primary biliary cholangitis - Read more

Shionogi and JEIL's Fetroja (cefiderocol), targeting carbapenem-resistant gram-negative bacteria, approved in South Korea for bacterial infections
Small molecule, bacterial infection - Read more

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THE GOOD
Business Development

Photys Therapeutics in-licenses HPB-143 (IRAK4 degrader) from Polymed to advance clinical development
Small molecule, inflammatory, autoimmune - Read more

THE GOOD
Clinical Trials

MeiraGTx's discloses results from first-in-human trials of rAAV8.hRKp.AIPL1 gene therapy for Leber Congenital Amaurosis 4 retinal dystrophy
Gene therapy, Leber congenital amaurosis 4 (LCA4) retinal dystrophy - Read more

SELLAS's Ph2a trial: SLS009 (tambiciclib) with zanubrutinib targets CDK9 in diffuse large B-cell lymphoma, showing 67% response rate.
Small molecule, B-cell lymphoma - Read more

Johnson & Johnson's Tremfya (targeting IL-23) delivers positive Ph3 trial results in ulcerative colitis
Monoclonal antibody, ulcerative colitis - Read more

Teva Pharmaceuticals and Sanofi's duvakitug (targeting TL1A) shows promising Ph2b results for ulcerative colitis and Crohn's disease
Monoclonal antibody, ulcerative colitis, Crohn's disease - Read more

THE GOOD
Earnings & Finances

Exelixis announces new $500 million stock buyback program through 2025, following completion of previous repurchase programs totaling $1.2 billion
Small molecule, antibody-drug conjugate, cancer - Read more

Neurocrine Biosciences approves new $500 million share buyback program, following completion of previous $300 million repurchase plan
Small molecule, tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis, uterine fibroid - Read more

THE GOOD
Fundraises

CircNova $3.3M Seed round, AI-powered drug discovery platform based in Detroit
RNA, drug discovery, AI - Read more

Achira $33M raise (Series unspecified), creating AI simulation models for drug discovery, backed by Nvidia and VC firm Dimension 
Drug discovery, drug development, AI - Read more

ZYMVOL raises €3M ($3.1M) Seed round, computational enzyme discovery platform for green chemistry solutions
Green chemistry, enzyme discovery - Read more

InVirtuoLabs €2.85M ($3.0M) “first funding round”, AI-powered drug discovery platform combining ML with physics simulations
Drug development, AI - Read more

THE GOOD
Investments

Hims & Hers acquires California peptide facility to boost personalized medicine capabilities and secure domestic supply chain
Peptide manufacturing, facility acquisition - Read more

THE GOOD
Mergers & Acquisition

Concentra offers $3 per share to buy Acelyrin, potentially derailing planned merger with Alumis.
Monoclonal antibody, thyroid eye disease, small molecule, plaque psoriasis - Read more

Cosette Pharmaceuticals acquires Mayne Pharma for $430M, expanding its women's healthcare portfolio and manufacturing capabilities
Small molecule, women’s health, birth control, menopause, hypoactive sexual desire disorder, rosacea - Read more

THE GOOD
Partnerships

Vicore Pharma, Qureight extend AI imaging partnership to track lung fibrosis drug buloxibutid in Phase IIb trial
Small molecule, idiopathic pulmonary fibrosis, drug development, imaging - Read more

ReCerise, National Cancer Center Singapore partner hepatocellular carcinoma R&D partnership utilizing multi-omics data analysis
Research & development, multi-omics, hepatocellular carcinoma - Read more

Tempus AI, Stemline Therapeutics, partner to use AI for identifying breast cancer patients needing ESR1 mutation testing
Small molecule, breast cancer, AI, companion diagnostic - Read more

THE GOOD
Politics & Policy

Federal judge extends temporary halt on Trump administration's restrictions to NIH grant recipient indirect cost payments, pending final decision
National Institute of Health, federal research funding - Read more [Paywall]

THE GOOD
Product Launches

Teva Pharmaceutiacls and Alvotech launch Selarsdi, their second biosimilar to Stelara (targeting IL-12, IL-23; Janssen), treating multiple inflammatory conditions in the US market
Monoclonal antibody, psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, biosimilar - Read more

THE GOOD
Regulatory

In a not-so-suprising reversal, FDA seeks to rehire 300 recently fired scientists, including those reviewing Neuralink, after Trump's agency-wide dismissals last week
Food & Drug Administration (FDA), rehiring - Read more

THE GOOD
Shortages

FDA confirms semaglutide shortage is over - good news for Novo Nordisk, bad news for compounders like Hims & Hers
GLP-1, obesity - Read more

THE GOOD
Strategic Plans

Eli Lilly bullish on orforglipron (GLP-1 receptor agonist) pending approval and launch, invests $548M in pre-launch inventory
Small molecule, obesity, commercialization, commercial supply - Read more

BioMarin assessing flurry of deals that came through from 150+ JPM meetings, though concerns over future innovation from cut NIH funding linger
Life science innovation space, National Institute of Health - Read more

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THE BAD
Mergers & Acquisition

Private equity firms Carlyle and SK Capital acquire struggling gene therapy developer bluebird bio for $29M, down from $10B peak valuation
Gene therapy, sickle cell disease, beta thalassemia - Read more

THE BAD
Regulatory

Report reveals illegal GLP-1 drug ingredients entering US; state attorneys general urge FDA action against counterfeit weight-loss medications
GLP-1, obesity, illegal importation - Read more

THE BAD
Strategic Plans

Pfizer discontinues hemophilia B gene therapy Beqvez globally, citing low patient and physician interest in the $3.5M treatment
Gene therapy, hemophilia - Read more

THE UGLY
Criminal Acts

DOJ investigates UnitedHealth for potential Medicare Advantage upcoding, allegedly leading to billions in improper payments
Health insurance, upcoding - Read more

THE UGLY
Politics & Policy

Federal funding for NIH research grants remains frozen despite judge's order, as Trump administration exploits procedural loophole
National Institute of Health, federal research grants - Read more

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

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