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Independent news organization reporting daily on biotech and pharma R&D – covers breaking industry news, business deals, FDA actions, and clinical trial results.

Pentagon Adds, Then Withdraws, WuXi AppTec to Chinese Military List
NewsFeb 13, 2026

Pentagon Adds, Then Withdraws, WuXi AppTec to Chinese Military List

The Pentagon briefly placed WuXi AppTec, a major Chinese contract research organization, on its list of firms that support the People’s Liberation Army, then withdrew the designation hours later without explanation. The move occurred amid intensified U.S. scrutiny of Chinese...

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Lilly Appeals Retatrutide Classification Ruling in Case that Could Impact Compounders
NewsFeb 13, 2026

Lilly Appeals Retatrutide Classification Ruling in Case that Could Impact Compounders

Eli Lilly has filed a notice of appeal challenging the FDA’s classification of its experimental obesity injection, retatrutide. The agency labeled the product as a new molecular entity, granting it a 12‑year data exclusivity period. Lilly argues the classification is incorrect...

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Epigenetic Editing Startup Moonwalk Shifts Focus to siRNA for Obesity
NewsFeb 13, 2026

Epigenetic Editing Startup Moonwalk Shifts Focus to siRNA for Obesity

Moonwalk Biosciences, founded by CRISPR pioneer Feng Zhang and former Illumina CTO Alex Aravanis, announced a strategic pivot from epigenetic editing to siRNA‑based obesity therapies. The company secured a $120 million Series A round to fund the new platform, which targets liver‑expressed...

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Moderna's Flu Shot Dilemma Muddies 2028 Break-Even Guidance
NewsFeb 13, 2026

Moderna's Flu Shot Dilemma Muddies 2028 Break-Even Guidance

Moderna’s chief financial officer indicated that the company cannot yet confirm whether its 2028 cash‑flow break‑even goal will hold, as the outlook for its seasonal flu vaccine remains uncertain. The flu shot, once expected to be a steady revenue stream,...

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Lilly Stockpiles $1.5B Worth of Weight Loss Pill Ahead of US Approval
NewsFeb 13, 2026

Lilly Stockpiles $1.5B Worth of Weight Loss Pill Ahead of US Approval

Eli Lilly has amassed roughly $1.5 billion worth of its experimental obesity drug orforglipron. The company began stockpiling the product months before the U.S. Food and Drug Administration is expected to grant approval later this year. Orforglipron, a GLP‑1 receptor agonist, joins...

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Immunic's Private Placement; Vertex's Cystic Fibrosis Data in Young Kids
NewsFeb 13, 2026

Immunic's Private Placement; Vertex's Cystic Fibrosis Data in Young Kids

Immunic announced an oversubscribed private placement raising up to $400 million to fund its shift toward a commercial‑stage biotech. The capital injection will support late‑stage development programs and accelerate the search for a new chief executive officer. Meanwhile, Vertex Pharmaceuticals disclosed...

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Paul Hudson Couldn’t Quite Get Sanofi over the Hump; PROTAC Developer Arvinas Appoints CEO
NewsFeb 13, 2026

Paul Hudson Couldn’t Quite Get Sanofi over the Hump; PROTAC Developer Arvinas Appoints CEO

Paul Hudson has struggled to revitalize Sanofi’s R&D engine despite a series of high‑profile acquisitions since becoming CEO in 2019. The French group’s pipeline has underperformed, and recent buyouts have failed to deliver the expected boost in innovative drug candidates....

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Isomorphic Claims Major Advance with New AI Drug Design Engine
NewsFeb 10, 2026

Isomorphic Claims Major Advance with New AI Drug Design Engine

Isomorphic Labs, the DeepMind spin‑off behind AlphaFold 3, announced a new AI‑driven drug design engine that builds on its protein‑structure predictions. The platform claims to generate novel small‑molecule candidates up to ten times faster while achieving sub‑nanomolar binding‑affinity accuracy. Early validation...

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ILiAD Raises $115M Round to Advance Whooping Cough Vaccine
NewsFeb 10, 2026

ILiAD Raises $115M Round to Advance Whooping Cough Vaccine

ILiAD Biotechnologies announced an oversubscribed $115 million Series B financing round to accelerate development of its next‑generation whooping cough (pertussis) vaccine. The capital will fund pivotal Phase 3 clinical trials, aiming to demonstrate superior efficacy and longer‑lasting immunity compared with current acellular vaccines....

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AbbVie, AstraZeneca Lose Appeal in Louisiana 340B Contract Pharmacy Fight
NewsFeb 10, 2026

AbbVie, AstraZeneca Lose Appeal in Louisiana 340B Contract Pharmacy Fight

A U.S. appeals court upheld Louisiana's law that restricts how 340B‑discounted drugs can be dispensed through contract pharmacies. The ruling rejected the challenge mounted by AbbVie and AstraZeneca, marking another defeat for drugmakers contesting state oversight of the federal 340B...

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NIH Stops Low-Dose Xarelto Arm of Large Stroke Study Due to Safety Concerns
NewsFeb 10, 2026

NIH Stops Low-Dose Xarelto Arm of Large Stroke Study Due to Safety Concerns

The National Institutes of Health has stopped the low‑dose Xarelto arm of a large, multi‑center stroke trial after an interim safety analysis revealed excess bleeding. The study, which enrolled roughly 5,000 patients with recent ischemic stroke, was testing rivaroxaban 2.5 mg...

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Shanghai's Cascade Gets $72M to Pursue MASH, Obesity and Diabetes Drugs
NewsFeb 10, 2026

Shanghai's Cascade Gets $72M to Pursue MASH, Obesity and Diabetes Drugs

Shanghai‑based Cascade Pharmaceuticals announced a financing round of roughly 500 million yuan ($72 million). The capital will fund the development of novel therapeutics targeting metabolic dysfunction‑associated steatohepatitis (MASH), obesity and type‑2 diabetes. Cascade joins a growing cohort of private biotech firms receiving...

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CSL’s Paul McKenzie Out, as Gordon Naylor Named Interim CEO
NewsFeb 10, 2026

CSL’s Paul McKenzie Out, as Gordon Naylor Named Interim CEO

CSL Limited announced that CEO Paul McKenzie will step down immediately after more than five years with the Australian biotech group. The board appointed Gordon Naylor, a veteran pharma executive, as interim chief executive. The decision reflects the board’s view...

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AstraZeneca’s Obesity Pill Hits in Phase 2, Key Cancer Trials Pushed Back
NewsFeb 10, 2026

AstraZeneca’s Obesity Pill Hits in Phase 2, Key Cancer Trials Pushed Back

AstraZeneca announced that its oral GLP‑1 candidate elecoglipron achieved its primary efficacy endpoints in two Phase 2 obesity studies. The trials demonstrated statistically significant weight loss and a favorable safety profile, positioning the drug as a potential first‑in‑class oral therapy. Simultaneously,...

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'Bat-Sh*t Crazy': Biopharma Leaders Unload on Regulatory Chaos
NewsFeb 10, 2026

'Bat-Sh*t Crazy': Biopharma Leaders Unload on Regulatory Chaos

The provided excerpt contains only the title and a brief introductory sentence of an article about biopharma executives criticizing regulatory complexity, without the full body text. Consequently, no substantive details about specific comments, companies, regulatory issues, or market impacts are...

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FDA Rejects Regenxbio's Hunter Syndrome Gene Therapy
NewsFeb 9, 2026

FDA Rejects Regenxbio's Hunter Syndrome Gene Therapy

The U.S. Food and Drug Administration has officially rejected Regenxbio's investigational gene therapy for Hunter syndrome, a severe X‑linked lysosomal storage disorder. The agency cited gaps in efficacy data and unresolved safety signals from the early‑stage clinical program. Regenxbio had...

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With Scant Data, RFK Jr. Credits Trump for Higher European Drug Prices
NewsFeb 9, 2026

With Scant Data, RFK Jr. Credits Trump for Higher European Drug Prices

Robert F. Kennedy Jr., serving as HHS Secretary, reiterated his claim that President Donald Trump's personal intervention and the threat of tariffs forced European nations to raise drug prices. He offered no empirical evidence to substantiate the assertion, and analysts...

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QuantX Raises $85M Series B From Lilly, Sanofi Ventures
NewsFeb 9, 2026

QuantX Raises $85M Series B From Lilly, Sanofi Ventures

QuantX Biosciences, a China‑American biotech, announced an $85 million Series B financing round led by the venture arms of Eli Lilly and Sanofi. The capital will fund the company’s immunology pipeline, which targets several high‑profile immune‑modulating proteins. The round underscores growing pharma interest...

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Despite FDA’s Crackdown, Pharma Is Still Spending Millions on Ads
NewsFeb 9, 2026

Despite FDA’s Crackdown, Pharma Is Still Spending Millions on Ads

The FDA launched an aggressive crackdown on pharmaceutical advertising last fall, issuing thousands of warning letters to drugmakers over misleading consumer ads. Despite the heightened scrutiny, the industry continued to pour roughly $2 billion into promotional campaigns, shifting spend toward digital...

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Galux Raises $29M Series B; CSL Teams up with Memo
NewsFeb 9, 2026

Galux Raises $29M Series B; CSL Teams up with Memo

South Korean biotech Galux secured $29 million in a Series B round to accelerate its AI‑driven research platform that designs novel protein therapeutics. The funding, led by regional venture partners, will expand Galux’s computational pipeline and scale up pre‑clinical collaborations. In parallel,...

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#ACTRIMS26: Roche’s MS Drug Fenebrutinib Beats Ocrevus, Cutting Risk of Disability Progression by 12%
NewsFeb 9, 2026

#ACTRIMS26: Roche’s MS Drug Fenebrutinib Beats Ocrevus, Cutting Risk of Disability Progression by 12%

Roche announced that its Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib achieved non‑inferior efficacy to the company’s blockbuster Ocrevus in a Phase 3 trial for primary progressive multiple sclerosis (PPMS). The oral agent lowered the risk of confirmed disability progression by 12%...

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Takeda, Iambic Sign Multiyear R&D Deal for AI Drug Discovery
NewsFeb 9, 2026

Takeda, Iambic Sign Multiyear R&D Deal for AI Drug Discovery

Takeda Pharmaceutical announced a multi‑year research agreement with San Diego biotech Iambic to develop AI‑driven small‑molecule drug candidates. The collaboration merges Takeda’s therapeutic expertise with Iambic’s generative AI platform to accelerate hit identification and lead optimization. Joint R&D labs, data...

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Novo Nordisk Sues Hims over Wegovy Patent Infringement, Considers Seeking 'Hundreds of Millions' In Damages
NewsFeb 9, 2026

Novo Nordisk Sues Hims over Wegovy Patent Infringement, Considers Seeking 'Hundreds of Millions' In Damages

Novo Nordisk has filed a federal lawsuit against Hims Inc., alleging that the company infringed on patents covering Wegovy, Novo's flagship semaglutide obesity treatment. The complaint seeks damages in the “hundreds of millions” of dollars, reflecting the high commercial stakes...

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Lilly Returns to Innovent to Partner on Cancer and Immune Diseases
NewsFeb 9, 2026

Lilly Returns to Innovent to Partner on Cancer and Immune Diseases

Eli Lilly has deepened its alliance with China‑based Innovent Biologics, signing a new agreement that includes a $350 million upfront payment. The partnership will focus on co‑developing bispecific antibody candidates targeting oncology and immunology indications. Both companies will share development costs, milestone...

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#ACTRIMS26: Sanofi Unpacks Data From a Failed Phase 3 Tolebrutinib Trial in PPMS
NewsFeb 7, 2026

#ACTRIMS26: Sanofi Unpacks Data From a Failed Phase 3 Tolebrutinib Trial in PPMS

Sanofi disclosed results from its Phase 3 trial of the BTK inhibitor tolebrutinib in primary progressive multiple sclerosis (PPMS). The study failed to meet its primary endpoint of slowing disability progression, and secondary outcomes showed no meaningful benefit. Safety data...

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US Calls for DOJ Investigation of Hims over GLP-1 Drugs
NewsFeb 6, 2026

US Calls for DOJ Investigation of Hims over GLP-1 Drugs

The U.S. government has referred tele‑health firm Hims & Hers to the Department of Justice for a formal investigation into its GLP‑1 weight‑loss program. Hims, which recently launched a compounded version of GLP‑1 drugs to compete with Novo Nordisk’s market‑leading injectables, is...

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TrumpRx Launch Falls Flat for some, Citing Generic Access
NewsFeb 6, 2026

TrumpRx Launch Falls Flat for some, Citing Generic Access

President Donald Trump unveiled TrumpRx, a direct‑to‑consumer drug platform promising to let Americans purchase prescription medicines without traditional insurance intermediaries. The rollout was framed as a fulfillment of broken political promises to lower drug costs. However, early feedback highlights that...

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HHS Drops Legal Fight over Blocked 340B Rebate Pilot
NewsFeb 6, 2026

HHS Drops Legal Fight over Blocked 340B Rebate Pilot

The U.S. Department of Health and Human Services has abandoned its legal challenge to a federal court’s injunction that halted a proposed 340B drug‑price rebate pilot. The pilot, designed by the Trump administration to test new rebate mechanisms for hospitals...

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Orphan Drug Tweak in US Spending Bill Will Make Life Easier for the FDA
NewsFeb 6, 2026

Orphan Drug Tweak in US Spending Bill Will Make Life Easier for the FDA

President Donald Trump signed the federal spending bill preserving the FDA’s ability to grant a seven‑year exclusivity period for orphan drugs that receive new indications. The provision reverses earlier suggestions to shorten the exclusivity term, embedding the policy in the...

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Agomab, SpyGlass Cap Biggest Week for Biotech IPOs Since 2021
NewsFeb 6, 2026

Agomab, SpyGlass Cap Biggest Week for Biotech IPOs Since 2021

Biotech IPO activity is rebounding as Agomab Therapeutics and SpyGlass Pharma launch public offerings on Friday. Agomab, a fibrosis‑focused company, aims to raise capital to advance its antibody candidates, while SpyGlass seeks funding for its eye‑disease pipeline. The combined debut...

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UniQure Pauses Higher Doses in Fabry Study; Aro Shares Pompe Data
NewsFeb 6, 2026

UniQure Pauses Higher Doses in Fabry Study; Aro Shares Pompe Data

UniQure announced a pause on the mid‑ and high‑dose cohorts of its Fabry disease gene‑therapy trial after two participants receiving 4×10^13 genome copies per kilogram experienced safety concerns. The low‑dose arm will continue while the company conducts a detailed safety...

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Geoff McDonough's Big Plans for NodThera's NLRP3; Enhertu Leader Steps Down at Daiichi
NewsFeb 6, 2026

Geoff McDonough's Big Plans for NodThera's NLRP3; Enhertu Leader Steps Down at Daiichi

Former Generation Bio CEO Geoff McDonough has joined biotech NodThera to accelerate its NLRP3 inflammasome program, targeting a Phase 3 trial launch next year. The move underscores NodThera’s ambition to capture a fast‑growing market for anti‑inflammatory therapies. In parallel, Daiichi...

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Roivant Spinout Priovant Touts Phase 2 Brepocitinib Data in Cutaneous Sarcoidosis
NewsFeb 6, 2026

Roivant Spinout Priovant Touts Phase 2 Brepocitinib Data in Cutaneous Sarcoidosis

Priovant Therapeutics, a Roivant spin‑out, announced that brepocitinib – an experimental immune modulator inherited from Pfizer – achieved its primary efficacy endpoint in a Phase 2 trial for cutaneous sarcoidosis. The study demonstrated statistically significant reductions in skin lesion severity and...

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Post-Hoc Live: Analyzing the Novo Vs. Hims GLP-1 Showdown
NewsFeb 6, 2026

Post-Hoc Live: Analyzing the Novo Vs. Hims GLP-1 Showdown

Post‑Hoc Live hosted a deep‑dive into the emerging rivalry between Novo Nordisk and Hims & Hers over GLP‑1 therapies. Novo, the long‑time market leader with drugs like Ozempic and Wegovy, faces a new challenger as Hims rolls out a lower‑priced...

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Illumina Bets on Healthcare After Trump Administration's NIH Funding Disruptions
NewsFeb 6, 2026

Illumina Bets on Healthcare After Trump Administration's NIH Funding Disruptions

Illumina announced a strategic pivot toward healthcare customers after the Trump administration’s disruptions to NIH funding slashed research‑sector spending. The company will expand its clinical‑grade sequencing platforms, accelerate partnerships with diagnostic labs, and pursue new reimbursement pathways. Illumina projects its...

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FDA Chief Makary Takes Aim at Hims' Compounded Wegovy Pill Plans
NewsFeb 5, 2026

FDA Chief Makary Takes Aim at Hims' Compounded Wegovy Pill Plans

FDA Commissioner Marty Makary publicly warned Hims & Hers that the agency will act quickly against its plan to compound Wegovy, the popular semaglutide weight‑loss injection. The warning follows reports that the telehealth firm intends to sell a lower‑cost, compounded...

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White House Launches TrumpRx
NewsFeb 5, 2026

White House Launches TrumpRx

The White House unveiled TrumpRx, a new direct‑to‑consumer website that lets Americans compare prescription drug prices and find lower‑cost options. The platform pulls real‑time pricing data from pharmacies, insurers and manufacturers, and provides discount coupons and pharmacy locators. TrumpRx is...

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Veradermics CEO Has a Great Hair Day with 122% Pop in IPO
NewsFeb 5, 2026

Veradermics CEO Has a Great Hair Day with 122% Pop in IPO

Veradermics, a biotech developing an oral formulation of minoxidil, saw its shares soar 122% on the first day of trading. The company aims to capture the growing consumer demand for hair‑loss solutions, positioning its product as a convenient alternative to...

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#ISC26: Bayer’s Asundexian Reduced Ischemic Strokes by 26% in Phase 3 Trial
NewsFeb 5, 2026

#ISC26: Bayer’s Asundexian Reduced Ischemic Strokes by 26% in Phase 3 Trial

Bayer announced that its next‑generation factor XIa inhibitor asundexian cut ischemic stroke incidence by 26% in a pivotal Phase 3 trial for secondary stroke prevention. The study also reported a favorable safety profile, with fewer major bleeding events compared with standard anticoagulants....

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Bristol Myers Draws Pipeline Excitement as Several Data Readouts Near
NewsFeb 5, 2026

Bristol Myers Draws Pipeline Excitement as Several Data Readouts Near

Bristol Myers Squibb highlighted at least ten late‑stage data readouts slated for 2024, reigniting investor enthusiasm after a period of muted pipeline news. The readouts span oncology, immunology and rare disease programs, many of which could support new label extensions...

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GLP-1s and the Super Bowl
NewsFeb 5, 2026

GLP-1s and the Super Bowl

Hims & Hers launched a new Super Bowl commercial promoting GLP‑1 weight‑loss drugs, positioning the brand amid a surge in public interest. The ad directly calls out disparities in healthcare access, contrasting affluent consumers’ ability to afford the medication with...

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Thermo Fisher, Charles River Workforce Cuts; WuXi Signs Contract with Vertex
NewsFeb 5, 2026

Thermo Fisher, Charles River Workforce Cuts; WuXi Signs Contract with Vertex

Thermo Fisher Scientific announced the closure of its chemical analysis manufacturing site in Franklin, Massachusetts, citing current customer demand shifts. The shutdown will affect the plant’s workforce, adding to a wave of staffing reductions across the life‑science services sector, including...

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Telehealth Provider Hims Goes After Novo's Weight Loss Pill with Compounded Version
NewsFeb 5, 2026

Telehealth Provider Hims Goes After Novo's Weight Loss Pill with Compounded Version

Hims & Hers announced it will begin selling a compounded version of Novo Nordisk's Wegovy weight‑loss injection on Thursday, just weeks after the FDA approved the brand‑name drug. The telehealth firm positions the lower‑cost alternative as a more accessible option...

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Eikon IPO Analysis: Big Biotech Names, Big Valuation Cut
NewsFeb 5, 2026

Eikon IPO Analysis: Big Biotech Names, Big Valuation Cut

Eikon Therapeutics, a Bay Area biotech that has raised more than $1 billion, launched its initial public offering this week. The IPO was priced at a valuation significantly lower than the $2 billion range previously projected, reflecting a broader pullback in biotech...

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Eisai Gains Henlius Therapy; LB Pharma Snags $100M in Funding
NewsFeb 5, 2026

Eisai Gains Henlius Therapy; LB Pharma Snags $100M in Funding

Eisai announced an exclusive commercial license with China’s Henlius to sell the anti‑PD‑1 antibody serplulimab in Japan. The agreement gives Eisai sole rights to market the immunotherapy, positioning it alongside the company’s existing oncology portfolio. Serplulimab, a checkpoint inhibitor, is...

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Angitia Gets $130M Series D for Pipeline of Musculoskeletal Drugs
NewsFeb 5, 2026

Angitia Gets $130M Series D for Pipeline of Musculoskeletal Drugs

Angitia Biopharmaceuticals announced a $130 million Series D financing round, led by a consortium of U.S. and Chinese investors. The capital will fund three biologic candidates currently in clinical trials for musculoskeletal disorders. One candidate targets a disease where Ultragenyx recently reported...

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Flagship's Generate:Biomedicines Files for IPO, Pitching AI-Driven Drugs
NewsFeb 5, 2026

Flagship's Generate:Biomedicines Files for IPO, Pitching AI-Driven Drugs

Generate:Biomedicines, the Flagship Pioneering‑backed AI drug‑discovery startup, filed for an initial public offering just nine days after dosing its first patient in a Phase 3 trial. The company has positioned itself as a leading, heavily funded player in the emerging AI‑bio...

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FTC Settles Insulin Lawsuit with Express Scripts
NewsFeb 4, 2026

FTC Settles Insulin Lawsuit with Express Scripts

The Federal Trade Commission reached a settlement with pharmacy‑benefit manager Express Scripts over its handling of insulin rebates, securing an agreement that extends across virtually every segment of the company’s operations. The deal requires changes to rebate structures, increased transparency,...

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AbbVie Says Immunology Blockbusters Will Be 'Main Drivers' Of Growth Post-Humira
NewsFeb 4, 2026

AbbVie Says Immunology Blockbusters Will Be 'Main Drivers' Of Growth Post-Humira

AbbVie announced that its newer immunology drugs are compensating for the imminent loss of Humira’s patent protection. The combined sales of Skyrizi and Rinvoq have already surpassed Humira’s historic peak, signaling a successful transition to next‑generation biologics. The company frames...

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