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DATA COMPILATION #PharmaFlow

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Top news of 2025: Drugmakers invest in US capacities, agree to lower Medicaid prices; Pfizer buys obesity-focused biotech Metsera
The year 2025 was an eventful one, marked by increased trade tensions, tariff threats, accelerated adoption of artificial intelligence (AI) in drug development, and an intensified race for next-gen obesity treatments. Major drugmakers pledged substantial investments in the US to mitigate potential tariffs. By the year-end, the Trump Administration announced deals with several drugmakers to lower prices for its Medicaid program and for cash payers.The year also saw significant changes at the US Food and Drug Administration (FDA), including high-profile leadership changes and workforce reductions. The agency rolled out advanced AI systems — known as agentic AI — to help its staff achieve specific goals.Several large mergers and acquisitions also shaped 2025. Pfizer bought obesity-focused biopharma Metsera for US$ 10 billion and Johnson & Johnson acquired Intra-Cellular for US$ 14.6 billion. Vertex Pharmaceuticals introduced a new, non-opioid painkiller, Journavx (suzetrigine), and GSK launched Blujepa (gepotidacin) which is now approved for treating uncomplicated urinary tract infections (uUTIs) and gonorrhea. Here are the top stories that made it to PharmaCompass’ top 10 Phispers of 2025.I. Drugmakers pledge over US$ 370 bn in building US capacities; lower Medicaid prices From the outset, 2025 was defined by tariff threats and trade tensions as the US government signaled potential steep tariffs on imported branded drugs. To mitigate the impact of potential tariffs, multinational drugmakers announced sizable investments in the US.Eli Lilly has announced a US$ 27 billion investment, followed by Johnson & Johnson (US$ 55 billion), Novartis (US$ 23 billion), Roche (US$ 50 billion), Bristol Myers Squibb (US$ 40 billion), AstraZeneca (US$ 50 billion), and GSK (US$ 30 billion). A Wall Street Journal report dated September 16 states that drugmakers have pledged more than US$ 370 billion in US investments due to tariff threats, while ThinkGlobalHealth estimates this number at over US$ 480 billion.On September 30, Pfizer struck a US$ 70 billion deal with the US government to lower Medicaid drug prices and expand domestic manufacturing. And in December, US President Donald Trump and nine major drugmakers announced agreements to lower medicine prices for the government’s Medicaid program and for cash payers. These prices will be in line with the lowest prices paid by other developed nations (known as the ‘most-favored-nation’ pricing).II.  Pfizer doubles down on obesity market, buys Metsera for US$ 10 bn, inks deal with YaoPharmaPfizer aggressively pursued the booming obesity market. In November, Pfizer completed the US$ 10 billion (approximately) acquisition of Metsera, a clinical-stage biopharma focused on drugs for obesity and cardiometabolic diseases, after winning a bidding war against Novo Nordisk. The following month, Pfizer signed a deal worth up to US$ 2.1 billion with China’s YaoPharma, a subsidiary of Shanghai Fosun Pharmaceutical, to develop and commercialize an experimental GLP-1 weight-loss drug — YP05002.III.  FDA approves Vertex’s non-opioid painkiller that blocks acute pain at sourceFDA approved Vertex Pharmaceuticals’ non-opioid painkiller, Journavx (suzetrigine), for the treatment of moderate-to-severe acute pain in adults. This represents the first new class of pain medication in over two decades, and offers an alternative to opioid analgesics.IV. GSK’s Blujepa approved for treating uncomplicated UTIs; also okayed for gonorrheaIn March 2025, FDA approved GSK’s antibiotic, Blujepa (gepotidacin), for the treatment of uncomplicated urinary tract infections (uUTIs) in female patients aged 12 years and older who weigh at least 40 kg. This marked the first approval of a new class of        for uUTIs in nearly 30 years. In December, FDA expanded Blujepa’s label to include treatment for gonorrhea, a sexually transmitted disease.V. J&J acquires neuroscience biotech Intra-Cellular for US$ 14.6 billionJohnson & Johnson kicked off 2025 with the US$ 14.6 billion acquisition of Intra-Cellular Therapies, strengthening its neuroscience portfolio. Intra-Cellular’s Caplyta (lumateperone) is a once-daily oral therapy approved for treating adults with schizophrenia and depressive episodes associated with bipolar I or II disorder.VI. Changes at FDA: A year marked by high-profile resignations, rollout of agentic AIFDA experienced significant organizational changes in 2025, including senior leadership departures, amid the Trump administration’s policy shifts. Approximately 3,500 FDA staff were slated for layoffs beginning in April, raising concerns about the agency's review systems. Health and Human Services (HHS) secretary Robert F Kennedy Jr’s anti-vaccine stance led to internal tensions, controversies and departures of senior vaccine officials.The agency is transforming itself  — in December, it announced the deployment of agentic AI capabilities for all its employees. Agentic AI refers to advanced AI systems designed to achieve specific goals by planning, reasoning, and executing multi-step actions.VII. Sanofi-Alnylam’s Qfitlia becomes first approved RNAi med for hemophilia A, BFDA approved Qfitlia (fitusiran) — the first RNA interface (RNAi) therapeutic for treating rare bleeding disorders hemophilia A and B. Developed through a collaboration between Sanofi and Alnylam Pharmaceuticals, Qfitlia is indicated for routine prophylaxis to prevent or reduce bleeding episodes in hemophilia patients aged 12 and older.VIII. Astra-Daiichi Sankyo’s Datroway bags FDA nod for treating advanced lung, breast cancerAstraZeneca and Daiichi Sankyo’s precision drug Datroway (datopotamab deruxtecan) won two key approvals in 2025. In January, Datroway received FDA approval for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer. And in June, it bagged accelerated approval for the treatment of an advanced form of non-small cell lung cancer in adults who had received prior treatment.IX. Novartis continues to forge deals; inks US$ 12 bn deal with Avidity, US$ 2 bn deal with Arrowhead Following active deal-making in 2024, Novartis continued to make strategic acquisitions in 2025. It acquired US-based Avidity Biosciences for approximately US$ 12 billion to expand its rare muscle disorders portfolio. As part of the deal, Avidity will spin off its early-stage cardiology drug programs into a new publicly-traded company called SpinCo.Novartis also signed a licensing and options deal with China-based Argo Biopharmaceuticals worth up to US$ 5.2 billion for experimental cardiovascular drug candidates, and a US$ 2 billion licensing and collaboration agreement with Arrowhead Pharmaceuticals for its preclinical neurodegenerative disease candidate. Novartis also agreed to buy Anthos Therapeutics, a drug development company majority-owned by investment firm Blackstone, for up to US$ 3.1 billion.X. Merck acquires Verona for US$ 10 billion; inks US$ 9.2 billion deal to buy CidaraMerck acquired London‑based Verona Pharma for approximately US$ 10 billion as part of its strategy to diversify ahead of the 2028 patent expiration of its cancer blockbuster, Keytruda (pembrolizumab). Merck also agreed to acquire Cidara Therapeutics in a deal valued at approximately US$ 9.2 billion, strengthening its infectious disease portfolio.  

Impressions: 3128

https://www.pharmacompass.com/radio-compass-blog/top-news-of-2025-drugmakers-invest-in-us-capacities-agree-to-lower-medicaid-prices-pfizer-buys-obesity-focused-biotech-metsera

#Phispers by PHARMACOMPASS
01 Jan 2026

STOCK RECAP #PipelineProspector

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Pipeline Prospector November 2025: Kimberly-Clark to buy Kenvue for US$ 48.7 bn; FDA approves Novartis’ gene therapy
November saw several big ticket acquisitions across the consumer health and biopharma space, including the US$ 48.7 billion acquisition of Johnson & Johnson’s consumer health unit Kenvue by Kimberly-Clark and Pfizer’s up to US$ 10 billion acquisition of obesity-focused biotech Metsera. Additionally, the trend of companies announcing capacity expansions continued unabated.The month saw several key drug approvals by the US Food and Drug Administration (FDA), including Kura Oncology-Kyowa Kirin’s Komzifti (ziftomenib) for treating adults with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation.The indices rose substantially during the month. The Nasdaq Biotechnology Index (NBI) rose 8.85 percent, from 5,344.91 at the end of October to 5,818.03 by November-end. The SPDR S&P Biotech ETF (XBI) gained 10.97 percent from 110.98 to 123.16. The S&P Biotechnology Select Industry Index (SPSIBI) also advanced 9.08 percent — from 8,789.93 to 9,588.09. Access the Pipeline Prospector Dashboard for November 2025 Newsmakers (Free Excel)Pfizer clinches up to US$ 10 bn deal for Metsera; Merck to buy Cidara for US$ 9.2 bnPfizer inked an agreement worth up to US$ 10 billion to acquire obesity-focused biotech Metsera. The deal ended a competitive bidding process between Pfizer and Novo Nordisk. Pfizer had filed lawsuits, alleging that Metsera breached an earlier merger agreement. Metsera accepted Pfizer’s revised offer after raising concerns about potential antitrust risks associated with Novo’s competing bid. In early November, Kimberly-Clark announced the acquisition of Johnson & Johnson’s consumer health unit — Kenvue — in a cash-and-stock deal valued at US$ 48.7 billion. The merger will create a consumer health company with expected annual revenue of about US$ 32 billion and a portfolio of highly-valued brands, including Tylenol (paracetamol), Neutrogena, Aveeno, and Listerine.Merck announced the acquisition of Cidara Therapeutics in a deal valued at US$ 9.2 billion. The acquisition gives Merck access to an experimental influenza antiviral designed to provide season-long protection with a single dose. Its stock rose 22 percent in November.Johnson & Johnson is buying Halda Therapeutics for US$ 3.05 billion in cash. Halda, a Connecticut-based biotech, adds early-stage cancer programs to J&J’s pipeline, including a lead candidate in prostate cancer.Like Pfizer and Novo Nordisk, Lundbeck and Alkermes were also embroiled in a bidding war for Avadel Pharmaceuticals. Lundbeck later withdrew from the race, clearing the way for Alkermes, which eventually agreed to acquire Avadel for US$ 2.37 billion.Drugmakers continued to announce plans to expand capacities. Eli Lilly (whose stock rose 22 percent in November) announced plans to invest US$ 3 billion to build an oral medicines manufacturing site in the Netherlands to support its experimental GLP-1 pill, orforglipron. It will also invest more than US$ 1.2 billion to expand its facility in Puerto Rico.AstraZeneca said it will invest US$ 2 billion to expand its manufacturing capacity in Maryland (US). And Novartis said it will set up a flagship manufacturing hub in North Carolina, post a trade agreement that lowers US tariff rates on Swiss imports. Access the Pipeline Prospector Dashboard for November 2025 Newsmakers (Free Excel) FDA approves Komzifti for leukemia; Bayer’s Hyrnuo wins accelerated approval for lung cancerFDA approved Komzifti (ziftomenib), a once-daily pill from Kura Oncology and Japan’s Kyowa Kirin, for adults with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation.The agency also expanded the approval of Epkinly (epcoritamab), developed by AbbVie and Genmab, for use as a second-line treatment of relapsed or refractory follicular lymphoma.The agency also granted accelerated approval to Bayer’s Hyrnuo (sevabertinib) for people with non-squamous non-small cell lung cancer (NSCLC) that has recurred or spread and carries a specific HER2 mutation.Moreover, FDA approved UCB’s Kygevvi (doxecitine and doxribtimine), the first treatment for thymidine kinase 2 deficiency (TK2d), a rare inherited mitochondrial disorder that leads to progressive muscle weakness and respiratory complications.Further, FDA approved Redemplo (plozasiran sodium), Arrowhead Pharmaceuticals’ first marketed drug for adults with familial chylomicronemia syndrome (FCS), a rare genetic disorder that causes extremely high levels of triglycerides in the blood that can cause acute pancreatitis. During the month, Arrowhead’s stock price went up by 31 percent.FDA also granted accelerated approval to Otsuka’s Voyxact (sibeprenlimab-szsi) to help reduce excess urinary protein in adults with IgA nephropathy, a chronic kidney disease.Separately, FDA approved Novartis’ gene-replacement therapy Itvisma (onasemnogene abeparvovec-brve) for patients aged two years and older with spinal muscular atrophy (SMA) caused by an SMN1 mutation. Itvisma uses the same active ingredient as Zolgensma and is the first approved gene therapy for a broader SMA population.Other than these, the regulator approved the Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) regimen for people with muscle-invasive bladder cancer who cannot receive cisplatin-based chemotherapy. The combination is the first and only approved regimen that can be used before and after surgery. Access the Pipeline Prospector Dashboard for November 2025 Newsmakers (Free Excel) Bayer’s asundexian shows benefit in strokes; Novo’s Rybelsus fails Alzheimer’s trialsThe month saw several trial wins. For instance, Bayer reported positive phase 3 results for asundexian, an experimental blood thinner that lowered the risk of repeated strokes without increasing major bleeding. In another phase 3 trial, Amgen’s Repatha (evolocumab) reduced major cardiovascular events in adults without prior heart attack or stroke when added to statins or other therapies.Cogent Biosciences (stock up 146 percent in November) reported strong phase 3 results for bezuclastinib in combination with sunitinib in patients with gastrointestinal stromal tumor (GIST) whose disease had progressed after earlier treatment.In trial failures, Novo Nordisk’s oral semaglutide pill, Rybelsus, failed to slow Alzheimer’s disease progression in two large phase 3 trials. The studies showed no benefit over placebo in more than 3,800 people with early-stage disease.The agency also paused two phase 3 studies of Intellia’s gene-editing therapy nexiguran ziclumeran after a patient developed severe liver problems. The share price of the company fell by 33 percent over the month.November wasn’t a good month for Sarepta (its stock was down 13 percent). The company said its late-stage trial of casimersen and golodirsen for Duchenne muscular dystrophy did not meet its main goal. Moreover, FDA added a boxed warning to Sarepta’s gene therapy Elevidys (delandistrogene moxeparvovec-rokl) following the deaths of two non-ambulatory children from acute liver failure. Access the Pipeline Prospector Dashboard for November 2025 Newsmakers (Free Excel) Our viewAfter a few difficult years marked by stock-market volatility and disruptions in global supply chains, the pharmaceutical sector is finally showing signs of sustained growth and stability. The uptick in big-ticket M&A activity is a clear indicator of the industry’s confidence. These are all huge positives as we move closer to 2026. Access the Pipeline Prospector Dashboard for November 2025 Newsmakers (Free Excel) 

Impressions: 2145

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-november-2025-kimberly-clark-to-buy-kenvue-for-us-48-7-bn-fda-approves-novartis-gene-therapy

#PharmaFlow by PHARMACOMPASS
04 Dec 2025

NEWS #PharmaBuzz

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https://www.pharmiweb.com/press-release/2026-01-13/immunitybio-announces-positive-results-demonstrating-anktiva-as-a-lymphocyte-stimulating-agent-in-c

PHARMIWEB
13 Jan 2026

https://www.biospace.com/business/jpm26-confident-merck-sees-growth-through-keytruda-loss-of-exclusivity

BIOSPACE
13 Jan 2026

https://www.indianpharmapost.com/clinical-trials/merck-initiates-phase-3-trial-of-calderasib-with-keytruda-qlex-for-nsclc-18842

INDPHARMAPOST
11 Jan 2026

https://www.globenewswire.com/news-release/2026/01/08/3215318/37704/en/CytomX-Therapeutics-Announces-Business-Update-and-Company-Milestones-for-2026.html

GLOBENEWSWIRE
08 Jan 2026

https://economictimes.indiatimes.com/industry/healthcare/biotech/biocon-biologics-to-introduce-3-new-biosimilars-for-cancer-treatment/articleshow/126376289.cms

ECONOMICTIMES
06 Jan 2026

https://www.globenewswire.com/news-release/2025/12/18/3207556/0/en/Pyxis-Oncology-Announces-Positive-Preliminary-Phase-1-Data-for-Micvotabart-Pelidotin-MICVO-in-Recurrent-Metastatic-Head-and-Neck-Squamous-Cell-Carcinoma.html

GLOBENEWSWIRE
18 Dec 2025