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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: 2142

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 Jan 2025: J&J’s US$ 14.6 bn Intra-Cellular buyout kicks off deal frenzy; Ozempic clinches FDA nod for CKD
January was a busy month that saw several deals being announced at the JP Morgan Healthcare Conference. In all, deals worth over US$ 19.3 billion were signed at the annual event. The month also saw several key drugs getting approved by the US Food and Drug Administration (FDA). This got reflected in the indices — while the Nasdaq Biotechnology Index (NBI) rebounded 4.42 percent to reach 4,532.75, the SPDR S&P Biotech ETF (XBI) and S&P Biotechnology Select Industry Index (SPSIBI) posted gains of 1.89 percent and 2.84 percent respectively.   Access the Pipeline Prospector Dashboard for January 2025 Newsmakers (Free Excel)    J&J buys Intra-Cellular for US$ 14.6 bn, Lilly strikes US$ 2.5 bn cancer deal with Scorpion Johnson & Johnson (stock up 5 percent) announced the biggest biotech buyout since March 2023 with its acquisition of Intra-Cellular Therapies (stock up 49 percent), a neuroscience-focused biopharmaceutical company, for US$ 14.6 billion. Intra-Cellular’s lead drug, Caplyta (lumateperone), approved for bipolar depression, is undergoing FDA review for major depressive disorder (MDD).  Eli Lilly (stock up 5 percent) announced a US$ 2.5 billion deal to acquire Scorpion Therapeutics’ experimental cancer therapy, STX-478. This therapy targets specific mutations in breast cancer and other solid tumors. Lilly also partnered with UK-based Alchemab Therapeutics to develop up to five new antibodies targeting amyotrophic lateral sclerosis (ALS). Gilead Sciences (stock up 5 percent) and LEO Pharma teamed up in a deal worth up to US$ 1.7 billion to develop oral STAT6 inhibitors for inflammatory diseases. These inhibitors will target key pathways in conditions like atopic dermatitis, asthma, and COPD, offering a potential oral alternative to injectable biologics. GSK (stock up 6 percent) agreed to acquire IDRx, a Massachusetts-based developer of rare cancer therapies, for up to US$ 1.15 billion. IDRx focuses on treatments for gastrointestinal stromal tumors (GIST), rare cancers that develop in the digestive tract.   Access the Pipeline Prospector Dashboard for January 2025 Newsmakers (Free Excel)   Ozempic becomes first GLP-1 to treat CKD in diabetes patients; Novo puts another US$ 4.6 bn in deal with Valo FDA approved Novo Nordisk’s Ozempic (semaglutide) to reduce the risk of kidney disease progression, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). This approval makes Ozempic the first glucagon-like peptide 1 (GLP-1) receptor agonist indicated for this patient population. This most broadly indicated GLP-1 drug is already approved for cardiovascular events. Novo also announced expansion of its collaboration with Valo Health to discover and develop novel treatments for obesity, type 2 diabetes, and cardiovascular diseases. This partnership leverages Valo’s extensive human datasets and artificial intelligence capabilities.  The expanded agreement is potentially worth US$ 4.6 billion for up to 20 drug programs. Akero Therapeutics’ stock jumped 100 percent after data from its mid-stage trial showed that 39 percent of patients treated with a 50 mg dose of efruxifermin experienced reversal of cirrhosis with no worsening of metabolic dysfunction-associated steatohepatitis (MASH) after 96 weeks, compared to 15 percent in the placebo group. Meanwhile, FDA expanded the use of Eli Lilly’s Omvoh (mirikizumab)to include treatment for moderate-to-severe Crohn’s disease, bolstering the company’s immunology portfolio beyond its focus on obesity treatments.   Access the Pipeline Prospector Dashboard for January 2025 Newsmakers (Free Excel)  AbbVie in US$ 1.64 bn molecular glue degraders deal with Neomorph; Galapagos splits into two AbbVie (stock up 8 percent) and Neomorph entered into a US$ 1.64 billion collaboration to develop molecular glue degraders targeting previously “undruggable” proteins in oncology and immunology. AbbVie also acquired an option to license Simcere Zaiming’s SIM0500, a novel trispecific antibody candidate for multiple myeloma, in a deal valued at up to US$ 1.06 billion. SIM0500 is currently in early-stage clinical trials in both China and the US. Boehringer Ingelheim has expanded its oncology pipeline with two licensing deals. First, the company partnered Synaffix in a deal worth up to US$ 1.3 billion to advance antibody-drug conjugates (ADCs). Second, it exercised the option to gain rights to a fourth novel cancer target from an ongoing discovery collaboration with Oxford BioTherapeutics, which began in 2013. Sanofi (stock up 10 percent) announced plans to buy back € 5 billion (US$ 5.21 billion) in shares in 2025, signaling potential increases in acquisition activities following the sale of its Opella consumer health unit. This divestment marks Sanofi’s shift to focusing exclusively on drugs and vaccines. Galapagos (stock down 18 percent) announced plans to split into two distinct publicly traded entities. The entity that retains the Galapagos name will focus on advancing its cell therapy programs in oncology, while the other one will focus on developing a pipeline of innovative medicines through strategic transactions. It will be capitalized with approximately € 2.45 billion (US$ 2.53 billion) from Galapagos’ current cash reserves.   Access the Pipeline Prospector Dashboard for January 2025 Newsmakers (Free Excel)  J&J’s Spravato approved for depression by FDA; another Astra-Daiichi ADC sees light of day The psychedelic medicine frontier showed promise with J&J’s Spravato (esketamine) achieving a breakthrough as FDA approved it for treatment-resistant depression (standalone treatment). The nasal spray demonstrated impressive efficacy, with 22.5 percent of patients achieving remission by week four.  Atai Life Sciences also announced encouraging results from a mid-phase study evaluating BPL-003, an intranasal formulation of 5-MeO-DMT benzoate in patients with moderate to severe alcohol use disorder (AUD). In oncology, AstraZeneca (stock up 9 percent) and Daiichi Sankyo (stock up 3 percent) secured US approval for Datroway (datopotamab deruxtecan) for treating unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer. Meanwhile, Amgen’s combination therapy of Lumakras (sotorasib) with Vectibix (panitumumab) received FDA approval for KRAS G12C-mutated metastatic colorectal cancer. Amgen’s stock gained 9 percent. FDA approved Vertex Pharmaceuticals’ Journavx (suzetrigine), a first-in-class non-opioid oral pain signal inhibitor. This approval marks the first new class of pain medicine in over 20 years, offering an effective alternative without addictive potential. The US agency also approved Axsome Therapeutics’ rapid-acting Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine.   Access the Pipeline Prospector Dashboard for January 2025 Newsmakers (Free Excel)  Our view If 2024 ended with a spate of drug approvals, 2025 began with both increased dealmaking and approvals. However, post January 20, the world is a different place. Trump administration’s tariff policies have spurred a trade war, and China has retaliated with tariffs of US coal and gas. At present, there is little certainty on what the tariffs mean for different pharma companies, especially those who don’t manufacture in the US. While some drugmakers are hopeful that Trump will crack down on the pharmacy benefit managers, others are more concerned on what higher tariffs on EU and Indian drugmakers would mean for generic drug prices. We expect volatility for at least some months.  Access the Pipeline Prospector Dashboard for January 2025 Newsmakers (Free Excel)  

Impressions: 4671

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-jan-2025-j-j-s-us-14-6-bn-intra-cellular-buyout-kicks-off-deal-frenzy-ozempic-clinches-fda-nod-for-ckd

#PharmaFlow by PHARMACOMPASS
06 Feb 2025

NEWS #PharmaBuzz

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https://www.businesswire.com/news/home/20250714536618/en/Vertex-Named-a-Premier-Inc.-Breakthroughs-Innovation-Celebration-Winner-for-JOURNAVX-a-First-in-Class-Non-Opioid-Treatment-for-Adults-With-Moderate-to-Severe-Acute-Pain

BUSINESSWIRE
14 Jul 2025

https://www.businesswire.com/news/home/20250312542179/en/Ark-Clinical-Research-at-the-Forefront-of-Advancing-Non-Opioid-Pain-Research

BUSINESSWIRE
19 Mar 2025

https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/cenexel-celebrates-fda-approval-of-journavxtm-a-groundbreaking-non-opi-980797

ACCESSWIRE
06 Feb 2025

https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain

FDA
31 Jan 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process

FDA
30 Jan 2025

https://www.biospace.com/drug-development/vertex-dips-on-mixed-phase-ii-data-for-non-opioid-pain-therapy

BIOSPACE
20 Dec 2024