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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: 4387

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 June 2024: FDA approves Merck’s next-gen pneumococcal vaccine, Verona’s COPD therapy
The pharma indices were back in the black in May, and the good streak continued through June with the Nasdaq Biotechnology Index (NBI) gaining 3 percent, the SPDR S&P Biotech ETF (XBI) index up over 3.1 percent and the S&P Biotechnology Select Industry Index (SPSIBI) rising 4.25 percent.The two summer months were similar in more ways than one. In May, Eli Lilly had announced an investment of US$ 5.3 billion to boost the supply of Zepbound and Mounjaro. In June, Novo Nordisk followed suit, investing US$ 4.1 billion to develop a new manufacturing facility to boost the supply of Ozempic and Wegovy.Similarly, the US Food and Drug Administration (FDA) continued to grant vaccine approvals in June after okaying Moderna’s mRNA respiratory syncytial virus (RSV) vaccine in May. Last month, Merck’s next-generation pneumococcal vaccine won an FDA nod, and the agency expanded the use of GSK’s respiratory syncytial virus (RSV) vaccine to include adults aged 50 to 59.However, June was a lackluster month for mergers and acquisitions. The month had to be content with some tie-ups. For instance, Roche signed an up to US$ 1.8 billion deal with Boston-based startup Ascidian Therapeutics to discover and develop novel gene therapies for difficult-to-treat neurological diseases. AbbVie inked a US$ 1.7 billion agreement with China’s FutureGen to bring the latter’s next-generation treatment (FG-M701) for inflammatory bowel disease to market. Takeda signed an option agreement with China’s Ascentage Pharma for an exclusive license to a promising drug for chronic myeloid leukemia and other blood cancers. And Day One Biopharmaceuticals struck a licensing deal with MabCare for a novel antibody drug conjugate (ADC) to treat multiple cancers. The deal’s potential value is US$ 1.2 billion.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel)Merck’s pneumococcal jab wins FDA nod; Moderna’s combo vaccine scores trial winVaccines took centerstage in June. FDA approved Merck’s Capvaxive, a next-generation pneumococcal vaccine designed to protect adults from a broader range of pneumococcus bacteria strains that cause serious illnesses and pneumonia. Capvaxive targets 21 bacterial variations responsible for about 85 percent of invasive pneumococcal disease cases in older adults. Similarly, GSK secured FDA approval for its RSV vaccine for adults aged 50 to 59 years. This makes Arexvy the only RSV shot endorsed for that age group.In a late-stage trial, Moderna’s mRNA-1083, an investigational combination vaccine against influenza and Covid, elicited a higher immune response compared to separate shots in people aged 50 and over. The combo jab generated more antibodies than currently marketed flu vaccines and Moderna’s Spikevax. And the world’s first personalized mRNA cancer vaccine from Moderna has raised hopes for patients with skin cancer, as three-year data from a mid-stage trial showed some benefits on patients who took the vaccine in combination with Merck’s Keytruda.Despite these developments, Moderna’s stock dropped 19 percent in June after it said the efficacy of its RSV vaccine mRESVIA had vaned substantially to 50 percent after 18 months.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel) Verona, Geron score maiden FDA approvals; BMS’ Augtyro bags tumor-agnostic nodTwo companies obtained their first FDA approvals last month. The first one was Verona Pharma (stock up 15 percent) — it received its maiden FDA approval for Ohtuvayre for treating chronic obstructive pulmonary disease (COPD). This is also the first inhaled COPD treatment with a novel mechanism of action.The second company to get its maiden FDA approval was Geron, a commercial-stage biopharmaceutical company. FDA signed off on Geron’s Rytelo for treating transfusion-dependent anemia in patients with low- to intermediate-risk myelodysplastic syndromes (MDS), a group of blood cancers.In June, FDA granted accelerated approvals to at least three drugs. BMS’ Augtyro was granted FDA’s accelerated approval for treating adult and pediatric patients (over 12 years) with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, regardless of where they occur in the body.Ipsen received FDA’s accelerated approval for Iqirvo, a first-in-class, once-daily oral medication for treating primary biliary cholangitis (PBC), a progressive liver disease affecting mostly women.Sarepta Therapeutics’ (stock up 24 percent) Elevidys received accelerated approval for Duchenne muscular dystrophy (DMD) despite failing its primary endpoint in a late-stage trial.Amongst other approvals, Argenx’s Vyvgart Hytrulo was approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP). This is a novel treatment option for this rare and debilitating neuromuscular disorder. And BMS’ Krazati got its second approval for treating colorectal cancer with a specific KRAS mutation.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel) GSK’s failed cancer drug posts trial win; Gilead’s HIV prophylaxis shows efficacyIn late-stage trials, GSK’s multiple myeloma therapy Blenrep cut the risk of disease progression or death by almost half compared to standard-of-care treatments. The once-failed ADC was pulled from the lucrative US market in 2022, but the results could signal a comeback for Blenrep.Intra-Cellular’s antipsychotic drug Caplyta scored another remarkable late-stage win for treating major depressive disorder (MDD). In another late-stage trial, Gilead’s (stock up 6 percent) long-acting injection proved to be more effective in preventing HIV infection in women compared to the daily pill Truvada. This is the first time that an HIV pre-exposure prophylaxis (PrEP) has shown zero infections in a phase 3 trial, the drugmaker said. Dosed just twice a year, Sunlenca could be a game-changer in HIV prevention. Analysts estimate that PrEP-related sales could be over US$ 1.7 billion.In a blow to millions affected by long Covid, Pfizer’s Paxlovid did not appear to improve the symptoms as was hoped. Pfizer’s stock fell 7 percent in June.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel) Our view This was the second month when pharma indices showed an upward trend. It’s been a good first half for the US stock markets. But there are mixed reports on how markets will perform in the second half, given the uncertainties around interest rate cuts and the outcome of the presidential elections in the US slated to be held in November. Though for those tracking biopharma news, there are enough interesting developments to fret over the markets.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel) 

Impressions: 3815

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-june-2024-fda-approves-merck-s-next-gen-pneumococcal-vaccine-verona-s-copd-therapy

#PharmaFlow by PHARMACOMPASS
04 Jul 2024

WEEKLY NEWS RECAP #Phispers

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J&J buys Intra-Cellular for US$ 14.6 bn; FTC exposes PBMs’ US$ 7.3 bn drug price markup scheme
The week saw the J.P. Morgan Healthcare Conference kick off with a flurry of deals. In all, deals worth over US$ 19.3 billion were signed at the annual event.Johnson & Johnson made waves with its US$ 14.6 billion acquisition of Intra-Cellular Therapies, betting big on brain disease treatments. Eli Lilly strengthened its cancer portfolio by scooping up Scorpion Therapeutics’ cancer program for US$ 2.5 billion, while GSK bolstered its gastrointestinal stromal tumor pipeline with its US$ 1.15 billion purchase of Boston-based biotech IDRx.The Federal Trade Commission (FTC) exposed how America’s largest pharmacy benefit managers (PBMs) pocketed US$ 7.3 billion through drug price markups.In a strategic partnership, Gilead and LEO Pharma joined forces in a US$ 1.7 billion deal targeting inflammatory diseases. AbbVie looked east, securing rights to Chinese drugmaker Simcere’s promising blood cancer drug.In news from clinical trials, Regeneron’s Libtayo posted impressive results in treating skin cancer in a late stage trial, succeeding where Merck’s Keytruda had previously fallen short.J&J doubles down on neuroscience with US$ 14.6 bn acquisition of Intra-CellularJohnson & Johnson has announced acquisition of Intra-Cellular Therapies for US$ 14.6 billion, marking its biggest deal in over two years and boosting its presence in the market for brain disease treatments. 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. Intra-Cellular is also seeking expanded regulatory approval in the US for Caplyta as an add-on therapy for major depressive disorder (MDD). Caplyta is expected to generate over US$ 5 billion in peak year sales.Among other candidates, the deal includes ITI-1284 — a promising phase 2 compound being studied for generalized anxiety disorder and Alzheimer’s disease-related psychosis and agitation. This acquisition aligns with J&J’s notable presence in the neuroscience market which brought in sales worth US$ 7.14 billion in 2023.Three major PBMs gained US$ 7.3 bn by inflating drug prices, finds FTCThe US Federal Trade Commission (FTC) has found that the nation’s three largest pharmacy benefit managers (PBMs) significantly inflated drug prices, netting an extra US$ 7.3 billion from 2017 to 2022. The companies involved are UnitedHealth Group’s Optum, CVS Health’s CVS Caremark, and Cigna’s Express Scripts. They marked up prices at their pharmacies by hundreds or thousands of percent, particularly for heart disease, cancer, and HIV medications. The FTC has sued the three PBMs, accusing them of steering diabetes patients towards higher-priced insulin products to reap millions of dollars in rebates from drugmakers.Lilly to buy Scorpion’s cancer program for up to US$ 2.5 bn; partners Alchemab for ALS medsEli Lilly has announced the acquisition of Scorpion Therapeutics’ experimental cancer therapy, STX-478 (a PI3Kα inhibitor program), for up to US$ 2.5 billion in cash. STX-478, a once-daily oral therapy, is currently in phase 1/2 clinical trials for breast cancer and other advanced solid tumors. As part of the deal, Scorpion will spin out its non-PI3Kα pipeline assets and employees into a new entity. This new company will be owned by Scorpion’s current shareholders, with Lilly holding a minority equity interest. The existing entity (with the PI3Ka program) will be acquired by Lilly.Partners UK’s Alchemab for ALS drug development: Lilly has partnered UK-based Alchemab Therapeutics to develop up to five new antibodies targeting amyotrophic lateral sclerosis (ALS). This collaboration comes at a challenging time for ALS drug development, as several rival candidates have recently failed in clinical trials.GSK buys Boston-based biotech IDRx for US$ 1.15 bn, gains its gastro tumor assetGSK has agreed to acquire IDRx, a Boston-based clinical-stage biopharmaceutical company, for up to US$ 1.15 billion. This acquisition includes IDRx’s lead molecule, IDRX-42, a highly selective KIT tyrosine kinase inhibitor (TKI) designed to treat gastrointestinal stromal tumors (GIST). IDRX-42 is currently being investigated in an early-to-mid-stage trial for patients with advanced GIST. The British drugmaker will pay US$ 1 billion upfront, with an additional US$ 150 million contingent on achieving regulatory approval milestones. Boehringer, Synaffix sign ADC deal: Boehringer Ingelheim has expanded its oncology pipeline with two licensing deals. One, the company has partnered Synaffix in a deal worth up to US$ 1.3 billion to advance antibody-drug conjugates (ADCs). Two, it exercised the option to gain rights to a fourth novel cancer target from an ongoing discovery collaboration with Oxford BioTherapeutics signed in 2014.Novartis in deal with Light House Therapeutics: A San Diego-based startup Light Horse Therapeutics has received US$ 62 million in series A funding. And on the same day, it inked a potential US$ 1 billion deal with Novartis. The deal with Novartis involves an upfront payment of US$ 25 million. Novartis will identify and develop potentially first-in-class cancer therapeutics using Light Horse’s precision genetic editing-based platform.Gilead, LEO Pharma ink US$ 1.7 bn deal to develop meds for inflammatory diseasesGilead Sciences and LEO Pharma have teamed up in a deal worth up to US$ 1.7 billion to develop oral STAT6 (signal transducer and activator of transcription 6) inhibitors for inflammatory diseases. Gilead will handle the development and commercialization of the oral treatments, while LEO Pharma will focus on topical formulations. The STAT6 inhibitors will target key pathways in conditions like atopic dermatitis, asthma, and COPD (chronic obstructive pulmonary disease), offering a potential oral alternative to injectable biologics. Gilead will pay LEO US$ 250 million upfront.AbbVie to license Simcere’s blood cancer med: AbbVie has 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. AbbVie will hold the rights to develop and commercialize SIM0500 outside of Greater China, while Simcere retains rights within Greater China.Regeneron’s Libtayo posts late-stage win: Regeneron has announced that its PD-1 inhibitor, Libtayo (cemiplimab) significantly improved disease-free survival (DFS) in a phase 3 trial for patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery. Libtayo is the first and only immunotherapy to demonstrate a statistically significant and clinically meaningful benefit in high-risk CSCC in the adjuvant setting. This success comes after Merck’s Keytruda failed in the same indication in August 2024.Temporary pause on Novartis’ Entresto generic: An appeals court in the US has temporarily paused the launch of MSN Pharmaceuticals’ generic version of Novartis’ blockbuster heart-failure drug Entresto. The court is considering Novartis’ emergency request for a longer pause. 

Impressions: 1739

https://www.pharmacompass.com/radio-compass-phisper/j-j-buys-intra-cellular-for-us-14-6-bn-ftc-exposes-pbms-us-7-3-bn-drug-price-markup-scheme

#Phispers by PHARMACOMPASS
16 Jan 2025

NEWS #PharmaBuzz

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https://www.prnewswire.com/news-releases/caplyta-lumateperone-showed-greatest-improvement-across-key-efficacy-outcomes-among-adjunctive-mdd-treatments-in-new-network-meta-analysis-302760765.html

PR NEWSWIRE
04 May 2026

https://www.prnewswire.com/news-releases/fda-approves-caplyta-lumateperone-snda-with-robust-new-data-supporting-reduced-risk-of-relapse-in-schizophrenia-302753851.html

PR NEWSWIRE
27 Apr 2026

https://www.prnewswire.com/news-releases/new-clinical-data-highlights-caplyta-lumateperone-as-a-promising-option-for-achieving-remission-in-adults-with-major-depressive-disorder-302662763.html

PR NEWSWIRE
16 Jan 2026

https://www.prnewswire.com/news-releases/johnson--johnson-elevates-leadership-in-depression-with-new-data-at-2026-american-college-of-neuropsychopharmacology-annual-meeting-302659160.html

PR NEWSWIRE
13 Jan 2026

https://www.prnewswire.com/news-releases/fda-approval-of-caplyta-lumateperone-has-the-potential-to-reset-treatment-expectations-offering-hope-for-remission-in-adults-with-major-depressive-disorder-302606717.html

PR NEWSWIRE
06 Nov 2025

https://amilifesciences.com/media.php

PRESS RELEASE
25 Aug 2025