Please Wait
Applying Filters...
Menu
$ API Ref.Price (USD/KG) : 10,205Xls

Digital Content read-more

Create Content with PharmaCompass, ask us

DATA COMPILATION #PharmaFlow

read-more
read-more
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: 2192

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

read-more
read-more
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: 3375

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

NEWS #PharmaBuzz

read-more
read-more

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://api.drreddys.com/news/tentative-approval-generic-lumateperone-capsules

PRESS RELEASE
05 Aug 2025

https://www.prnewswire.com/news-releases/supplemental-new-drug-application-submitted-to-us-fda-for-caplyta-lumateperone-with-data-demonstrating-significant-schizophrenia-relapse-prevention-compared-to-placebo-302499436.html

PR NEWSWIRE
09 Jul 2025

https://www.globenewswire.com/news-release/2025/01/10/3007508/30597/en/Intra-Cellular-Therapies-Settles-CAPLYTA-lumateperone-Patent-Litigation-with-Sandoz.html

GLOBENEWSWIRE
10 Jan 2025

https://www.globenewswire.com/news-release/2024/12/03/2990492/30597/en/Intra-Cellular-Therapies-Submits-Supplemental-New-Drug-Application-sNDA-to-FDA-for-CAPLYTA-lumateperone-for-the-Treatment-of-Major-Depressive-Disorder-as-Adjunctive-Therapy.html

GLOBENEWSWIRE
03 Dec 2024

https://www.fiercepharma.com/pharma/intra-cellulars-unstoppable-caplyta-nails-another-trial-time-relapse-prevention

FIERCE PHARMA
06 Nov 2024