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By PharmaCompass
2026-01-22
Impressions: 1,333 Article || 171 Video || 8 Listen
In 2022, Pfizer had crossed US$ 100 billion in revenue owing to its Covid products. While that was a one-off, Johnson & Johnson has been growing organically and has projected its revenues to cross US$ 100 billion in 2026.
In regulatory news, the US Food and Drug Administration (FDA) has delayed fast-track reviews of two drugs selected under the Trump administration’s National Priority Voucher Program, citing safety and efficacy concerns. The FDA has also extended review timelines for Boehringer Ingelheim’s lung cancer drug zongertinib and Eli Lilly’s oral obesity drug orforglipron.
In deals, GSK announced the acquisition of US-based RAPT Therapeutics for US$ 2.2 billion to gain global rights to an experimental food allergy drug. Indian drugmaker Sun Pharmaceutical is reportedly exploring a potential US$ 10 billion acquisition of US-based Organon.
Pfizer exited ViiV Healthcare, selling its stake in the HIV-focused company for US$ 1.9 billion. Japan’s Shionogi increased its stake from 10 percent to 21.7 percent, while GSK retained its majority holding in ViiV Healthcare. Meanwhile, Genentech said it will invest nearly US$ 2 billion to expand its manufacturing facility in North Carolina (US).
New research published in The Lancet Obstetrics, Gynaecology & Women’s Health found no evidence linking the use of paracetamol during pregnancy to autism or other neurodevelopmental disorders.
In clinical trials, Moderna and Merck said long-term data showed their mRNA cancer vaccine candidate, when combined with Keytruda, significantly reduced the risk of recurrence or death in high-risk melanoma patients.
FDA delays fast-track reviews of two drugs due to safety, efficacy concerns
The FDA has delayed reviews of two drugs selected for the Trump administration’s Commissioner’s National Priority Voucher Program after internal reviewers raised safety and efficacy concerns. Reviews were pushed back for Disc Medicine’s experimental blood disorder drug bitopertin due to questions over trial data and potential abuse risk, and for Sanofi’s type 1 diabetes therapy Tzield (teplizumab-mzwv) following adverse event reports, including seizures, blood clotting and one patient death.
FDA also extended review timelines for Boehringer Ingelheim’s lung cancer drug zongertinib and Eli Lilly’s oral obesity drug orforglipron, with the latter now facing a target action date of April 10, 2026. Launched in June 2025, the fast-track program aims to cut drug review times to one or two months.
J&J posts US$ 94.2 bn in 2025 sales; expects to touch US$ 100 bn in 2026
Johnson & Johnson has projected its 2026 revenue in the range of about US$ 100 billion to US$ 101 billion, exceeding analyst expectations. In 2022, Pfizer became the first biopharma company to reach US$ 100 billion in revenue due to its Covid-related products. While this was a one-off, J&J’s outlook reflects more diversified and sustained growth. The company reported 2025 sales of US$ 94.2 billion, up 6 percent year-on-year. Darzalex (daratumumab) remains J&J’s largest growth driver, generating US$ 14.4 billion in 2025 sales.
GSK to acquire RAPT Therapeutics for US$ 2.2 bn, gains global rights to food allergy drug
British drugmaker GSK said it will acquire US-based RAPT Therapeutics in a deal valued at US$ 2.2 billion. Through this deal, GSK will acquire global rights to the experimental food allergy drug ozureprubart, excluding rights in mainland China, Macau, Taiwan and Hong Kong. The acquisition marks GSK’s first major deal under the new CEO Luke Miels.
Pfizer exits ViiV Healthcare, Shionogi doubles stake: GSK and Japan’s Shionogi have said Pfizer will exit ViiV Healthcare in a transaction that values Pfizer’s 11.7 percent stake in the HIV-focused company at about US$ 1.9 billion. Shionogi will pay US$ 2.13 billion for newly issued shares, increasing its stake in ViiV Healthcare from 10 percent to 21.7 percent, while GSK will retain its 78.3 percent majority holding. ViiV Healthcare was established by GSK and Pfizer in 2009, with Shionogi joining as a shareholder in 2012.
Sun Pharma exploring US$ 10 bn acquisition of beleaguered Organon, says report
India’s largest drugmaker, Sun Pharmaceutical Industries, is exploring a potential acquisition of US-based Organon, according to a report published in The Economic Times. The proposed transaction could be valued at around US$ 10 billion. Organon has a debt burden of about US$ 9.5 billion. Sun Pharma, however, has described the report as speculative.
Genentech commits nearly US$ 2 bn to expand US facility: Genentech, a member of the Roche Group, announced that it will more than double its initial investment in a new biomanufacturing facility in Holly Springs, North Carolina. It will now invest US$ 2 billion in the facility. The site will manufacture next-generation treatments for metabolic conditions, including obesity, using advanced biomanufacturing, automation, and digital technologies to improve efficiency, sustainability, and US-based supply capacity. Roche has committed to invest US$ 50 billion in the US over the next five years in order to avoid tariffs and create 12,000 jobs.
Paracetamol use in pregnancy found to be safe; research dismisses links to autism
Paracetamol (acetaminophen/Tylenol) is safe to use during pregnancy when taken as recommended, according to a review published in The Lancet Obstetrics, Gynaecology & Women’s Health. The team conducted a systematic review and meta-analysis of 43 studies, including three large sibling-comparison studies covering more than 260,000 children for autism and hundreds of thousands for ADHD and intellectual disability, and found no significant link between prenatal paracetamol use and these conditions. The review was conducted in response to claims made by US President Donald Trump that the drug could be linked to autism.
Keytruda-mRNA therapy combo show long-term survival in high-risk melanoma
Merck and Moderna have reported five-year follow-up results from a phase 2b trial on their mRNA neoantigen therapy — intismeran autogene. The therapy reduced the risk of recurrence or death by 49 percent when used in combination with Keytruda (pembrolizumab) in patients with high-risk melanoma. Intismeran autogene, formerly known as mRNA-4157, is a personalized therapeutic cancer vaccine designed to generate T-cell responses targeting a patient’s specific tumor.
Nxera Pharma posts phase 3 win for its insomnia drug: Nxera Pharma announced positive top-line results from a phase 3 trial in South Korea evaluating daridorexant 50 mg in adult and elderly patients with insomnia. The company plans to submit a marketing authorization application in South Korea in Q1 2026, with approval expected in Q1 2027.
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