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By PharmaCompass
2025-11-27
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In Phispers this week, Eli Lilly became the first pharmaceutical company to reach a market valuation of US$ 1 trillion, driven by strong demand for its obesity and diabetes drugs Zepbound and Mounjaro. AstraZeneca announced a US$ 2 billion investment to expand its Maryland biologics plant.
In approvals, the US Food and Drug Administration (FDA) cleared a Padcev-Keytruda combination for treating people with muscle-invasive bladder cancer who can’t receive cisplatin-based chemotherapy. It okayed AstraZeneca’s Imfinzi as the first perioperative immunotherapy for resectable, early-stage and locally advanced stomach cancer. It approved Novartis’ new gene therapy Itvisma for treating spinal muscular atrophy (SMA). The agency also granted accelerated approval to Otsuka’s kidney drug Voyxact.
Separately, FDA initiated a safety investigation into Takeda’s Adzynma after the death of a child with a rare blood disorder. The agency delayed its decision on Ascendis Pharma’s treatment for achondroplasia, a rare genetic condition, by three months. Meanwhile, Denmark granted compensation to four patients who experienced vision loss after using Novo Nordisk’s semaglutide-based drugs.
The US Medicare program has announced large price cuts under the Inflation Reduction Act for 15 of its most expensive prescription drugs, which will take effect in 2027.
In news from clinical trials, Bayer reported a major phase 3 win for its next-generation blood thinner asundexian. However, Novo Nordisk’s oral semaglutide pill failed in two phase 3 Alzheimer’s trials.
Eli Lilly becomes first pharma company to hit US$ 1 trillion market valuation
Eli Lilly has reached a market valuation of US$ 1 trillion, becoming the first drugmaker to join a league largely dominated by tech companies. The milestone was achieved on account of the overwhelming demand for its obesity and diabetes medicines Mounjaro (tirzepatide) and Zepbound (tirzepatide). Lilly pulled ahead of Novo Nordisk as supply issues impacted its obesity drug Wegovy (semaglutide).
Medicare unveils price cuts for next 15 drugs: The US Medicare program has announced large price cuts for 15 of its most expensive prescription drugs, which will take effect in 2027 under the Inflation Reduction Act. The drugs include Ozempic and Rybelsus for diabetes, Wegovy for weight loss (all semaglutide), Xtandi (enzalutamide) for prostate cancer, Ibrance (palbociclib) for breast cancer and Trelegy Ellipta (fluticasone+umeclidinium+vilanterol) for lung conditions. According to Medicare, the negotiated prices will lower the program’s annual spending by US$ 8.5 billion each year. Another set of 15 drugs will be selected for negotiation next year, with prices taking effect in 2028.
Astra to expand Maryland operations: AstraZeneca will invest US$ 2 billion to expand its manufacturing operations in Maryland. The company will nearly double capacity at its biologics plant and begin producing medicines for rare diseases and cancer. It will also open a new clinical manufacturing site to expand its footprint in Gaithersburg.
FDA approves Padcev-Keytruda combo for bladder cancer patients
FDA has approved a combination of Pfizer-Astella’s Padcev (enfortumab vedotin-ejfv) and Merck’s Keytruda (pembrolizumab) for people with muscle-invasive bladder cancer who cannot receive cisplatin-based chemotherapy, a common but harsh chemo drug that many patients are unable to tolerate because it can affect the kidneys, hearing, and nerves. This regimen can be used before and after surgery.
Grants accelerated approval to Otsuka’s kidney drug: FDA has granted accelerated approval to Otsuka’s Voyxact (sibeprenlimab-szsi) to help reduce excess protein in urine of adults with IgA nephropathy, a kidney disease that can worsen over time.
FDA approves Imfinzi for early-stage stomach cancer
AstraZeneca’s Imfinzi (durvalumab) has become the first and only immunotherapy approved to treat resectable, early-stage stomach and gastroesophageal junction (GEJ) cancers both before and after surgery. FDA has allowed doctors to add Imfinzi to standard FLOT (fluorouracil, leucovorin, oxaliplatin and docetaxel) chemotherapy before surgery, continue it with chemo after surgery, and then give Imfinzi alone as maintenance treatment. Imfinzi already has approvals in similar perioperative settings for lung and bladder cancers.
Okays Novartis’ Itvisma for treating SMA: FDA has approved Novartis’ new gene therapy Itvisma (onasemnogene abeparvovec-brve) for patients aged two years and older with spinal muscular atrophy (SMA) caused by a confirmed SMN1 mutation. Itvisma uses the same active ingredient as Novartis’ earlier therapy Zolgensma (onasemnogene abeparvovec-xioi), which is approved only for children under two. With this approval, Itvisma becomes the first and only gene-replacement therapy available to a broader SMA population.
Probes Takeda’s Adzynma post death of child: FDA is investigating Takeda’s rare-disease therapy Adzynma (ADAMTS13, recombinant-krhn) after the death of a child with congenital thrombotic thrombocytopenic purpura (cTTP), a rare, inherited blood disorder. The regulator says multiple patients have developed harmful “neutralizing antibodies” after treatment. Takeda said it has been updating the agency since July and maintains that no confirmed causal link has been established.
Delays decision on Ascendis’ dwarfism med: FDA has pushed back its decision on TransCon CNP (navepegritide), Ascendis Pharma’s treatment for achondroplasia, a rare genetic condition that causes dwarfism. The agency has extended the review deadline to February 28, 2026 after Ascendis submitted new information earlier this month related to a required follow-up study.
Bayer claims major phase 3 win for its next-gen blood thinner
Bayer has reported a strong phase 3 win for its experimental pill asundexian, which aims to prevent repeat strokes. In the study, the drug significantly lowered the risk of another stroke without increasing major bleeding, a key safety concern with today’s blood thinners. The result is a big turnaround for Bayer after a previous major trial failed two years ago.
Novo’s oral semaglutide pill fails in two phase 3 Alzheimer’s trials
Novo Nordisk’s oral semaglutide pill (Rybelsus) has failed to slow the progression of Alzheimer’s disease in two large phase 3 trials. The studies tested the drug in more than 3,800 people with early-stage Alzheimer’s but found no meaningful benefit compared with placebo. The results end hopes that semaglutide, best known as Ozempic and Wegovy, could open a major new treatment area for Alzheimer’s.
Meanwhile, four patients in Denmark who experienced vision loss after using Novo’s Wegovy or Ozempic have been granted compensation. The two drugs, which contain semaglutide, have been linked in very rare cases to a serious eye condition, which can cause permanent vision loss.
Lundbeck opts out of Avadel race: Lundbeck has officially withdrawn from its effort to acquire sleep-medicine biotech Avadel Pharmaceuticals. Last week, Lundbeck had made an unsolicited offer worth up to US$ 2.42 billion, topping Alkermes’ earlier US$ 2.1 billion agreement.
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