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STOCK RECAP #PipelineProspector

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Pipeline Prospector October 2025: Novartis to buy Avidity for US$ 12 bn; FDA approves Bayer’s med to treat hot flashes
October was abuzz with dealmaking. Pharma majors such as Novartis, Novo Nordisk, and Bristol Myers Squibb (BMS) led the acquisition wave, targeting innovative platforms in rare muscle disorders, metabolic diseases, and next-generation cell therapy for autoimmune diseases. The US Food and Drug Administration (FDA) approved Bayer’s Lynkuet (elinzanetant) — the first-of-its-kind oral non-hormonal drug to treat moderate to severe hot flashes in menopausal women. The agency also expanded the indication for Teva Pharmaceuticals and Medincell’s schizophrenia drug received Uzedy (risperidone), allowing it to be used for the maintenance treatment of bipolar I disorder in adults.In clinical trials, companies such as Eli Lilly and AstraZeneca reported positive data, while Moderna and Alector announced late-stage trial setbacks.The pharma indices continued to march upwards. The Nasdaq Biotechnology Index (NBI) rose nine percent, climbing from 4,916.11 at the end of September to 5,366.46 in October, while the SPDR S&P Biotech ETF (XBI) gained 13 percent from 100.11 to 112.71. The S&P Biotechnology Select Industry Index (SPSIBI) also advanced 13 percent from 7,805.59 to 8,789.9. Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel) Novartis to acquire Avidity for US$ 12 bn; Novo in up to US$ 5.2 bn deal to buy Akero The month saw several big M&A deals. Novartis entered into an agreement to acquire Avidity Biosciences for about US$ 12 billion in cash, in a bid to bolster its portfolio of treatments for rare muscle disorders. In September too, Novartis had struck four deals valued at over US$ 14 billion.Novo Nordisk announced it will acquire Akero Therapeutics, a San Francisco-based clinical-stage biotech, in a deal valued at up to US$ 5.2 billion. The agreement includes an upfront payment of US$ 4.7 billion, with additional milestone payments contingent on FDA approval of Akero’s lead candidate, efruxifermin, by mid-2031. Efruxifermin is being developed as a treatment for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease.Bristol Myers Squibb announced the acquisition of privately-held biotech Orbital Therapeutics in a US$ 1.5 billion all-cash deal. Orbital is developing new generation, RNA-based medicines.France’s Ipsen announced the acquisition of ImCheck Therapeutics for up to €1 billion (approximately US$ 1.16 billion) to enhance its oncology pipeline. Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)  FDA approves Bayer’s non-hormonal drug to treat hot flashes in menopausal women; okays Teva’s Uzedy for bipolar I disorderOctober brought good news for menopausal women dealing with hot flashes. FDA approved Bayer’s Lynkuet (elinzanetant) — the first-of-its-kind oral non-hormonal drug to treat moderate to severe hot flashes in menopausal women.Teva Pharmaceuticals and Medincell received FDA’s approval for expanding the indication of Uzedy (risperidone). An injection of Uzedy can be administered once a month as a maintenance treatment of bipolar I disorder in adults. Uzedy was approved in 2023 for schizophrenia.FDA also expanded the approval of Novo Nordisk’s Rybelsus (semaglutide) for use in adults with type 2 diabetes to reduce the risk of major adverse cardiovascular events. Rybelsus, the first and only FDA-approved GLP-1 drug, was first approved in 2019.Meanwhile, Glaukos’ Epioxa (riboflavin 5'-phosphate) was cleared by the FDA for treating keratoconus, a rare, progressive eye disorder that thins and bulges the cornea. The non-surgical therapy offers an incision-free option for patients at risk of vision loss.FDA also approved Regeneron’s immunotherapy Libtayo (cemiplimab) to help prevent relapse in adults with high-risk cutaneous squamous cell carcinoma after surgery and radiation. Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)  Innovent, Takeda sign up to US$ 11.4 bn oncology deal; J&J to spin off its orthopedics businessInnovent Biologics has signed a deal worth up to US$ 11.4 billion with Takeda Pharmaceutical to co-develop two next-generation cancer therapies. The collaboration covers an antibody-drug conjugate (ADC) and a fusion protein, targeting a range of solid tumors, including lung, colorectal, gastric, and pancreatic cancers. Takeda will hold commercialization rights for both therapies outside the US and Greater China, while the companies will jointly develop and commercialize one of the drugs, IBI363, in the US.Novo Nordisk has signed a deal worth up to US$ 2.1 billion with Omeros Corporation for rights to develop and commercialize zaltenibart (OMS906), Omeros’ experimental drug for rare blood and kidney disorders. The deal strengthens Novo Nordisk’s rare disease portfolio.Massachusetts-based Zenas BioPharma entered into a licensing agreement worth over US$ 2 billion with China’s InnoCare Pharma for orelabrutinib, an oral treatment for multiple sclerosis (a chronic disease in which the immune system attacks the brain and spinal cord).  And Johnson & Johnson announced it will spin off its orthopedics business, DePuy Synthes, into a separate company within 18 to 24 months.Besides these deals, the month saw several capacity expansions. Merck broke ground on a US$ 3 billion plant at its Elkton, Virginia campus, as part of a wider US$ 70 billion commitment to expand manufacturing, R&D, and capital projects in the US. Similarly, AstraZeneca announced a US$ 4.5 billion investment to build a state-of-the-art manufacturing facility in Virginia, as part of its US$ 50 billion investment plan for the US.Eli Lilly said it plans to invest over US$ 1 billion in India over the next few years to boost drug manufacturing and supply through partnerships with local producers. Lilly will also invest over US$ 1.2 billion to expand its manufacturing site in Puerto Rico. Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)  Lilly’s orforglipron scores trial wins in diabetes; Astra-Daiichi breast cancer med shows promise Eli Lilly’s oral GLP-1 drug orforglipron scored two major phase 3 wins in diabetes, outperforming AstraZeneca’s Farxiga (dapagliflozin) and a placebo in separate studies.In a phase 3 trial, AstraZeneca’s experimental drug baxdrostat significantly lowered blood pressure in patients with treatment-resistant hypertension. AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan), an antibody-drug conjugate, significantly improved survival in patients with metastatic triple-negative breast cancer compared to chemotherapy in a phase 3 clinical trial.In trial failures, Moderna said it will stop developing its experimental vaccine, mRNA-1647, designed to prevent cytomegalovirus (CMV), a virus that can cause birth defects, after it failed to meet the main goal in a phase 3 trial. Similarly, Alector stopped developing its GSK-partnered experimental dementia drug, latozinemab, after it failed to help patients in a major phase 3 trial. Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)  Our viewWith drugs like Bayer’s Lynkuet bagging approval, we see both innovation and competition steering the pharma industry into 2026. Novo Nordisk’s US$ 8.5 billion bid to acquire US-based obesity biotech Metsera, surpassing Pfizer’s US$ 7.3 billion offer, underscores where much of the excitement lies — the rapidly expanding US$150 billion weight loss drugs market. The pharmaceutical industry seems to be on a high-speed treadmill, with no scope for sluggishness. Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)  

Impressions: 5637

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-october-2025-novartis-to-buy-avidity-for-us-12-bn-fda-approves-bayer-s-med-to-treat-hot-flashes

#PharmaFlow by PHARMACOMPASS
06 Nov 2025

WEEKLY NEWS RECAP #Phispers

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FDA issues warning letter to Chinese supplier of semaglutide; approves AstraZeneca’s new treatment for hypertension
In Phispers this week, the US Food and Drug Administration (FDA) approved AstraZeneca’s first-in-class treatment for hypertension Baxfendy (baxdrostat). The agency also granted two new approvals to AstraZeneca-Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for treating early-stage HER2-positive breast cancer.In regulatory news, FDA issued a warning letter to Harbin Jixianglong Biotech, a Chinese manufacturer of semaglutide, the active pharmaceutical ingredient (API) used in GLP-1 drugs Ozempic and Wegovy, for violating current good manufacturing practices (CGMP) and import rules.Amgen’s rare disease drug Tavneos has been linked to 20 deaths in Japan, since its launch in 2022. Indian drugmaker Sun Pharmaceutical is recalling 675 vials of the intravenous chemotherapy drug — doxorubicin hydrochloride liposome — from the US market after glass particles were found in some vials.In news from clinical trials, Merck’s experimental drug sacituzumab tirumotecan, developed in collaboration with China’s Kelun-Biotech, has shown positive results in a late-stage trial in certain patients with advanced or recurrent uterine cancer. UCB’s Bimzelx (bimekizumab) has outperformed AbbVie’s Skyrizi (risankizumab) in a first head-to-head study comparing the two drugs in active psoriatic arthritis. And Regeneron’s  fianlimab, in combination with its approved drug Libtayo (cemiplimab), failed to beat Merck’s Keytruda (pembrolizumab) in treating metastatic melanoma (a type of skin cancer).Meanwhile, Bristol Myers Squibb (BMS) has signed a strategic agreement with Anthropic to deploy Claude Enterprise across its global operations.FDA approves AstraZeneca’s new treatment for hypertensionFDA has approved AstraZeneca’s Baxfendy (baxdrostat), a first-in-class treatment for hypertension to be used in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled. The drug works by blocking aldosterone, a hormone that raises blood pressure. Astra has named Baxfendy as one of the key product launches that would help the company achieve its goal of reaching US$ 80 billion in revenue by 2030.New approvals for Astra-Daiichi’s Enhertu: FDA has granted two new approvals to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for treating early-stage HER2-positive breast cancer. The drug has now been approved for use before surgery (to shrink tumors) and after surgery (to reduce risk of recurrence). Enhertu is already approved for treating advanced breast cancer, and these approvals expand its use to earlier stages, potentially improving long-term outcomes for patients.FDA issues warning letter to Chinese supplier of semaglutideFDA has issued a warning letter to Harbin Jixianglong Biotech, a Chinese manufacturer of semaglutide, the API used in diabetes drug Ozempic and weight management drug Wegovy, for violating current good manufacturing practices (CGMP) and import rules.Though Jixianglong was on FDA’s approved “green list” of GLP-1 suppliers, inspectors found it had purchased semaglutide from a factory not on that list, relabeled it as its own, and shipped it to the US. The green list was created by the FDA in 2025 to keep potentially unsafe ingredients out of the booming compounded weight-loss drug market. The batches were eventually recalled.Sun Pharma recalls chemo vials: Indian drugmaker Sun Pharmaceutical is recalling 675 vials of the intravenous chemotherapy drug doxorubicin hydrochloride liposome from the US market after glass particles were found in some vials. The recalled drug treats AIDS-related cancers, multiple myeloma, and ovarian cancer. The affected batch was manufactured at Sun’s Halol facility in India — a plant with a long history of FDA quality and compliance issues.TrumpRx platform expands list: The US government has expanded its TrumpRx platform by including 600 generic medicines as part of its efforts to lower drug prices.Merck’s experimental uterine cancer drug shows benefit in late-stage trialMerck’s experimental drug sacituzumab tirumotecan, developed in collaboration with China’s Kelun-Biotech, has shown positive results in a late-stage trial in certain patients with advanced or recurrent endometrial cancer, a type of uterine cancer. The treatment, which is an antibody-drug conjugate, helped patients live longer and delayed disease progression compared to standard therapies. As of today, treatment options for advanced endometrial cancer are limited.Bimzelx beats Skyrizi in psoriatic arthritis trial: UCB’s Bimzelx (bimekizumab) has outperformed AbbVie’s Skyrizi (risankizumab) in the first head-to-head study comparing the two drugs in active psoriatic arthritis (a condition that causes both joint inflammation and skin plaques.) In the late stage study, more patients on Bimzelx achieved the benchmark joint improvement response than those on Skyrizi.Regeneron’s drug combo fails to beat Keytruda in late-stage skin cancer trialIn a key phase 3 trial, Regeneron’s  fianlimab, in combination with its approved drug Libtayo (cemiplimab), failed to beat Merck’s Keytruda (pembrolizumab) in treating metastatic melanoma (a type of skin cancer). The combination failed to significantly delay disease progression compared to Keytruda in patients with advanced melanoma.Teams up with Parabilis Medicines: Hours after its melanoma trial miss, Regeneron struck a strategic research collaboration with biotech Parabilis Medicines worth up to US$ 2.3 billion. The collaboration will focus on “antibody-helicon conjugates,” a novel class of therapeutics designed to target challenging and historically “undruggable” targets.Amgen’s rare disease drug Tavneos linked to 20 deaths in JapanSince its 2022 launch in Japan, around 20 deaths have been reported that are linked to serious liver dysfunction in patients treated with Amgen’s Tavneos (avacopan), according to a safety notice ‌issued by Kissei Pharmaceutical, a company that sells the rare immune-disease drug in the country. Thirteen deaths were attributed to a condition known as vanishing bile duct syndrome. Additionally, at least 22 have developed a potentially fatal liver injury. Kissei is urging doctors not to prescribe the drug to new patients.BMS taps Anthropic’s Claude for enterprise-wide AI adoptionBristol Myers Squibb (BMS) has signed a strategic agreement with Anthropic to deploy Claude Enterprise across its entire global operations — covering drug research, clinical trials, manufacturing, and commercial and other medical affairs. BMS is embedding Claude’s agentic capabilities into core workflows. More than 30,000 BMS employees are expected to use Claude to speed up drug discovery and operations.Plans US$ 1 bn manufacturing plant in Houston: BMS plans to build a US$ 1 billion pharmaceutical manufacturing facility in the Sheldon area of Houston, Texas. The plant would expand BMS’ manufacturing footprint and create hundreds of jobs in the US.

Impressions: 2279

https://www.pharmacompass.com/radio-compass-phisper/fda-issues-warning-letter-to-chinese-supplier-of-semaglutide-approves-astrazeneca-s-new-treatment-for-hypertension

#Phispers by PHARMACOMPASS
21 May 2026

NEWS #PharmaBuzz

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https://www.globenewswire.com/news-release/2026/06/02/3304850/0/en/greywolf-therapeutics-reports-durable-clinical-responses-with-first-in-class-oral-erap1-inhibitor-grwd5769-across-six-solid-tumor-types.html

GLOBENEWSWIRE
02 Jun 2026

https://www.reuters.com/business/healthcare-pharmaceuticals/regeneron-drops-after-skin-cancer-treatment-misses-late-stage-trial-goal-2026-05-18/

REUTERS
18 May 2026

https://www.globenewswire.com/news-release/2026/03/31/3265650/0/en/MAIA-Biotechnology-Reports-Overall-Survival-Exceeding-Two-Years-for-Eight-Patients-in-Ongoing-Phase-2-Clinical-Trial-in-Non-Small-Cell-Lung-Cancer.html

GLOBENEWSWIRE
31 Mar 2026

https://www.prnewswire.com/news-releases/biohaven-presents-clinical-safety-and-efficacy-data-for-bhv-1510-a-next-generation-trop2-antibody-drug-conjugate-in-combination-with-cemiplimab-at-the-2025-european-society-for-medical-oncology-esmo-immuno-oncology-congress-302638503.html

PR NEWSWIRE
11 Dec 2025

https://www.globenewswire.com/news-release/2025/11/19/3190794/0/en/Libtayo-cemiplimab-Approved-in-the-European-Union-as-First-and-Only-Immunotherapy-for-Adjuvant-Treatment-of-Cutaneous-Squamous-Cell-Carcinoma-CSCC-with-High-Risk-of-Recurrence-afte.html

GLOBENEWSWIRE
19 Nov 2025

https://www.businesswire.com/news/home/20251027757071/en/OncoNano-Medicine-Presents-First-in-Human-Data-Demonstrating-Safety-and-Early-Signs-of-Clinical-Activity-of-ONM-501-a-Dual-Acting-STING-Agonist-at-the-AACR-NCI-EORTC-International-Conference-on-Molecular-Targets-and-Cancer-Therapeutics

BUSINESSWIRE
27 Oct 2025