Merck & Co. agreed on Wednesday to acquire London-based Verona Pharma for about $10 billion in cash, offering $107 for each American depositary share of the respiratory-drug maker. The price represents a roughly 23% premium to Verona’s latest closing price and values the company at 13 times analysts’ forecast 2026 sales, according to deal documents.

By buying Verona, Merck will add Ohtuvayre (ensifentrine), the first new inhaled maintenance therapy for chronic obstructive pulmonary disease in more than two decades. Approved by the U.S. Food and Drug Administration in June 2024, the dual PDE3/4 inhibitor generated $71.3 million of revenue in the first quarter and is projected by some analysts to exceed $4 billion in annual peak sales. Merck said the medicine has “multi-billion-dollar potential” and fits its expanding cardio-pulmonary portfolio.

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A revamped Advisory Committee on Immunization Practices, meeting for the first time since Health and Human Services Secretary Robert F. Kennedy Jr. replaced all 17 members, voted 5-2 on 26 June to recommend Merck’s monoclonal antibody clesrovimab, marketed as Enflonsia, for infants eight months and younger who were not protected by a maternal RSV vaccine. The panel also unanimously amended the federal Vaccines for Children programme to cover the shot, easing concerns that Kennedy’s scepticism toward some immunisations might delay uptake.

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The Advisory Committee on Immunization Practices (ACIP), recently appointed by Health and Human Services Secretary Robert F. Kennedy Jr., has voted to recommend Merck's monoclonal antibody shot, Enflonsia, for the prevention of respiratory syncytial virus (RSV) in infants. The panel voted 5-2 in favor of endorsing the new RSV therapy, which is intended to protect newborns and young children during the RSV season. In a separate but related decision, the same committee voted 5-1 to recommend against the use of influenza vaccines containing thimerosal, a mercury-based preservative.

This move aligns with Kennedy Jr.'s long-standing opposition to thimerosal and fulfills a goal of the anti-vaccine movement. Despite controversy surrounding these decisions, the committee continues to recommend annual flu vaccinations but advises against those containing thimerosal. The FDA recently approved Clesrovimab, another RSV treatment for newborns and young infants, which has also been endorsed by experts associated with Kennedy Jr. These developments mark a notable shift in vaccine advisory policies under Kennedy Jr.'s leadership at the Department of Health and Human Services.

Merck said its Phase 3 HYPERION study showed WINREVAIR (sotatercept-csrk) significantly delayed clinical worsening in 320 adults recently diagnosed with pulmonary arterial hypertension. The double-blind trial met its primary composite endpoint of time to clinical worsening, which includes death, unplanned PAH-related hospitalisation, lung transplantation, or other markers of disease progression.

More than 70 percent of participants were already receiving double background therapy, yet WINREVAIR delivered a statistically significant and clinically meaningful benefit compared with placebo. HYPERION is the third late-stage study in which the activin-signalling inhibitor has demonstrated efficacy, following the STELLAR and ZENITH trials.

The programme was stopped early after interim data confirmed benefit, and all participants were offered the drug in an open-label extension. Merck plans to present full results at a forthcoming medical meeting and to submit the data to regulators, aiming to expand WINREVAIR’s existing approvals in more than 45 countries.

The World Health Organization (WHO) and its partners have launched new global guidance aimed at expanding access to trusted midwives worldwide. This initiative emphasizes the critical role of midwifery care in saving lives, improving health outcomes, empowering women and families, and fostering hopeful futures. According to WHO, making midwives universally accessible through policy measures and awareness campaigns could prevent 83% of maternal, stillborn, and newborn deaths globally. In parallel, WHO continues to advocate for the elimination of cervical cancer, highlighting the effectiveness of human papillomavirus (HPV) vaccination, screening, and treatment as key tools to prevent this disease. These efforts align with a broader global health agenda to reduce maternal and infant mortality and improve women's health worldwide.

Pakistan has been selected to join a global initiative led by the World Health Organization that will provide free essential cancer medicines for children, according to Pakistan's health ministry. In Turkey, Health Minister Kemal Memişoğlu announced that the human papillomavirus (HPV) vaccine will be made available free of charge by the end of 2025. The national HPV vaccination program will target children aged 13 and older as well as adults aged 15 and above. Additionally, Turkey plans to produce cancer medicines domestically and become one of the first countries to manufacture a vaccine for Crimean-Congo hemorrhagic fever. The HPV vaccination drive in Pakistan's Sindh province is scheduled to launch in September 2025.

A newly appointed U.S. vaccine adviser named by Health Secretary Robert F. Kennedy Jr. has previously served as an expert witness in litigation against Merck's Gardasil vaccine. Court records reveal that this adviser earned thousands of dollars in connection with the legal proceedings targeting the Merck vaccine. The appointment has drawn attention due to the adviser's prior involvement in cases challenging the safety or efficacy of Gardasil, a vaccine produced by Merck.

A resurgence of vaccine-preventable diseases such as measles has raised concerns amid shifting U.S. vaccine policies and increasing vaccine hesitancy. Health experts emphasize the critical role of vaccination campaigns, which have historically nearly eradicated deadly diseases like measles, polio, and pertussis. Measles can lead to severe complications including pneumonia and brain swelling, with one in five hospitalized, while polio causes paralysis in one in 200 cases.

Human papillomavirus (HPV) vaccination is highlighted for its potential to reduce infection rates by up to 90% and significantly lower cervical cancer incidence. College health centers are identified as key venues to promote completion of the HPV vaccine series to prevent HPV-related cancers. Public health officials, such as those in Polk County, are actively developing strategies to combat measles outbreaks. In Australia, declining vaccination rates have prompted the federal government to launch a national immunization strategy aimed at protecting children and vulnerable populations from infectious diseases. The discussion underscores the importance of vaccines in preventing fatal outcomes associated with meningitis, tetanus, and pertussis, reinforcing the need for robust immunization efforts globally.

The human papillomavirus (HPV) vaccine is highly effective in preventing approximately 90% of HPV-related cancers, including cervical, throat, and penile cancers. Despite its proven benefits, only 45% of US campus clinicians routinely screen most women for HPV vaccination, with higher screening rates observed in larger institutions and where positive provider attitudes and college policies support vaccination efforts. College health centers play a crucial role in promoting completion of the HPV vaccine series to reduce future cancer risks. Studies indicate that widespread HPV vaccination could reduce infection rates by up to 90% and potentially nearly eliminate cervical cancer in the coming decades. Additionally, recommending HPV vaccination to parents of children aged 9 to 10 facilitates discussions on cancer prevention while avoiding concerns related to sexual activity that arise with older age groups. The broader context highlights vaccines as one of the greatest public health achievements, preventing diseases such as polio, measles, meningitis, pertussis, tetanus, and smallpox, the latter of which was eradicated by 1980 due to vaccination efforts.

The U.S. Food and Drug Administration (FDA) has approved Merck's monoclonal antibody shot to prevent respiratory syncytial virus (RSV) infections in infants up to one year old during their first RSV season. This approval marks the second monoclonal antibody preventive treatment authorized for infants against RSV, which is the leading cause of hospitalization in this age group. Clinical trials showed the treatment reduced RSV-related medically attended lower respiratory infections by 60.5% and hospitalizations by 84.3% over five months compared to placebo. Merck's new preventive shot will compete with existing RSV treatments from Sanofi and AstraZeneca in the U.S. market.

Taiwan will begin offering free human papillomavirus (HPV) vaccinations to junior high school boys starting in September 2025. The HPV vaccine has been shown to be highly effective in preventing HPV-related cancers, including cervical cancer, which a major Swedish study found to be reduced by nearly 90% when the vaccine is administered before age 17. Public health authorities, including the World Health Organization, emphasize that vaccines are rigorously tested, safe, and have saved over 150 million lives worldwide in the past 50 years. Despite increasing vaccine hesitancy, research indicates that targeted strategies can help overcome public doubts. In the United States, New York City has launched a campaign encouraging parents to vaccinate their children against HPV, highlighting the vaccine's safety and its ability to prevent up to 90% of HPV-related cancers over the past two decades.

Merck & Co. announced positive topline results from the first two Phase 3 CORALreef trials—CORALreef HeFH and CORALreef AddOn—evaluating enlicitide decanoate, an investigational oral PCSK9 inhibitor, for the treatment of adults with hyperlipidemia. The trials successfully met their primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol (LDL-C) compared to placebo and other oral non-statin therapies, including ezetimibe and bempedoic acid.

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Merck & Co. engaged in discussions to acquire MoonLake Immunotherapeutics for over $3 billion as part of its strategy to bolster its drug development pipeline. The potential takeover has driven a surge in MoonLake's stock price, reflecting investor interest in the deal. Reports indicate that Merck's offer could revive attention in late-phase biotechnology companies. Meanwhile, MoonLake's potential sale has been interpreted by some analysts as a sign of distress for the biotech firm. In a separate development, Owens & Minor and Rotech Healthcare mutually agreed to terminate their previously announced acquisition agreement.

The World Health Organization (WHO) has approved two vaccines aimed at protecting infants from respiratory syncytial virus (RSV), a major cause of bronchiolitis. Recent findings suggest that a one-time antibody shot administered directly to infants may offer more effective protection against RSV than vaccines given during pregnancy. In France, the preventive treatment Beyfortus has seen increased usage, with over 650,000 doses delivered this year compared to 250,000 last year. Approximately 60% of French infants received Beyfortus during the latest RSV immunization season, reflecting its growing adoption in combating bronchiolitis caused by RSV.

Merck has announced promising results from its investigational KRAS G12C inhibitor, MK-1084, which demonstrated antitumor activity in a Phase 1 trial involving patients with advanced colorectal cancer and non-small cell lung cancer harboring KRAS G12C mutations. This development adds to Merck's oncology portfolio, which includes potential new standards of care such as petosemtamab in combination with Keytruda for first-line head and neck squamous cell carcinoma (HNSCC). Additionally, other oncology assets like JANX's 007 in prostate cancer are noted as potential acquisition targets. At the ASCO 2025 conference, several studies were highlighted, including a first-in-human dose-escalation study of the trispecific antibody ISB 2001 in relapsed/refractory myeloma, the STELLAR-002 trial evaluating zanzalintinib plus nivolumab with or without relatlimab in clear cell renal cell carcinoma (ccRCC), and data on amivantamab combined with chemotherapy versus chemotherapy alone in EGFR-mutant advanced non-small cell lung cancer after progression on osimertinib. Discussions also covered the combination of sotorasib and panitumumab in chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC). These developments reflect ongoing advances in targeted therapies across multiple cancer types.

At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, results from the Phase 3 ASCENT-04/KEYNOTE-D19 trial showed that the combination of Merck's Keytruda (pembrolizumab) and Gilead Sciences' Trodelvy (sacituzumab govitecan-hziy) reduced the risk of disease progression or death by 35% (hazard ratio 0.65, p<0.001) compared to Keytruda plus chemotherapy in patients with PD-L1-positive (CPS ≥10) inoperable or metastatic triple-negative breast cancer (TNBC).

The trial enrolled 443 patients, and the combination therapy achieved a median progression-free survival (PFS) of 11.2 months versus 7.8 months for the standard Keytruda plus chemotherapy regimen. Objective response rates were higher with the combination (59.7% vs 53.2%), including higher complete response rates, and the duration of response was notably longer (16.5 months vs 9.2 months). The median follow-up was 14 months.

The safety profile of Keytruda plus Trodelvy was consistent with known profiles of each drug, with no new safety signals identified. Serious side effects included neutropenia in 43% of patients and diarrhea in 10%.

Overall survival data are still maturing, and patients will continue to be followed for this endpoint.

China has approved its first domestically developed nine-valent human papillomavirus (HPV) vaccine, Cecolin 9, becoming the second country worldwide after the United States to independently supply high-valency HPV vaccines. This development follows global health recommendations emphasizing HPV vaccination as an effective measure to prevent cervical cancer, with health authorities urging vaccination for girls worldwide. Meanwhile, health agencies in Hong Kong and South Korea are encouraging COVID-19 booster vaccinations, particularly for high-risk groups such as adults aged 65 and older and residents of vulnerable facilities, to reduce the risk of severe illness amid concerns of rising cases in Asia. Public health messages also highlight the preventability of Hepatitis A and B through vaccination and the treatability of Hepatitis C, underscoring the importance of staying informed and vaccinated to protect liver health.

Merck and Daiichi Sankyo have withdrawn their U.S. Biologics License Application for patritumab deruxtecan (HER3-DXd), an investigational HER3 directed antibody-drug conjugate (ADC), for the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in patients previously treated with two or more systemic therapies.

The decision follows topline results from the Phase 3 HERTHENA-Lung02 trial, which showed that the therapy did not achieve statistical significance for overall survival. The therapy had previously met the primary endpoint of progression-free survival in the HERTHENA-Lung01 Phase 2 trial. Patients in the Phase 3 trial received a 5.6 mg/kg dose of patritumab deruxtecan.

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Genor Biopharma has received approval from China's National Medical Products Administration (NMPA) for its new drug application for Lerociclib (GB491). Meanwhile, Merck & Co. has voluntarily withdrawn its Biologics License Application (BLA) for Patritumab Deruxtecan, a treatment targeting patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer. The withdrawal follows the topline overall survival data from the HERTHENA-Lung02 trial and was also reflected in a separate FDA marketing application withdrawal by Daiichi Sankyo for the same drug.

Merck & Co., Inc. has announced the initiation of a Phase 3 clinical trial named IDeate-Esophageal01, targeting patients with unresectable advanced or metastatic esophageal squamous cell carcinoma who have been pretreated. This trial is conducted in collaboration with Daiichi Sankyo. Meanwhile, findings from the phase 3 HARMONi-6 trial indicate that the combination of ivonescimab and chemotherapy has led to clinically meaningful improvements in progression-free survival (PFS) in patients with advanced squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression status.

Merck & Co. agreed on Wednesday to acquire London-based Verona Pharma for about $10 billion in cash, offering $107 for each American depositary share of the respiratory-drug maker. The price represents a roughly 23% premium to Verona’s latest closing price and values the company at 13 times analysts’ forecast 2026 sales, according to deal documents.

By buying Verona, Merck will add Ohtuvayre (ensifentrine), the first new inhaled maintenance therapy for chronic obstructive pulmonary disease in more than two decades. Approved by the U.S. Food and Drug Administration in June 2024, the dual PDE3/4 inhibitor generated $71.3 million of revenue in the first quarter and is projected by some analysts to exceed $4 billion in annual peak sales. Merck said the medicine has “multi-billion-dollar potential” and fits its expanding cardio-pulmonary portfolio.

Read more

A revamped Advisory Committee on Immunization Practices, meeting for the first time since Health and Human Services Secretary Robert F. Kennedy Jr. replaced all 17 members, voted 5-2 on 26 June to recommend Merck’s monoclonal antibody clesrovimab, marketed as Enflonsia, for infants eight months and younger who were not protected by a maternal RSV vaccine. The panel also unanimously amended the federal Vaccines for Children programme to cover the shot, easing concerns that Kennedy’s scepticism toward some immunisations might delay uptake.

Read more

The Advisory Committee on Immunization Practices (ACIP), recently appointed by Health and Human Services Secretary Robert F. Kennedy Jr., has voted to recommend Merck's monoclonal antibody shot, Enflonsia, for the prevention of respiratory syncytial virus (RSV) in infants. The panel voted 5-2 in favor of endorsing the new RSV therapy, which is intended to protect newborns and young children during the RSV season. In a separate but related decision, the same committee voted 5-1 to recommend against the use of influenza vaccines containing thimerosal, a mercury-based preservative.

This move aligns with Kennedy Jr.'s long-standing opposition to thimerosal and fulfills a goal of the anti-vaccine movement. Despite controversy surrounding these decisions, the committee continues to recommend annual flu vaccinations but advises against those containing thimerosal. The FDA recently approved Clesrovimab, another RSV treatment for newborns and young infants, which has also been endorsed by experts associated with Kennedy Jr. These developments mark a notable shift in vaccine advisory policies under Kennedy Jr.'s leadership at the Department of Health and Human Services.

Merck said its Phase 3 HYPERION study showed WINREVAIR (sotatercept-csrk) significantly delayed clinical worsening in 320 adults recently diagnosed with pulmonary arterial hypertension. The double-blind trial met its primary composite endpoint of time to clinical worsening, which includes death, unplanned PAH-related hospitalisation, lung transplantation, or other markers of disease progression.

More than 70 percent of participants were already receiving double background therapy, yet WINREVAIR delivered a statistically significant and clinically meaningful benefit compared with placebo. HYPERION is the third late-stage study in which the activin-signalling inhibitor has demonstrated efficacy, following the STELLAR and ZENITH trials.

The programme was stopped early after interim data confirmed benefit, and all participants were offered the drug in an open-label extension. Merck plans to present full results at a forthcoming medical meeting and to submit the data to regulators, aiming to expand WINREVAIR’s existing approvals in more than 45 countries.

The World Health Organization (WHO) and its partners have launched new global guidance aimed at expanding access to trusted midwives worldwide. This initiative emphasizes the critical role of midwifery care in saving lives, improving health outcomes, empowering women and families, and fostering hopeful futures. According to WHO, making midwives universally accessible through policy measures and awareness campaigns could prevent 83% of maternal, stillborn, and newborn deaths globally. In parallel, WHO continues to advocate for the elimination of cervical cancer, highlighting the effectiveness of human papillomavirus (HPV) vaccination, screening, and treatment as key tools to prevent this disease. These efforts align with a broader global health agenda to reduce maternal and infant mortality and improve women's health worldwide.

Pakistan has been selected to join a global initiative led by the World Health Organization that will provide free essential cancer medicines for children, according to Pakistan's health ministry. In Turkey, Health Minister Kemal Memişoğlu announced that the human papillomavirus (HPV) vaccine will be made available free of charge by the end of 2025. The national HPV vaccination program will target children aged 13 and older as well as adults aged 15 and above. Additionally, Turkey plans to produce cancer medicines domestically and become one of the first countries to manufacture a vaccine for Crimean-Congo hemorrhagic fever. The HPV vaccination drive in Pakistan's Sindh province is scheduled to launch in September 2025.

A newly appointed U.S. vaccine adviser named by Health Secretary Robert F. Kennedy Jr. has previously served as an expert witness in litigation against Merck's Gardasil vaccine. Court records reveal that this adviser earned thousands of dollars in connection with the legal proceedings targeting the Merck vaccine. The appointment has drawn attention due to the adviser's prior involvement in cases challenging the safety or efficacy of Gardasil, a vaccine produced by Merck.

A resurgence of vaccine-preventable diseases such as measles has raised concerns amid shifting U.S. vaccine policies and increasing vaccine hesitancy. Health experts emphasize the critical role of vaccination campaigns, which have historically nearly eradicated deadly diseases like measles, polio, and pertussis. Measles can lead to severe complications including pneumonia and brain swelling, with one in five hospitalized, while polio causes paralysis in one in 200 cases.

Human papillomavirus (HPV) vaccination is highlighted for its potential to reduce infection rates by up to 90% and significantly lower cervical cancer incidence. College health centers are identified as key venues to promote completion of the HPV vaccine series to prevent HPV-related cancers. Public health officials, such as those in Polk County, are actively developing strategies to combat measles outbreaks. In Australia, declining vaccination rates have prompted the federal government to launch a national immunization strategy aimed at protecting children and vulnerable populations from infectious diseases. The discussion underscores the importance of vaccines in preventing fatal outcomes associated with meningitis, tetanus, and pertussis, reinforcing the need for robust immunization efforts globally.

The human papillomavirus (HPV) vaccine is highly effective in preventing approximately 90% of HPV-related cancers, including cervical, throat, and penile cancers. Despite its proven benefits, only 45% of US campus clinicians routinely screen most women for HPV vaccination, with higher screening rates observed in larger institutions and where positive provider attitudes and college policies support vaccination efforts. College health centers play a crucial role in promoting completion of the HPV vaccine series to reduce future cancer risks. Studies indicate that widespread HPV vaccination could reduce infection rates by up to 90% and potentially nearly eliminate cervical cancer in the coming decades. Additionally, recommending HPV vaccination to parents of children aged 9 to 10 facilitates discussions on cancer prevention while avoiding concerns related to sexual activity that arise with older age groups. The broader context highlights vaccines as one of the greatest public health achievements, preventing diseases such as polio, measles, meningitis, pertussis, tetanus, and smallpox, the latter of which was eradicated by 1980 due to vaccination efforts.

The U.S. Food and Drug Administration (FDA) has approved Merck's monoclonal antibody shot to prevent respiratory syncytial virus (RSV) infections in infants up to one year old during their first RSV season. This approval marks the second monoclonal antibody preventive treatment authorized for infants against RSV, which is the leading cause of hospitalization in this age group. Clinical trials showed the treatment reduced RSV-related medically attended lower respiratory infections by 60.5% and hospitalizations by 84.3% over five months compared to placebo. Merck's new preventive shot will compete with existing RSV treatments from Sanofi and AstraZeneca in the U.S. market.

Taiwan will begin offering free human papillomavirus (HPV) vaccinations to junior high school boys starting in September 2025. The HPV vaccine has been shown to be highly effective in preventing HPV-related cancers, including cervical cancer, which a major Swedish study found to be reduced by nearly 90% when the vaccine is administered before age 17. Public health authorities, including the World Health Organization, emphasize that vaccines are rigorously tested, safe, and have saved over 150 million lives worldwide in the past 50 years. Despite increasing vaccine hesitancy, research indicates that targeted strategies can help overcome public doubts. In the United States, New York City has launched a campaign encouraging parents to vaccinate their children against HPV, highlighting the vaccine's safety and its ability to prevent up to 90% of HPV-related cancers over the past two decades.

Merck & Co. announced positive topline results from the first two Phase 3 CORALreef trials—CORALreef HeFH and CORALreef AddOn—evaluating enlicitide decanoate, an investigational oral PCSK9 inhibitor, for the treatment of adults with hyperlipidemia. The trials successfully met their primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol (LDL-C) compared to placebo and other oral non-statin therapies, including ezetimibe and bempedoic acid.

Read more

Merck & Co. engaged in discussions to acquire MoonLake Immunotherapeutics for over $3 billion as part of its strategy to bolster its drug development pipeline. The potential takeover has driven a surge in MoonLake's stock price, reflecting investor interest in the deal. Reports indicate that Merck's offer could revive attention in late-phase biotechnology companies. Meanwhile, MoonLake's potential sale has been interpreted by some analysts as a sign of distress for the biotech firm. In a separate development, Owens & Minor and Rotech Healthcare mutually agreed to terminate their previously announced acquisition agreement.

The World Health Organization (WHO) has approved two vaccines aimed at protecting infants from respiratory syncytial virus (RSV), a major cause of bronchiolitis. Recent findings suggest that a one-time antibody shot administered directly to infants may offer more effective protection against RSV than vaccines given during pregnancy. In France, the preventive treatment Beyfortus has seen increased usage, with over 650,000 doses delivered this year compared to 250,000 last year. Approximately 60% of French infants received Beyfortus during the latest RSV immunization season, reflecting its growing adoption in combating bronchiolitis caused by RSV.

Merck has announced promising results from its investigational KRAS G12C inhibitor, MK-1084, which demonstrated antitumor activity in a Phase 1 trial involving patients with advanced colorectal cancer and non-small cell lung cancer harboring KRAS G12C mutations. This development adds to Merck's oncology portfolio, which includes potential new standards of care such as petosemtamab in combination with Keytruda for first-line head and neck squamous cell carcinoma (HNSCC). Additionally, other oncology assets like JANX's 007 in prostate cancer are noted as potential acquisition targets. At the ASCO 2025 conference, several studies were highlighted, including a first-in-human dose-escalation study of the trispecific antibody ISB 2001 in relapsed/refractory myeloma, the STELLAR-002 trial evaluating zanzalintinib plus nivolumab with or without relatlimab in clear cell renal cell carcinoma (ccRCC), and data on amivantamab combined with chemotherapy versus chemotherapy alone in EGFR-mutant advanced non-small cell lung cancer after progression on osimertinib. Discussions also covered the combination of sotorasib and panitumumab in chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC). These developments reflect ongoing advances in targeted therapies across multiple cancer types.

At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, results from the Phase 3 ASCENT-04/KEYNOTE-D19 trial showed that the combination of Merck's Keytruda (pembrolizumab) and Gilead Sciences' Trodelvy (sacituzumab govitecan-hziy) reduced the risk of disease progression or death by 35% (hazard ratio 0.65, p<0.001) compared to Keytruda plus chemotherapy in patients with PD-L1-positive (CPS ≥10) inoperable or metastatic triple-negative breast cancer (TNBC).

The trial enrolled 443 patients, and the combination therapy achieved a median progression-free survival (PFS) of 11.2 months versus 7.8 months for the standard Keytruda plus chemotherapy regimen. Objective response rates were higher with the combination (59.7% vs 53.2%), including higher complete response rates, and the duration of response was notably longer (16.5 months vs 9.2 months). The median follow-up was 14 months.

The safety profile of Keytruda plus Trodelvy was consistent with known profiles of each drug, with no new safety signals identified. Serious side effects included neutropenia in 43% of patients and diarrhea in 10%.

Overall survival data are still maturing, and patients will continue to be followed for this endpoint.

China has approved its first domestically developed nine-valent human papillomavirus (HPV) vaccine, Cecolin 9, becoming the second country worldwide after the United States to independently supply high-valency HPV vaccines. This development follows global health recommendations emphasizing HPV vaccination as an effective measure to prevent cervical cancer, with health authorities urging vaccination for girls worldwide. Meanwhile, health agencies in Hong Kong and South Korea are encouraging COVID-19 booster vaccinations, particularly for high-risk groups such as adults aged 65 and older and residents of vulnerable facilities, to reduce the risk of severe illness amid concerns of rising cases in Asia. Public health messages also highlight the preventability of Hepatitis A and B through vaccination and the treatability of Hepatitis C, underscoring the importance of staying informed and vaccinated to protect liver health.

Merck and Daiichi Sankyo have withdrawn their U.S. Biologics License Application for patritumab deruxtecan (HER3-DXd), an investigational HER3 directed antibody-drug conjugate (ADC), for the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in patients previously treated with two or more systemic therapies.

The decision follows topline results from the Phase 3 HERTHENA-Lung02 trial, which showed that the therapy did not achieve statistical significance for overall survival. The therapy had previously met the primary endpoint of progression-free survival in the HERTHENA-Lung01 Phase 2 trial. Patients in the Phase 3 trial received a 5.6 mg/kg dose of patritumab deruxtecan.

Read more

Genor Biopharma has received approval from China's National Medical Products Administration (NMPA) for its new drug application for Lerociclib (GB491). Meanwhile, Merck & Co. has voluntarily withdrawn its Biologics License Application (BLA) for Patritumab Deruxtecan, a treatment targeting patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer. The withdrawal follows the topline overall survival data from the HERTHENA-Lung02 trial and was also reflected in a separate FDA marketing application withdrawal by Daiichi Sankyo for the same drug.

Merck & Co., Inc. has announced the initiation of a Phase 3 clinical trial named IDeate-Esophageal01, targeting patients with unresectable advanced or metastatic esophageal squamous cell carcinoma who have been pretreated. This trial is conducted in collaboration with Daiichi Sankyo. Meanwhile, findings from the phase 3 HARMONi-6 trial indicate that the combination of ivonescimab and chemotherapy has led to clinically meaningful improvements in progression-free survival (PFS) in patients with advanced squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression status.