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Zai Lab Ltd Partners with Pfizer for Commercialization of Xacduro in China
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China-based biotechnology company Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced a strategic collaboration agreement with global pharmaceutical giant Pfizer (NYSE: PFE). The partnership grants Pfizer’s affiliated companies the exclusive rights to commercialize Xacduro (durlobactam, sulbactam) in mainland China. This collaboration, set to be in effect through November 2028,…
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Pfizer and Flagship Pioneering Expand Partnership with Two New Biotechnology Agreements
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The billion-dollar, multi-program partnership between US pharmaceutical giant Pfizer (NYSE: PFE) and bioplatform innovation company Flagship Pioneering, initiated in July 2023, has expanded with two new additions. Ampersand Biomedicines and Montai Therapeutics, both Flagship-founded biotechs, have entered into agreements to identify targeted molecules aimed at treating obesity and non-small cell…
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Pfizer’s Hympavzi Receives European Commission Approval for Hemophilia A and B
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US pharmaceutical major Pfizer Inc. (NYSE: PFE) has announced that the European Commission (EC) has granted approval for its drug Hympavzi (marstacimab-hncq) for the routine prophylaxis of bleeding episodes in patients aged 12 years and older weighing at least 35 kg with severe hemophilia A (congenital factor VIII [FVIII] deficiency,…
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Pfizer Considers Sale of Hospital Unit Amid Pressure from Starboard Value
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Pfizer Inc. (NYSE: PFE) is reportedly considering the sale of its hospital unit, Pfizer Hospital, in response to pressure from activist investor Starboard Value, as per information from Reuters. The move is part of the US pharmaceutical giant’s strategy to divest non-core assets and focus on its core businesses. Background…
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GSK Leaves BIO, Joining Other Major Companies in Withdrawing Membership
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GlaxoSmithKline (GSK; NYSE: GSK), a leading pharmaceutical company based in the UK, has reportedly withdrawn from the US industry trade group Biotechnology Innovation Organization (BIO). This decision follows a similar trend set by Pfizer (NSE: PFIZER), UCB (EBR: UCB), WuXi AppTec (HKG: 2359, SHA: 603259), Takeda (TYO: 4502), and other…
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Pfizer Partners with Beijing Mabworks and KYinno Biotechnology on Multiple Myeloma Treatments in China
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At the 7th China International Import Expo (CIIE), Chinese firms Beijing Mabworks Biotech Co., Ltd, and KYinno Biotechnology Co., Ltd, have jointly announced a cooperation Memorandum of Understanding (MoU) with global pharmaceutical leader Pfizer (NYSE: PFE). The collaboration focuses on the clinical development of innovative treatment solutions for patients with…
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Shanghai Pharmaceutical Co., Ltd Secures Multiple Partnerships at CIIE
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At the 7th China International Import Expo (CIIE), China-based Shanghai Pharmaceutical Co., Ltd (SPH, SHA: 601607, HKG: 2607) announced a series of partnerships with prominent pharmaceutical companies, spanning domestic and international entities. Expanding Collaborations in Pharmaceutical InnovationFrance’s Sanofi (NASDAQ: SNY) has agreed to deepen its existing partnership with SPH, initially…
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Pfizer’s Talzenna (talazoparib) Approved by China’s NMPA for mCRPC Treatment
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The National Medical Products Administration (NMPA) website has indicated that Pfizer’s (NYSE: PFE) marketing filing for Talzenna (talazoparib) has been approved, clearing the way for the poly ADP-ribose polymerase (PARP) inhibitor to treat metastatic castration-resistant prostate cancer (mCRPC) in China. Talazoparib’s Global Approvals and IndicationsTalazoparib received approval in the US…
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AbbVie Partners with EvolveImmune to Develop Immunotherapies for Cancer
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US pharmaceutical company AbbVie (NYSE: ABBV) has entered into a collaboration and option-to-license agreement with EvolveImmune Therapeutics, Inc., an immunotherapy platform company backed by industry giants including Pfizer (NYSE: PFE) and BMS (NYSE: BMY). The partnership will focus on leveraging EvolveImmune’s T-cell engager platform to develop novel antibody-based therapies for…
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Pfizer Reports Strong Q3 Results, Boosts 2024 Guidance to $61-$64 Billion
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Pfizer Inc. (NYSE: PFE) released its Q3 2024 financial results, reporting revenues of $17.702 billion for the third quarter, a 32% year-on-year (YOY) increase at constant exchange rates. For the first nine months of the year, revenues totaled $45.864 billion, reflecting a 3% YOY growth. This strong performance has prompted…
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Pfizer Partners with TRIANA Biomedicines to Develop Molecular Glue Degraders for Oncology and Other Diseases
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Pfizer (NSE: PFIZER), a leading US pharmaceutical company, has entered into a strategic partnership and licensing agreement with Massachusetts-based biotech firm TRIANA Biomedicines. The collaboration aims to develop innovative molecular glue degraders targeting a variety of diseases, with a focus on oncology, according to a press release from TRIANA. Under…
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Pfizer’s Talzenna Combo Shows Improved Survival in mCRPC Patients, According to TALAPRO-2 Study
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Pfizer Inc. (NYSE: PFE) has announced positive topline results regarding overall survival (OS) in the Phase III TALAPRO-2 study for Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, when combined with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI). This combination is used for the treatment of patients with…
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Pfizer’s Hympavzi Secures FDA Nod, Offering Novel Once-Weekly Treatment for Hemophilia B
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Pfizer Inc. (NYSE: PFE) has scored a significant win with the US Food and Drug Administration’s (FDA) approval of its drug Hympavzi (marstacimab-hncq) for routine prophylaxis in adults and pediatric patients aged 12 and older with hemophilia A, characterized by a congenital deficiency of factor VIII (FVIII), or hemophilia B,…
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Pfizer Halts Development of Sisunatovir, an RSV Antiviral, After Phase II/III Trials
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U.S. pharmaceutical giant Pfizer (NYSE: PFE) has decided to discontinue the development of sisunatovir, an antiviral drug for respiratory syncytial virus (RSV), following challenges including drug-drug interactions with antacids. The drug had reached the Phase II/III trial stage, and the decision will see two trials discontinued, according to Endpoints News.…
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China’s CDE Announces “Care Plan” to Include Pfizer’s Marstaximab for Rare Disease Drug Development
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The National Health Commission (NHC) of China, through its Center for Drug Evaluation (CDE), has announced that Pfizer (NSE: PFIZER, NYSE: PFE, ETR: PFE)’s Marstaximab (PF-06741086) has been included in the “Care Plan” for patient-centered rare disease drug development. The publicity period for this decision ends on October 12, 2024.…
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Pfizer Partners with Shanghai Pharmaceutical for Long-Term Vaccine Collaboration in China
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Pfizer Inc. (NSE: PFIZER, NYSE: PFE, ETR: PFE), a leading pharmaceutical company in the U.S., has entered into a partnership with China’s Shanghai Pharmaceutical Holding Co., Ltd (SHA: 601607; SPH) to establish a long-term collaboration in the vaccine sector. The collaboration will focus on product promotion, introduction of innovative products,…
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Pfizer Partners with Quotient Therapeutics for Somatic Mutations Research in Cardiovascular and Renal Diseases
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NEW YORK—Pfizer Inc., a pharmaceutical giant listed on the New York Stock Exchange (NYSE: PFE), has entered into a research collaboration with Quotient Therapeutics, a Cambridge, Massachusetts-based biotech firm. The partnership will focus on analyzing somatic mutations in diseased patient tissue, with a goal of uncovering new therapeutic approaches for…
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US FDA Approves Updated COVID-19 mRNA Vaccines from Pfizer/BioNTech and Moderna Ahead of Winter
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The U.S. Food and Drug Administration (FDA) has granted approval to two updated mRNA COVID-19 vaccines in anticipation of the winter season. Pfizer/BioNTech and Moderna have both received authorization for their vaccines, which are designed to address the KP.2 variant of the virus, a subset of the omicron strain. The…
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Pfizer’s Hemophilia Treatment Marstacimab Accepted for Review in China
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The China Center for Drug Evaluation (CDE) has accepted for review a market approval filing for Pfizer Inc.’s (NYSE: PFE) Category 1 biologic drug marstacimab (PF-06741086), according to the agency’s website. This regulatory milestone in China follows similar submissions to the U.S. Food and Drug Administration (FDA) and the European…
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Pfizer’s RSV Vaccine Abrysvo Shows Strong Protection in Immunocompromised Adults, Phase III Sub-Study Reveals
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Pfizer Inc. (NYSE: PFE), a pharmaceutical titan based in the US, has announced encouraging topline results from a sub-study within its ongoing Phase III clinical trial (NCT05842967) for Abrysvo, a vaccine designed to combat respiratory syncytial virus (RSV). The data indicate that Abrysvo offers robust protection against RSV infections in…
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Pfizer, Astellas, and University of California Sue Qilu Pharma Over Xtandi Patent Infringement
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Pfizer Inc. (NYSE: PFE), through its subsidiary Medivation, and co-development partner Astellas Pharma Inc. (TYO: 4503), are stepping up their efforts to safeguard the intellectual property of their blockbuster prostate cancer drug, Xtandi (enzalutamide). In a joint legal action with the University of California, the companies have filed a lawsuit…
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Pfizer Enters Multi-Year R&D Collaboration with Telescope Innovations to Leverage AI and Robotics
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Pfizer Inc. (NYSE: PFE), a leading US pharmaceutical company, has entered into a multi-year collaborative research agreement with Canada-based Telescope Innovations Corp. (CNSX: TELI). The financial details of the agreement have not been disclosed. The partnership aims to harness Telescope’s expertise in automation, robotics, and artificial intelligence (AI) to expedite…
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Pfizer Inc. Reports Q2 2024 Earnings with First Positive Growth Since Q4 2022 Peak
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Pfizer Inc. (NYSE: PFE), a leading US pharmaceutical company, has announced its financial results for the second quarter of 2024, showing a 3% year-on-year (YOY) increase in global revenues in constant currency terms, reaching USD 13.283 billion. This marks the first quarter of positive growth for Pfizer since the peak…
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Pfizer’s Hemophilia A Gene Therapy Shows Promise in Phase III AFFINE Study
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Pfizer Inc. (NYSE: PFE), a US pharmaceutical giant, has announced positive topline results from the Phase III AFFINE study for its gene therapy candidate, giroctocogene fitelparvovec, for the treatment of hemophilia A. With these results, Pfizer is now poised to prepare for regulatory submission for this one-time gene therapy, which…
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Pfizer Launches SGD 1 Billion API Plant Expansion in Singapore, Creating 250 New Jobs
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Pfizer Inc., (NYSE: PFE) a leading global pharmaceutical company, has announced the opening of an extension to its active pharmaceutical ingredient (API) manufacturing plant in Singapore. This significant expansion comes with an investment of SGD 1 billion (USD 743 million) and is set to bolster Pfizer’s production capabilities with the…
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Pfizer’s Once-Daily Danuglipron Selected for Full Clinical Development for Type 2 Diabetes and Obesity
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Pfizer Inc. (NSE: PFIZER), a leading pharmaceutical company in the U.S., has announced that a once-daily oral formulation of danuglipron, its investigational GLP-1 agonist for the treatment of type 2 diabetes and obesity, has been selected for full clinical development. This decision is based on positive findings from an ongoing…
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Pfizer and AbbVie Announce Leadership Changes in Global R&D Divisions
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In significant executive reshuffling, Pfizer Inc. (NYSE: PFE) and AbbVie (NYSE: ABBV) have both announced changes to their top leadership teams, particularly impacting their global research and development divisions. Pfizer’s Dr. Mikael Dolsten has stepped down from his role as Chief Scientific Officer (CSO) and President of Pfizer Research &…
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Pfizer Collaborates with Evotec for Drug Candidates in Metabolic and Infectious Diseases
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Pfizer Inc. (NYSE: PFE) has entered into a multi-year collaboration with Germany-based biotechnology company Evotec SE (F: EVT; Nasdaq: EVO), focusing initially on discovering new drug candidates for metabolic and infectious diseases. Evotec, known for its expertise in proteomics and metabolomics, will apply its capabilities to target first-in-class therapeutic approaches…
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Pharmaceutical Giants Face UK Industry Code Breach Allegations, Including Novartis and Pfizer
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Several multinational pharmaceutical corporations have been reprimanded for violating the UK’s Prescription Medicines Code, a set of voluntary industry standards established by the Association of the British Pharmaceutical Industry (ABPI) and overseen by the Prescription Medicines Code of Practice Authority (PMCPA). The PMCPA has called out Novartis (NYSE: NVS), Pfizer…
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Qilu Pharmaceutical’s Generic Version of Vyndaqel Receives NMPA Marketing Approval
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The National Medical Products Administration (NMPA) has granted marketing approval to Qilu Pharmaceutical’s generic version of Pfizer’s Vyndaqel (tafamidis meglumine), marking it as the first generic to pass the generic quality consistency evaluation (GQCE) in China. This development is highlighted on the NMPA’s official website. Tafamidis meglumine is indicated for…
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Pfizer’s Gene Therapy for Duchenne Muscular Dystrophy Misses Late-Stage Trial Endpoints
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Pfizer Inc. (NYSE: PFE) has announced that a late-stage clinical trial for its investigational gene therapy, fordadistrogene movaparvovec, in children aged 4 to 7 with Duchenne muscular dystrophy (DMD) failed to meet its primary endpoint of improving motor function. Additionally, secondary endpoints related to motor function showed no significant improvement…
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Pfizer Forges Partnership with Flagship Pioneering for Novel Obesity Treatments
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Pharmaceutical giant Pfizer Inc. (NYSE: PFE) has initiated a strategic partnership with Flagship Pioneering, a life sciences innovation enterprise, to embark on a collaborative quest for groundbreaking obesity treatments in 2023. The alliance will tap into ProFound Therapeutics’ proprietary technology platform, a Flagship-founded entity, to bolster Pfizer’s research and development…
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Pfizer’s Lorbrena Outperforms Xalkori in 5-Year ALK-Positive NSCLC Follow-Up
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Pfizer Inc. (NYSE: PFE) has announced the release of five-year follow-up data for its kinase inhibitor Lorbrena/Lorviqua (lorlatinib) in untreated ALK-positive advanced non-small cell lung cancer (NSCLC). The data revealed that Lorbrena demonstrated an 81% reduction in the rate of disease progression or death compared to Xalkori (crizotinib), and increased…
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Asymchem Laboratories Enters European Market with Pfizer’s UK API Plant and R&D Lab Purchase
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Asymchem Laboratories (Tianjin) Co., Ltd (SHE: 002821), a leading China-based Contract Development and Manufacturing Organization (CDMO), has announced the acquisition of a state-of-the-art Active Pharmaceutical Ingredient (API) pilot plant and R&D laboratory in Sandwich, UK. These facilities, previously under the ownership of US pharmaceutical giant Pfizer, mark Asymchem’s inaugural foray…
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Pfizer Pauses Dosing in DMD Gene Therapy Trial Following Participant’s Sudden Death
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This week, Pfizer Inc. (NYSE: PFE) announced the unfortunate sudden death of a participant in a Phase II study for its investigational gene therapy, fordadistrogene movaparvovec, used to treat Duchenne muscular dystrophy (DMD). The patient, aged between 2 and 4 years, had received the treatment in the previous year. In…
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Pfizer Appoints Citigroup’s Andrew Baum as Executive Vice-President for Strategy and Innovation
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Pfizer Inc. (NYSE: PFE) has announced the appointment of Andrew Baum, M.D., to serve as Chief Strategy and Innovation Officer and Executive Vice-President. Baum, who will report directly to Pfizer’s Chairman and CEO Dr. Albert Bourla, brings a wealth of financial experience to the role, despite having no prior experience…
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Pfizer’s Q1 2024 Results Highlight Robust Portfolio Growth and Profitability
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Pfizer Inc. (NYSE: PFE) saw its share price surge over 5% following the release of its financial results for the first quarter of 2024. The market responded positively to the underlying portfolio growth and increased profitability, which was amplified by recent operational cost-cutting measures. Despite a challenging comparison with the…
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Astellas Pharma Inc. Reports Revenue Growth in FY2023, Driven by Xtandi and Padcev Sales
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced its financial results for the year ended March 31, 2024, with revenues reaching ¥1.603 trillion (USD 10.13 billion), marking a 5.6% year-on-year (YOY) increase. The company’s core growth drivers for the year included the prostate cancer drug Xtandi (enzalutamide), which is co-developed…
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Pfizer’s Gene Therapy Beqvez Wins FDA Nod for Moderate-to-Severe Hemophilia B
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The US Food and Drug Administration (FDA) has granted marketing authorization to Pfizer (NYSE: PFE) for its gene therapy Beqvez (fidanacogene elaparvovec) for the treatment of adults with moderate-to-severe hemophilia B. The one-time treatment is indicated for patients using factor IX prophylaxis therapy, those experiencing life-threatening hemorrhages, or those with…
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European Commission Approves Pfizer’s Antibiotic Emblaveo for Multiple Indications
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The European Commission (EC) has granted approval for Pfizer’s (NYSE: PFE) antibiotic Emblaveo (aztreonam + avibactam) for the treatment of complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), complicated urinary tract infections (cUTI), and infections caused by aerobic Gram-negative organisms in adults. The drug was reviewed under an accelerated assessment process…
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Kangtai Biological Receives NMPA Approval for 20-Valent Pneumococcal Vaccine Clinical Trial
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Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601), a leading biopharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its 20-valent pneumococcal polysaccharide conjugate vaccine. The vaccine is designed to prevent infectious diseases caused by…
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Pfizer Reports Positive Phase III Results for RSV Vaccine Abrysvo in Younger Adults
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Pfizer (NYSE: PFE) has announced interim results from a Phase III trial evaluating its respiratory syncytial virus (RSV) vaccine, Abrysvo, in adults aged 18 to 59 at risk of severe RSV-associated lower respiratory tract disease (LRTD). Currently, the vaccine is approved for preventing RSV-associated LRTD in older adults and for…
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Dr. Reddy’s Launches Biosimilar Versavo in UK to Challenge Roche’s Cancer Therapy Avastin
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Dr. Reddy’s Laboratories (NYSE: RDY), a prominent Indian pharmaceutical company, has launched its biosimilar Versavo (bevacizumab) in the UK market, presenting a challenge to Roche’s established cancer therapy Avastin. Versavo, a biosimilar to Avastin, has been approved for the treatment of various metastatic cancers, including colorectal cancer, non-squamous non-small cell…
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Pfizer’s Sugemalimab Secures NMPA Approval for Gastric and Gastroesophageal Junction Adenocarcinoma
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Pfizer (NYSE: PFE), a leading pharmaceutical company in the US, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for sugemalimab, a programmed death-ligand 1 (PD-L1) inhibitor, for the first-line treatment of inoperable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma (G/GEJ) expressing…
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European Commission Approves Pfizer’s Prevenar 20 for Pediatric Use
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The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its 20-valent pneumococcal vaccine, Prevenar 20, aimed at preventing invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in individuals aged 6 weeks to 18 years. This vaccine was previously approved for use in adults…
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Pfizer’s Adcetris Combo Shows Improved Survival in Relapsed/Refractory DLBCL Late-Stage Trial
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Pfizer (NYSE: PFE) has announced positive results from a late-stage clinical trial for its antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The study successfully met its primary endpoint, demonstrating an improvement in overall survival (OS)…
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MSD Partners with IDEAYA Biosciences to Develop Combination Therapy for Endometrial Cancer
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a partnership with IDEAYA Biosciences (NASDAQ: IDYA), a US-based biotechnology company, to clinically develop the combination of MSD’s top-selling anti-PD-1 therapy Keytruda (pembrolizumab) with IDEAYA’s potential first-in-class poly (ADP-ribose) glycohydrolase (PARG) inhibitor IDE161. The collaboration focuses on treating microsatellite instability-high (MSI-high)…
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Pfizer’s Cibinqo Secures NMPA Approval for Expanded Use in Atopic Dermatitis
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The National Medical Products Administration (NMPA) has released drug approval certificate delivery information that points to a new indication approval for Pfizer (NYSE: PFE)’s JAK1 inhibitor Cibinqo (abrocitinib), a small molecule targeted therapy. This approval expands the drug’s use to include the treatment of moderate to severe atopic dermatitis (AD)…
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Pfizer’s Velsipity Approved by European Commission for Moderately to Severely Active Ulcerative Colitis
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The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its S1P receptor modulator Velsipity (etrasimod) as a treatment for patients aged 16 and older with moderately to severely active ulcerative colitis (UC). The approval applies to patients who have had an inadequate response, lost response, or…
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LianBio to Wind Down Operations Amid Market Challenges, Announces Special Dividend
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LianBio (OTCMKTS: LIANY), one of China’s prominent biotechnology firms, has announced plans to wind down its operations following a strategic review in light of challenging biotech market conditions. This decision initiates a gradual process that includes the divestiture of remaining pipeline assets, delisting from NASDAQ, and deregistration as a corporate…
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Pfizer’s Nurtec Approved by China’s NMPA for Acute Treatment of Migraines
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Pfizer Inc. (NYSE: PFE), a leading pharmaceutical company in the U.S., has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for Nurtec (rimegepant), indicated for the acute treatment of migraine with or without aura. Rimegepant, developed originally by Biohaven, is the first oral CGRP…
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BMS’s Opdivo-Yervoy Combo Cuts Cancer Progression Risk by 79% in Phase III Study
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Bristol Myers Squibb (BMS; NYSE: BMY) has published late-stage and long-term data for its anti-PD-1 drug Opdivo (nivolumab) across various cancer indications. Early results from a Phase III trial in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) indicate that the combination of Opdivo with anti-CTLA-4…
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Merck’s Bavencio Shows Promising Survival Data in Real-World Urothelial Carcinoma Studies
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German pharmaceutical company Merck (NYSE: MRK) has released data from real-world studies for its anti-PD-L1 biologic Bavencio (avelumab), used as a maintenance therapy in eligible patients with locally advanced or metastatic urothelial carcinoma (UC). Preliminary results indicate that the median overall survival (OS) in patients without progression after first-line chemotherapy…
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USPTO Invalidates Key Seagen-Held Patent in ADC Conjugation Dispute with Daiichi Sankyo
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In a surprising turn of events in the ongoing intellectual property dispute, the US Patent and Trademark Office (PTO) has invalidated a 2020 patent for conjugation compounds used in antibody-drug conjugates (ADCs), which was held by Pfizer’s (NYSE: PFE) subsidiary Seagen and contested by Japan’s Daiichi Sankyo (TYO: 4568). The…
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Pfizer Eyes Further ADC Expansion, Potentially in China, Says Chief Oncology Officer
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Dr. Chris Boshoff, Pfizer (NYSE: PFE)’s recently appointed chief oncology officer, disclosed in an interview with FiercePharma.com on the margins of the JP Morgan Healthcare Conference that the company is contemplating additional strategic deals, particularly in the realm of antibody drug conjugates (ADCs), with a focus that may include Chinese…
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Pfizer and Genmab’s Tivdak Earns Priority Review from FDA for Full Registration
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The US Food and Drug Administration (FDA) has accepted for priority review a filing from Pfizer (NYSE: PFE) and Genmab (NASDAQ: GMAB) for the full registration of their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). Tivdak currently holds an accelerated approval from 2021 for the treatment of recurrent or metastatic cervical…
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Medilink Therapeutics Secures Multi-Billion Dollar Deal with Roche for c-MET Targeting ADC
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Medilink Therapeutics, a Suzhou-based biopharmaceutical company, has entered into a global collaboration and licensing agreement with Swiss pharmaceutical giant Roche concerning YL211, an antibody drug conjugate (ADC) targeting c-Mesenchymal-epithelial transition factor (c-MET) for the development of a treatment for solid tumors. This agreement marks Medilink’s fifth out-license deal for ADC…
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FDA Approves Pfizer-Astellas-MSD Combo Therapy for Advanced Urothelial Cancer
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Pfizer (NYSE: PFE), Astellas (TYO: 4503), and Merck, Sharp & Dohme (MSD; NYSE: MRK) have secured U.S. Food and Drug Administration (FDA) approval for their combination therapy consisting of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) for the treatment of locally advanced or metastatic urothelial cancer (la/mUC). The FDA’s decision is…
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Seagen Inc. Acquires Global Rights to HBM9033 ADC in Deal with Nona Biosciences and Medilink Therapeutics
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Nona Biosciences, a subsidiary of HBM Holdings Ltd (HKG: 2142), and Suzhou-based Medilink Therapeutics have jointly announced the licensing of their co-developed antibody-drug conjugate (ADC), HBM9033 (YL215), to Pfizer Inc.’s (NYSE: PFE) unit Seagen Inc. (NASDAQ: SGEN). According to the agreement, Seagen will secure global clinical development and commercialization rights…
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Pfizer’s $43 Billion Seagen Acquisition Closes Amid Lackluster 2024 Forecast
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Pfizer Inc. (NYSE: PFE) has secured all necessary regulatory approvals to finalize its $43 billion acquisition of antibody-drug conjugate (ADC) specialist Seagen Inc. (NASDAQ: SGEN), with the deal set to close today. The US pharmaceutical giant had to make concessions to address the US Federal Trade Commission’s (FTC) concerns over…
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AstraZeneca Acquires Icosavax to Boost Infectious Disease Pipeline with VLP Vaccine Technology
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has announced the acquisition of US vaccines specialist Icosavax (NASDAQ: ICVX), including its protein virus-like particle (VLP) platform. AstraZeneca will pay approximately USD 800 million upfront for all outstanding shares, plus about USD 300 million in milestone payments. The acquisition is set to…
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Pfizer and CStone Secure NMPA Approval for Sugemalimab, First PD-L1 Inhibitor for ESCC
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Pfizer (NYSE: PFE) and CStone Pharmaceuticals (HKG: 2616) have secured market approval from the National Medical Products Administration (NMPA) for sugemalimab, a treatment for first-line irresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) in combination with fluorouracil and platinum. This approval marks sugemalimab as the first programmed…
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Roche Expands Beyond Oncology with USD 2.7 Billion Carmot Therapeutics Acquisition
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Swiss pharmaceutical giant Roche (SWX: ROG) has entered into an agreement to acquire U.S. biotech firm Carmot Therapeutics, a specialist in anti-obesity and diabetes drugs, in a transaction valued at USD 2.7 billion with potential milestone payments of up to USD 400 million. The acquisition is expected to close in…
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Pfizer’s Danuglipron Phase IIb Trial Achieves Weight Loss Goals Amid Tolerability Concerns
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Pfizer (NYSE: PFE) announced last week that its Phase IIb trial evaluating danuglipron, a glucagon-like peptide-1 (GLP-1) receptor agonist, in adults with obesity but without type 2 diabetes (T2D) has successfully met its primary endpoint. The study demonstrated significant reductions in body weight from baseline, with participants achieving placebo-adjusted mean…
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Pfizer Enters Strategic Alliance with Guangdong Government to Boost Biomedicine R&D
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Pfizer (NYSE: PFE), the US pharmaceutical powerhouse, has signed a strategic memorandum of understanding with the People’s Government of Guangdong Municipality to collaborate on various initiatives within the biomedicine sector. This partnership will focus on research and development innovation, R&D translation, and talent cultivation, with the overarching goal of enhancing…
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Merck’s V116 Pneumococcal Vaccine Shows Promising Data Against Pfizer’s Prevnar 20
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has unveiled new data from a late-stage trial of its 21-valent pneumococcal conjugate vaccine, V116, confirming earlier topline results. The data, released this week, highlights the vaccine’s immunogenicity, tolerability, and safety in comparison to Pfizer’s (NYSE: PFE) 20-valent Prevnar 20/Apexxnar in unvaccinated adults.…
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Jiangxi Jemincare Group Secures NMPA Approval for Generic Ibrance Capsules
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Jiangxi Jemincare Group, a Chinese pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Pfizer’s (NYSE: PFE) Ibrance (palbociclib). This follows the company’s earlier approval for its active pharmaceutical ingredients (APIs) of palbociclib in China. Palbociclib, initially…
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Pfizer and Astellas Pharma Secure FDA Approval for Xtandi in High-Risk Non-Metastatic Prostate Cancer
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Partners Pfizer (NYSE: PFE) and Astellas Pharma (TSE: 4503) last week received indication extension approval from the US Food and Drug Administration (FDA) for their androgen receptor signaling inhibitor Xtandi (enzalutamide). The drug is now approved as a treatment for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high…
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Seagen’s Adcetris Combo with Keytruda Shows Promising Results in Phase II Study
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has released the results of a Phase II study combining its antibody drug conjugate (ADC) Adcetris (brentuximab vedotin) with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 therapy Keytruda (pembrolizumab). The study focused on patients with…
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Pfizer Inc. Reports Q3 2023 Revenue Contraction and Launches Cost Realignment Program
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US pharmaceutical giant Pfizer Inc., (NYSE: PFE) has released its financial results for the third quarter of 2023, reporting a contraction of -41% year-on-year (YOY) in operational terms to USD 13.2 billion, excluding foreign currency fluctuations. The quarter was marked by a net loss of USD 2.38 billion, the company’s…
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Roche Agrees to Acquire Telavant for $7.1 Billion to Boost IBD Treatment Portfolio
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Switzerland-headquartered pharmaceutical giant Roche (SWX: ROG) announced this week an agreement to purchase Telavant Holdings, a biotechnology firm co-owned by UK’s Roivant Sciences (NASDAQ: ROIV) and US-based Pfizer (NYSE: PFE). The acquisition will grant Roche rights to RVT-3101, a potential best-in-class and first-in-class anti-TL1A subcutaneous antibody, in the US and…
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Pfizer’s Penbraya Receives FDA Approval for Meningococcal Immunization
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Pfizer Inc. (NYSE: PFE) announced last week that it has successfully registered its pentavalent meningococcal vaccine, Penbraya, with the US Food and Drug Administration (FDA). The vaccine is designed for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals aged…
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Health Canada Approves Pfizer and Sumitomo Pharma’s Myfembree for Endometriosis Pain Management
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Health Canada has granted regulatory approval to Pfizer (NYSE: PFE) and Sumitomo Pharma (TYO: 4506) for their women’s health product Myfembree (relugolix + estradiol + norethindrone acetate). The approval is for the management of moderate-to-severe pain associated with endometriosis in pre-menopausal women, supported by late-stage data from multiple trials. Previous…
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Pfizer’s Velsipity Approved by FDA for Ulcerative Colitis Treatment
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China-based pharmaceutical company Everest Medicines (HKG: 1952) announced that its licensing partner, Pfizer Inc. (NYSE: PFE), has secured market approval from the US FDA for Velsipity (etrasimod). This oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator is indicated for adults with moderately to severely active ulcerative colitis (UC), marking a significant…
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Pfizer Adjusts 2023 Revenue Projections Amidst Decreased COVID-19 Solution Demand
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Pharmaceutical giant Pfizer Inc. (NYSE: PFE) has revised its projected 2023 revenues downward, reflecting a decrease in demand for COVID-19 solutions. The new revenue projection falls between USD 58.0 billion and 61.0 billion, a significant adjustment from the previously anticipated range of USD 67.0 billion to 70.0 billion as reported…
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FDA Approves Pfizer’s Braftovi + Mektovi Combo for BRAF V600E Metastatic NSCLC
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The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) regulatory approval for the combination therapy of Braftovi (encorafenib) and Mektovi (binimetinib) for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. This decision is supported by interim results from an ongoing Phase…
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CDC Provisionally Recommends Pfizer’s Abrysvo for Maternal Immunization Against RSV
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The US Centers for Disease Control and Prevention (CDC) has issued a provisional recommendation for the use of Pfizer’s (NYSE: PFE) bivalent respiratory syncytial virus (RSV) vaccine, Abrysvo, as a seasonal maternal immunization strategy. This measure aims to prevent RSV lower respiratory tract infection in infants, a significant cause of…
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Pfizer’s Cibinqo and Everest Medicines’ Cefepime-Taniborbactam Selected for Priority Reviews by CDE
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The Center for Drug Evaluation (CDE) has indicated on its website that Pfizer’s (NYSE: PFE) Cibinqo (abrocitinib) and Everest Medicines’ (HKG: 1952) cefepime-taniborbactam are slated for priority reviews. These drugs target specific patient populations: teenage patients aged 12 years and above with refractory, moderate to severe atopic dermatitis (AD) who…
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Pfizer’s Litfulo Earns EU Approval as First Treatment for Severe Alopecia Areata in Teens
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Pfizer (NYSE: PFE) has been granted registration authorization by the European Commission (EC) for Litfulo (ritlecitinib), a JAK3/TEC inhibitor, for the treatment of severe alopecia areata in adults and adolescents. This once-daily drug is the first to be approved in the region for this autoimmune disease, including teenage patients. The…
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FDA Extends Pfizer’s Comirnaty Vaccine Indication for Omicron XBB.1.5 Variant
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The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) an indication extension for its SARS-CoV-2 Omicron XBB.1.5 single-dose monovalent vaccine, Comirnaty. The vaccine is now approved for individuals aged 12 years and older, in addition to receiving an emergency use authorization (EUA) for children between 6 months…
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Pfizer and Valneva’s Lyme Disease Vaccine VLA15 Shows Promise as Booster in Pediatric Trials
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Partners Pfizer (NYSE: PFE) and Valneva SE (NASDAQ: VALN) have revealed that their Lyme disease vaccine candidate, VLA15, has demonstrated immunogenicity and safety as a booster shot in individuals aged between 5 and 17 years. The primary scheme resulted in seroconversion rates of 94.6% to 95.3% for all serotypes of…
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Seagen and Genmab Announce Positive Phase III Results for Tivdak in Cervical Cancer
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), and its partner Genmab (NASDAQ: GMAB), have announced the achievement of the primary endpoint in a Phase III trial for their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). The trial focuses on patients with recurrent or metastatic…
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Pfizer and BioNTech Receive Positive CHMP Opinion for Comirnaty Vaccine
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the Omicron XBB.1.5-adapted monovalent version of the SARS-CoV-2 vaccine Comirnaty, developed in partnership by Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX). The vaccine is intended for use in children…
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Pfizer’s RSV Vaccine Abrysvo Receives European Commission Approval for Maternal Immunization
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Pfizer (NYSE: PFE) has received registration approval from the European Commission (EC) for its respiratory syncytial virus (RSV) vaccine, Abrysvo. The vaccine is approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in infants from birth through 6 months of age following maternal immunization during pregnancy,…
