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Eisai and Biogen announced the results from large global Phase 3 confirmatory Clarity AD clinical study of lecanemab

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Business
30 November 2022
EisaiEisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced that the results from Eisai's large global Phase 3 confirmatory Clarity AD clinical study of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain,
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Salvat Laboratories announces submission of New Drug Application to the U.S. FDA for Clobetasol Nanoemulsion for treating inflammation and pain after ocular surgery

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Business
02 November 2022
Salvat LaboratoriesSalvat Laboratories announced that it has submitted a New Drug Application (NDA) to the FDA for the approval of the first ocular corticosteroid formulated in a nanoemulsion for inflammation and pain in post-ocular surgery patients.

This submission comes after two successful phase III clinical trials conducted between 2020 and 2021.

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Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster in European Union

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15 September 2022
BioNTechPfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals ages 12 years and older.
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BioNTech's statement on patent infringement lawsuit filed by Moderna

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29 August 2022
BioNTechBioNTech SE (Nasdaq: BNTX, "BioNTech") published an official statment: "BioNTech is aware of reports that Moderna has sued Pfizer and BioNTech, alleging that COMIRNATY® infringes certain Moderna patents. BioNTech's work is original, and we will vigorously defend against all allegations of patent infringement.
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Moderna sues Pfizer and BioNTech for infringing patents central to Modernas innovative mRNA technology platform

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Business
26 August 2022
Moderna, Inc.Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today is filing patent infringement lawsuits against Pfizer and BioNTech in the United States District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany.
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Positive Phase 1 data from mRNA-based individualized neoantigen specific immunotherapy in patients with resected pancreatic cancer

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Business
09 June 2022
BioNTechBioNTech SE (Nasdaq: BNTX, "BioNTech") announced initial data from an ongoing investigator-initiated first-in-human Phase 1 study evaluating the safety and tolerability of the mRNA-based individualized neoantigen specific immunotherapy (iNeST) autogene cevumeran (also known as BNT122, RO7198457) in combination with anti-PD-L1 immune checkpoint inhibitor atezolizumab and chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC).
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Nearly 700,000 US hospitalizations and 110,000 deaths prevented from the Pfizer-BioNTech COVID-19 vaccine

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Business
16 May 2022
The profound health and economic impact of the Pfizer-BioNTech vaccine during its first year of rollout in the US is described in detail in a new study in the peer-reviewed Journal of Medical Economics.

It is estimated that in 2021 the vaccine, the most widely used against COVID-19 in the US, prevented 8.7 million symptomatic cases of the virus, as well as 690,000 hospitalizations and more than 110,000 deaths.

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More Pharma News ...

  1. Pfizer and BioNTech provide update on COVID-19 vaccine supply agreement with European Commission
  2. Pfizer and BioNTech receive expanded U.S. emergency use authorization for an additional COVID-19 vaccine booster in individuals aged 50 years and older
  3. Statement on humanitarian aid in Ukraine
  4. BioNTech and Medigene announce global collaboration to advance T cell receptor immunotherapies against cancer
  5. BioNTech introduces first modular mRNA manufacturing facility to promote scalable vaccine production in Africa
  6. Pfizer and BioNTech sign new global collaboration agreement to develop first mRNA-based shingles vaccine
  7. Leiden University Medical Center and Intravacc to start clinical trial with new intranasal corona vaccine
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Tahmeena

Business & Industry

  • AMJEVITA™ (adalimumab-atto), first biosimilar to Humira® now available in the United States
  • CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer
  • Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above
  • Pfizer expands 'An Accord for a Healthier World' product offering to include full portfolio for greater benefit to 1.2 billion people in 45 lower-income countries
  • Acquisition of Neogene Therapeutics completed

Research & Development

  • Antidepressants used for chronic pain on the rise, but are they effective?
  • Keys to making immunotherapy work against pancreatic cancer found in tumor microenvironment
  • Discovery of anti-cancer chemistry makes skullcap fit for modern medicine
  • Coordination of COVID-19 vaccine clinical trials produces a 'treasure trove' of data and a model for the future
  • Power of cancer drugs may see boost by targeting newly ID'd pathway
  • A soybean protein blocks LDL cholesterol production, reducing risks of metabolic diseases
  • 500,000 missed out on blood pressure lowering drugs during pandemic

Conferences & Events

  • SAE Media Group proudly presents the 4th Annual AI in Drug Discovery Conference
  • SAE Media Group's 6th annual 3D Cell Culture Conference
  • CPHI Frankfurt returns to pre-pandemic strength as pharma industry booms again
  • 14th Annual RNA Therapeutics: Investigating the next generation of genetic medicine through RNA based therapies
  • CPHI Excellence in Pharma Award Winners 2022
  • CPHI Frankfurt Report predicts huge funding overhang to drive contract services growth
  • CPHI Frankfurt 2022: Global pharma confidence hits record high in the annual CPHI Pharma Index

Regulatory Affairs

  • FDA grants Accelerated Approval for Alzheimer's disease treatment
  • FDA approves new HIV drug for adults with limited treatment options
  • FDA approves first gene therapy for the treatment of high-risk, non-muscle-invasive bladder cancer
  • FDA approves first gene therapy to treat adults with Hemophilia B
  • FDA approves first treatment for Acid Sphingomyelinase Deficiency, a rare genetic disease
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