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UK medicines regulator gives approval for first UK COVID-19 vaccine

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Development
02 December 2020
The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).

The decision by the UK regulatory authority was made with advice from the Commission on Human Medicines (CHM), the government's independent expert scientific advisory body.

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European Commission approves contract with Moderna to ensure access to a potential vaccine

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Development
25 November 2020
European CommissionToday, the European Commission approved a sixth contract under the EU Vaccines Strategy, this time with the pharmaceutical company Moderna. The contract provides for the initial purchase of 80 million doses on behalf of all EU Member States, plus an option to request up to a further 80 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19.
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European Commission approves contract with CureVac to ensure access to a potential vaccine

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Development
17 November 2020
European CommissionToday, the European Commission approved a fifth contract with the European pharmaceutical company CureVac, which provides for the initial purchase of 225 million doses on behalf of all EU Member States, plus an option to request up to a further 180 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19.
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European Commission approves contract with BioNTech-Pfizer alliance

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Development
11 November 2020
European CommissionToday, the European Commission approved a fourth contract with pharmaceutical companies BioNTech and Pfizer, which provides for the initial purchase of 200 million doses on behalf of all EU Member States, plus an option to request up to a further 100 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19.
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Work to develop a COVID-19 vaccine is faster than ever

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Development
21 October 2020
While the Americas urgently awaits a breakthrough, the Pan American Health Organization (PAHO) will only support the distribution of a vaccine that has proven to be safe and effective in clinical trials, reviewed by National Regulatory Authorities and recommended by the World Health Organization (WHO), PAHO Director Carissa F Etienne, said today.
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A vaccine project funded by the Federal Ministry for Economic Affairs and Energy develops a second generation COVID-19 vaccine

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Development
20 October 2020
A vaccine project funded by the EXIST programme initiated by the Federal Ministry for Economic Affairs and Energy (Germany) is developing a second generation Covid-19 vaccine. The "Prime Vector Technologies - PVT" start-up from Tübingen is engaged in a successful demonstration of Germany's scientific capabilities. This new generation of vaccines directly addresses the most common SARS-CoV-2 variants.
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NIH begins large clinical trial to test immune modulators for treatment of COVID-19

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Development
19 October 2020
The National Institutes of Health has launched an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19. Some COVID-19 patients experience an immune response in which the immune system unleashes excessive amounts of proteins that trigger inflammation - called a "cytokine storm" - that can lead to acute respiratory distress syndrome, multiple organ failure and other life-threatening complications.
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More Pharma News ...

  1. World Bank approves $12 billion for COVID-19 vaccines
  2. New clinical trial for a COVID-19 vaccine authorised in Germany
  3. Boost for global response to COVID-19 as economies worldwide formally sign up to COVAX facility
  4. 73,000 Scientists collaborate over new COVID-19 Data Portal to speed up vaccine development
  5. Oxford COVID-19 vaccine programme opens for clinical trial recruitment
  6. NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options
  7. New guidelines on caring for ICU patients with COVID-19
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Business & Industry

  • Novartis shares Zolgensma long-term data demonstrating sustained durability up to 7.5 years post-dosing; 100% achievement of all assessed milestones in children treated prior to SMA symptom onset
  • CPHI Pharma Awards open to global innovators, scientists, entrepreneurs and social leaders
  • Insilico Medicine brings AI-powered "ChatPandaGPT" to its target discovery platform
  • BlueRock Therapeutics to incorporate wearable and invisible contactless digital health technologies from Rune Labs and Emerald Innovations in Parkinson's disease clinical trial
  • Novartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma

Research & Development

  • Candidate found to inhibit malignant melanoma growth
  • A nasal spray protects against coronavirus infection - Effective also against recent immune-evasive variants
  • 'Biohybrid' device could restore function in paralysed limbs
  • Scientists use tardigrade proteins for human health breakthrough
  • DNA treatment could delay paralysis that strikes nearly all patients with ALS
  • Scientists reveal a potential new approach to treating liver cancer
  • Normalizing tumor blood vessels may improve immunotherapy against brain cancer

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 approves first over-the-counter naloxone nasal spray
  • 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
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