pharmaphorum

DECEMBER 16, 2022

Ben Hargreaves discovers why some have referred to the distribution of COVID-19 vaccines and treatments as a form of apartheid. There are already rules that dictate how countries should react against public health events that have the potential to traverse country borders, through the International Health Regulations.

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pharmaphorum

DECEMBER 2, 2020

Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it. Distribution will be prioritised – the Joint Committee on Vaccine and Immunisation has already set out priority groups who will receive the vaccine.

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BioPharma Reporter

JUNE 14, 2021

Ocugen will pursue submission of a biologics license application (BLA) in the US for the COVID-19 vaccine candidate, COVAXIN, rather than a EUA application. The company believes that the differentiated vaccine has the potential to address variants, as well as planning to undertake paediatric and booster trials.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.

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Pharma in Brief

APRIL 13, 2021

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Drug establishment licensing.

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pharmaphorum

DECEMBER 8, 2022

Novavax’s COVID-19 vaccine now in hand and licensed around the globe, Trizzino discussed the need to nurture its EU relationships and investments during the company’s current commercialisation drive. The conversation concludes on how tangible innovation and data speaks for itself.

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pharmaphorum

FEBRUARY 19, 2021

billion doses of its COVID-19 vaccine to the COVAX global initiative led by Gavi, the vaccine alliance, which aims to ensure fair access across the globe. There are growing concerns about the lack of COVID vaccines available to poorer countries. Novavax has signed a deal to provide 1.1

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pharmaphorum

SEPTEMBER 8, 2022

On the strength of phase 2 data, the FDA has awarded coveted breakthrough status to Pfizer’s vaccine against Group B Streptococcus (GBS), given to expectant mothers to prevent invasive infections in newborns and young infants. The post FDA gives Pfizer’s Group B strep vaccine breakthrough status appeared first on.

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BioPharma Reporter

NOVEMBER 23, 2021

Vaccibody, a Norway-based pioneer in the neoantigen cancer vaccine space, has changed its name to Nykode Therapeutics, and has entered into a license and collaboration agreement with US company, Regeneron, to develop vaccines against cancer and infectious diseases.

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BioPharma Reporter

JUNE 1, 2021

Moderna has initiated the rolling submission process with the US Food and Drug Administration (FDA) for a Biologics License Application (BLA) to distribute and market its mRNA COVID-19 vaccine in the US for use in individuals aged 18 and older.

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The Pharma Data

MARCH 14, 2021

Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Safety is of paramount importance and the Company is continually monitoring the safety of its vaccine. COVID-19 Vaccine AstraZeneca , formerly AZD1222.

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FDA Law Blog

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

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Pfizer

JANUARY 27, 2023

telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply: Sufficient information is not available to assess renal and hepatic function.

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pharmaphorum

NOVEMBER 24, 2021

The pandemic has propelled issues for the pharmaceutical industry to the top of the political and public agenda, from clinical trial recruitment to the journey required for medicines or vaccines to reach patients. Getting the UK’s COVID vaccine and treatments programme ahead of schedule. Creating the conditions for the MHRA to thrive.

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XTalks

APRIL 2, 2021

Pfizer released new COVID-19 vaccine trial results this week from its ongoing clinical studies, which include data showing that its COVID-19 mRNA vaccine is 100 percent effective in children between the ages of 12 and 15 and has a 91 percent efficacy against variants with protection lasting at least six months.

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Pharma in Brief

JANUARY 19, 2023

Health Canada has launched a consultation on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations (the Regulatory Amendments ). Consultation on the Regulatory Amendments, which have been published in the Canada Gazette, Part 1 , is open until March 27, 2023. We previously reported on the IO here.

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BioPharma Reporter

SEPTEMBER 21, 2022

The two entities have signed a non-exclusive licensing agreement.

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pharmaphorum

DECEMBER 21, 2020

Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge.

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Pharma in Brief

JANUARY 10, 2024

However, many details remain to be addressed in forthcoming regulations. CIPO consulted on proposed features of the regulations in 2023 (see here ), including many factors that would reduce the length of the PTA term. Draft regulations are expected to be released for consultation in 2024. The Guidance was last updated in 2005.

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pharmaphorum

MARCH 19, 2021

The chip is loaded with binding agents produced by Avacta and Aptamer that detect Spike proteins found on the surface of the virus, which are also the targets for many of the vaccines available and under development. It has licensed in a patented breathalyser, the analysts noted.

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pharmaphorum

JUNE 2, 2021

Capacity to supply Moderna’s COVID-19 vaccine in Europe could be swelled by round 300 million doses a year, following an agreement to set up a new production line at contract manufacturer Lonza. US marketing application. Pfizer and BioNTech filed for FDA approval of their COVID-19 vaccine on 7 May. WHO backs Sinovac shot.

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The Pharma Data

OCTOBER 19, 2020

.–( BUSINESS WIRE )– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from two additional Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. among adults 65 years of age or older.

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Drug Channels

FEBRUARY 22, 2022

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Click to Enlarge]. d/b/a Drug Channels Institute.

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The Pharma Data

SEPTEMBER 9, 2020

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. The proposed supply agreement with the European Commission would represent the largest initial order of vaccine doses for Pfizer and BioNTech to date. billion doses by the end of 2021.

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pharmaphorum

JULY 5, 2021

Parexel has been a champion of the concept for years, but while adoption was fairly slow pre-COVID, it has accelerated at a fast pace since the crisis, aided by the increasing willingness of regulators to accept decentralised trial data in marketing applications.

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The Pharma Data

MAY 13, 2021

CDC Advisers Endorse Pfizer Vaccine for Children Ages 12 to 15 ( NYTimes ) ( Reuters ) ( STAT ). US CDC finds more clotting cases after J&J vaccine, sees causal link ( Reuters ) ( NBC ) ( NYTimes ). Covid vaccines may not protect people with immune disorders. In Focus: US.

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pharmaphorum

MARCH 29, 2021

The EU’s medicines regulator is also reviewing COVID-19 antibodies from AstraZeneca , GlaxoSmithKline/Vir Biotechnology, and Brii Biosciences. 1.351), which is causing concern as there is evidence current vaccines are less effective in protecting against it. New drugs recommended.

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Drug Discovery World

MAY 6, 2024

During the period 2016-2021, the Brazilian, Chinese and Indian markets grew by 11.7%, 6.7% respectively compared to an average market growth of 5.8% for the top five European Union markets and 5.6% for the US market 2. However, Europe is facing increasing competition from emerging economies.

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Drug Discovery World

JANUARY 2, 2024

More significantly, she says, with the boost from what we have learned from Covid, cancer vaccines will become a reality. She believes we might start to see a combination of vaccines with other immunotherapies or classical therapies out there, and that this will become more and more prevalent because of the nature of cancer.

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Pharmaceutical Technology

JANUARY 19, 2023

The Korean Ministry of Food and Drug Safety (KMFDS) has granted expanded approval to Novavax partner SK bioscience for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use as a booster dose in adults aged 18 and above. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.

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pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. Digital technologies can cover a broad range of applications, and include mobile health (mHealth) tools (e.g.

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XTalks

DECEMBER 29, 2022

This highlights potentially new marketing trends that life science companies may have to start looking into if they haven’t already. In 2022 alone, the US regulator approved four new gene therapies, showing the high interest in getting these therapies to market. 4. Social Media Marketing.

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pharmaphorum

OCTOBER 28, 2020

Once a drug is licensed and launched, however, there is a deafening silence. Some of these issues fall out of well-intentioned codes and regulations to protect patients, but this can no longer be cited as an excuse for pharma’s continuing lack of engagement with its ultimate end users. The way back. From bad medicine to good.

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pharmaphorum

APRIL 16, 2021

The launch environment was directly impacted by the COVID-19 pandemic, which hit two key drivers of launch uptake particularly hard: the dynamic market, i.e. new and switch prescriptions, and face-to-face interactive engagement with healthcare professionals. We measured the pandemic impact on the launch of NAS at four levels.

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XTalks

FEBRUARY 8, 2021

They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed. What is a Biosimilar? What is an Interchangeable Biological Product?

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The Pharma Data

SEPTEMBER 8, 2020

Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

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