BioPharma Reporter

FEBRUARY 9, 2021

Health officials in Azerbaijan have granted approval for a clinical trial to take place in that country combining Russiaâs Sputnik V vaccine with the Oxford-AstraZeneca COVID-19 shot in adults 18 years and older.

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Pharmaceutical Technology

JUNE 20, 2023

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator.

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Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Hence, there is a need to increase clinical investigations in this promising area.”

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pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

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BioSpace

DECEMBER 8, 2020

AstraZeneca and the University of Oxford published an interim analysis of their four Phase III clinical trials of AZD1222, their COVID-19 vaccine.

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The Pharma Data

MAY 7, 2021

World regulatory authorities are calling for increased transparency from the pharmaceutical industry in how they report and give access to clinical trial data. Only personally identifying information and individual patient data should be redacted from publicly available clinical trial data, wrote WHO and ICMRA. . “In

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pharmaphorum

JANUARY 6, 2023

The UK has formed an partnership with German biotech BioNTech to provide up to 10,000 patients with access to personalised cancer therapies, in another example of the country embracing the mRNA technologies that underpinned COVID-19 vaccines. The post UK partners with BioNTech on clinical trials of mRNA cancer therapies appeared first on.

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ACRP blog

MARCH 23, 2023

Generating evidence by integrating research into patient care Clinical trials are increasingly using longitudinal evidence generation, where repeated measurements are taken over time from the same set of patients. This is leading to changes in expectations of how research sites carry out trials.

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BioPharma Reporter

FEBRUARY 14, 2023

Australiaâs Vaxxas has initiated a Phase I clinical trial with the first needle-free inactivated seasonal influenza vaccine quadrivalent (IIV4) candidate.

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Pharma Mirror

OCTOBER 22, 2021

ADELAIDE, AUS, Oct 19, 2021 – (ACN Newswire) – Agilex Biolabs, the Australian regulated bioanalytical and toxicology laboratory facilities for clinical trials is presenting a new webinar entitled “Getting it right! Agilex Biolabs’ Director, Immunoassay, Kurt J. Sales (B.Sc; B.Sc (MED) Hons; M.Sc, Ph.D,

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STAT News

NOVEMBER 15, 2022

As the Covid-19 pandemic spread across the world two years ago, one of India’s leading biotech companies was racing to develop a vaccine with crucial backing from the Indian government.

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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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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 11, 2023

The Central Drugs Standard Control Organisation (CDSCO) has declared a batch of Typbar, the typhoid polysaccharide vaccine from Bharat Biotech International Ltd as not of standard quality (NSQ).

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pharmaphorum

MAY 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

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Pharmaceutical Technology

NOVEMBER 9, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 Based on all data available on the original Pfizer/BioNTech Covid-19 vaccine and its adapted vaccines, the MHRA granted the approval.

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pharmaphorum

MARCH 5, 2021

For International Women’s Day, Medidata’s global compliance and strategy lead Fiona Maini discusses the importance of increasing female participation in clinical trials and how technology may solve some of the barriers. Levelling the field through technology.

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XTalks

MAY 28, 2024

In a move signaling a major shift in influenza prevention strategies, CSL Seqirus, a global leader in flu vaccines, has transitioned from quadrivalent to trivalent formulations for the upcoming 2024/25 flu season in the US.

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BioPharma Reporter

APRIL 28, 2021

As COVID-19 response initiatives and vaccine rollouts begin to bring the pandemic under control, we consider what changes to clinical trials will be made permanent.

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BioPharma Reporter

SEPTEMBER 14, 2020

AstraZeneca has resumed UK clinical trials for its Oxford coronavirus vaccine, having paused all trials last week for a safety review. Other late-stage global trials, however, remain on hold while AstraZeneca waits for regulators in each market.

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Drug Discovery World

APRIL 14, 2023

Clinical trials are, undoubtedly, an essential part of the drug development process, providing us with valuable information about the safety and efficacy of new treatments and therapies. of participants 2 Covid-19 vaccination trials. In fact, these demographics which make up 13.8%

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XTalks

SEPTEMBER 5, 2023

Vaccines have been an integral piece of the global public health toolbox for over 200 years, but the COVID-19 pandemic brought about a new era in vaccine development with renewed interest in mRNA technology and unprecedented accelerated regulatory approvals. What are the major challenges you’re facing right now in vaccine development?

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The Pharma Data

JANUARY 29, 2021

EU Regulator Approves Oxford-AstraZeneca COVID-19 Vaccine. 29, 2021 — European Union regulators have authorized the AstraZeneca COVID-19 vaccine for use in adults, CBS News reported Friday. The move comes after the European Medicines Agency has been criticized for not moving fast enough to vaccinate its population.

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pharmaphorum

AUGUST 16, 2021

Over the past two years, the pharma industry’s demand for automated research solutions has increased significantly and, particularly when it comes to clinical trial design, the need has never been greater. COVID-19 has demonstrated that trials can be run much more efficiently, to everyone’s benefit. Compliance is key.

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XTalks

MAY 20, 2021

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. Amid the alarmist headlines posted by other media outlets, Xtalks has remained balanced in its reporting of COVID-19 clinical trial results and safety data.

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Rethinking Clinical Trials

FEBRUARY 7, 2024

Food and Drug Administration (FDA) Commissioner Robert Califf asked the Reagan-Udall Foundation to conduct research and consult with experts to better understand how consumers find, consume, and perceive health information, especially regarding FDA-regulated products. Winckler, RPh, Esq) appeared first on Rethinking Clinical Trials.

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STAT News

JANUARY 19, 2023

In their own statement, the companies acknowledged that they were aware of limited reports of ischemic strokes in people 65 and older following vaccination with their updated booster. Continue to STAT+ to read the full story…

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The Pharma Data

SEPTEMBER 22, 2020

Clinical trials testing Russia’s Sputnik-V coronavirus vaccine in India could begin in the next few weeks, according to Indian pharma firm Dr Reddy’s Laboratories Ltd. . The trials are part of a deal by Dr Reddy’s and the Russian Direct Investment Fund (RDIF). Photo by NIAID.

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pharmaphorum

JUNE 11, 2021

The development of vaccines for COVID-19 has been a masterclass in effective collaboration and applied digitisation in healthcare. Abel Archundia discusses how COVID-19 has highlighted the importance of securing clinical trials against cyber threats. billion doses were administered to people worldwide.

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pharmaphorum

DECEMBER 9, 2020

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. of participants. of participants.

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BioPharma Reporter

SEPTEMBER 22, 2020

AstraZeneca paused its COVID-19 vaccine trial earlier this month for a safety review â generating headlines across mainstream press worldwide. Such pauses are not uncommon in clinical trials â so whatâs the best way to deal with them?

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Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.

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Drug Discovery World

AUGUST 3, 2023

It becomes the ninth Covid-19 vaccine to be authorised by the UK’s independent medicines regulator. The vaccine demonstrated a strong immune response, and the most common side effects were mild, and self-resolved within a few days of vaccination. It is approved as a booster injection for those aged 16 years and over.

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pharmaphorum

DECEMBER 4, 2020

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses.

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pharmaphorum

MAY 20, 2022

Last year, the company added clinical trials to the list with the launch of CVS Health Clinical Trial Services , an initiative that works with pharma companies on clinical trial recruitment and even hosts trial sites at certain retail locations. This interview has been edited for length and clarity.

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pharmaphorum

NOVEMBER 4, 2020

It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. There are many reasons as to why so few eligible patients are being recruited into clinical trials even though infection numbers are high.

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pharmaphorum

DECEMBER 9, 2021

Instead, Britain needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured” it recommends. “As The same principle applies to regulation,” she went on.

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World of DTC Marketing

SEPTEMBER 11, 2020

IN SHORT: Pharma companies have finally banded together to ask the FDA to better regulate any new drug approvals including a possible new COVID vaccine. And only about 4 in 10 would get the vaccine, even if it were free if the FDA approved it before the election. Big pharma is clearly worried. Transparency vs. the Media.

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