pharmaphorum

JUNE 6, 2022

With vaccine hesitancy leading to a rise in measles cases, the FDA’s approval of GlaxoSmithKline’s venerable vaccine Priorix for sale in the US looks timely. The post FDA clears GSK’s Priorix, first new MMR vaccine in 50 years appeared first on.

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pharmaphorum

SEPTEMBER 29, 2020

Inovio Pharma’s plan to start pivotal testing of its COVID-19 vaccine has been delayed by FDA requests for more information, sending its shares into a swift decline. Inovio’s vaccine takes the form of a DNA plasmid coding for the full length of the spike or ‘s’ glycoprotein antigen of SARS-CoV-2, the vaccine that causes COVID-19.

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European Pharmaceutical Review

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Valneva SE’s IXCHIQ ® , the first chikungunya vaccine to be authorised in the world. The single-dose, live-attenuated vaccine is indicated for preventing chikungunya virus disease in individuals over 18 years old who are at increased risk of contracting the virus.

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Pharmaceutical Technology

MAY 30, 2023

Valneva has submitted a regulatory application to Health Canada, seeking marketing approval for its chikungunya vaccine candidate, VLA1553. The vaccine is designed to be administered as a single shot and is intended for individuals aged 18 years and older. Valneva plans to make further regulatory submissions.

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pharmaphorum

MARCH 3, 2022

Pfizer has been awarded breakthrough status from the FDA for its respiratory syncytial virus (RSV) vaccine in pregnant women, putting the company in pole position to bring a shot to market that will protect infants from the life-threatening infection. AZ, Sanofi antibody aces phase 3 trial. Last year, sales were around $273 million.

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pharmaphorum

FEBRUARY 10, 2022

AstraZeneca confirmed today that it has discontinued clinical development of a follow-up to its COVID-19 vaccine Vaxzevria targeted at the Beta variant of the virus, which started development before the emergence of the Delta and Omicron strains. The post AZ halts development of Beta variant COVID-19 vaccine appeared first on.

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pharmaphorum

DECEMBER 23, 2020

It has been a year dominated by the pandemic and many life sciences research projects were put on hold as big pharma turned its attention to vaccines and therapies. The FDA has gone on to grant a fast review of the results ahead of a regulatory decision on the new lung cancer indication next year. months, compared with 6.7

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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. Pfizer and BioNTech have an agreement to supply the UK with 40 million doses of the vaccine, which is called BNT162b2 and was shown to be 95% effective in a phase 3 trial.

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European Pharmaceutical Review

MAY 4, 2023

For the first time, a respiratory syncytial virus (RSV) vaccine for older adults has been granted regulatory approval. While it is now approved in the US, it is the first RSV vaccine to be given a marketing authorisation anywhere in the world. Adjuvanted vaccine Arexvy has been approved by the US Food and Drug Administration (FDA).

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pharmaphorum

NOVEMBER 9, 2020

As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering the disease in an interim analysis. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

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pharmaphorum

OCTOBER 26, 2020

Moderna is close to completing its phase 3 trial of COVID-19 vaccine candidate mRNA-1273 after completing recruitment of the 30,000 subjects in the trial. Moderna shared demographic data from the study at an FDA committee meeting today which showed that it included some of the groups most at risk from COVID-19.

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pharmaphorum

SEPTEMBER 8, 2020

billion USD will be spent in cancer care worldwide this year (2020), compared to 13.8 When the day hopefully comes where a vaccine is widely available, we will be relieved of the great stress and uncertainty of this time. ‘IMF slashes economic outlook and warns of public debt burden’. Published on 24 June 2020. Touch Oncology.

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pharmaphorum

JANUARY 8, 2021

The UK has approved the Moderna coronavirus vaccine, hard on the heels of its go-ahead in Europe, although supplies are not expected to arrive for several weeks. The UK government has ordered 17 million doses of the new vaccine, but none will be available before March, when Moderna is able to bring new production capacity online.

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pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford-AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

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pharmaphorum

JANUARY 8, 2021

As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses. When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

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pharmaphorum

JANUARY 12, 2022

At the same time, personalised mRNA vaccines and CAR-T treatments are promising to revolutionise the oncology landscape. Yet when the EFPIA compared the timelines of six regulatory agencies between 2011 and 2020, it found the European Medicines Agency (EMA) “lagged behind”.

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PharmaShots

MAY 23, 2023

Stock Exchange: TYO With focus areas extending to the discovery and development of biopharma products, AnGes is dedicated to developing genetic medicines and therapeutic vaccines for intractable or rare diseases. Approved Cell and Gene Therapy: Collategene Founded Year: 1999 Total Employees: ~140 Headquarters: Osaka, Japan Market Cap: $162.8M

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pharmaphorum

APRIL 16, 2021

IQVIA’s Sarah Rickwood reviews the launch of innovative medicines in 2020 and outlines three key pillars of activity for companies to focus on and address in 2021. It is undeniable that 2020 was a particularly challenging year to launch non-COVID innovative prescription medicines.

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pharmaphorum

MAY 13, 2022

Way back in January 2020, Pfizer’s 2019 annual report could only note the potential disruption from a novel strain of coronavirus. In March 2020 Pfizer began collaborating with BioNTech on a vaccine for COVID-19 and 269 days later it received emergency use authorisation from the FDA.

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ISPE

AUGUST 29, 2022

In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. The European Medicines Agency (EMA) issued its implementation guidance in March 2020. Journal of Pharmaceutical Sciences 109 (2020):1427–1438. doi:10.1016/j.xphs.2021.09.046.

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pharmaphorum

FEBRUARY 19, 2021

A global emergency stockpile of Ebola vaccine is being deployed to curb the epidemic, although experts are confident that synergies in public health practises will ensure a rapid response to both. The injectable single-dose Ebola vaccine is manufactured by MSD, known as Merck & Co in the US and Canada.

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ISPE

FEBRUARY 17, 2023

Peter Marks, MD, PhD Director, Center for Biologics Evaluation and Research CBER/FDA Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, US FDA, presented on “The Importance of Manufacturing in Cell and Gene Therapy Development” in an afternoon keynote on 1 February.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Following AstraZeneca’s success in vaccine development during the Covid-19 pandemic , the pharmaceutical giant is now looking to expand its scope through acquisitions across a range of indications, says CEO Pascal Soriot. “We In 2020, AstraZeneca acquired Dogma Therapeutics’ preclinical oral PCSK9 inhibitor program.

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pharmaphorum

FEBRUARY 23, 2022

The global health crisis caused spending on healthcare to increase , due to the funding provided to the development and purchases of vaccines and treatments, as well as support provided for the associated infrastructure. In 2020, AMA’s research showed that savings from the use of biosimilars tripled from 2019. billion in 2020.

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pharmaphorum

AUGUST 31, 2022

FDA backing. Earlier this year, bluebird bio received the support of the FDA’s advisory committee for approval in a vote, which emerged 15 to 0 in favour of approval. The update from the FDA targets the public and aims to educate them on how gene therapies function and addressed concerns over potential safety issues.

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European Pharmaceutical Review

JANUARY 29, 2024

During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance. 3 Differences include that potency category 1 in FDA’s CPCA approach is 26.5 FDA has also published the AIs of some 265 NDSRIs. ng/day, compared to EMA which is 18 ng/day.

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pharmaphorum

JUNE 22, 2022

The US FDA plays a key role in ensuring the quality of drugs that are being manufactured and brought into the country, a task that became fundamentally more difficult alongside the pandemic. By its own figures, the agency managed 61% of the planned inspections it had scheduled for 2020.

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The Checkup by Singlecare

JULY 8, 2024

The Food & Drug Administration (FDA) has approved Rinvoq to treat: Atopic dermatitis Rheumatoid arthritis Psoriatic arthritis Ulcerative colitis Crohn’s disease Ankylosing spondylitis Non-radiographic axial spondyloarthritis This article will unpack the benefits, dosage, side effects, and risks of Rinvoq for atopic dermatitis.

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The Checkup by Singlecare

APRIL 3, 2024

It may worsen the side effects of prednisone One study published in 2020 showed that consuming caffeine , especially in high amounts, can cause sleep disturbances and sleep disorders like insomnia, while another 2020 study indicated that caffeine may play a role in migraine headaches. These medications may interfere with prednisone.

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European Pharmaceutical Review

JUNE 27, 2023

Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines. Since these fresh FDA approvals for microbiome-based therapies, regulatory pathways are becoming clearer and opening new perspectives for companies.

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pharmaphorum

NOVEMBER 4, 2022

BioNTech and Pfizer have announced that they are initiating a phase 1 study to evaluate a single dose mRNA-based combination vaccine candidate against influenza and COVID-19 – a novel combination approach to help protect individuals against two severe respiratory viral diseases in one dose.

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pharmaphorum

SEPTEMBER 27, 2021

trillion by end of 2020. As the vaccines were developed and rolled out, the disparity in their take up among different sections of the community highlighted how excluded some minority communities felt from areas of healthcare. This already significant industry is growing – it is estimated to be worth $1.27

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Pharmaceutical Technology

MARCH 22, 2023

Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report. Among other things, supply chain optimisation, maintaining access to affordable vaccines, and supporting innovation for unmet clinical needs will be the discussion topics, she adds.

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The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target.

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Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. Increased reluctance to authorise innovative and unproven drugs for use, stemming from the FDA’s experience with Aduhelm, reduced the overall novel approvals in 2022. months longer on the treatment.

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ISPE

AUGUST 16, 2023

Food and Drug Administration (FDA). “By For example, for product and inspection types included under the MRA with the US, this resulted in a reduction of inspections conducted by EU authorities in the USA by 70%, as inspections conducted by the FDA could be relied on.

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Pharmaceutical Technology

NOVEMBER 22, 2022

China will continue to take steps towards becoming as competitive in high-value innovative pharma as it is in the generics industry, with The Wall Street Journal reporting Chinese biotechs raised $1.6tn through 568 venture financings last year, up from $11bn in 418 deals in 2020.

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