Pharmaceutical Technology

JUNE 23, 2022

4369) directs the FDA to spend $100m on creating continuous manufacturing centres within universities over the next four years. Larger CMOs have been increasingly adopting the use of continuous manufacturing for biologics production, following the first FDA approvals of biologics continuously manufactured dose products last year.

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European Pharmaceutical Review

MAY 11, 2023

The US Food and Drug Administration (FDA) has released a discussion paper to complement and inform future guidance on artificial intelligence (AI) and machine learning (ML) in drug development. According to the FDA, the organisation has seen “a rapid growth in the number of submissions that reference AI/ML” over the past few years.

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PharmaTech

DECEMBER 22, 2022

The Consolidated Appropriations Act for 2023 provides FDA with a $6.6 billion total budget.

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European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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Pharmaceutical Technology

OCTOBER 4, 2023

Strides earned market approval in the US as part of a larger government endeavor to address HIV worldwide.

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PharmaTech

SEPTEMBER 23, 2022

Legislative leaders are looking to approve a bare-bones measure to fund FDA operations as part of a short-term government funding bill.

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PharmExec

DECEMBER 22, 2022

The Consolidated Appropriations Act for 2023 includes dozens of measures involving drug development and regulation.

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Pharmaceutical Technology

MARCH 30, 2023

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research and the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) have launched the Lupus Research Alliance (LRA) in a bid to advance research for the condition.

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Pharmaceutical Technology

APRIL 11, 2023

The US Food and Drug Administration (FDA) has granted final approval to India-based Zydus Lifesciences ‘ 500mg azithromycin tablets for the treatment of bacterial infections. The company began supplying the first consignment to the government of India in February 2022.

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World of DTC Marketing

JANUARY 8, 2021

At the time, pharmaceutical giant Pfizer and its partner BioNTech—which now have the other US-authorized COVID-19 vaccine—had inked a deal with the US government to supply doses at $19.50 Also, Johnson & Johnson had a deal to supply the US government with doses of its vaccine—still in the works—at a rate of $10 per dose.

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Pharmaceutical Technology

SEPTEMBER 13, 2022

On 1 September, the US Food and Drug Administration (FDA) approved both Pfizer/BioNTech and Moderna's Omicron-specific Covid-19 vaccine boosters. This followed news that Moderna had signed a contract with the US Government to supply 66 million doses, while Pfizer and BioNTech have a contract with the US Government to supply 105 million doses.

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pharmaphorum

JANUARY 11, 2023

The filing with the European Medicines Agency (EMA) is based on the results of the phase 2b Study 201 – which supported the approval of lecanemab as Leqembi by the FDA under its accelerated pathway – as well as data from the ongoing phase 3 CLARITY-AD study. The post After FDA nod, Eisai and Biogen file lecanemab in EU appeared first on.

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pharmaphorum

AUGUST 31, 2022

As expected, the FDA has moved quickly to grant emergency use authorisation (EUA) to two new-generation COVID-19 mRNA vaccines from Pfizer/BioNTech and Moderna, both targeting the new Omicron subvariants BA.5 The FDA said in a statement that the BA.4 The post FDA clears bivalent Omicron shots from Pfizer, Moderna appeared first on.

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PharmExec

JANUARY 11, 2023

The parameters governing pharma promotional speech in digital and social media have struggled to keep pace with the rapidly evolving healthcare communications landscape. How can FDA play catch-up in advancing an agenda more reflective of industry and patient needs?

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European Pharmaceutical Review

MARCH 12, 2024

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. There is growing awareness of the importance of implementing robust data governance frameworks and compliance programmes to ensure the integrity of data.

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PharmaTech

OCTOBER 2, 2023

Government provides a spoonful of sugar, and genuine leadership, for good medicines.

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Pharmaceutical Technology

FEBRUARY 14, 2023

It will also support smaller dose vials development, selection of strain as per the US Food and Drug Administration (FDA) recommendations, and transition to the commercial market. The US FDA granted emergency use authorization to the vaccine for use in adults aged 18 and above and in adolescents aged 12 to 17 as a primary series.

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pharmaphorum

JUNE 22, 2022

The reason the US government is worried about the supply of pharmaceuticals is immediately clear, a problem securing access to antibiotics, for example, would be a major public health issue. In particular, China is the second largest exporter of drugs and biologics to the US and the largest for medical devices. Security of supply.

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Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments. billion in funding, a $226 million increase on the previous year.

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World of DTC Marketing

APRIL 19, 2021

A real conspiracy actually exists, and it is usually uncovered by journalists, whistleblowers, document dumps from a corporation or government, or it’s discovered by a government agency. . They have been tested per the FDA, and to die, those who have been vaccinated have less than a.008% That also is a huge falsehood.

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pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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Pharmaceutical Technology

SEPTEMBER 23, 2022

The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. In 2018, the FDA had granted Pedmark a breakthrough orphan drug designation.

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European Pharmaceutical Review

DECEMBER 21, 2022

The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines. Under normal circumstances, GMPs govern that the end product should be devoid or contain a very limited number of microorganism(s).

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World of DTC Marketing

JULY 22, 2020

QUICK READ : The government is agreeing to pay billions of dollars to the first company that developed a COVID-19 vaccine. The government also can acquire up to an additional 500 million doses. Money can be a bad incentive to cut corners or hide data at a time when both the FDA and CDC are politicized.

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European Pharmaceutical Review

MAY 7, 2024

major drivers for the injectable drug delivery market include a greater advancement in technology” The research also shared that major drivers for the injectable drug delivery market include a greater advancement in technology, more widespread chronic disease, and higher funding from government around the world.

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World of DTC Marketing

JULY 21, 2021

The FDA needs to study what people do when they see a DTC ad. The FDA, in its wisdom, has never studied what patients actually do when they see a DTC TV ad. If drug prices are to come down, the federal government needs to negotiate drug prices for Medicare, and a new breed of CEO, who really puts patients first, needs to take control.

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European Pharmaceutical Review

AUGUST 22, 2023

The US Food and Drug Administration (FDA)-approved treatment, is the first RSV vaccine indicated for infants from birth to six months of age. US FDA granted approval of Abrysvo to Pfizer Inc. This news follows similar regulatory action by the US FDA in recent months.

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Pharmaceutical Technology

NOVEMBER 22, 2022

The Chinese government announced its ten-year 'Made in China 2025' strategic plan in 2015, which aimed to make the country a global leader in several high-tech industries. Since 2015, the government has greatly increased its investment and support for biotech to stimulate innovation in the sector.

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Nixon Gwilt Law

APRIL 22, 2024

Its three separate Rules (Security, Privacy, and Breach) impose a variety of security controls, documentation, governance, and notice requirements on custodians of protected health information (PHI). The HTI-1 Final Rule is an AI disclosure and governance rule published by the US Department of Health and Human Services (HHS).

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Pharmaceutical Technology

SEPTEMBER 28, 2022

In June last year, the US Food and Drug Administration (FDA) granted approval for the antiviral therapy to treat human smallpox disease in adult as well as paediatric patients, including neonates. Chimerix entered a ten-year contract worth up to $680m with the US Government in August this year for delivering up to 1.7

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World of DTC Marketing

JANUARY 24, 2022

VCs invest money in biotech because they see a potential windfall via a profitable acquisition or sale, but when the FDA weighs in with delays, VCs can be ruthless. ” “More than 50% of FDA-approved medicines now have their start in venture-backed private biotech companies in the United States. .

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Pharmaceutical Technology

APRIL 3, 2023

Under this system, patients can request the government for access to medical treatment using unapproved drugs not covered by insurance. Treatment is then conducted as a clinical trial by the National Cancer Center Hospital to confirm its safety and efficacy.

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Pharmaceutical Technology

JULY 12, 2022

Novavax has signed an agreement with the US Department of Health and Human Services (HHS), in partnership with the Department of Defense, under which the US government will procure 3.2 Presently, the EUA application for the vaccine submitted by the company is being reviewed by the FDA.

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PM360

OCTOBER 28, 2022

With this in mind, in order to maximize the benefits of AI while mitigating its related risks, pharmaceutical incumbents and startups need to implement AI governance processes and tools. Food and Drug Administration (FDA), released a report making a series of recommendations to its members. Promising AI Use Cases in Pharma.

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European Pharmaceutical Review

MARCH 6, 2023

This milestone follows the finalisation of Moderna’s ten-year strategic partnership with the UK government, announced in December 2022. This exciting milestone follows finalization of Moderna’s ten-year strategic partnership with the UK government in December 2022.

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MedCity News

JUNE 30, 2022

government agreed to a purchasing contract covering 105 million doses of the Pfizer/BioNTech vaccine for a planned vaccination campaign in the fall. New Covid-19 vaccine booster shots are coming and they’ll include protection against the omicron variant.

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Pharmaceutical Technology

JULY 21, 2022

The pharma industry has deeply rooted environmental, social, and governance (ESG) issues that challenge sustainability. Aprecia Pharmaceuticals’ Spritam, an anti-epileptic drug, is the first and only 3D-printed pharmaceutical, having received US Food and Drug Administration (FDA) approval in 2015.

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