Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

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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. Zydus will manufacture the drug at its formulation facility in Moraiya, Ahmedabad, in the Indian state of Gujarat.

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European Pharmaceutical Review

JANUARY 16, 2023

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. What were the main challenges for pharmaceutical microbiology in 2022?

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World of DTC Marketing

SEPTEMBER 28, 2020

As you all know Trump has promised a vaccine shortly before the election while Secretary Azar barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.

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World of DTC Marketing

NOVEMBER 12, 2020

Pfizer did not take government money to develop a COVID vaccine and said the release of preliminary vaccine data was based on receiving the data on Monday. The median premarket clinical development period (investigational new drug submission to FDA approval) was 8.1 Of these, 4 (19.0%) received Accelerated Approval.

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Pharmaceutical Technology

JULY 21, 2022

The pharma industry has deeply rooted environmental, social, and governance (ESG) issues that challenge sustainability. AI also speeds up the drug development process, which could translate into cheaper drugs for patients. 3D bioprinting offers an alternative to animal testing in drug development. 3D printing.

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World of DTC Marketing

MAY 6, 2021

The Biden administration’s decision to support a temporary waiver of Covid-19 vaccine patents prompted instant outrage in the pharma sector, which argues that the move rides roughshod over their intellectual property rights and will discourage US innovation while sending jobs abroad. This is the right and moral decision.

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European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

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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. 1 It defined LBPs as drug products containing live microorganism(s) to be used to prevent, treat or cure a disease or condition in human beings. Download and read more now… .

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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. The treatment landscape is therefore one that is relatively bare.

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European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. What is the biggest impact of having compromised data when working with regulatory bodies in the pharmaceutical industry?

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Pharmaceutical Technology

AUGUST 1, 2022

Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. 4/5 Omicron strain is being developed in line with the latest recommendations from the Food and Drug Administration (FDA). 4/5 strain messenger RNA (mRNA).

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European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. The Dutch government offers a prime example.

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Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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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 post US to buy additional Novavax Covid-19 vaccine doses appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

JULY 14, 2022

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. Covid-19 vaccines stay in the spotlight.

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European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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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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Pharmaceutical Technology

JULY 7, 2022

In December last year, China’s National Medical Products Administration (NMPA) granted approval for amubarvimab/romlusevimab combination to treat mild and normal Covid-19 in adults and paediatric patients aged 12 to 17 years. The post Brii Bio introduces Covid-19 combination therapy in China appeared first on Pharmaceutical Technology.

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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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PM360

OCTOBER 28, 2022

Shepherding a new drug to market is a long, expensive, and uncertain process. billion dollars to bring a new drug from discovery to regulatory approval and market launch. Approval success rates of drug candidates are between 10%–20% in the United States, the European Union, and Japan. in 2010 to only 1.9%

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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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Pharmaceutical Technology

APRIL 17, 2023

Health Canada has accepted Pfizer Canada’s new drug submission for a bivalent respiratory syncytial virus (RSV) vaccine for review. The company announced that Health Canada’s acceptance follows the acceptance by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

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European Pharmaceutical Review

DECEMBER 13, 2022

North American psychedelic drug developers Mindset, PharmAla, Mydecine and Psyence have signed with clinical research organisation (CRO) Clerkenwell Health to trial therapies for mental health conditions, in London, UK, to benefit from the country’s swift drug regulatory process.

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Pharmaceutical Technology

MAY 26, 2023

The device received US Food and Drug Administration 510(k) clearance last week for those ages six years and above living with type 1 diabetes. In recent months, Insulin prices reached dizzying heights , forcing the US government to apply cost caps on the treatment.

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Pharmaceutical Technology

MAY 17, 2023

The Inflation Reduction Act, which became US law in August 2022, has invited its fair share of critics and supporters over its drug pricing provisions. At the core of the debate was a new provision allowing the US Centers for Medicare & Medicaid Services (CMS) to negotiate prices with pharmaceutical companies for a select number of drugs.

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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. In July 2023, the US government body approved the only monoclonal antibody for protection of infants in their first RSV season. US FDA granted approval of Abrysvo to Pfizer Inc.

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Contrarian Sales Techniques

DECEMBER 14, 2022

The biotechnology and drug sectors performed well in the second half of 2022 after struggling in the first six months. Despite the uncertainty surrounding the global economy, the pharmaceutical industry has continued to deliver positive regulatory updates and clinical data. What Influence the Future of the Large-Cap Pharma Industry?

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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 million doses of Covid-19 vaccine from Novavax appeared first on Pharmaceutical Technology. The post US to procure 3.2

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European Pharmaceutical Review

APRIL 13, 2023

As psychedelics diffused into wider society and recreational use increased, some individuals reported…ongoing symptoms after the drugs had left the body” At a time when psychiatry lacked effective medical therapies, the discovery of LSD was of interest.

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Pharmaceutical Technology

SEPTEMBER 12, 2022

In accordance with the recommendations of the Canadian government and public health authorities across the country, the companies plan to commence shipping the 3?g The post Health Canada authorises Pfizer-BioNTech’s Covid-19 vaccine for children appeared first on Pharmaceutical Technology.

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European Pharmaceutical Review

MARCH 2, 2023

Last year was another challenging one for the pharmaceutical industry. However, a good many companies are not yet well set up for this” In terms of drug development and clinical trials, EU Clinical Trial Regulation and more specifically the Clinical Trial Information System (CTIS) presented one of the main practical changes of 2022.

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European Pharmaceutical Review

AUGUST 23, 2022

The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs can be categorised as substandard, falsified, counterfeit and diverted drugs, and the World Health Organization (WHO) broadly defines a counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source.”

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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. The post FDA nod for Omicron-specific boosters is groundbreaking, but uptake remains poor appeared first on Pharmaceutical Technology.

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Pharma Marketing Network

JULY 10, 2023

Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. It can be a complex and challenging process, as pharmaceutical companies must adhere to strict regulations while also developing creative and effective marketing campaigns.

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MedCity News

JUNE 12, 2023

During Covid-19, governing agencies loosened regulatory requirements and increased incentives for DTx. The conventional pharmaceutical approach failed an industry leader due to government inaction and lack of private payer support. One headwind is uncertainty around the right business model for DTx products.

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Pharmaceutical Technology

MARCH 22, 2023

In the 1990s, generic pharmaceutical companies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

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