Download, FDA and Pharmaceutical Companies

FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

Dosage

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PPC Campaign Optimization for Pharma: Boosting ROI

Pharma Marketing Network

MARCH 8, 2025

Introduction Pharmaceutical companies are investing heavily in digital advertising , and PPC campaign optimization is key to maximizing ROI while staying compliant. Optimize landing pages to ensure message consistency and compliance with FDA regulations. download a whitepaper, request a sample).

HIPAA

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How to use Pay Per Click Advertising to Reach HCPs in Pharma

Pharma Marketing Network

MARCH 18, 2025

Brand Authority: By appearing at the top of search engine results, pharmaceutical companies increase brand credibility among HCPs. Conversion Rate: Tracks how many users complete a desired action, such as signing up for a webinar or downloading whitepapers. Offer incentives like exclusive research reports or webinar invites.

Pharmaceutical Companies

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Does Medicare cover Wegovy?

The Checkup by Singlecare

APRIL 17, 2024

Food and Drug Administration (FDA) approved Wegovy for adults and children 12 years and older who have a body mass index (BMI) of 30 or higher or who have a BMI of 27 or higher with a related medical condition, such as high blood pressure, Type 2 diabetes, or high cholesterol. Medicare prohibits Part D plans from covering certain medications.

Insurance

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Exclusive Pharma Microbiology interview with Maria Jose Lopez Barragan, formerly at FDA

pharmaphorum

OCTOBER 7, 2020

SMi Reports: An exclusive interview with María José López Barragán, Founder, Barragan BioConsulting, formerly CMC Product Quality Reviewer, FDA, who will be speaking at the 3rd Annual Pharmaceutical Microbiology East Coast Conference released. The full interview can be downloaded at: www.pharma-microbiology.com/PR9.

FDA

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FDA approves Biostar’s Phase II/III plans with utidelone injectable for NSCLC

Pharmaceutical Technology

JUNE 16, 2023

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study. Please check your email to download the Report.

FDA

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Operations Data Challenges Limit the Value Realized from Pharma 4.0

ISPE

MARCH 6, 2023

To meet these challenges, pharmaceutical companies are accelerating digital transformation and making manufacturing more responsive to changing market conditions while improving efficiency. Pharma/Biopharma companies prefer a single system across a global manufacturing network, which further exacerbates this challenge.

Communication

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Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

OCTOBER 25, 2022

Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 More FDC products flowing into pharma pipelines. The numbers tell the story. new FDC products per year.

Pharmaceutical Companies

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Pliant snags $287.5 million in oversubscribed public offering amid market uncertainty

Pharmaceutical Technology

FEBRUARY 6, 2023

The FDA approved both drugs in 2014. In an email , a Pliant spokesperson told Pharmaceutical Technology , “As currently approved therapies are not well tolerated, a new agent with a favorable safety profile and demonstrated efficacy would be a welcome addition to the IPF treatment armamentarium”. The post Pliant snags $287.5

FDA

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After US approval, Amylyx faces regulatory hurdle in Europe for ALS treatment

Pharmaceutical Technology

MAY 31, 2023

Following a rocky and somewhat controversial road to securing a US Food and Drug Administration (FDA) approval, Amylyx’s amyotrophic lateral sclerosis (ALS) drug is likely to hit another regulatory snag in Europe. However, the FDA prefers a joint-assessment of both function and survival that requires time-consuming data collection.

FDA

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Rising demand for pediatric dosage forms requires reformulation, expertise, and to-scale manufacturing capabilities

Pharmaceutical Technology

NOVEMBER 25, 2022

Pharmaceutical companies are looking to paediatric indications of approved adult dosage forms (ADFs) to sustain and fuel growth. Cambrex, for example, has a track record of success in partnering with several pharmaceutical companies in the development and commercialisation of clinically suitable PDFs.

Dosage

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Genmab and argenx team up to engineer novel antibody therapies

Pharmaceutical Technology

APRIL 17, 2023

Pharmaceutical company Genmab is entering a partnership with argenx to develop antibody therapies for oncology and immunology. This collaboration is being made to combine the companies’ capabilities to develop novel therapeutic antibodies with applications in the two disease areas. Evaluate the effects of COVID-19 on the sector.

Immunization

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Outsourcing Biologics Fill Finish Manufacturing : Streamlining the Production Process for Biopharmaceutical Companies

Roots Analysis

APRIL 15, 2024

In order to ensure that this critical aspect is maintained, the pharmaceutical company should carry out a detailed evaluation of the quality control and quality assurance departments of the CMO partner. Chances of de-prioritization: Usually, CMOs are involved in multiple projects and agreements with different pharmaceutical companies.

Pharmaceutical Companies

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Why demand is rising for secure and climate-controlled gene therapy services

Pharmaceutical Technology

JUNE 19, 2023

Pharmaceutical companies are putting their trust in the immense potential this new generation of medicine has for treating individuals with rare genetic diseases, which currently affect an estimated 280 million patients worldwide. To learn more, please download the whitepaper below.

Packaging

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‘Right shoring’ API production in Europe

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. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report.

Packaging

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Dawn of a new indication: how to study drugs for aging

Pharmaceutical Technology

MARCH 6, 2023

Currently, most drugs being investigated for their healthy aging or anti-aging properties are being repurposed from readily accessible FDA-approved drugs. Barzilai hopes that the well-established profile of the drug may allow the FDA to accept the trial more easily and then other aging-related studies can follow.

FDA

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Race to the finish: pharma edges closer to approval with RSV vaccines

Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind.

Vaccines

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Q&A: As RSV vaccine approvals loom, regulators need to devise vaccination strategies

Pharmaceutical Technology

MAY 1, 2023

After a long period of inactivity in RSV vaccine development , two pharmaceutical companies are now approaching regulatory decisions for their RSV vaccines. An FDA decision is expected for the use of RSVPreF3 in adults of ages 60 years and above by May 3. Please check your email to download the Report.

Vaccines

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Quality first: How pharma can meet injectables demand while staying compliant

Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. To learn how to optimise BL & GF profiles to ensure efficacious drug delivery for your pre-filled syringe system, download now.

Packaging

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Excellence Awards 2022 – Winners Announced!

Pharmaceutical Technology

DECEMBER 22, 2022

Our programme is designed to highlight excellence within the sector by looking at a range of corporate activities including deals, business projects and company initiatives, both internal and in the community. Business Expansion. In May the drug became the first medicine available in the US for eosinophilic oesophagitis following approval.

FDA

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Primate models in pharma: What the future holds

Pharmaceutical Technology

APRIL 12, 2023

However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. The ABPI points to the FDA in the US as an example. The FDA’s Modernization Act 2.0 Please check your email to download the Report.

Vaccines

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What to Keep in Your Integrative Medicine Cabinet

The Thyroid Pharmacist

OCTOBER 27, 2023

For this reason, most supplement companies do not take the extra steps to test their products to ensure safety and purity. P.S. You can download a free Thyroid Diet Guide, 10 thyroid-friendly recipes, and the Nutrient Depletions and Digestion chapter of my first book for free by signing up for my newsletter.

Health and Personal Care Stores

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Legal challenges put off label use of gender affirming care drugs in jeopardy

Pharmaceutical Technology

MARCH 16, 2023

Most drugs used here are prescribed off-label, and experts say pharmaceutical companies remain hesitant to conduct clinical trials studying gender-affirming care. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report.

Labelling

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Pharmacy Technician Pulse

FDA drug dosage optimisation guidelines signal clinical trial reform

PPC Campaign Optimization for Pharma: Boosting ROI

Trending Sources

How to use Pay Per Click Advertising to Reach HCPs in Pharma

Does Medicare cover Wegovy?

Exclusive Pharma Microbiology interview with Maria Jose Lopez Barragan, formerly at FDA

FDA approves Biostar’s Phase II/III plans with utidelone injectable for NSCLC

Operations Data Challenges Limit the Value Realized from Pharma 4.0

Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pliant snags $287.5 million in oversubscribed public offering amid market uncertainty

After US approval, Amylyx faces regulatory hurdle in Europe for ALS treatment

Rising demand for pediatric dosage forms requires reformulation, expertise, and to-scale manufacturing capabilities

Genmab and argenx team up to engineer novel antibody therapies

Outsourcing Biologics Fill Finish Manufacturing : Streamlining the Production Process for Biopharmaceutical Companies

Why demand is rising for secure and climate-controlled gene therapy services

‘Right shoring’ API production in Europe

Dawn of a new indication: how to study drugs for aging

Race to the finish: pharma edges closer to approval with RSV vaccines

Q&A: As RSV vaccine approvals loom, regulators need to devise vaccination strategies

Quality first: How pharma can meet injectables demand while staying compliant

Excellence Awards 2022 – Winners Announced!

Primate models in pharma: What the future holds

What to Keep in Your Integrative Medicine Cabinet

Legal challenges put off label use of gender affirming care drugs in jeopardy

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