Camargo

APRIL 7, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Rare Disease Clinical Trials Most Often Terminated Due to Regulatory and Recruitment Issues. Vice President, Regulatory Operations.

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Camargo

JULY 8, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. At Camargo, we have worked with hundreds of investigators who have found new targets for established drugs. So how did the FDA do?

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Camargo

OCTOBER 14, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Innovating regulatory approaches to provide efficient and least burdensome oversight while meeting FDA standards. FDA Commissioner Stephen M.

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Camargo

AUGUST 13, 2020

Each month, Camargo’s “In the News” series will highlight important changes and advancements in the. The post In the News: July Regulatory and Development Updates appeared first on Camargo.

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Camargo

JANUARY 14, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The guidance could also serve as a good regulatory primer for those new to combination products. Vice President, Regulatory Operations.

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Camargo

MARCH 9, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Vice President, Regulatory Operations. In the News: March 2021 Regulatory and Development Updates. Bill Stoltman, JD.

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Camargo

JUNE 4, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Vice President, Regulatory Operations.

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Camargo

FEBRUARY 4, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Vice President, Regulatory Operations. In the News: March 2021 Regulatory and Development Updates. Bill Stoltman, JD.

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Camargo

SEPTEMBER 15, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explore how those changes could impact your program. Senior Director of Regulatory Compliance and Submissions. Fitbit developing algorithm COVID-19 early detection. Co-Authors: Ken Phelps.

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Camargo

DECEMBER 9, 2020

The August edition of In the News discussed recent FDA guidance detailing the approach to inspections during the COVID-19 pandemic, including the proposed use of various “remote” inspection methods—such as document review—to allow inspections to progress without physical access to the facilities involved. Co-Authors: Robb Lawrence.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 23, 2024

Wegovy, Ozempic and Mounjaro are weight loss and diabetes drugs that have made quite a splash in health news. They target regulatory pathways involved in both obesity and diabetes and are widely considered breakthroughs for weight loss and blood sugar control. link] But do these drugs point toward a root cause of metabolic disease?

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Bio Pharma Dive

SEPTEMBER 10, 2022

Sotyktu has been on the pharma’s top pipeline candidates and its clearance continues a string of positive regulatory news for the company.

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BioTech 365

OCTOBER 25, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: EMA starts rolling review of Merck’s molnupiravir, continuing rapid regulatory response to COVID-19 antiviral data.EMA starts rolling review of Merck’s molnupiravir, continuing rapid regulatory response to COVID-19 (..)

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BioTech 365

MAY 17, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Incyte’s ruxolitinib cream hits goal in vitiligo phase 3 trials, teeing up regulatory submissions.Incyte’s ruxolitinib cream hits goal in vitiligo phase 3 trials, teeing up regulatory submissions … Continue reading (..)

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BioTech 365

AUGUST 7, 2020

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Integration of gene regulatory networks in understanding animal behavior.For years, scientists have attributed animal behavior to the coordinated activities of neuronal cells and its circuits of neurons, … Continue reading (..)

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BioTech 365

DECEMBER 4, 2020

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Takeda’s maribavir hits phase 3 goal as pharma looks forward to regulatory talks.Takeda’s maribavir hits phase 3 goal as pharma looks forward to regulatory talks badams Fri, … Continue reading →

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BioTech 365

SEPTEMBER 16, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: ESMO: Novartis links prostate cancer drug to improved pain, quality of life as regulatory filings near.ESMO: Novartis links prostate cancer drug to improved pain, quality of life … Continue reading →

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Pharma Times

OCTOBER 27, 2023

The new principles will remove the regulatory burden for MLMD manufacturers - News - PharmaTimes

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BioTech 365

OCTOBER 7, 2020

Cancer Vaccine Daily has the latest updates on peer-reviewed research, clinical trials, and industry and regulatory news on the development, testing, safety, and approval of cancer vaccines. DUBLIN–(BUSINESS WIRE)–The “Cancer Vaccine Daily” newsletter has been added to ResearchAndMarkets.com’s offering.

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STAT News

SEPTEMBER 7, 2022

For Illumina, the leading maker of DNA sequencing equipment, there was bad news and worse news Tuesday. The bad news: The European Commission said it was blocking Illumina’s $8 billion acquisition of Grail, a firm focused on the early detection of cancer. The worse news?

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Pharma Times

JULY 28, 2023

The vital second batch represents a critical step on the candidate’s pathway to regulatory approval - News - PharmaTimes

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Drug Discovery World

JANUARY 5, 2024

News round-up for 1-5 January by DDW Digital Content Editor Diana Spencer. The start of 2024 has seen quite a bit of regulatory activity, with the UK MHRA’s launch of a new procedure for assessing drugs, along with significant regulatory approvals for therapeutics for cytomegalovirus, melanoma, amyloidosis and multiple sclerosis.

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Drug Discovery World

MARCH 1, 2024

News round-up for 26 Feb – 1 March by DDW Digital Content Editor Diana Spencer. The news highlights this week all focus on regulatory decisions, both positive and negative.

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Fierce Pharma

JULY 11, 2023

With Xspray Pharma and Eversana’s cancer med hitting a regulatory setback, a launch in the second half of 2023 now looks unlikely. With Xspray Pharma and Eversana’s cancer med hitting a regulatory setback, a launch in the second half of 2023 now looks unlikely.

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BioSpace

JANUARY 15, 2021

As the 2021 virtual JP Morgan Healthcare Conference wrapped up, there was still news from companies regarding their deals, pipeline and regulatory updates. Here’s a look.

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World of DTC Marketing

AUGUST 9, 2021

Most HCPs go to Medscape as a “first stop” in the morning to get their healthcare news. million other healthcare professionals worldwide, including medical students, residents, nurses, and more,45 Medscape is the largest news site for HCPs around the world, . Reaching 730,000 physicians and 1.9

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Drug Discovery World

JUNE 19, 2023

Regulatory approvals and industry guidelines are key to the continued development and discovery of drugs, which is a common theme throughout this week’s news highlights, including an FDA approval for Pfizer, a NICE recommendation for AstraZeneca UK, and an update to the HER2 Breast Cancer Testing Guidelines.

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Drug Discovery World

NOVEMBER 20, 2023

The breaking news this week was certainly the first regulatory approval for Casgevy, not only the first gene therapy approved for sickle cell disease, but also the first therapy to use CRISPR gene editing. The latest episode of the DDW Highlights podcast is now available to listen to below.

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Drug Discovery World

NOVEMBER 20, 2023

The breaking news this week was certainly the first regulatory approval for Casgevy, not only the first gene therapy approved for sickle cell disease, but also the first therapy to use CRISPR gene editing. The latest episode of the DDW Highlights podcast is now available to listen to below.

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Drug Discovery World

NOVEMBER 20, 2023

The breaking news this week was certainly the first regulatory approval for Casgevy, not only the first gene therapy approved for sickle cell disease, but also the first therapy to use CRISPR gene editing. The latest episode of the DDW Highlights podcast is now available to listen to below.

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Drug Discovery World

NOVEMBER 27, 2023

In the UK, following Medicines and Healthcare products Regulatory Agency (MHRA) approval on 15 November 2023, and as a result of the existing reimbursement agreement between Vertex and the NHS, children aged two years and above in the UK have access to this expanded indication for Kaftrio in a combination regimen with ivacaftor.

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FDA Law Blog

MAY 30, 2022

FDA has avoided labeling these as “remote inspections”, preferring the terms “Remote Interactive Evaluation” for manufacturing sites and “Remote Regulatory Assessment” for Bi-Mo. This is good news for some and bad news for others. Anecdotally, though, FDA inspections have resumed.

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Drug Discovery World

DECEMBER 7, 2023

Despite research efforts to combat the growing prevalence of NASH, there are currently no regulatory approved therapeutics due to the inability of traditional in vivo approaches to accurately predict the human response to this complex metabolic disease.

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WCG Clinical

APRIL 3, 2023

Each business day, the new FDAnews will deliver precisely what pharmaceutical and medical device manufacturers have told us they need to know about regulatory compliance and good manufacturing practices,” said Terri Moench, RPh, MS, President, Research Solutions for WCG.

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Drug Discovery World

JUNE 19, 2023

Regulatory approvals and industry guidelines are key to the continued development and discovery of drugs, which is a common theme throughout this week’s news highlights, including an FDA approval for Pfizer, a NICE recommendation for AstraZeneca UK, and an update to the HER2 Breast Cancer Testing Guidelines.

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Drug Discovery World

NOVEMBER 3, 2023

News round-up for 30 October – 3 November by DDW Editor Reece Armstrong My news highlights this week feature a variety of exciting clinical trial results and launches that are examining therapies for much-needed disease areas, new drug approvals and even a space mission with a pharma twist.

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BioTech 365

JUNE 22, 2022

Innate Pharma to Participate in Upcoming Investor Conference Innate Pharma to Participate in Upcoming Investor Conference MARSEILLE, France–(BUSINESS WIRE)–Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that its investor relation team will … Continue reading → (..)

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