BioTech 365

AUGUST 24, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: The FDA wants more data. Stealth is filing for approval anyway.The FDA wants more data.

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BioPharma Reporter

JULY 7, 2023

The first and only approved anti-amyloid Alzheimer's Disease (AD) treatment shown to reduce the rate of disease progression and slow cognitive impairment has been granted approval by the FDA.

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Drugs Clinical Development Development 98

BioTech 365

AUGUST 26, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Sesen, still reeling from FDA rejection, pulls filing for EU approval of cancer drug.Sesen, still reeling from FDA rejection, pulls filing for EU approval of cancer drug … Continue reading →

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BioTech 365

JANUARY 26, 2022

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Incyte pulls FDA filing for cancer drug approval over confirmatory study, following Gilead out of the exit.Incyte pulls FDA filing for cancer drug approval over confirmatory study, … Continue reading →

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Drugs Research 40

BioTech 365

FEBRUARY 17, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Amgen KRAS drug gets FDA priority review, teeing up August approval decision.Amgen KRAS drug gets FDA priority review, teeing up August approval decision ntaylor Wed, 02/17/2021 – … Continue reading →

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Drugs Research 40

Camargo

AUGUST 5, 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. Approval of the Month: Repurposed Transplant Drug Approved Based Only on Real-World Evidence. FDA Inspections Ramping Up?

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BioTech 365

OCTOBER 11, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Merck makes beeline to FDA, seeking approval for COVID-19 antiviral 10 days after reporting data.Merck makes beeline to FDA, seeking approval for COVID-19 antiviral 10 days after … Continue reading →

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Research 40

BioTech 365

JANUARY 14, 2022

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: FDA approval, global partnership on the agenda at Mithra as phase 3 menopause trials hit goals—with one blemish .FDA

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BioTech 365

JUNE 24, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Lilly to file for accelerated FDA approval of Alzheimer’s drug after Aduhelm OK opens the floodgates.Lilly to file for accelerated FDA approval of Alzheimer’s drug after Aduhelm … Continue reading →

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FDA Approval Drugs Research 40

BioTech 365

APRIL 5, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Pfizer’s Vizimpro is among 3 FDA-approved drugs that combat COVID-19 in lung cells: report.Pfizer’s Vizimpro is among 3 FDA-approved drugs that combat COVID-19 in lung cells: report … Continue reading → (..)

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FDA Approval Drugs Research 40

BioTech 365

SEPTEMBER 23, 2020

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: FDA to set high bar for emergency COVID-19 vaccine approvals.FDA to set high bar for emergency COVID-19 vaccine approvals ntaylor Wed, 09/23/2020 – 08:50 from FierceBiotech: Biotech … Continue reading →

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Vaccination Vaccine Research 40

Camargo

DECEMBER 10, 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. Voxzogo Approved as a Growth-Improvement Therapy for Children with Dwarfism. Most (119) of the participants were enrolled in an open-label extension.

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Development Genetics Production Clinical Trials 176

Camargo

MAY 10, 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. FDA’s Accelerated Approval Program Comes Under Fire. It will be interesting to see if the FDA follows the ODAC recommendations.

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Development Clinical Trials Clinical Trials Trials 185

Camargo

SEPTEMBER 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. Genus contested the FDA’s classification of its barium sulfate contrast imaging agent as a drug rather than a device.

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Development Regulation Production Drugs 186

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. The post This week in drug discovery (26 Feb – 1 March) appeared first on Drug Discovery World (DDW).

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Drugs Allergies FDA Approval Medicine 52

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. FDA Issues Advice on Combination Products. The guidance could also serve as a good regulatory primer for those new to combination products.

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Development Production FDA Approval Drugs 148

XTalks

FEBRUARY 26, 2024

The US Food and Drug Administration (FDA) has granted expanded approval to Genentech’s (part of Roche) Xolair (omalizumab) to help reduce allergic reactions to various foods after accidental exposure. The FDA said patients who take Xolair must continue to avoid foods they are allergic to. million children and 13.6

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Allergies FDA Approval Drugs Protein 100

BioSpace

MARCH 22, 2021

The life sciences industry is a bustling beehive of activity. Here’s a quick compilation of some of today’s newsworthy announcements.

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Life Science 66

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. FDA: Sponsors Seldom Disclose RTF Letters’ Existence or Contents and Often Ignore Agency Advice. The FDA found that fully 84.5%

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Development Manufacturing Drugs Production 146

Pharmaceutical Technology

DECEMBER 23, 2022

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Sunlenca (lenacapavir) plus other antiretroviral(s) (ARV) to treat human immunodeficiency virus type 1 (HIV-1) infection. Sunlenca is also said to be the first-ever capsid inhibitor-based HIV therapy to receive such approval.

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Drugs FDA Approval Clinical Trials Clinical Trials 147

STAT News

MARCH 8, 2023

The news came just days after the test’s maker, Lucira, filed for bankruptcy, blaming the FDA’s “protracted” approval process for its financial problems. Now the FDA has released a rare comment clarifying what happened during its authorization process. Read the rest…

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Manufacturing Drugs 105

Pharmaceutical Technology

MAY 26, 2023

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir). In response to the approval news, some pointed concerns about long-term safety.

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HR Clinical Trials Clinical Trials Drugs 147

World of DTC Marketing

JULY 13, 2021

SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process. Our healthcare system cannot continue to support marginally effective drugs.

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Drugs FDA Approval Medicine Trials 187

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. FDA Establishes Digital Health Center of Excellence. FDA Commissioner Stephen M. FDA Issues Guidances Dealing with ANDAs.

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Development Insulin Drug Delivery Production 196

Camargo

NOVEMBER 15, 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. FDA Guidance Addresses Real-World Evidence Data Standards. FDA Publishes ICH Guidelines on Continuous Manufacturing. Emphasis in the original).

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Development Manufacturing Production Packaging 187

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. To be successful, such trials require out-of-the-box thinking and experience with the FDA. The FDA then rejected the NDA later in 2013.

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Development Trials Clinical Trials Clinical Trials 152

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. Approval of the Month: Non-Opioid for Post-Surgical Pain Gets FDA Nod. Since two-thirds of the more than 50 million U.S.

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Development Production Drugs Marketing 130

World of DTC Marketing

NOVEMBER 10, 2020

SUMMARY : Pfizer’s 90 percent effectiveness is very impressive, but the rate is based on a relatively small number of people and the data has not been peer-reviewed but today headlines rule the news, not content. Pfizer’s results are promising and are coming at a time when the world is anxiously awaiting positive news.

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Vaccination Vaccine Marketing Drugs 286

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. Approval of the Month: Previously Approved Oncology Drug Cleared for Rare Pediatric Indication.

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Development Production Drugs Manufacturing 131

Camargo

OCTOBER 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. FDA Discusses Focus Areas for PDUFA VII During Public Meeting. Improved predictability in Human Factors and User-Related Risk reviews.

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Development Packaging Packaging Generic Drugs 189

BioPharma Reporter

NOVEMBER 7, 2022

The news comes two years after the drug received US Food and Drug Administration (FDA) accelerated approval. GSKâs Blenrep has proved unsuccessful in a Phase III study in multiple myeloma.

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Trials Drugs Regulation Marketing 92

World of DTC Marketing

JULY 15, 2021

SUMMARY: The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug. Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.

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Pharma Companies Drugs Development Production 202

XTalks

JULY 10, 2023

Euronext Brussels (UCB), a biopharma company headquartered in Brussels, Belgium, recently announced that the US Food and Drug Administration (FDA) has granted approval for its drug, Rystiggo (rozanolixizumab), for the treatment of generalized myasthenia gravis (gMG). What Is Generalized Myasthenia Gravis (gMG)?

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FDA Approval Antibody Protein Engineer 98

XTalks

JUNE 30, 2023

Bayer, a renowned German pharmaceutical company, has recently announced that its Ultravist 300 and 370 (iopromide) injection has won approval from the US Food and Drug Administration (FDA) for use in contrast-enhanced mammography (CEM). The FDA has not approved Iomeron.

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FDA Approval Radiology Trials Life Science 98

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. This is due to generally more stringent criteria on approvals in the wake of the Aduhelm scandal. However, non-NME and biosimilar approvals increased in 2022.

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Drugs Manufacturing Contract Manufacturing FDA Approval 130

Pharmaceutical Technology

JANUARY 12, 2023

The US Food and Drug Administration (FDA) has approved AstraZeneca and Avillion’s Airsupra (albuterol/budesonide), to treat asthma. Airsupra has been approved for the as-needed treatment or prevention of bronchoconstriction and for reducing the exacerbations risk in asthma patients aged 18 years and above.

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FDA Approval Trials Development Drugs 130

Drug Discovery World

MARCH 22, 2024

News round-up for 18-22 March by DDW Digital Content Editor Diana Spencer. This has been an interesting week for cell and gene therapies, with two landmark FDA approvals, two significant fundraising efforts and potentially ground-breaking study results in glioblastoma.

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Gene Therapy In-Vivo FDA Approval Drugs 52