BioTech 365

NOVEMBER 4, 2020

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: BioMarin nabs FDA review for dwarfism drug vosoritide, forgoes AdComm as it eyes 2021 approval.BioMarin nabs FDA review for dwarfism drug vosoritide, forgoes AdComm as it eyes … Continue reading →

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BioTech 365

AUGUST 21, 2020

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Virtual FDA AdComm for Alkermes’ ALKS 3831 adds new focus on drug-drug interactions.Virtual FDA AdComm for Alkermes’ ALKS 3831 adds new focus on drug-drug interactions badams Fri, … Continue reading →

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BioTech 365

JANUARY 11, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: JPM: Biogen bullish on Alzheimer’s drug approval, sees Lilly data as a positive, despite AdComm rejection.JPM: Biogen bullish on Alzheimer’s drug approval, sees Lilly data as a … Continue reading →

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Drugs Research 40

BioTech 365

MAY 25, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Provention Bio, in need of AdComm’s support for diabetes drug, may have what it needs to satisfy the FDA.Provention Bio, in need of AdComm’s support for diabetes … Continue reading →

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Eye on FDA

JANUARY 16, 2023

FDA Advisory Committees (AdComms) ain’t what they used to be. For anyone who had to suffer the onerous security ritual at FDA’s campus where the meetings were generally held that may be good news. In-person FDA AdComms were not really fun. So that is one – albeit small – way in which AdComms have changed.

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Drugs Production FDA Approval 52

Eye on FDA

JULY 5, 2022

New Molecular Entity Approvals – The most obvious is to see how we are doing on new molecular approvals – those approvals representing entirely new treatments. The news is not so hot. By the end of June this year, FDA had approved only 16 novel drugs. By this time last year, there were 27.

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Clinical Trials Clinical Trials Gene Therapy Drugs 81

Eye on FDA

JULY 28, 2020

Last year by June 30, FDA had held 9 meetings to consider new approvals. During the first half of 2020, FDA AdComms were scheduled to discuss 8 NDAs, BLAs or sBLAs. In the end, that leaves this a good news/bad news proposition.

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The Pharma Data

MAY 7, 2021

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. . Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ). In Focus: US. Covid-19 Vaccines Are Wasted as Special Syringes Run Short ( WSJ ).

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Vaccination Vaccine Drugs Regulation 52

Eye on FDA

AUGUST 4, 2021

Below is a chart that looks at 3 numbers – the number of AdComms; the number of new molecular entities approved each year, and the number of drugs that had breakthrough therapy designation. That said, BT would be a lagging indicator since it can be granted so early in the development process.

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Drugs FDA Approval Clinical Trials Clinical Trials 122

pharmaphorum

SEPTEMBER 2, 2021

The adcomm is scheduled for 17 September and will consider the Pfizer/BioNTech filing as well as booster doses more generally. The news comes as Moderna has just announced the submission of initial data to the FDA for its own COVID-19 vaccine booster.

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