Pharma in Brief

JUNE 20, 2023

The proposed changes would affect products classified as “New Medicines” with list prices that are below the median of prices in the basket of 11 comparator countries set out in the Patented Medicines Regulations (the PMPRB11 ). [1] The rights holders of these New Medicines will receive a Status Report letter once the assessment is completed.

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GMPSOP

MARCH 20, 2024

Instrument calibration procedure for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Last Updated on March 20, 2024 Prev PREVIOUS POST Have you ever wondered if the scales at the grocery checkout show the right amount? – If certification is a local mandatory requirement (e.g.,

Documentation 52

Documentation Pharmaceutical Manufacturing Labelling Communication 52

Pharmaceutical Technology

JULY 29, 2022

5 compared with the currently authorised Moderna booster, regardless of prior infection status or age. The expansion will be operational in 2024. The booster dose elicited a significantly higher neutralising antibody response against Omicron subvariants BA.4 Regulators are well-disposed to these boosters.

Vaccines 52

Vaccines Packaging Immunity Immunization 52

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. That did not happen.

Documentation 59

Documentation 59

FDA Law Blog: Biosimilars

APRIL 16, 2024

In 2020, CMS issued a final rule providing a broad definition of “new formulation” as “any change to the drug, provided that the new formulation contains at least one active ingredient in common with the initial brand name listed drug.” Vanda Pharmaceuticals, Inc. Centers for Medicare and Medicaid Servs., 23-1457 (4th Cir.

Dosage 59

Dosage Drug Pricing Pharmaceutical Manufacturing 59

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

In keeping with the goal of standardization, the Draft Guidance is issued by a long list of agency level offices (including the Offices of the Commissioner, Minority Health and Health Equity, and Women’s Health, among others) and all three human medical product centers (CDER, CBER and CDRH), as well as the Oncology Center of Excellence.

Medical Records 59

Medical Records Drug Development 59

PharmaShots

JUNE 1, 2023

The study flowchart is divided into two parts after pre-screening: an active phase (screening, treatment phase and safety period up to 4 weeks after the last injection) and a long-term follow-up period (up to 2 years after the end-of-treatment visit) during which information about clinical status and disease assessment will be collected.

Immunity 40

Immunity Immunization Vaccines Health and Personal Care Stores 40

Pharmaceutical Technology

JANUARY 25, 2023

Instead, reverse mergers, like privately-held Elicio Therapeutics’s plans to merge with the NASDAQ-listed company Angion Biomedica, might be a sign of things to come. While there will be some exceptions, fundraising and initial public offerings (IPOs) will be difficult for most. range in December 2022.

Communication 69

Communication 69

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Houck — With apologies to David Letterman, who introduced the first Top Ten List on Late Night with David Letterman on September 18, 1985, we present “Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not.”* January 29, 2024). By Larry K. Letter to DEA Administrator Anne Milgram, from Phil Weiser, et al., (Jan.

Controlled Substances 59

Controlled Substances Chemotherapy Compounding 59