2007, FDA and Vaccines - Pharmacy Technician Pulse

First continuous mRNA manufacturing platform to be developed

European Pharmaceutical Review

JULY 17, 2023

The $82 million project is funded by the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research. This $85 million programme ran between 2007 and 2019. This new pilot-scale system builds on success of the Novartis-MIT Center for Continuous Manufacturing.

FDA

FDA Vaccines

Apellis set to take on Alexion as FDA clears PNH drug Empaveli

pharmaphorum

MAY 17, 2021

Apellis Pharma has secured FDA approval for its complement C3 inhibitor Empaveli as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) – with a label that will allow it to challenge Alexion’s established therapies directly. . The post Apellis set to take on Alexion as FDA clears PNH drug Empaveli appeared first on.

FDA

FDA Labelling Vaccines

Getting on with Rare Disease Therapeutic Options (Orphan Disease Therapies)

PharmaShots

MARCH 14, 2023

4 Government Incentive Programs FDA (USA): The orphan drug act was passed in January 1983, with a joint effort of the National Organization for Rare Disorders (NORD), and other organizations. The act includes drugs, vaccines, and therapeutics that are intended to treat a disease affecting <200,000 American citizens.

FDA

FDA Immunization Compounding Vaccines

Record number of health firms feature in UK top 100 private tech list

pharmaphorum

OCTOBER 13, 2020

There are pharma companies on the list, including Kymab , which at number 87 is working with the Bill & Melinda Gates Foundation to test several potential vaccines. However there have been two spectacular failures – payday loans firm Wonga and e-commerce and digital advertising firm Ve Interactive.

Vaccines

Vaccines FDA

A history of AstraZeneca

pharmaphorum

SEPTEMBER 18, 2020

In 1990, the US Food and Drug Administration (FDA) requested Astra to change Losec’s brand name to Prilosec, to avoid confusion with Sanofi-Aventis’ diuretic, Lasix (furosemide). In June 2007, AstraZeneca completed the acquisition of vaccine maker MedImmune, buying its drug-development pipeline for $15.2 MedImmune acquisition.

Vaccines

Vaccines Pharmaceutical Companies Pharmaceutical Companies FDA

FDA-Approved Labeling: Is Enough Enough?

The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. But we digress.

Labelling

Labelling FDA Vaccines Communication

Dr B raises $8m for telehealth service to deliver COVID antivirals

pharmaphorum

AUGUST 19, 2022

US startup Dr B – formed in 2021 to help match patients seeking a COVID-19 vaccine to suppliers with leftover stock – is branching out into antivirals with the help of an $8 million fundraising. The “visitless prescription” service will be available for free for people with low incomes, according to Dr B’s website.

Vaccines

Vaccines Compounding FDA

Accommodating Multiple Modalities in the Same Facility

ISPE

OCTOBER 26, 2022

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , Complete Data Gathering.

Vaccines

Vaccines Compounding Documentation FDA

Acetaminophen interactions to avoid

The Checkup by Singlecare

NOVEMBER 30, 2023

Acetaminophen may also blunt the effects of other medications that impact the immune system, including some medicines used to manage cancer diagnoses and even the immune response following vaccinations. There are over 50 TKIs approved by the Food and Drug Administration (FDA), with the ongoing rapid development of new drugs every year.

Immunization

Immunization Vaccines FDA Labelling

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2003-2022)

PharmaShots

APRIL 13, 2023

Its subsidiary, DePuy's CHARITE Artificial Disc for degenerative disc disease was the first device to be approved by the US FDA By acquiring Roche’s OTC business, Bayer was able to strengthen its consumer health business. Its top 8 products contributed more than $1B to the company’s net revenue. over the previous year.

Vaccines

Vaccines Pharmaceutical Companies Pharmaceutical Companies Labelling

Top 20 IPOs in Healthcare by Total Fund Value

PharmaShots

JANUARY 31, 2023

Founded Year: 2007 No. Founded Year: 2007 No. MyoVista wavECG is the company’s first FDA-cleared product which is designed to provide diagnostic information related to cardiac dysfunction in addition to being a resting 12-lead ECG. Founded Year: 2007 No. Founded Year: 2007 No. of Shares: 1.5M of Shares: 1.5M

Vaccines

Vaccines Immunization FDA

Nine for 2023, part two: healthcare’s hard problem, the prognosis for diagnosis, and key new pharmacotherapy platforms

pharmaphorum

JANUARY 16, 2023

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. Difficile at the end of November 2022, but in 2023 they will be joined by Seres, which expects an FDA decision in April 2023 on its C.

FDA

FDA Pharmaceutical Companies Pharmaceutical Companies Compounding

Contamination Trends & Proposed Solutions

ISPE

MARCH 8, 2023

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.

Compounding

Compounding Compounding Pharmacies Packaging FDA

ICH Q6(R1): test criteria and specifications

European Pharmaceutical Review

DECEMBER 23, 2024

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. EMA/CHMP/ICH/214732/2007. Internet] Vaccines Europe. EU Official Says ICH Q6B Is Outdated And Needs Revision. Internet] Regulatory Focus. cited 2024August]. Available from: [link] 4. Pharmaceutics. 2021; 13(1): 48. 22 June 2017. 3 February 2023.

Vaccines

Vaccines FDA

Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

The FDA Law Blog

FEBRUARY 4, 2025

With the current lapse in authorization, FDA may only award RPD PRVs for applications that have received an RPD designation before December 20, 2024, andunless reauthorized before thenmay not award any RPD PRVs after September 30, 2026. Below, we discuss some of its downstream impacts on the PRV landscape.

Vaccines

Vaccines FDA

Pharmacy Technician Pulse

First continuous mRNA manufacturing platform to be developed

Apellis set to take on Alexion as FDA clears PNH drug Empaveli

Trending Sources

Getting on with Rare Disease Therapeutic Options (Orphan Disease Therapies)

Record number of health firms feature in UK top 100 private tech list

A history of AstraZeneca

FDA-Approved Labeling: Is Enough Enough?

Dr B raises $8m for telehealth service to deliver COVID antivirals

Accommodating Multiple Modalities in the Same Facility

Acetaminophen interactions to avoid

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2003-2022)

Top 20 IPOs in Healthcare by Total Fund Value

Nine for 2023, part two: healthcare’s hard problem, the prognosis for diagnosis, and key new pharmacotherapy platforms

Contamination Trends & Proposed Solutions

ICH Q6(R1): test criteria and specifications

Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

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