pharmaphorum

SEPTEMBER 21, 2020

AstraZeneca may have had a rough ride following a safety scare with its COVID-19 vaccine, but the company’s busy pipeline is producing successes in other areas. Lynparza was the first PARP (poly (ADP-ribose) polymerase) drug on the market in 2014, first approved in the US for ovarian cancer. months versus 17.7

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European Pharmaceutical Review

JUNE 27, 2023

Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines. Since these fresh FDA approvals for microbiome-based therapies, regulatory pathways are becoming clearer and opening new perspectives for companies.

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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.

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PharmaShots

MAY 23, 2023

Stock Exchange: TYO With focus areas extending to the discovery and development of biopharma products, AnGes is dedicated to developing genetic medicines and therapeutic vaccines for intractable or rare diseases. The company's cell therapy portfolio contains a US FDA-approved StrataGraft. Total Revenue: $1.9B

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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.

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ISPE

MAY 9, 2023

Jaguar Gene Therapy is building a $125 million facility in RTP to manufacture adeno-associated virus (AAV)-based gene therapies, Beam Therapeutics is constructing an $83 million plant to develop precision medicines, and IQVIA, a CRO, opened an innovation lab in the park in 2021, focusing on bioanalytics, vaccines, biomarkers, and genomics.

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PharmaShots

FEBRUARY 21, 2023

In Aug’21, the US FDA cleared QSam’s IND application for CycloSam. In Jun’21, the company initiated the evaluation of FAP-2286 in a P-I/II clinical trial (LuMIERE) following the US FDA’s IND clearance. In Sep’21, the US FDA granted DUNP19 an ODD for Osteosarcoma.

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ISPE

SEPTEMBER 11, 2023

Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” www.fiercepharma.com/manufacturing/sanofi-pumps-554m-into-new-vaccine-manufacturing-facility-eastern-france 41 Boccard. New Project: Evolutive Vaccines Facility for Sanofi.” www.boccard.com/evolutive-vaccines-facility-for-sanofi/ 42 Amgen.

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PharmaShots

JANUARY 31, 2023

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. LP-310, another lead asset of the company received FDA Type-B Pre-IND guidance recently for Oral Lichen Planus. Founded Year: 2014 No.

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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. to the revenue.

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ISPE

AUGUST 29, 2022

In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. The FDA has also offered both early dialogue and training to share knowledge and experience with the industry, providing an excellent example for other regulators to follow.

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The Checkup by Singlecare

JULY 31, 2024

Gardasil 9 isn’t just for girls and women; boys and men can benefit from this vaccine too. In 2014, the Food and Drug Administration (FDA) approved Gardasil 9 for females between the ages of 9 and 26 and males between the ages of 9 and 15. Given these updates, many people are now eligible for the vaccine.

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PharmaShots

MARCH 22, 2023

As per the terms of the agreement, Immunomedics received an up front payment of $65M and would have been eligible to receive $60M in regulatory milestones upon the approval of sacituzumab govitecan by the US FDA to treat mTNBC. As per the transaction, Bavarian received an up front payment of $10M and $33M in up front equity investment.

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pharmaphorum

FEBRUARY 19, 2021

A global emergency stockpile of Ebola vaccine is being deployed to curb the epidemic, although experts are confident that synergies in public health practises will ensure a rapid response to both. During the 2014-2016 Ebola outbreak, Guinea was one of the worst impacted countries and saw more than 2,543 deaths.

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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.

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