PharmaVoice

JULY 23, 2025

Despite past criticism of public health policies, Tidmarsh recently praised the FDA and said he’ll focus on boosting review efficiencies. But his history as a physician, academic, biotech entrepreneur and importantly, his blossoming ties to the FDA’s new band of leadership, were enough to land him a top post at the agency.

FDA

The Checkup by Singlecare

JULY 11, 2024

Food and Drug Administration ( FDA ), some common side effects include: Headache Nausea Increased appetite Trouble sleeping Weight gain Fatigue Fluid retention Acne Prednisone may also cause certain serious side effects. Prednisone might treat some of gout’s most frustrating symptoms, but it might also cause some minor side effects.

Dosage

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

ISPE

AUGUST 30, 2022

Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). It is considered a moderate change by the FDA (CBE30) and NMPA. This change ranges from a moderate change (CBE-30) by the FDA to a minor change not requiring prior approval by the WHO.

Documentation

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.

Vaccines

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

Pharmaceutical Companies

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

PharmaShots

MARCH 9, 2023

In addition to serving as Associate Editor-in-Chief of the IEEE Open Access Journal of Circuits and Systems, she has been an Associate Editor of IEEE Transactions on Biomedical Circuits and Systems since 2008. Designation: Global Head Previous company: Merck Global Vaccines (2 yrs. LinkedIn Total experience: 26 yrs.

Pharmaceutical Companies

Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

Packaging

pharmaphorum

NOVEMBER 16, 2020

In his final message as head of the EMA, Rasi said the number of COVID-19 drugs and vaccines being developed by pharma companies is “encouraging,” and pointing to the agency’s pivotal role “in reviewing the available data packages to ensure that our usual high standards of safety, efficacy and quality are achieved and upheld.”.

Vaccines

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. Abbott achieved substantial double-digit growth in 2008 with an inclined sale of 13.9%. compared to 2015.

Vaccines

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: 2008 No.

Vaccines

ISPE

OCTOBER 28, 2022

The conference focused on the ongoing development and growth in these technologies, and featured speakers on a broad range of topics, including advanced manufacturing and how lessons learned from COVID-19 vaccine development can apply to biologics development. Also having enough glass vials to put the vaccines in!

Vaccines

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

The Checkup by Singlecare

NOVEMBER 13, 2023

To help decrease the risk of shingles, Shingrix vaccine is FDA-approved for adults 50 and older. It is a two-vaccine series and significantly decreases the risk of a shingles outbreak. Antiviral medications such as Acyclovir ( zovirax ) and famciclovir are often prescribed.

Mayo Clinic

pharmaphorum

JANUARY 21, 2021

Agency veteran Dr Janet Woodcock is the new interim FDA commissioner appointed by president Joe Biden to replace outgoing Trump appointee Stephen Hahn. Woodcock has most recently been working with the Operation Warp Speed coronavirus vaccine and drug project started by the Trump administration.

FDA