Pharmaceutical Technology

OCTOBER 5, 2022

These, along with other similar claims, meant Biogen owed potential damages of $1,036,900,151 to the US and the various States, as per court documents. In 2005, Biogen withdrew Tysabri from the market following a clinical trial that resulted in two participants contracting progressive multifocal leukoencephalopathy (PML).

Documentation 59

Documentation Pharmaceutical Companies Pharmaceutical Companies 59

Pharmaceutical Technology

OCTOBER 28, 2022

Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Biosimilars 52

Biosimilars Vaccines Drug Development Documentation 52

The Thyroid Pharmacist

MARCH 31, 2023

I had always been an outspoken, level-headed and calm person, but sometime in 2005, something called “new-onset anxiety” rocked my world. Anxiety was one of the most challenging and disempowering symptoms I experienced when I was first diagnosed with Hashimoto’s. I was scared. I couldn’t deal with life.

Immunity 105

Immunity Immunization Dosage Documentation 105

Board Vitals - Pharmacist

JANUARY 6, 2023

A one-time requirement of six credits for cultural competence is to be completed in addition to the 100 hour requirement for physicians licensed before March 24, 2005. Of the 40 AMA PRA Category 1 Credits , 2 shall be related to End-of-Life care. These credits may be included if licensed after this date.

Controlled Substances 59

Controlled Substances Documentation 59

European Pharmaceutical Review

JULY 13, 2023

5 When these medicines are prescribed to patients, we can use feedback from the real-world data that documents clinical outcomes, efficacy measures, patient-reported outcomes, and adverse events. 2005 Dec;146(7):913-5. Expert Review of Clinical Pharmacology. 2023 Mar 4;16(3):257-66. Mechoulam R. British journal of pharmacology.

Compounding 98

Compounding Drug Development Clinical Pharmacology Documentation 98

European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

Pharma in Brief

JANUARY 10, 2024

The Guidance was last updated in 2005. The Court now requires a declaration identifying documents with AI-generated content that are prepared for the purpose of litigation and submitted to the Court. The Guidance outlines the factors that contribute to rendering a message or activity promotional in nature.

Drug Pricing 52

Drug Pricing Documentation Biosimilars Vaccines 52

pharmaphorum

NOVEMBER 27, 2020

Although Teva and Cephalon are now the same company, the case dates back to June 2005 when the firms were separate entities. The deal was agreed well before Teva bought Cephalon in 2011 for $6.8 billion and involved a complex series of transactions instead of an up-front payment.

Packaging 52

Packaging Documentation 52

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

Along with the proposed order, FDA issued as a supporting document the “ Scientific Review Supporting Proposed Administrative Order ” in which it describes the scientific data on the efficacy, pharmacology, and safety of oral PE underlying its determination to issue the proposed order. a); OTC Monograph M012: § M012.20.

Pharmacy Management 111

Pharmacy Management Dosage Documentation 111

The Thyroid Pharmacist

JANUARY 20, 2023

Holy Basil ( Ocimum sanctum ) The anti-inflammatory effects of holy basil (also known as tulsi) have been documented in many in vitro and in vivo studies. Epub 2005 Oct 7; Costa CA, Tanimoto A, Quaglio AE, et al. Int J Ayurveda Res. 2010;1(1):37-40. doi:10.4103/0974-7788.59942 [57] Pinello KC, Fonseca Ede S, Akisue G, et al.

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Diabetes Immunity Immunization 98

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition.

Dosage 98

Dosage Documentation Diabetes Labelling 98

Pharmaceutical Technology

APRIL 27, 2023

Joe Makowiecki, business and product development leader for Enterprise Solutions at Cytiva, says the situation now reminds him of when single-use technology was in its nascency for monoclonal antibody (mAb) manufacture in 2005. “We There was a lot of cynicism and questions, like: ‘Why would you want to use single use?

Vaccines 52

Vaccines Drug Development Documentation Communication 52