pharmaphorum

APRIL 27, 2021

Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies. A similar trial called Impassion131 of Tecentriq with regular paclitaxel flopped, and even suggested patients treated with paclitaxel alone may have fared better.

Chemotherapy 90

Chemotherapy Documentation Drug Development 90

European Pharmaceutical Review

SEPTEMBER 22, 2022

11 have recently conducted an analysis of international HTA submissions from 2011-2019 to determine the acceptability of single arm clinical studies and ECs as part of the drug reimbursement process. 2011 May; 46(3): 399–424. Patel et al. Multivariate Behav Res. doi: 1080/00273171.2011.568786. Available at: [link].

Drug Development 122

Drug Development Pharmaceutical Companies Pharmaceutical Companies Documentation 122

pharmaphorum

NOVEMBER 27, 2020

The deal was agreed well before Teva bought Cephalon in 2011 for $6.8 In a statement the EU said the scheme prevented generic competition for Provigil, which is used to treat narcolepsy, after its main patents expired. billion and involved a complex series of transactions instead of an up-front payment.

Packaging 52

Packaging Documentation 52

pharmaphorum

JANUARY 12, 2023

For example, there were 12 HCV infections associated with an emergency department nurse at a hospital in Washington in 2018, and 25 gram-negative bacteremia infections in 2011 that emerged in Minnesota.

Hospitals 105

Hospitals Documentation 105

FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. In contrast , the two previous withdrawals, Makena in 2023 and Avastin in 2011, took 30 months and 11 months, respectively. All in all, the new expedited procedures took about 7 months from proposal to withdrawal.

Documentation 59

Documentation Labelling Drug Development 59

GMPSOP

JUNE 9, 2024

Additional documents included each month. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. gown qualification).

Method Validation 52

Method Validation Documentation Health and Personal Care Stores Labelling 52

pharmaphorum

DECEMBER 29, 2022

The case revolves around allegations that Novartis made an agreement in 2011 with Par Pharmaceutical when Exforge (valsartan/amlodipine) was nearing the end of its patent life that was designed to keep Par’s generic version of the drug off the market until 30 September, 2014.

Specialty Pharmacies 52

Specialty Pharmacies Documentation 52

European Pharmaceutical Review

FEBRUARY 1, 2024

Even though patients are on existing [statins] that are well-documented and most likely safe and effective, there are many patients who still have cardiovascular disease, the leading cause of death” We are recognising now is that there is great data on how to reduce risk by applying lipid lowering therapy like statins.

Documentation 97

Documentation Diabetes Pharmaceutical Companies Pharmaceutical Companies 97

pharmaphorum

FEBRUARY 26, 2021

That period was preceded by several years in which the price of nortriptyline had been rising dramatically, with NHS spending on the drug escalating from just over £6 million in 2011 to £38 million in 2015.

Documentation 52

Documentation 52

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 Compounding 103

Pharmacy Joe

FEBRUARY 5, 2025

Because serum creatinine laboratory assays were not standardized until 2011, the results of previous formulas, including Cockcroft Gault, cannot be generalized to patients today. Your lab’s creatinine assay is different than the one used to study pharmacokinetics and make the prescribing information’s renal dosing recommendations.

Hospitals 52

Hospitals Inpatient Documentation 52

Syner-G

AUGUST 9, 2022

In 2011, following referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a small development stage pharmaceutical company located in the United Kingdom to assist them with pre-IND activities for a new chemical entity for the treatment of asthma. Authored the client’s Pre-IND Briefing Document.

Documentation 40

Documentation Pharmaceutical Companies Pharmaceutical Companies 40

RX Note

MARCH 14, 2023

Document the antimicrobial therapy in the patient's medical record or medication chart, including the indication and the intended duration of therapy before further review or cessation. Example of patients with altered pharmacokinetics (e.g. fluoroquinolones and glycopeptides.

Medical Records 52

Medical Records Hospitals Documentation 52

pharmaphorum

SEPTEMBER 13, 2022

The first well-documented case of multiple myeloma was reported in 1844 by renowned British surgeon Samuel Solly. This research paved the way for the first successful treatment of a patient with acute lymphoblastic leukaemia in 2011. 1844 – First reported case of multiple myeloma. 2012 – The 100,000 Genomics Project begins.

Chemotherapy 98

Chemotherapy Immunization Immunity Documentation 98

FDA Law Blog: Biosimilars

MAY 11, 2023

No reasonable jury could have concluded that the carved-out labeling for petitioner’s generic carvedilol from 2007-2011 was itself evidence of intent to induce infringement.” Plainly, the Government brief states “The decision below is incorrect. GSK filed a supplemental brief in response to the Government’s brief.

Labelling 72

Labelling Documentation Communication 72

pharmaphorum

FEBRUARY 2, 2021

In 2011, government officials in Germany introduced legislation called the Arzneimittelmarkt-Neuordnungsgesetz (Act on the Reform of the Market for Medical Products, or AMNOG), which allows payers to assess products in accordance with evidence-based methods and weigh-up clinical benefit against budget impact.

Documentation 65

Documentation 65

Pharma in Brief

DECEMBER 3, 2023

The amended Regulations promote faster litigation, including provisions for mandatory case management, early discovery of key documents, limits on interlocutory appeals, and a requirement that parties act diligently or risk having the statutory stay shortened or extended. 2011 FC 239 , at para. More efficient? 1] Bayer AG v.

Biosimilars 52

Biosimilars Dosage Documentation 52

Ramblings of a pharmacist

FEBRUARY 16, 2022

It’s a well-thought through survey document, but I still have uncertainties about how to answer some of the questions – a part asks how many prescriptions were filled with brands and how many with generics. It’s an invaluable document, even if it isn’t perfect. How much were they?).

Independent Pharmacies 52

Independent Pharmacies Compounding Specialty Pharmacies Prescription Filling 52

The Thyroid Pharmacist

DECEMBER 7, 2022

Breast milk and in-utero transmission have also been documented as a means for exposure and concern. [13]. 2011 Jan;119(1):A11. Published May 2011. Published May 2011. While some flame retardants have been banned in the U.S. Endocr Connect. 2018;7(4):R160-R186. [2] 2] Birnbaum LS, Bergman A. Environ Health Perspect.

Health and Personal Care Stores 80

Health and Personal Care Stores Labelling Immunization Immunity 80

The Thyroid Pharmacist

MARCH 31, 2023

There are many well-documented side effects of antidepressants and benzodiazepines, ranging from the rare but serious – suicidal ideation/action, homicidal ideation/action, and even death – to the very common – brain fog , weight gain , sexual dysfunction , and feeling disconnected from reality Magnes Res. 2016;29(3):120-125. doi:10.1684/mrh.2016.0411

Immunization 105

Immunization Immunity Dosage Documentation 105

The Thyroid Pharmacist

JULY 14, 2023

This group also performed a randomized, larger placebo-controlled trial of 43 patients in 2011. Remission of Hashimoto’s thyroiditis in a twelve-year-old girl with thyroid changes documented by ultrasonography. The remainder also saw an improvement toward normalization, reaching near-normal values. 2010;20(10):1187-1190.

Dosage 98

Dosage Immunity Immunization Documentation 98

Putting Patients First Blog

JANUARY 10, 2024

Addressing the critical issue faced by States and consumers, the previous policy, which required States to defray the cost of benefits mandated after December 31, 2011, but not subjecting some benefits included in EHB-benchmark plans to defrayal requirements, led to confusion and operational challenges. Retrieved from https ://w ww.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Diabetes 40

The Thyroid Pharmacist

JULY 29, 2022

Feel free to use my own health timeline as a guideline to document your health journey. Published September 12, 2011. As you add your symptoms to a health history timeline, reflect on what season it was when your allergy or thyroid symptoms worsened. Accessed October 30, 2020. Paul Pestano. Environmental Working Group.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Immunity 52

Pharmacy Friday Pearls

AUGUST 29, 2022

mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET. 2011 Consecutive case series (n=12) Patients included if toxicology service was present to participate in management. Greene et al., units/kg/hr) Euglycemia was maintained using 5-10% dextrose infusions. Holger et al.,

Packaging 52

Packaging Documentation 52

Putting Patients First Blog

SEPTEMBER 9, 2024

These codes facilitate proper documentation and reimbursement, ensuring that health care providers are fairly compensated for the critical services they offer. The NHC supports the increased utilization of Z-codes to document social risk factors as part of the PIN services. American Journal of Public Health , 108(9), 1167-1170.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Documentation Vaccines Communication 40

The Thyroid Pharmacist

DECEMBER 1, 2023

Vitamin D deficiency has been documented in Hashimoto’s, Graves’ disease, thyroid cancer, as well as postpartum thyroiditis. [13] 11] Research has also shown that vitamin D actively prevents the development of autoimmunity in animal models. [12] 13] One study in Turkey found that 92 percent of Hashimoto’s patients were deficient in vitamin D!

Immunization 98

Immunization Immunity Diabetes Dosage 98

STAT

FEBRUARY 10, 2025

He pitched the synthetic biology company he had founded in a tiny basement lab in 2011, touting what he considered striking new evidence of Absci’s ability to create brand-new antibodies with artificial intelligence.  Morgan Healthcare Conference.

Documentation 360

Documentation 360

Pharmaceutical Technology

JANUARY 6, 2023

This class-action litigation specifically focused on a 2011 licensing agreement between the two companies. According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”.

Documentation 97

Documentation Hospitals Dosage Drug Pricing 97

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. 2011 May;20(3):225-39. [11] Please do consult with your doctor when taking any new supplements; this is especially true for one with so many contraindications. Published 2019 Dec 9.

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Diabetes Immunization Immunity 98

The Thyroid Pharmacist

NOVEMBER 8, 2024

Leaky gut has been documented in a number of autoimmune diseases (and we know it is considered a requirement in someone developing Hashimoto’s), including rheumatoid arthritis, inflammatory bowel disease, celiac disease, multiple sclerosis, ankylosing spondylitis, nonalcoholic steatohepatitis, and IgA nephropathy. [75] Published 2020 Nov 1.

Immunization 72

Immunization Immunity Diabetes Adverse Reactions 72