FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

In brief, in regard to proof of identity, the seller must obtain sufficient information to identify and document the identity of the purchaser. Thus, such persons are subject to identification, recordkeeping, and reporting requirements. Also, a DEA Form 452 report must be electronically filed within 15 days after the order is shipped.

Controlled Substances 116

Controlled Substances Documentation 116

pharmaphorum

DECEMBER 29, 2022

The complaint claims that Par agreed not to launch its generic, in return for Novartis not launching a patent infringement suit and agreeing not to launch its own authorised generic of the drug until 30 March, 2015, giving Par a valuable six months to sell its generic unopposed in the market.

Specialty Pharmacies 52

Specialty Pharmacies Documentation 52

pharmaphorum

NOVEMBER 11, 2022

According to court documents, Cohen reached out in 2015 to Moshe Alafi, former general partner at Alafi Capital who he had known for decades – and his son Christopher Alafi, who is the firm’s capital director – to seek investment in Nuredis.

Documentation 113

Documentation 113

pharmaphorum

NOVEMBER 25, 2022

In review documents published ahead of the ODAC meeting, the agency took issue with what it described as marginal efficacy in clinical trials of the drug, high toxicity rates, and concerns about the dose selected for study. Spectrum licensed worldwide rights to poziotinib – excluding Korea and China – from Hanmi in back in 2015.

Documentation 98

Documentation 98

pharmaphorum

MARCH 23, 2021

Safety has been an issue throughout development and in 2012 the FDA put tanezumab on clinical hold because of a class-related issue with joint destruction, which was finally lifted in 2015. Tanezumab is now the most developed of the two remaining drugs in development in the NGF class, in pain caused by osteoarthritis.

Documentation 59

Documentation 59

Pharma in Brief

OCTOBER 29, 2020

These new consolidated FC Guidelines address many of the topics raised in the following earlier FC Notices to the Profession: Case management: Increased Proportionality in Complex Litigation before the Federal Court (June 24, 2015) ; Trial Management Guidelines (April 2017) ; Intellectual Property (experimental testing) (May 12, 2016) ; and.

Documentation 52

Documentation 52

pharmaphorum

FEBRUARY 26, 2021

From 2015 to 2017, when the cost of the drug was falling, the three suppliers exchanged information about prices, the volumes they were supplying, and Alissa’s plans to enter the market,” said the CMA.

Documentation 52

Documentation 52

Pulses

APRIL 4, 2023

In addition, utilizing CT assessments could help evaluate curricular changes and serve as documentation for the Accreditation Council for Pharmacy Education (ACPE) and Center for Advancement of Pharmacy Education (CAPE) outcomes that emphasize development of critical thinking skills in student-pharmacists. Approved January 25, 2015.

Doctor of Pharmacy 98

Doctor of Pharmacy Documentation 98

pharmaphorum

JULY 7, 2021

This ambitious document is a blueprint for how the UK can become a global hub for life sciences and, in turn, a science superpower. “Health and science have never been higher on the agenda and today’s vision document sets a clear ambition for the UK to lead the way. Today the Government publishes the Life Sciences Sector Vision.

Documentation 59

Documentation Vaccines 59

pharmaphorum

APRIL 20, 2021

NICE’s final appraisal document for Kesimpta will be followed by technology appraisal guidance (TAG) that will pave the way for NHS prescribing in England and Wales. Novartis took ownership of the drug in 2015. The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year.

Hospitals 111

Hospitals Documentation 111

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

According to documents in the PTO’s Patent Center, Lilly has not yet filed a response. FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615), and concern FDA’s July 23, 2014 Accelerated Approval of NDA 205858 and NDA 206545 for ZYDELIG (idelalisib) Tablets for different uses. Patent Nos.

Documentation 59

Documentation 59

RX Note

APRIL 16, 2023

In Malaysia, Bumiputera agents charge a fee of between 2-3% for passing tender documents from supplier to government. Additionally, many middlemen are involved in the drug supply chain , each taking a cut of the profits. Mark-up costs are added by both distributors and pharmacies.

Drug Pricing 40

Drug Pricing Documentation Pharmaceutical Companies Pharmaceutical Companies 40

pharmaphorum

JANUARY 4, 2022

Everything started to unravel however when a Wall Street Journal investigation in 2015 discovered that most of the tests Theranos claimed to perform on its analyser were actually being performed by standard blood-testing machines.

Documentation 52

Documentation Communication 52

Pharmaceutical Technology

AUGUST 26, 2022

Earlier this month, the World Health Organisation (WHO) released a new guidance document with a strategic plan to counter TB on a national level. This guidance is in line with the WHO’s End TB Strategy, which aims for an 80% fall in worldwide TB incidence and a 90% decrease in TB deaths by 2030, compared with 2015.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation 98

ID Stewardship

APRIL 13, 2023

In 2015 a National Action Plan for Combating Antibiotic Resistant Bacteria was released, known as CARB. The most recent CARB addresses the years 2020-2025, building upon the initial one released in 2015. The latest antimicrobial stewardship regulations from The Joint Commission went into effect in January 2023.

Hospitals 94

Hospitals Inpatient Documentation Communication 94

pharmaphorum

JULY 27, 2022

These values have seen a year-on-year decline since 2016 for exports and 2015 for imports, in contrast with a general upward trend seen in most comparator countries, said the ABPI. In 2020, exports were valued at $25.9bn, placing the UK ninth out of 20 countries, and imports at $26.8bn, meaning a ranking of tenth out of 20.

Documentation 98

Documentation 98

Board Vitals - Pharmacist

FEBRUARY 5, 2020

between 2012 and 2015. The benefits offered by advanced level practitioners to practice is well documented as well. The study said, “Most of these specialists were advanced practitioners, physician assistants and nurse practitioners, delivering post-acute care.” or lower.”

Nursing Homes 52

Nursing Homes Hospitals Inpatient Documentation 52

Pulses

SEPTEMBER 26, 2023

Within PharmCas, applicants have the option to document a maximum of eight previous employments. Published 2015. One evaluating the communication skills that the student pharmacist exhibited while performing their scenarios and a second score that evaluated whether or not the clinical recommendations they made were correct.

Communication 59

Communication Hospitals Documentation 59

pharmaphorum

APRIL 16, 2021

The longer term impact of 2020 on clinical trial activity, given widely documented pauses on trials, will only be evaluable in coming years. We compared the cumulative number of New Active Substances entering each of the EU4+UK for the first time in 2020 with the average of the same measure in previous years – from 2015-2019.

Pharmaceutical Companies 95

Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 95

Pulses

MAY 25, 2023

While I was able to keep all documentation on Canvas, I had to constantly check submissions, which took a significant amount of time. Stylus Publishing ; 2015. Students seemed to appreciate the flexibility with using tokens, however keeping track of tokens and assignment resubmissions was challenging on my part.

Documentation 98

Documentation 98

Pharmacy Joe

NOVEMBER 17, 2021

They describe the evolution in 3 phases: In phase one, which began in early 2015, the following enhancements were made: 1. The electronic health record was updated to support the use of U-500 insulin multidose vials with insulin drawn in patient-specific syringes.

Hospitals 40

Hospitals Communication Inpatient Documentation 40

The Pharmacist Blog

MARCH 21, 2015

It is March and already my motivation to complete my goals for the year of 2015 has been waning. Even in this blog I document my goals and publicize them to hold myself accountable. It is strange how I felt so much energy and motivation to be productive in January. My energy overall seems to be declining each day.

Documentation 52

Documentation 52

Pharma in Brief

DECEMBER 3, 2023

These provisions were further amended in 2015 to clarify the level of product specificity required for combination drugs and formulations. Full actions (2017–present). The most significant amendments came into force in September 2017, when the Regulations were completely overhauled (discussed here ). More efficient?

Biosimilars 52

Biosimilars Dosage Documentation 52

GMPSOP

DECEMBER 28, 2022

Environmental monitoring is a documented program which describes the routine particulate and microbiological monitoring of processing and manufacturing areas. Additional documents included each month. Additional documents included each month. Table of Contents What is meant by environmental monitoring? Checkout sample preview s.

Documentation 52

Documentation Vaccines 52

Putting Patients First Blog

FEBRUARY 6, 2024

The economic contribution of university/nonprofit inventions in the United States: 1996-2015. autm.net/AUTMMain/media/Partner-Events/Documents/Economic-_Contribution_University- Nonprofit_Inventions_US_1996-2015_BIO_AUTM.pdf 16 Lanahan, L., The Review of Economic Studies, 86(1) , 117-152. Retrieved from https ://w ww. Graddy-Reed, A.,

Communication 40

Communication Documentation Drug Development 40

The Digital Apothecary

MAY 11, 2018

My Years as an Assitant Professor Luckily (sarcasm) part of going up for promotion includes creating a document a couple hundred of pages long detailing what you did. So a lot of the past few years are fresh in my mind and by annual activity, reports are useful just to document my experiences.

Hospitals 130

Hospitals Documentation 130

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Subpart A – General Provisions Subpart A – General Provisions, incorporates by reference ISO 13485:2016 and Clause 3 of ISO 9000:2015 (new § 820.7), and requirements for a quality management system (new § 820.10). The new § 820.10 Under § 820.45, FDA also requires manufacturers to inspect labeling and packaging for accuracy.

Labelling 59

Labelling Packaging Documentation 59

pharmaphorum

OCTOBER 30, 2022

The two groups were also separated by a sizeable time difference, with data from the control group ranging between 1990 and 2015, while Study 03-133 started enrolling patients in 2004. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

Documentation 52

Documentation Labelling Immunity Immunization 52

Pharmacy Joe

AUGUST 27, 2023

Augmented renal clearance is well-documented in trauma patients , especially those under the age of 50. A 2015 review article found that there is a clear association between ARC and subtherapeutic antibiotic concentrations as well as literature suggesting worse clinical outcomes.

Inpatient 52

Inpatient Documentation 52

Pharmacy Joe

AUGUST 27, 2023

Augmented renal clearance is well-documented in trauma patients , especially those under the age of 50. A 2015 review article found that there is a clear association between ARC and subtherapeutic antibiotic concentrations as well as literature suggesting worse clinical outcomes.

Inpatient 52

Inpatient Documentation 52

The Thyroid Pharmacist

JUNE 16, 2023

Black seed oil has likely been used as a medicinal herb for 3000 years or more, and its use has been documented in Ayurveda, Unani, Tibb, Siddha, and other systems of medicine. [4] 2015; 95-96: 138-58. Interestingly, the Arabic phrase for black seed oil, “Hibbatul barakah,” means “the seed of blessing.” Pharmacological Research.

Diabetes 111

Diabetes Dosage Compounding Immunity 111

pharmaphorum

MARCH 5, 2021

Teva’s Copaxone patent expired in Europe in 2015 and the Commission said it will investigate whether the company broke antitrust rules by defending the drug’s market position after the expiry. Now the European Commission has opened an investigation to see whether Teva acted illegally by blocking competition for Copaxone in the EU.

Documentation 98

Documentation Communication Hospitals 98

pharmaphorum

OCTOBER 29, 2020

Since 2009 the agency has added further charged-for services; in 2015 NICE added the Office for Market Access (OMA). For PRIMA, the agency quotes Peter Wheatley-Price, market access and pricing director at Takeda UK, who said : “The Takeda team highly regarded the quality of the PRIMA reports and model review documentation.

Documentation 101

Documentation Drug Development 101

The Thyroid Pharmacist

MARCH 31, 2023

I know I’m not alone in this, as 18 percent of people with Hashimoto’s who took my 2015 survey reported that they had lost a loved one before their Hashimoto’s diagnosis, and other clients have reported losing loved ones as significant exacerbating factors. and anxiolytic medications like benzodiazepines (Ativan, Xanax, etc.).

Immunity 105

Immunity Immunization Dosage Documentation 105

pharmaphorum

SEPTEMBER 13, 2022

The first well-documented case of multiple myeloma was reported in 1844 by renowned British surgeon Samuel Solly. The monoclonal antibody first received FDA approval in November 2015 as a monotherapy for patients with multiple myeloma, marking it as the first CD38-directed antibody to receive regulatory approval to treat the disease.

Chemotherapy 98

Chemotherapy Immunity Immunization Documentation 98

European Pharmaceutical Review

JANUARY 16, 2023

He warned, “Implementation of a CCS will require more than writing documents.”. He is a member of the 2015‑2020 USP Microbiology Committee of Experts where he takes a leadership role in the area of modern microbiology methods. He questioned how regulators will enforce revisions to Good Manufacturing Practice (GMP) regulations.

Vaccines 124

Vaccines Research Laboratories Documentation Compounding 124

Pharmacy Joe

OCTOBER 25, 2020

Augmented renal clearance is well-documented in trauma patients , especially those under the age of 50. A 2015 review article found that there is a clear association between ARC and subtherapeutic antibiotic concentrations as well as literature suggesting worse clinical outcomes.

Inpatient 40

Inpatient Documentation 40