pharmaphorum

APRIL 21, 2021

Advair lost US patent protection in 2010 and exclusivity on the Diskus inhaler went in 2016 – but it took until February 2019 for the FDA to approve a generic from Mylan, now part of Viatris. The amendment was required because of enhanced packaging controls to meet new industry standards adopted since the filing.

Packaging 59

Packaging 59

Amber

SEPTEMBER 14, 2023

“The new Vitality program marks our latest advancement in transplant as we strive to support patients and their caregivers during the post-transplant period with a comprehensive package of services and resources to guide them in their recovery journey.” In 2016, Amber Specialty Pharmacy ranked highest for patient satisfaction among U.S.

Specialty Pharmacies 105

Specialty Pharmacies Medication Delivery Dosage Packaging 105

Eye on FDA

AUGUST 22, 2023

Second, a claim was made in the communication that OPDP said was not supported by the clinical studies section of the package insert. After all, back in 2016, the agency issued six letters in the month of December alone. First, while presenting the indication in the posting, there was no risk information included in the communication.

Communication 68

Communication Packaging Labelling 68

Pharmaceutical Technology

APRIL 5, 2023

The European Medicines Agency (EMA) has announced plans to expedite scientific advice and support the preparation of regulatory packages under its PRIority Medicines (PRIME) scheme. The PRIME scheme, launched in March 2016, gives applicants a number of exclusive benefits to help reach regulatory approval.

Drug Development 52

Drug Development Packaging 52

The Digital Apothecary

APRIL 26, 2019

This includes companies providing on-demand drug deliveries, alternative packaging solutions, or other personable entreaties to entice customers to get their medications filled at their location. The authors went back and analyzed much of the past data using previous methods to estimate costs in dollars and reflect inflation for 2016 prices.

Medication Therapy Management (MTM) 130

Medication Therapy Management (MTM) Communication Packaging Hospitals 130

Pharmaceutical Technology

NOVEMBER 21, 2022

According to the report, five member companies decided to decrease their investment in Japan between 2016 and 2017, four companies changed their investment targets between 2018 and 2020, and one company lowered the priority given to Japan after 2021.

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Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing 69

RX Note

JUNE 5, 2023

The Hidden Truth Studies have shown that the antineoplastic residues can be found be on the external packaging of both oral and IV drugs. Use a fit-tested N95 respirator for routine handling of hazardous drug if there is potential for inhalation of fine powders. A surgical mask does not offer respiratory protection.

Compounding 52

Compounding Packaging Hospitals Chemotherapy 52

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

Labelling 59

Labelling Packaging Documentation 59

European Pharmaceutical Review

DECEMBER 5, 2024

If not properly coated and packaged, Amoxicillin and Clavulanic acid tablets can degrade, leading to a loss of potency and therapeutic efficacy. Humidity control is critical during manufacturing and packaging. Handbook of Pharmaceutical Excipients (6th ed.). Pharmaceutical Press. Qiu Y, Chen Y, Zhang G G Z, Yu L, Mantri R V.

Packaging 52

Packaging Dosage Compounding 52

pharmaphorum

APRIL 11, 2022

If we are to move towards a value-based healthcare system, then we must utilise the power of both clinical trials data and real-world evidence, to produce the best possible data package for regulatory submissions. Between 2016-2019, she was the medical affairs therapeutic area lead in haematology for Janssen Oncology across the EMEA region.

Pharmaceutical Companies 115

Pharmaceutical Companies Pharmaceutical Companies Vaccines Packaging 115

pharmaphorum

NOVEMBER 16, 2020

She first joined the EMA in 2002 and filled a number of senior roles at the regulator including head of inspections, head of international liaison and head of international affairs before switching to the WHO in 2016.

Vaccines 64

Vaccines Packaging 64

Pharmaceutical Technology

NOVEMBER 21, 2022

According to the report, five member companies decided to decrease their investment in Japan between 2016 and 2017, four companies changed their investment targets between 2018 and 2020, and one company lowered the priority given to Japan after 2021.

Drug Pricing 52

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing 52

RX Note

JUNE 5, 2023

mg/mL oral suspensions extemporaneously compounded from tablets with three different vehicles and samples of each finished suspension were packaged in 120mL amber polyethylene terephthalate plastic prescription bottles and stored at 5 and 25°C in the dark. Sorption to PVC Container Regarding to clonazepam 0.1

Compounding 52

Compounding Labelling Packaging Hospitals 52

European Pharmaceutical Review

NOVEMBER 4, 2022

6 In March 2021, following a pre-NDA meeting, the company issued a release stating “[the company] has concluded that the clinical data package for Tesetaxel is unlikely to support FDA approval”, and the programme was subsequently terminated. Patient Preference and Adherence, 2016. Krohe M, Eek D, Mazar I, et al. Volume 10, pp.1609–1621.

Chemotherapy 98

Chemotherapy Hospitals Packaging 98

European Pharmaceutical Review

FEBRUARY 23, 2023

With Raman spectroscopy, the scattering efficiency is low, which means that the search for, and attempts to interpret, subtle spectral differences can sometimes be problematic, especially where there is background noise caused from other materials (either in the sample or from packaging) and because bacteria produce a relatively weak signal.

Labelling 121

Labelling Packaging Drug Development 121

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. The payload is packaged inside a dissolvable needle, loaded within a microsyringe that is attached to a folded, self-inflating balloon. Biologics represent an increasingly large part of the pharmaceutical industry.

Biosimilars 105

Biosimilars Diabetes Immunity Immunization 105

European Pharmaceutical Review

JULY 22, 2024

Tubing or parts should be visually inspected to ensure quality before being installed; eg, verifying package integrity, sterilisation cycle indicators and ensuring bonnets or muffs are secured on the end of tubing. It is important to ensure that the area in which materials are set down or handled is cleaned or is amenable to sanitisation.

Packaging 52

Packaging 52

pharmaphorum

MARCH 16, 2022

Moreover, no attendee data was available for physical symposia, whereas all virtual symposia packages provided full attendee metrics analyses. The University of California Santa Barbara (UCSB) has been developing and experimenting with an online, Nearly Carbon-Neutral (NCN) approach for conferences since 2016.

Communication 98

Communication Packaging 98

Pharmacy Friday Pearls

SEPTEMBER 23, 2022

The package insert for Kcentra® indicates dosing is to be based on both INR and weight, resulting in possible confusion and delayed time to administration of Kcentra®. Dosing According to Package Insert. Kcentra (prothrombin complex concentrate [Human]) [package insert]. Pre-treatment INR 2 – 3.9 with fixed dose INR ?2

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Packaging Hospitals 40

pharmaphorum

AUGUST 17, 2020

Since 2016, Joanna has led Tag’s client partnerships in the Financial Services sector in the US, providing dedicated creative production and strategic sourcing/print management services. The post What can pharma marketing learn from other regulated industries? appeared first on.

Communication 97

Communication Packaging Pharmaceutical Companies Pharmaceutical Companies 97

European Pharmaceutical Review

JUNE 24, 2022

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. It is too early to say because we have not seen the whole package of measures yet.

Compounding 105

Compounding Drug Development Drug Pricing Dosage 105

HealthPartners

MAY 6, 2021

According to Pew Charitable Trust, between 2014 and 2016, PBMs more than doubled the income they earned from spread pricing (markups on drugs) and fees from drug manufacturers. They may reclassify them as something else such as admin fees, market share fees, clinical program fees or data management fees. Where do drug rebates go?

Mail-Order Pharmacies 52

Mail-Order Pharmacies Drug Pricing Packaging 52

PharmaKinnex

AUGUST 23, 2022

The pharmaceutical industry of 2022 is very different from the space that we all knew in 2012, 2016, or even 2020. From whitespaces to vacant territories, PharmaKinnex puts you in touch with thousands of HCPs across the country—all for an affordable and cost-saving price package that will help your company grow. August 23, 2022.

Communication 52

Communication Packaging 52

The Thyroid Pharmacist

SEPTEMBER 6, 2023

They even have a trial package , so you can test their products out and see how they work for you! Published 2016 May 24. Skin Care : Annmarie Skin Care is a line of natural skin care products that you can trust because they use only herbs and extracts straight from nature in their purest form. 2010;20(7):755-761. doi:10.1089/thy.2010.1636

Health and Personal Care Stores 85

Health and Personal Care Stores Packaging Labelling Compounding 85

Fuld & Company Blog

APRIL 6, 2023

This was supposed to coincide with Tesla’s launch of its innovative Solar Roof shingles in 2016 following its acquisition of SolarCity, but these were not rolled out until 2018. This includes trading and microgrid packages. In 2015, it took this a step further by launching Tesla Energy and its residential 3.3

Packaging 52

Packaging 52

The Thyroid Pharmacist

AUGUST 19, 2022

MegaGuard and PyloGuard provide doses on the package. 2016; 16: 471. Published 2016 Jun 21. Note: Originally published October 14, 2016, this article has been revised and updated for accuracy and thoroughness. I suggest trying them individually, or using a combination of the three. 39,64-67). Bakathir HA, Abbas NA.

Health and Personal Care Stores 98

Health and Personal Care Stores Immunity Immunization Dosage 98

Fuld & Company Blog

JULY 31, 2023

A year later in 2016, he launched the smaller Powerwall battery systems for the domestic market, at the same time entering the solar roof market with the $2.6 For Genex, Tesla provides an effective turnkey and revenues maximizing solution in one package. billion acquisition of Solar City.

Packaging 52

Packaging 52

PharmaShots

MARCH 9, 2023

Other Affiliations: Angela is an active Board of Director member of the Pfizer Foundation (a charitable organization addressing global health challenges), European Federation of Pharmaceutical Industries and Associations (EFPIA), and UPS (the global leader in package delivery and supply chain logistics). and Banco Bilbao Vizcaya Argentaria S.A

Clinical Pharmacology 40

Clinical Pharmacology Immunity Immunization Pharmaceutical Companies 40

PharmaShots

MARCH 1, 2023

Multiple other adalimumab biosimilars are set to launch in the US in July 2023 In Sept 2016, Amjevita was the first adalimumab biosimilar to be approved in the US & is also available in the EU & Canada. One pricing will be a 5% discount below the current list price of Humira while the other pricing will be a 55% discount.

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Biosimilars Packaging Labelling 40

PharmaShots

APRIL 25, 2023

Founded Year: 2016 Total Employees: ~580 Headquarters: California, United States Market Cap: $3.4B Later in Dec 2022, Horizon initiated a P-I clinical trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of HZN-457. R&D Expenditure: $474.6M R&D Expenditure: $14.6B

HIV Treatment and Prevention Agents 40

HIV Treatment and Prevention Agents Diabetes Packaging Immunity 40

PharmaShots

JUNE 1, 2023

These new results reinforce our differentiating data package for PDC*lung01. The durability of response in all first-line stage IV (metastatic) NSCLC patients with partial response or stable disease is particularly encouraging and provides hope for this patient group where there is still a significant unmet need. 2015; Zhu et al.,

Immunity 40

Immunity Immunization Vaccines Health and Personal Care Stores 40

The Thyroid Pharmacist

JULY 29, 2022

Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating. Published 2016 Jul 19. Published 2016 May 24. 2016 Sep;124(9):1479-86. 2016 Sep;124(9):1479-86. 2016 Apr;26(4):504-11. Invest in a High-Quality Portable Air Filter.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

The Thyroid Pharmacist

MARCH 3, 2023

11] For insomnia : I like to recommend Epsom salt baths (one cup of salts per tub – follow package instructions, and don’t overdo it!), Please note: Originally Published in May 2016, this article has been updated for accuracy and thoroughness. and either magnesium citrate or magnesium glycinate at bedtime. 2014;12(3):44-64.

Health and Personal Care Stores 105

Health and Personal Care Stores Diabetes Dosage Packaging 105

The Thyroid Pharmacist

MARCH 10, 2023

Be sure to follow the package directions and your practitioner’s guidance to determine the right dosage for you. Published 2016 Jan 27. January 1997. Accessed January 25, 2023. link] [30] Kennedy DO. B Vitamins and the Brain: Mechanisms, Dose and Efficacy–A Review. 2016;8(2):68.

Health and Personal Care Stores 98

Health and Personal Care Stores Immunity Immunization Dosage 98

Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT. Time for change.

Drug Development 52

Drug Development Packaging Communication 52

GMPSOP

MARCH 6, 2025

Defects can be found in bulk products, during packaging and labelling activities, laboratory testing, warehouse storage conditions, etc. ISO 13485:2016 Medical Devices Quality Management System outlines specific requirements for rework procedures. The batch was successfully released for packaging and distribution.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Documentation Labelling Packaging 52

The Thyroid Pharmacist

MARCH 7, 2025

10] Its not only found in obvious sources like plastic containers and packaging, but also in the lining of canned foods and drinks, receipts, toys, electronics, and household items. When grocery shopping, try to purchase items that are packaged in glass and canned foods that are packaged with BPA-free lining. 2016;13(11):1153.

Health and Personal Care Stores 60

Health and Personal Care Stores Labelling Immunity Immunization 60