European Pharmaceutical Review

MARCH 14, 2023

In the judgment ‘Pharmacia & Upjohn SA vs Paranova A/S’ (CJEU judgment of 12 October 1999 in case C-379/97) 2 CJEU decided that BMS conditions apply also to the medicinal product rebranding. Four recent rulings on parallel imports In November 2022, the CJEU announced four rulings on the parallel import of medicinal products.

Packaging 98

Packaging Generic Medicine Labelling Pharmaceutical Companies 98

pharmaphorum

MARCH 14, 2022

For Sandoz, the acquisition gives it a technology platform in an area of the generic medicines market with a relatively high barrier to entry, as developing inhaled medicines poses “comparatively high technical complexity,” according to Sandoz chief executive Richard Saynor.

Generic Medicine 104

Generic Medicine Biosimilars 104

European Pharmaceutical Review

AUGUST 25, 2022

Meanwhile, Sandoz would leverage its strong brand and sustain its leading global position by continuing to invest in the key strategic areas of Biosimilars, Antibiotics and Generic Medicines. strength in technology platforms: Gene Therapy, Cell Therapy, Radioligand Therapy, Targeted Protein Degradation and xRNA.

Biosimilars 98

Biosimilars Generic Medicine 98

European Pharmaceutical Review

JANUARY 30, 2023

Four new medicines recommended for approval The CHMP recommended granting a marketing authorisation for Sotyktu (deucravacitinib) for the treatment of moderate to severe plaque psoriasis in adults. Sitagliptin/Metformin hydrochloride Sun (sitagliptin/metformin hydrochloride) for the treatment of type 2 diabetes mellitus.

Diabetes 96

Diabetes Generic Medicine 96

Express Pharma

JUNE 15, 2024

India, synonymous with the “pharmacy of the world” has rightfully earned the title, owing to its remarkable contribution in supplying 20 per cent of the global generic medicines, along with 60 per cent of the total vaccine demand worldwide.

Vaccines 111

Vaccines Generic Medicine 111

European Pharmaceutical Review

APRIL 3, 2023

The committee adopted positive opinions for three generic medicines: Dabigatran Etexilate Accord (dabigatran etexilate) for the prevention of venous thromboembolic events Lacosamide Adroiq (lacosamide) for epilepsy Sugammadex Adroiq (sugammadex) for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.

Vaccines 98

Vaccines Chemotherapy Generic Medicine Biosimilars 98

pharmaphorum

JANUARY 30, 2023

With the production of generic medicine being concentrated in China and India, the ability to flexibly influence the supply of generic medicine, which most antibiotics are, is relatively limited. Larger questions remain around the way in which to support manufacturers to invest in production capabilities for antibiotics.

Generic Medicine 104

Generic Medicine Packaging Labelling 104

European Pharmaceutical Review

FEBRUARY 2, 2023

This is long overdue as the current tender process has been one of the root causes for the decline in Europe’s essential medicines manufacturing due to the sole focus on price, to the exclusion of other factors like quality and sustainability of supply. Is localisation the answer for pharmaceutical supply chain resilience?

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Generic Medicine Packaging Documentation Pharmaceutical Companies 111

European Pharmaceutical Review

JULY 25, 2023

billion in 2022. The small molecule API market is influenced by several factors, including heightened R&D within the pharmaceutical sector, a growing prevalence of chronic illnesses and rising demand for generic medicines. This is a rise from $162.8 A compound annual growth rate (CAGR) growth of 5.9

Compounding 97

Compounding Generic Medicine Drug Development Diabetes 97

Quality Matters

JUNE 12, 2023

Complex generics: The need and challenges Generic medicines have benefited millions of Americans and saved trillions of dollars. Accounting for approximately 90% of prescriptions filled in the United States , generic medicines are essential to increasing patient access to important drug therapies.

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Generic Medicine Dosage Prescription Filling Diabetes 52

pharmaphorum

JANUARY 4, 2023

It looks like Astellas has been unsuccessful in its attempt to block Pfizer’s generic medicines unit Hospira from launching a copycat version of big-selling pharmacologic stress agent Lexiscan in the US. The drug was originally developed by CV Therapeutics – bought by Gilead in 2009 – and first launched in the US in 2008.

Generic Medicine 59

Generic Medicine 59

pharmaphorum

SEPTEMBER 26, 2022

Astellas has won a reprieve in its attempt to stop Pfizer’s generic medicines unit Hospira launching a copycat version of its pharmacologic stress agent Lexiscan in the US – but only for a couple of weeks. ” Hospira isn’t the only generics company trying to bring a version of regadenoson to the US market.

Generic Medicine 52

Generic Medicine 52

European Pharmaceutical Review

JULY 29, 2024

The treatment is already authorised in the US, Japan, China, South Korea, Hong Kong, and Israel, based on data from the worldwide Phase III Clarity AD study, of which results were published in November 2022. Tuznue (trastuzumab) for breast and gastric cancer.

Generic Medicine 52

Generic Medicine Biosimilars 52

pharmaphorum

MARCH 29, 2022

At the end of last year, Pfizer signed an agreement with The Medicines Patent Pool that allowed for its oral antiviral treatment candidate PF-07321332 to be produced and distributed to low- and middle-income countries.

Vaccines 95

Vaccines Generic Medicine 95

Express Pharma

MARCH 20, 2025

Over the past decade and more, Indias pharmaceutical sector has become the worlds largest supplier of generic medicines, with exports growing faster than the global average. This supported the industry to consistently and reliably maintain essential supplies in critical times such as the COVID-19 pandemic between 2020 and 2022.

Generic Medicine 66

Generic Medicine Dosage Packaging 66

Quality Matters

OCTOBER 24, 2023

is facing a shortage of medicines that have been the backbone of cancer treatment plans for decades. increased nearly 30% from 2021 and 2022, marking the highest level of shortages in five years, according to data from the American Society of Health-System Pharmacists. While novel cancer therapies offer hope to patients, the U.S.

Hospitals 52

Hospitals Generic Medicine Chemotherapy 52

Express Pharma

JULY 3, 2023

India is known as the ‘Pharmacy of the World’, as the generic medicine supplier for over 200 countries, both developed and emerging markets. A large presence of local players producing branded generics, along with lower price levels, has provided India with a unique opportunity. How poised are you to leverage them?

Biosimilars 95

Biosimilars Drug Development Generic Medicine Diabetes 95

Quality Matters

JANUARY 23, 2023

Omnibus Spending Law: Provisions Will Bolster Medicines Supply Chain Insights and Advanced Manufacturing Technologies Investments to create a more resilient medicines supply chain and prepare for future public health emergencies are among key provisions of the mammoth $1.7

Generic Medicine 52

Generic Medicine Pharmaceutical Manufacturing Biosimilars Communication 52

Pharmaceutical Technology

FEBRUARY 18, 2023

The company offers generic medicines and biosimilars through Sandoz. The company reported revenues of (US Dollars) US$51,742 million for the fiscal year ended December 2022 (FY2022), a decrease of 2.1% Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). over FY2021.

Diabetes 40

Diabetes Generic Medicine Biosimilars Immunity 40

Quality Matters

MAY 30, 2024

The USP Medicine Supply Map shows that 125 drug products were in shortage at the end of 2023, the highest number in a decade. And shortages are lasting longer than ever, with a 3-year average duration in 2023 compared to 2 years in 2022. drug shortages.

Generic Medicine 49

Generic Medicine Hospitals Vaccines 49

Quality Matters

JUNE 26, 2023

Complex generics: Are global regulators addressing the needs? The development of generic versions of innovator medicines is a global public health need. Food and Drug Administration. MAPP 5240.10. link] (accessed on June 12, 2023) 2 Daan J.A. Crommelin, Vinod P. Shah, et al. Government Accountability Office.

Dosage 52

Dosage Generic Medicine Labelling 52

Quality Matters

SEPTEMBER 15, 2023

For example, while some stakeholders may perceive PCM to be primarily for innovators and not for makers of generic medicines or biotech companies, it “can be for generic companies, biotechnology companies, and so on, and we have had engagements with generic drug companies in our emerging technologies program already,” Fisher said.

Generic Medicine 52

Generic Medicine Pharmaceutical Manufacturing Communication 52

Quality Matters

MAY 18, 2023

government’s fiscal 2023 funding bill , signed into law in December 2022, included a range of specific provisions to support medicines supply chain resilience, including those supporting development of AMT through creation of national centers of excellence. The supply of generic drugs has been unreliable for 15 years” in the U.S.,

Generic Medicine 52

Generic Medicine Pharmaceutical Manufacturing 52

Pharmaceutical Technology

MAY 3, 2023

In recent years, first generics have improved patient access to essential treatments and offered affordable treatment options for patients with multiple sclerosis, asthma, heart disease, diabetes, and even the flu. However, that percentage of multiple first generics is not very high—approximately 10.6% from 2001 to 2022.”

Generic Medicine 98

Generic Medicine Drug Development Communication Diabetes 98

Pharmaceutical Technology

DECEMBER 19, 2022

in 2022 to 1% in 2023 due to the “tightening of monetary and financial conditions”. Koerber-Walker discussed how the Inflation Reduction Act, introduced in 2022 , may benefit biologics companies’ funding plans going into the next year. Certain companies will struggle more than others with accruing investment from venture capital firms.

Pharmaceutical Companies 69

Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing Generic Medicine 69