Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning.

Development 242

Development Bioequivalency Generic Drugs Production 242

Drug Discovery World

AUGUST 22, 2023

This will continue to be the case going forward, but the nature of the off-patent landscape will evolve in line with ongoing changes in the segment’s ‘pipeline’: the originator products of today, which will become the generic and biosimilar medicines of tomorrow. There is significant need for more cost-effective generic versions.

Production 52

Production Bioequivalency In-Vivo In-Vitro 52

pharmaphorum

JUNE 8, 2021

Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharma companies, and gives tips for companies navigating this enormous market. At the same time, lots of people with experience at multinational pharmaceutical companies have chosen to return home.

Marketing 105

Marketing Drugs Regulation Development 105

pharmaphorum

SEPTEMBER 9, 2022

Pharma companies are “highly vulnerable” to the effects of climate change, due to their reliance on global networks. To meet the growing demand and market opportunity, a pharma company must ensure it has the resources, capacity, and supply chain to grow.”. Vulnerability . Making plans is not enough.

Production 104

Production Pharma Companies Generic Drugs Contamination 104

pharmaphorum

JULY 28, 2022

Logistical challenges of getting the right materials in the right place remain two years after the pandemic began, causing significant drug shortages to end-users. Many of the medicines most badly affected by these shortages are generic drugs to treat common conditions such as diabetes and heart disease.

Compliance 110

Compliance Drugs Manufacturing Generic Drugs 110

Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. This looks like it may change shape in the future for the region, if the proposal put forward by the commission is adopted.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

Drug Discovery World

AUGUST 8, 2023

In the global pharmaceuticals market, India ranks third worldwide for production by volume and the domestic pharmaceutical market is expected to reach US$120-130 billion by 2030 1. Similarly, The Times of India says that branded generic medicines have “long fuelled India’s pharmaceutical exports” 4.

Research 52

Research Drugs Genome Genomics 52

Pharmaceutical Technology

DECEMBER 15, 2022

Inflation at its current levels poses a major threat to generics production and usage. Since the summer, generics makers have been signalling that additional support for help with rising costs is required to keep generics production viable. Inflation can damage production viability of European drugs.

Medicine 246

Medicine Manufacturing Pharma Companies Production 246

Pharmaceutical Technology

SEPTEMBER 23, 2022

For pharma and biotech companies, there are many advantages to partnering with a Contract Development and Manufacturing Organisations (CDMO): they can access more specialized knowledge, state-of-the-art equipment, and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market.

Manufacturing 147

Manufacturing Drugs Production Packaging 147

World of DTC Marketing

JANUARY 31, 2021

So where to start… Congresswoman Porter may want to look at the percentage of generic drugs available virus branded (89%). I have worked with and stayed in contact with some R&D people within pharma and they have a different answer. In pharma R&D returns have declined to 1.8 percent—a slight decrease of 0.1

In-Vivo 187

In-Vivo Generic Drugs Gene Therapy Drugs 187

pharmaphorum

MARCH 5, 2021

The European Commission has formally opened an antitrust investigation into Teva, which will assess whether the pharma company illegally delayed launches and use of generic versions of its blockbuster multiple sclerosis drug Copaxone.

Drugs 98

Drugs Sales Pharma Companies Generic Drugs 98

Pharmaceutical Technology

AUGUST 12, 2022

In principle, the deal could create new opportunities for British pharma companies – not least the chance to work under a more supportive regulatory framework. Among the negative effects that have been reported are supply chain disruptions, skills shortages, issues around market authorisation, and added costs for pharma CMOs.

Medicine 290

Medicine Production Generic Drugs Regulation 290

pharmaphorum

AUGUST 20, 2020

.” This is the latest in a string of legal troubles for the Israel-based pharma in the US, where it already faces lawsuits that it improperly marketed an opioid painkiller, and colluded with other pharma companies to fix the price of generic drugs.

Generic Drugs 114

Generic Drugs Sales Pharmacy Pharma Companies 114

Pharmaceutical Technology

MARCH 22, 2023

During the pandemic, the shortage of basic drugs such as paracetamol in key EU countries led to growing calls to push local drug manufacturing to ensure a smooth supply and to minimise shortages. Despite having large biopharmaceutical companies on home ground, the UK and France experienced major shortages and supply chain issues.

Production 263

Production Manufacturing Generic Drugs Drugs 263