Generics Bulletin l Pharma Intelligence

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A comprehensive and dependable information source available to ensure that industry leaders can stay on top of the latest regulatory, legal, market and commercial developments to anticipate potential threats and identify new opportunities.

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A broad network of global expert analysts and journalists you can rely on to provide valuable news and insight from tracking market events and their impacts from around the globe, to help you understand the potential impact of developments and trends on your business. Plus, access to exclusive interviews with key opinion leaders and market movers for insiders-knowledge to keep you ahead of the competition.

Analysis and opinion covers key topic areas such as:

Regulatory and compliance changes
Legal and legislations advances
Competitive developments
Merger and acquisition activities
New product launches
Marketing challenges
Advertising strategies, and more.

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Generics Bulletin

Industry Steps Up To Help India Through Second Wave

As India sees a consistent rise in daily cases and deaths due to COVID-19, the off-patent industry is stepping up to make drugs affordable and available. Zydus Cadila is seeking approval for virafin, while Natco has applied for molnupiravir approval. Vaccine production and availability has also come under focus.

Generics Bulletin

European Biosimilars Can Benefit From Sharing Experiences

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Attendees to Medicines for Europe’s virtual summit on biosimilars heard how learning from experiences across Europe can allow individual countries to build a toolbox of policies to help create a sustainable biosimilars market.

Generics Bulletin

FDA Guides On Generic Development During COVID-19

Guidance published by the US FDA in the form of a question-and-answer document addresses questions from ANDA applicants about generic drug development during the COVID-19 pandemic.

Generics Bulletin

Pfizer Breaks With Biosimilars In China Through WuXi Bio Deal

Pfizer has announced plans to put a lid on its biosimilars programs in China, while agreeing the sale of its manufacturing site in Hangzhou.

Generics Bulletin

FDA Guides On Bioequivalence Studies And COVID-19

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Guidance on protecting participants in bioequivalence studies during the COVID-19 pandemic has been published by the FDA.

Generics Bulletin

EU Reforms Must Heed Pandemic Lessons

Reforms set out by the European Commission to better prepare the EU for future health crises must heed key lessons learned from experiences of the COVID-19 pandemic, such as the benefits of digitalization, Medicines for Europe has urged.

Generics Bulletin

Glenmark Debuts Favipiravir For COVID-19 In India

Glenmark has received the go-ahead in India for and launched its low-priced favipiravir product for mild to moderate COVID-19 under an accelerated approval process.

Generics Bulletin

Generics Industry Experiences Extraordinary First Quarter Due To COVID-19 Crisis

Coronavirus-induced stockpiling and advanced prescribing of medicines has resulted in generics companies across the world registering unprecedented growth during the first quarter of 2020. However, many companies predict sales will level off again in the next quarter and beyond. And as demand fluctuates following the COVID-19 outbreak, companies have started taking precautionary measures to avoid supply-chain disruptions.

Generics Bulletin

EU Sees Drug Shortage Risk From COVID-19 Second Wave

A second wave of COVID-19 infection later this year would put even greater pressure on drugs used in patients hospitalized with serious respiratory problems, a new report warns.

Generics Bulletin

European Industry Played Key Role In Mitigating COVID-19

In the first part of an exclusive two-part interview, James Burt – Accord’s executive vice-president for Europe, the Middle East and North Africa – talks to Generics Bulletin about the key actions taken by the generics industry to mitigate the coronavirus pandemic, and the changed landscape that the off-patent arena can expect to see in future.

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COVID-19 Infographic

Access the infographic below which explores the number of treatment drugs for COVID-19 currently in clinical trials or in development, events including progress updates, partnerships, regulatory and trial announcements etc, and the number of articles published on COVID-19 as of March 3, 2020. This data has been tracked and reported via Informa Pharma Intelligence’s clinical, regulatory and commercial data and analytics, and news and insight tools including Biomedtracker, Trialtrove, Pharmaprojects, Scrip, Pink Sheet, Medtech Insight, and Generics Bulletin etc.

Generics Bulletin

Coherus Is Confident After US Ranibizumab Filing

Having seen its development partner Bioeq file with the FDA in December last year, Coherus is confident that it will be a leader in the US biosimilar ranibizumab market targeting Lucentis.

Generics Bulletin

Celltrion's Remsima SC Ready For Early 2020 Launch

Celltrion says it is ready to roll out its Remsima SC subcutaneous infliximab in Europe in the first quarter of 2020, after receiving a formal pan-European marketing authorization from the European Commission.

Generics Bulletin

California Plans To Create Own Generics Label

California’s 2020-2021 fiscal budget includes plans to work with manufacturers to establish the state’s own generics label. But industry is sceptical that the initiative will deliver the savings that the US state hopes for.

Generics Bulletin

Biocon’s Malaysia Insulin Facility Hit With 12 FDA Observations

The US FDA has slapped Biocon with a dozen observations over three units at its insulin manufacturing facility in Malaysia, but the Indian biotech firm says the problems can be remedied quickly and that US launch plans are on track for its insulin product glargine challenging French drug-maker Sanofi’s multi-billion-dollar Lantus.

Generics Bulletin

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