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:

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Generics Bulletin

India Biosimilars Landscape

19 Aug 2021

India leads the ways with the highest number of approved biosimilars.

Generics Bulletin

Dr Reddy’s Gears For Sputnik Light In India, Jab For Adolescents

By Anju Ghangurde 30 Jul 2021

Dr Reddy’s is to press ahead with India filing plans for single-dose COVID-19 vaccine Sputnik Light and also expects to “build on” the Russian partner’s trial in adolescents of the two-dose Sputnik V. The company also pilots a partnered first-of-its-kind cashless digital health offering.

Generics Bulletin

Indian Leaders Begin Unique Collaboration On Molnupiravir

By Akriti Seth 01 Jul 2021

Major Indian pharmaceutical companies including Cipla, Dr Reddy’s, Emcure, Sun and Torrent have entered into a first-of-its-kind collaboration to jointly sponsor, supervise and monitor the clinical trial of the investigational oral anti-viral drug molnupiravir to fight against COVID-19 in India.

Generics Bulletin

Aspen Faces Vaccine Setback In South Africa As Strides Explores Oral COVID Treatment

By Akriti Seth 22 Jun 2021

After a production setback, Aspen and Johnson & Johnson announce a donation of 300,000 vaccines to South African teachers. Strides partners with Ennaid for an oral COVID drug, while Dr Reddy’s, Lupin, Cipla and Sun Pharma Partner with Eli Lilly for baricitinib in India and Formycon receives approval for early action for its COVID-19 drug.

Generics Bulletin

Overseas API Manufacturing Identified As Key Vulnerability In US Supply Chain

By Akriti Seth 16 Jun 2021

After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.

Generics Bulletin

New COVID-19 Vaccine Patent Database Launched

By Ian Schofield 11 Jun 2021

As part of its drive to maximize global access to coronavirus vaccines, the Medicines Patent Pool has developed a publicly accessible resource giving information on the patent status of approved and candidate vaccines.

Generics Bulletin

Celltrion Opens Up Canadian Market For Remsima SC

By David Wallace 08 Jun 2021

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Celltrion has pushed into another new market with its Remsima SC subcutaneous version of infliximab, launching the innovative biosimilar in Canada.

Generics Bulletin

Industry Steps Up To Help India Through Second Wave

By Akriti Seth 28 Apr 2021

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

By David Wallace 22 Apr 2021

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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

By David Wallace 06 Apr 2021

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

By Dean Rudge 18 Mar 2021

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

By David Wallace 18 Jan 2021

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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

By David Wallace 29 Nov 2020

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

By Anju Ghangurde 27 Nov 2020

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

27 Nov 2020

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

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