Generics Bulletin l Pharma Intelligence

How it helps
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.

How it works
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.

Start a free trial

Generics Bulletin

India Biosimilars Landscape

12 Oct 2021

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

Generics Bulletin

EU’s Health Emergency Response Plans Must Address Existing Flaws

By David Wallace 17 Sep 2021

GB2109_EU_Flag_COVID_Coronavirus_2BD8JRX_1200

The EU’s creation of a Health Emergency Response Authority to deal with future health threats has been welcomed by off-patent industry association Medicines for Europe. However, the organization pointed out current policy and regulatory weaknesses that must be addressed if HERA is to be successful.

Generics Bulletin

MPP Celebrates First UMIC Dolutegravir Shipments

By David Wallace 14 Sep 2021

GB2109_Azerbaijan_Belarus_flags_2DMGYB5_1200

The Medicines Patent Pool has announced that the first shipments of dolutegravir under a fresh agreement covering upper-middle-income countries have reached Azerbaijan and Belarus.

Generics Bulletin

Alkem Delivers Strong Quarter With Domestic Recovery

By Akriti Seth 14 Sep 2021

GB2109_Graphs_Up_Arrows_Blue_Yellow_Green_TAWEXE_1200

India’s Alkem has delivered a strong quarter with a boost in its domestic business on the back of “strong volume-led growth in the acute therapies and faster than market growth in chronic therapies.” However, the company saw a slight YoY decline in the US.

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

GB2106_Canada_Open_Door_Flag_DYRCJR_1200

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

GB2104_Europe_Connections_Map_Space_2A9CJEX_1200

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