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Featured Stories


 

People Round-Up: Dipharma And Xellia North America Get New Heads

Dipharma appoints a new CEO, Xellia gets a new commercial head in North America, promotions are made at Lek, GVK Bio and the APhA, while appointments are seen at Auris Medical and Tris Pharma.

Appointments Strategy International

Generium And Selexis Debut Dornase Alfa In Russia

Generium is claiming the launch of the world’s first biosimilar version of Roche’s Pulmozyme after receiving approval for dornase alfa in Russia.

Biosimilars Launches Regulation
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NEW from CMIC: Tailoring Bioanalytical Testing In A New Era Of Drug Development

With unrelenting pressure to enhance the speed, efficiency and cost-effectiveness of drug discovery and development, companies need to be confident their Bioanalytical testing is not only tailored to these translational goals, but delivers added value in an environment in which scientific innovation, commercial imperatives and unmet patient needs are rapidly transforming the drug-development paradigm.

Read the Whitepaper

Embedding Time-Critical Scheduling in Drug Production

Manufacturing is the engine room of the pharmaceutical industry. Ultimately, a medicine has little value if it does not reach patients on schedule, in the required quantity and quality. Download this whitepaper which discusses time-critical scheduling in drug production.

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Commercial Explore this Topic

Laurus Buys Way Into South African ARV Tenders

India’s Laurus Labs is aiming to supply antiretrovirals through South Africa’s public tender system after agreeing a deal to buy Aspen Pharmacare’s Phekolong Pharmaceuticals subsidiary.

Deals South Africa

Biocon Joins March Into China With CMS

Biocon has joined the march of Indian firms into China, tying up with Chinese firm CMS to sell three generic formulations in the world’s second-largest drug market.

Strategy Deals

CC-Pharming And iBio Expand Chinese Rituximab Venture

A year after their initial tie-up, US plant-based tech firm iBio Inc. and China’s CC-Pharming Ltd are expanding their collaboration on developing a plant-derived bio-better rituximab candidate for the Chinese market.

Deals Biosimilars

Zentiva Buys Sanofi's Ankleshwar Site

Zentiva has struck a deal to acquire a manufacturing site in Ankleshwar, India, from its former parent company Sanofi.

Deals Manufacturing

Samsung Bioepis Targets Brazil With Brenzys

Samsung Bioepis has entered a fifth continent by launching its Brenzys etanercept biosimilar in Brazil, as part of global expansion plans for the business.

Biosimilars Launches

Strides Grows In Central Europe Through Fairmed Deal

Strides Pharma Science has acquired a majority stake in Swiss generics firm Fairmed Healthcare in a move to bolster its presence in central Europe. The acquisition marks the latest in a string of transactions by the Indian firm.

Deals India
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Policy & Regulation Explore this Topic

Lupin’s ProAir Rival Has 'Moved Ahead' Despite CRL

Lupin is staring at stretched launch timelines in the US for its generic ProAir following a Complete Response Letter, but the company maintains that its application has progressed and the market opportunity for the product remains attractive.

Regulation Generic Drugs

Brand-Backed Body Bemoans British Columbia’s Biosimilars Boost

A body supported by biologic originators has attacked British Columbia’s move to switch Crohn’s and colitis patient to infliximab biosimilars, even though the resulting savings will be invested in patient care.

Canada Biosimilars

US Patent Reform Would Raise Drug Costs

By weakening ways to challenge drug patent thickets, proposed legislation to reform US patent law would extend brand monopolies and increase spending on medicines, the Association for Accessible Medicines is warning.

Intellectual Property Legislation

FDA Guidance Tackles Citizen Petition 'Shenanigans'

Final guidance published by the US FDA on citizen petitions seeks to put an end to the originator ‘shenanigans’ of using petitions to delay competition.

Regulation Generic Drugs

FDA Guidance Targets Over 50 Products

More than 50 product-specific guidances for generic drug development have been published by the FDA, comprising 34 new and 19 revised documents.

Generic Drugs Regulation

Interchangeability Is Inherent To Biosimilarity

Interchangeability should be seen as a scientific concept rather than a therapeutic choice of biosimilar or reference biologic, Spanish physicians argue in a journal article.

Biosimilars Regulation
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Generic Drugs Explore this Topic

Lupin’s ProAir Rival Has 'Moved Ahead' Despite CRL

Lupin is staring at stretched launch timelines in the US for its generic ProAir following a Complete Response Letter, but the company maintains that its application has progressed and the market opportunity for the product remains attractive.

Regulation Generic Drugs

Shortlist Revealed For Industry Awards

Shortlists for each of the 14 categories in the Global Generics & Biosimilars Awards 2019 have been announced, after our panel of expert judges considered almost 100 entries.

Generic Drugs Biosimilars

US Patent Reform Would Raise Drug Costs

By weakening ways to challenge drug patent thickets, proposed legislation to reform US patent law would extend brand monopolies and increase spending on medicines, the Association for Accessible Medicines is warning.

Intellectual Property Legislation
See All

Biosimilars Explore this Topic

Brand-Backed Body Bemoans British Columbia’s Biosimilars Boost

A body supported by biologic originators has attacked British Columbia’s move to switch Crohn’s and colitis patient to infliximab biosimilars, even though the resulting savings will be invested in patient care.

Canada Biosimilars

Shortlist Revealed For Industry Awards

Shortlists for each of the 14 categories in the Global Generics & Biosimilars Awards 2019 have been announced, after our panel of expert judges considered almost 100 entries.

Generic Drugs Biosimilars

US Patent Reform Would Raise Drug Costs

By weakening ways to challenge drug patent thickets, proposed legislation to reform US patent law would extend brand monopolies and increase spending on medicines, the Association for Accessible Medicines is warning.

Intellectual Property Legislation
See All

Value-Added Medicines Explore this Topic

Shortlist Revealed For Industry Awards

Shortlists for each of the 14 categories in the Global Generics & Biosimilars Awards 2019 have been announced, after our panel of expert judges considered almost 100 entries.

Generic Drugs Biosimilars

US Study Lends Support To Polypill Proposals

Fixed-dose polypills containing commonly available generic cardiovascular agents could cut risks in low-income populations within the US, a randomized clinical trial suggests.

Cardiovascular Clinical Trials

Awards Judges Weigh Record Number Of Entries

Judges for the Global Generics & Biosimilars Awards 2019 are weighing a record number of entries this year, ahead of the shortlists for each of the 14 categories being announced on 20 September.

Generic Drugs Biosimilars
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