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Third-Quarter Indian Results Roundup: Alkem, Neuland, JB, Zydus And Natco
Several Indian firms have posted growth in their financial third quarters ended 31 December 2018. Alkem’s International sales manage to offset a slide in its domestic turnover, Neuland picks up momentum despite the impact of raw material price increases, while a better product mix in India works in JB’s favor. Zydus obtains a raft of US product approvals and lays out its approach for generics and biosimilars across the globe, while Natco focuses on complex generics in Canada and Brazil.
E-Leaflets Could Benefit Both European Patients And Industry
By facilitating stock movements by enabling patients to access local-language product information digitally, plans to implement e-leaflets in Europe could also help to alleviate product shortages, the president of Medicines for Europe has suggested.
Sun Pharma Commits To Generic Investment But Admits It Is Not Attractive In Current Environment
Sun’s MD Dilip Shanghvi made the rather frank admission during the firm’s third-quarter earnings call, maintaining that generics is nevertheless an “interesting” business for the Indian major. In light of this outlook, Sun has continued its policy of withdrawing what it feels are “unviable” ANDAs from under FDA review.
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How to Drive Consistent and Long-Term Growth In the Off-Patent Pharma Arena
Read this new report which provides highlights from senior voices in the pharmaceutical and financial industry who participated in a roundtable in November at the House of Lords. Topics discussed include Brexit, moving up the value chain and much more.
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Commercial Explore this Topic
Glenmark Plans To Spin Out A US-Based ‘Innovation’ Business – And May Pull The Plug On Advair
Neuraxpharm Strengthens French Business By Appointing Brun As General Manager
European CNS specialist Neuraxpharm is set to enhance its position in the French market by appointing Pierre-Hervé Brun as general manager of its French affiliate. The firm has also strengthened its international identity by rebranding its Spanish subsidiary Qualigen to Neuraxpharm Spain.
Gedeon Richter Predicts Two-Year Wait To Refile Pegfilgrastim, But Teriparatide Is In The Wings
A timeline to refile, for a second time, its proposed biosimilar to Neulasta with the EMA and plans to launch its biosimilar to Eli Lilly’s Forsteo across the EU featured on Gedeon Richter’s full-year earnings call for 2018.
Bangladesh’s Beximco Sees Exports Boom As It Expands in North America
Indivior Sets Out Next Steps As It Braces For Suboxone Rivals
Indivior is exhausting all its options to try and stop the impending launch of US generic rivals to Suboxone from 19 February, including petitioning the country’s Supreme Court to intervene. But even if Dr Reddy’s and Alvogen do launch their versions next week, the originator is planning to combat them with an authorized generic.
ANDA Litigants Join Forces To Cut Costs And Cope With Competition
Generics firms challenging patents in the US are seeing benefits through teaming up, according to Kent Walker of Brinks Gilson & Lione.
Policy & Regulation Explore this Topic
FDA Guides On Pathway For Competitive Generic Therapies
Draft guidance on the approval pathway for competitive generic therapies (CGTs) has been published by the FDA in the agency’s latest move to advance generic drug competition.
Australia Pushes For Harmonization As ICH Paper Provides Framework
Deal On European SPC Manufacturing Waiver Is An Acceptable Compromise
A deal on the European SPC manufacturing waiver has been agreed by the European Council, Parliament and Commission, providing a concrete path for a Regulation to move forward, albeit with compromises on several key provisions. Meanwhile, the European off-patent and brand industries remain at odds over the benefits of the waiver.
Abilify And Vimpat Rivals Join France's Répertoire
Generic versions of brands such as Abilify, Flixotide, Sprycel and Vimpat have been added to France’s répertoire of generic equivalents by local medicines agency ANSM.
CHMP Knocks Back TLC’s Doxorubicin Hybrid
As the CHMP refuses to recommend granting approval for TLC’s doxorubicin hybrid, the committee within the EMA has given the nod to Teva’s Ajovy monoclonal antibody migraine remedy as well as two small-molecule generics from Krka.
Fresenius Nod In EU Adds To Crowded Adalimumab Market
Fresenius Kabi has become the latest firm to receive a nod for a European biosimilar rival to Humira, adding to an already crowded biosimilar adalimumab market.
Products Explore this Topic
Latest From Generic Drugs
Glenmark Plans To Spin Out A US-Based ‘Innovation’ Business – And May Pull The Plug On Advair
FDA Guides On Pathway For Competitive Generic Therapies
Draft guidance on the approval pathway for competitive generic therapies (CGTs) has been published by the FDA in the agency’s latest move to advance generic drug competition.
Australia Pushes For Harmonization As ICH Paper Provides Framework
Latest From Biosimilars
Glenmark Plans To Spin Out A US-Based ‘Innovation’ Business – And May Pull The Plug On Advair
Gedeon Richter Predicts Two-Year Wait To Refile Pegfilgrastim, But Teriparatide Is In The Wings
A timeline to refile, for a second time, its proposed biosimilar to Neulasta with the EMA and plans to launch its biosimilar to Eli Lilly’s Forsteo across the EU featured on Gedeon Richter’s full-year earnings call for 2018.
Amgevita Launch In Finland Is No Counterbalance For Remsima Loss, Orion Anticipates
Intensified competition and declining prices, coupled with a failure to scoop winner-takes-all tenders in certain Nordic markets, took a huge bite out of Orion’s biosimilars sales in 2018. Launching the first Humira biosimilar in Finland will not plug the gap, the company has stated.
Latest From Value-Added Medicines
CHMP Knocks Back TLC’s Doxorubicin Hybrid
As the CHMP refuses to recommend granting approval for TLC’s doxorubicin hybrid, the committee within the EMA has given the nod to Teva’s Ajovy monoclonal antibody migraine remedy as well as two small-molecule generics from Krka.
Basaglar Follow-On Insulin Booms For Eli Lilly
Amneal’s Stewart Chairs AAM Board
Amneal president Bob Stewart has been announced as chairman of the US Association for Accessible Medicines, alongside a raft of other appointments, as the AAM holds its annual meeting in New Orleans.
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