Medicines For Europe Sets Out Trade Priorities

 
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As Medicines for Europe gears up for a pair of conferences in Brussels next week, the organization has set out trade policy recommendations to strengthen access to medicines and the competitiveness of EU manufacturing, in a seminar with representatives from the European Commission and member states.

Celltrion Reinforces Commitment To UK Biosimilars Market With New HQ

 
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Celltrion has reinforced its commitment to the UK by opening a new central operations hub in Uxbridge, while acknowledging that “major questions over the attractiveness of the market” need to be addressed to encourage development and ensure a sustainable environment for UK biosimilars.

‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
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England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

Tevogen Will House Generics Unit In Much-Expanded New Headquarters

 
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Tevogen is looking to accelerate its growth with a major expansion of its headquarters in Warren, New Jersey, more than doubling its footprint to centralize research and development, regulatory, and corporate functions. The new facility will support the company’s evolving initiatives.


Pipeline And Parent: Meitheal CEO Shea Talks Paclitaxel And What’s Next

 
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In an exclusive interview, Meitheal Pharmaceuticals CEO Tom Shea discusses the company’s oncology strategy following the recent launch of generic Abraxane, alongside discussion of complex injectables, the biosimilars pipeline, and how $300m in backing is fueling the company's next phase of growth.

Endo Offloads Paladin As Shareholders Approve Mallinckrodt Merger

 
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As it prepares to complete its $6.7bn merger with Mallinckrodt, Endo has divested its International Pharmaceuticals business – consisting primarily of Canadian specialty firm Paladin Pharma – to Knight Therapeutics.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

Beyond ‘Vanilla’ Generics: How Lupin Is Evolving To Stay Ahead Of The UK Competition

 
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As UK players face increasing competitive pressures on “vanilla” generics – including potential new market entrants from China – Ben Ellis, Lupin’s UK and Ireland general manager, explains how the company is focusing on more complex opportunities that require a hybrid generic and branded mindset.


Teva Continues Push Beyond Generics in Fosun Immunotherapy Tie-Up

 
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Teva has agreed to partner with China’s Fosun Pharma to develop TEV-56278, a targeted cancer immunotherapy, marking the next step in its continued pivot from its generics roots toward complex biologics and innovative oncology treatments. The deal covers key Asian markets, including mainland China, w

IGBA Asks G7 To Consider Access Issues

 
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The International Generic and Biosimilar medicines Association has set out three priority areas that it says should be considered by G7 leaders at the current summit in Alberta, Canada, as part of efforts towards ensuring access to health.

Big Top-Level Shifts At Sun: Ganorkar Is MD, Ex-Takeda Exec To Helm US Business

 

Sun’s founder hands top job to company longtimer Kirti Ganorkar as the firm implements a “structured and forward-looking” succession plan, while Richard Ascroft will lead the Indian drugmaker’s North America business.

‘I Saw An Unpolished Diamond’: Iconovo CEO Wäborg On Breaking Even In 2027 And Beyond

 
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In an exclusive interview, Iconovo CEO Johan Wäborg outlines the company’s strategy to become a leader in dry powder inhalation by focusing on platform development, reformulated therapies, and B2B licensing, with a plan to break even by 2027.


Lupin Looks To Expand In China With Respiratory Alliance

 
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Lupin is planning to expand its footprint in China through a deal for a tiotropium dry powder inhaler with local player Sino Universal Pharmaceuticals.

Outlook Launches Ophthalmic Bevacizumab In Germany And The UK

 

Outlook Therapeutics has started to conquer European markets with its ophthalmic version of bevacizumab. Meanwhile, across the pond in the US, it awaits the FDA’s decision, again.

Welch Heads Up Par Ahead Of Planned Spin-Off After Endo-Mallinckrodt Merger

 
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As Endo and Mallinckrodt continue to work towards consummating the merger they announced earlier this year, the pair have revealed further organizational details of their combined generics and sterile injectables business, which is set to be spun off after the merger is complete.

Reshaped Xbrane Allies With OneSource For Commercial Biosimilar Manufacturing

 
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Xbrane Biopharma is partnering with India’s OneSource Specialty Pharma to manufacture its biosimilars, including its much-delayed ranibizumab product Ximluci. The move follows a SEK240m funding round and strategic refocus on commercialization after divesting key R&D assets to Alvotech.


Hyloris Secures US Approval For Avenacy-Partnered RTU Tranexamic Acid

 
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After signing a deal with Avenacy at the end of last year, Hyloris has now announced the approval of its intravenous formulation of tranexamic acid, which is used as a hemostatic agent.

Regeneron Monitoring Eylea Biosimilar Closely Following Innovative Setbacks

 
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Regeneron says it is closely watching Amgen’s Pavblu 2mg aflibercept biosimilar, which is gaining traction via financial incentives to physicians as “the only differentiator” to its Eylea reference brand. Meanwhile, Regeneron is aiming to boost Eylea HD uptake amid regulatory setbacks.

Generic Drug Office’s Policy Staff Returning To US FDA

 

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

Stelara Biosimilar Sees Stada’s Specialty Sales Start Strong In Q1

 
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Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.