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Strategy Explore this Topic

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Bio-Thera Gets Chinese Nod To Proceed On Ustekinumab

China’s Bio-Thera Solutions has received approval from the country’s NMPA to launch a Phase I clinical study comparing the pharmacokinetics and safety of its proposed ustekinumab biosimilar to Johnson & Johnson’s blockbuster psoriasis drug Stelara, the latest in a string of the biotech company’s products to advance into clinical development.

Biosimilars China

Hikma And Civica Ship Eight Essential Injectables

Hikma and Civica Rx have announced the launch of a first wave of eight essential injectable medicines, including heparin, as part of a deal struck between the two firms earlier this year.

Launches Strategy

Amneal Takes Control Of AvKARE In US

Amneal has acquired a majority stake in manufacturer and wholesaler AvKARE, giving the firm access to the “large, complex and growing federal healthcare market.”

Deals Strategy
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Deals Explore this Topic

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Amneal Takes Control Of AvKARE In US

Amneal has acquired a majority stake in manufacturer and wholesaler AvKARE, giving the firm access to the “large, complex and growing federal healthcare market.”

Deals Strategy

Lannett Reports Insulin Glargine Trial Success

Lannett’s Phase I trial for biosimilar insulin glargine has met “all primary endpoints,” the company has announced. The rival to Sanofi’s Lantus is being developed by Lannett with partner HEC through a deal for which financial details have just been revealed.

Biosimilars United States

Gene Techno Collaborates With Kishi Kasei On Aflibercept

Gene Techno Science and Kishi Kasei have struck a deal to jointly develop a Japanese aflibercept biosimilar rival to Eylea.

Deals Biosimilars
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Manufacturing Explore this Topic

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Teligent Slammed By FDA Warning Letter

Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.

Manufacturing Compliance

Julphar Focuses On Quality As Carle Departs

As its CEO Jerome Carle steps down following a 67% slump in sales to date this year, UAE-based Julphar is hopeful of putting manufacturing problems behind it under a new management team.

Manufacturing Middle East and Africa

Data Integrity Remains Challenging For API Manufacturers

Data integrity issues were raised in many warning letters to active pharmaceutical ingredient manufacturers over the past four years.

Manufacturing Regulation
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Sales & Earnings Explore this Topic

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Julphar Focuses On Quality As Carle Departs

As its CEO Jerome Carle steps down following a 67% slump in sales to date this year, UAE-based Julphar is hopeful of putting manufacturing problems behind it under a new management team.

Manufacturing Middle East and Africa

Krka Sets Out Strategy In Multiple Markets

Krka has revealed its new growth strategy for 2020-2024, including growing through joint ventures, partnerships and acquisitions and focusing on European, central Asian and Chinese markets. At the same time, the Slovenian firm has reported that its sales jumped by 12% in the first nine months of 2019.

Business Strategies Strategy

Ophthalmics Are Next Frontier For Teligent

US niche generics player Teligent intends to use its expertise in topical and injectable drugs manufacturing to push into the North American ophthalmics sector.

 

Ophthalmic Business Strategies
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People Explore this Topic

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Cipla's COO Steps Down

Cipla’s global chief operating officer is leaving the company to pursue new interests, amid a spate of top-level exits that have marked the pharma sector in India in 2019.

Leadership Strategy

Neuraxpharm Expands Into Portugal

Neuraxpharm is aiming to expand in the Portuguese market with its first commercial launch lined up for December. Javier Mercadé will be heading up the southern European region comprising Italy, Spain and now Portugal.

Strategy Appointments

Endo Starts Search For Campanelli’s Successor

With Endo’s CEO Paul Campanelli intending to step down for personal reasons, the US brands and generics player’s board has started to look for external and internal candidates to take over.

Leadership Appointments
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