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Limited Japan Nod For Cytori’s Osteoarthritis Cell Therapy

 
• By Ian Haydock

Japan's well-defined regulatory framework for cell and regenerative therapies has notched up another "win" with the limited-use approval of a product for knee osteoarthritis, which should also generate useful new revenues for originator Cytori.

US venture Cytori Therapeutics Inc. has won limited approval in Japan for its Cytori Cell Therapy for restricted commercial clinical use in knee osteoarthritis, marking another feather in the cap of the country's efforts to expedite the availability of cell and regenerative therapies, and a new revenue stream for the loss-making San Diego-based company.

Nasdaq-listed Cytori's adipose-derived regenerative cell (ADRCs) therapy will initially be available for this use only through the Tokyo Osteoarthritis Clinic...

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Zydus Looks To Ride gIbrance Exclusivity Wave; GLP-1 Battle-Ready With Differentiated Pen

 
• By Vibha Ravi

Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.

Asia Deal Watch: Lupin Picks Sandoz To Market Lucentis Biosimilar In Parts Of EU And Asia

 
• By Joseph Haas, Sushmita Panda, Xu Hu, Vibha Ravi, and Manas Mishra

Also deals involving Xspray/Handa, Fosun/Expedition, Kaken/Astria, Orchid/Allecra, Sanofi/Visirna, KKR/Healthcare Royalty Partners, Viridian/Kissei, Sandoz/Evotec, Dx&Vx, Dr. Falk/Allianthera, Madrigal/CSPC and Lilly/LTZ.

Japan Results Roundup: Reduced Forex Impact, Uncertain US Tariff Outlook

 
• By Lisa Takagi

Most major Japanese firms report generally positive fiscal first quarter results, led by mainstay growth and despite lower currency effects. But the future impact of any US pharma tariffs remains an overhang.

Lupin Confident Of US Growth On Tariff Mitigation, Rides High On Tolvaptan

 
• By Vibha Ravi

Lupin is hoping moves like intellectual property transfer for some products to the US will help mitigate the tariff impact even as it counts on growth from planned launches of GLP-1s and biosimilars while riding high on tolvaptan launched in Q1.

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Finance Watch: Did Mid-Summer Usher In A Mega-Round Comeback?

 
• By Mandy Jackson

Private Company Edition: Hatteras Venture Partners now has more than $900m under management. Also, in recent $100m-plus VC rounds, Strand Therapeutics raised a $153m series A, ARTBIO revealed a $132m series B and Minghui Pharmaceutical secured a $131m pre-IPO round.

Tonix Ready To Revive Fibromyalgia Market With Tonyma

 
• By Joseph Haas

The first new drug for fibromyalgia since 2009, Tonyma is a reformulation of cyclobenzaprine intended for chronic therapy. Tonix said the drug targets non-restorative sleep.

AstraZeneca Launches At-Home Flu Vaccine Amid Industry DTC Push

 
• By Alaric DeArment

The drugmaker announced the launch of an at-home version of its nasal FluMist vaccine, as more companies are looking into direct-to-patient drug sales in response to Trump’s most favored nation pricing proposals.