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Abbott Secures FDA Clearance and CE Nod for Amplatzer Piccolo Heart Device
Abbott has received US FDA clearance and CE Mark for its Amplatzer Piccolo Delivery System, the first device specifically designed to treat premature infants with Patent Ductus Arteriosus (PDA). The system enables precise placement of the Amplatzer Piccolo Occluder in infants, addressing a condition that affects around 20 percent of premature infants.
Novo Nordisk Seeks FDA Approval for CagriSema Weight-Loss Therapy
CagriSema 2.4 mg/2.4 mg is an investigational once-weekly injectable combining cagrilintide and semaglutide to target complementary obesity pathways. In the REDEFINE 1 phase III trial, patients with obesity or overweight achieved an average weight loss of 23 percent, reinforcing the company’s ongoing focus on innovation in obesity treatment.
ystral Opens Bengaluru Facility to Boost Mixing, Process Tech Capabilities
German mixing and process technology specialist ystral has expanded its footprint in India with the inauguration of a new facility in Bengaluru, significantly strengthening its regional operations.
Lupin Inks Exclusive Licensing Deal with Neopharmed for Plasil in Brazil and Philippines
Global pharmaceutical major Lupin Limited said its subsidiaries in the Philippines, Multicare Pharmaceuticals, and in Brazil, MedQuimica, have entered into an exclusive licensing agreement with Italy-based Neopharmed Gentili S.p.A. to market and promote the gastroenterology brand Plasil (metoclopramide) in their respective markets.
Nona Biosciences and Valink Partner to Advance Biologics Discovery
Nona Biosciences and Valink Therapeutics have partnered to advance biologics discovery by combining Nona’s Harbour Mice fully human antibody technologies, including heavy chain-only antibodies, with Valink’s LiliumX discovery platform to generate and screen thousands of novel drug candidates.
KEYTRUDA Plus Padcev Improves Survival Outcomes in MIBC
KEYTRUDA plus Padcev significantly improved survival and pathologic complete response rates in cisplatin-eligible patients with muscle-invasive bladder cancer when used before and after surgery.
Alembic Pharma Wins USFDA Approval for Travoprost Ophthalmic Solution
Alembic Pharmaceuticals has secured USFDA approval for its Travoprost Ophthalmic Solution, with the ANDA deemed therapeutically equivalent to the reference listed drug Travatan Z (0.004%) from Sandoz.
Senores Pharmaceuticals to Acquire Apnar Pharma and Five ANDAs
Senores Pharmaceuticals has entered into an agreement to acquire 100 percent equity in Apnar Pharma, along with a portfolio of five Abbreviated New Drug Applications (ANDAs), as part of its strategy to expand its footprint in regulated pharmaceutical markets.
Sathgen Therapeutics Expands Global Footprint with US Subsidiary Launch
Sathgen Therapeutics has expanded its global presence with the launch of a US-based subsidiary, appointing Dr Padmaja Ganpathy as Chief Executive Officer and Dr Sendurai Mani as Chief Scientific Officer to lead its next phase of growth and innovation.
Agilent Advances Sustainable Science with New India Refurbishment Centre
Agilent Technologies has inaugurated a new refurbishment centre in India, reinforcing its commitment to sustainable science and affordable innovation while enhancing customer engagement through an integrated, green-certified facility that also houses a dedicated education centre.
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