Pazopanib

GSK and Novartis Complete $16 Billion Asset Swap Deal, Reshaping Both Companies' Strategic Focus

8 days ago

• GlaxoSmithKline and Novartis have completed their $16 billion asset swap deal, with GSK exchanging its oncology portfolio for Novartis's vaccines business, while also creating a joint consumer healthcare venture. • Analysts question GSK's decision to exit oncology—a high-growth therapeutic area where its portfolio showed 32% growth in 2014—while Novartis is praised for strengthening its position in the lucrative cancer market. • The strategic realignment allows both companies to focus on core strengths, with GSK concentrating on respiratory, HIV, vaccines and consumer healthcare, while Novartis enhances its prescription medicine portfolio with particular emphasis on oncology.

FDA Breakthrough Therapy Status Emerges as Game-Changer for Oncology Drug Development

3 months ago

• FDA's Breakthrough Therapy designation offers accelerated approval pathways for promising oncology drugs, potentially reducing development timelines to just 3 years and extending patent life. • The new designation has shown particular promise in oncology, with the majority of the first 10 breakthrough approvals being cancer drugs, demonstrating significant market advantages over traditional orphan drug status. • Companies like Pharmacyclics and Genmab have seen immediate positive market response, with stock prices jumping 10-13% following breakthrough designation announcements for their cancer drugs.

Real-World Data Supports Efficacy of Opdivo Plus Yervoy in mRCC Treatment

4 months ago

A recent study highlights the real-world effectiveness of Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for patients with intermediate- or poor-risk advanced metastatic renal cell carcinoma (mRCC), showing promising overall survival and progression-free survival rates.

Aurobindo Pharma's Biosimilar Bevqolva Receives MHRA Approval for Cancer Treatment

5 months ago

• CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has secured MHRA approval in the UK for Bevqolva, a biosimilar of bevacizumab, expanding cancer treatment options. • Bevqolva is indicated for multiple cancers, including metastatic colorectal cancer, non-small cell lung cancer, renal cell carcinoma, cervical cancer, and ovarian cancers. • The biosimilar will be available as a 25 mg/mL concentrate in 4 mL and 16 mL single-use vials, administered intravenously, offering a cost-effective alternative. • This approval follows a positive opinion from the EMA's CHMP for Aurobindo Pharma's filgrastim biosimilar Zefylti, further strengthening its biosimilar portfolio.

FDA Approves New Pazopanib Formulation for RCC and Soft Tissue Sarcoma

6 months ago

• The FDA has approved a new 200 mg formulation of pazopanib tablets for advanced renal cell carcinoma (RCC) and soft tissue sarcoma (STS). • This approval is based on demonstrated bioequivalence and therapeutic equivalence to the reference pazopanib (Votrient). • Pazopanib was previously approved for advanced RCC in 2009 and advanced STS (post-chemotherapy) in 2012. • The new formulation, developed by Eugia Pharma Specialties Limited, is expected to launch in Q4 2025.

Aurobindo Pharma's Eugia Pharma Receives USFDA Approval for Generic Pazopanib Tablets

6 months ago

• Eugia Pharma Specialities, a subsidiary of Aurobindo Pharma, has secured USFDA approval to manufacture and market Pazopanib Tablets (200 mg) in the US. • The generic drug is therapeutically equivalent to Novartis' Votrient and is indicated for advanced Renal Cell Carcinoma and Soft Tissue Sarcoma after chemotherapy. • The product is slated for launch in Q4FY25, with an estimated market size of $106 million for the 12 months ending October 2024. • This marks the 179th ANDA approval for Eugia Pharma Specialities Group, which specializes in oncology oral and sterile products.

Adaptimmune Announces U.S. FDA Acceptance of Biologics License Application for Afami-cel

a year ago

Adaptimmune Therapeutics plc has announced the U.S. FDA's acceptance for priority review of its Biologics License Application for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarcoma, marking a significant step towards offering a new treatment option for this condition.