相关临床试验
4
4 进行中
药物批准
20
批准总数
监管机构
1
监管机构数
成立时间
N/A
进行中（未招募）
4
100.0%
- Alembic Pharmaceuticals Limited received final FDA approval for its generic methotrexate injection in two dosage strengths: 50 mg/2 ml multi-dose vials and 1g/40 ml single-dose vials. - The approved product is therapeutically equivalent to Hospira's reference listed drug and treats multiple cancers including acute lymphoblastic leukemia, osteosarcoma, and breast cancer. - The approval also covers autoimmune conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, and severe psoriasis, strengthening Alembic's presence in the US generics market. - This regulatory clearance supports the company's strategy of expanding complex injectable offerings in high-value therapeutic areas like oncology.
- The FDA quietly permitted more than 150 exempted products from officially banned foreign factories to continue shipping to the United States for over a dozen years to prevent drug shortages. - ProPublica's investigation revealed that most exempted drugs came from factories in India, with additional facilities in China and Hungary, despite dangerous manufacturing failures that led to import bans. - The agency did not regularly test these exempted drugs or proactively monitor safety reports describing products with foul odors, abnormal taste, or consumers experiencing unexplained health problems. - Several factories remain banned but continue receiving exemptions, while the FDA kept this practice largely hidden from the public without releasing a comprehensive list until now.
- Gland Pharma has received USFDA approval for Acetaminophen Injection (10 mg/mL) in 500mg/50mL and 1000mg/100mL bag formulations for pain management. - The injectable product is indicated for mild to moderate pain management in patients 2 years and older, and for moderate to severe pain when used with opioid analgesics. - With US sales of approximately $55 million for the twelve months ending February 2025, Gland Pharma plans to launch the product through a marketing partner soon.
• Pfizer has engaged Goldman Sachs to explore the potential sale of its hospital drugs unit, which generates approximately $500 million in EBITDA and focuses on antibiotics and sterile injectables. • The hospital drugs unit, established following Pfizer's $17 billion acquisition of Hospira in 2015, is being evaluated for divestiture amid pressure from activist investor Starboard Value to streamline operations. • This strategic move follows Pfizer's recent $3.26 billion stake sale in Haleon and comes as the company seeks to reduce its $61.5 billion long-term debt while responding to criticism over acquisition strategies.
• A Delaware district court has invalidated Astellas' key patent for Myrbetriq (mirabegron), their blockbuster overactive bladder medication that generated $1.35 billion in revenue last fiscal year. • Multiple generic versions of mirabegron have received approval, including from Zydus Cadila and Lupin Labs, though immediate launches are unlikely due to Astellas' planned appeal. • The patent invalidation adds to Astellas' upcoming revenue challenges, including recent Lexiscan generic competition and the anticipated 2027 US patent expiration of their top-selling drug Xtandi.
