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Latest From Heidelberg Pharma AG
Biotech’s Next Goal: ‘Addressing Resistance’ In The ADC Space
George Badescu, chief business officer at Heidelberg Pharma, discusses antibody-drug conjugate development, partnership styles and the appetite for risk-taking in the biopharma industry.
Lupin: Glad To Have Dodged Humira Bullet, Lucentis Biosimilar Closer As Phase III Trials Succeed
Lupin’s CEO highlights market access strategy as a key tool to ensure biosimilars success in the US while being relieved the company didn’t launch a Humira biosimilar. She also mentions Amazon and Mark Cuban have not upset market dynamics for generics in the US and a Lucentis biosimilar is closer to a global launch post Phase III trial success
Genetic Metabolic Diseases AC's First Meeting Will Be Long On Temporary Voting Members
The US FDA’s Genetic Metabolic Diseases Advisory Committee will comprise three regular voting members and 13 temporary members, including some adcomm veterans, when it reviews Zevra Denmark’s arimoclomol for Niemann-Pick disease type C.
Decoding Regulatory Agency Decisions: The Case of Amylyx’s Relyvrio/Albrioza In The US And EU
Relyvrio/Albrioza, Amylyx’s ill-fated treatment for amyotrophic lateral sclerosis, was approved for marketing by the US Food and Drug Administration but rejected by the European Medicines Agency. The Pink Sheet explores how the two agencies applied the available regulatory flexibilities and the impact of other factors, such as regulatory precedence and patient influence, on decision-making.
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Pharmaceuticals
- Radiopharmaceuticals, Contrast Agents
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Biotechnology
- Large Molecule
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- Heidelberg Pharma Research GmbH
- Wilex AG
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