The British pharma opens new innovation centers in San Diego and Cambridge, Mass., to connect with those academic, business and venture investment communities. Also, Roche and Biogen Idec make moves in neurodegenerative disease, Retrophin makes two deals for different forms of the same drug, and GSK makes the latest alliance in the cancer immunology arena.
GlaxoSmithKline PLC is following some of its big pharma peers to key innovation hubs in the U.S. by opening satellite R&D centers in San Diego and Cambridge, Mass.
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With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.
The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.
Two US FDA advisory committees will discuss results from epidemiological studies that attempted to quantify the prevalence, incidence and risk factors for misuse, abuse, overdose and death with opioid analgesics.
Employers and other health plan sponsors may need to push for better targeted reforms that lower cost sharing for patients.
FDA Commissioner Martin Makary's remarks that his special assistant Tracy Beth Høeg will "be involved in other approval procedures" besides Novavax's COVID-19 vaccine application could be a dramatic change in operations, potentially making the approval system unpredictable.
CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.
