As Congress works on an approval pathway for follow-on biologics, generic drug companies are jockeying for investors' attention. But given that most generic manufacturers may be ill-equipped to handle the development of follow-on proteins, some analysts think the real opportunity is where you'd least expect: inside Big Pharma and biotech.
Kate Rawson
Teva Pharmaceuticals CEO Shlomo Yanai makes some pretty big statements about the promise of follow-on proteins for the generic drug...
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The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.
New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.
50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.
