Generics
The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.
Private Company Edition: June’s eight $100m-plus venture capital rounds already outpace the seven each raised in March, April and May, including €255m ($274.2m) for ITM and $200m for Upstream, but while there were five $25m or less VC financings during the past week, mid-sized deals were lacking.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
The agency used a 10-year average with updated figures to calculate the FY 2025 PDUFA application fee and limit the impact of submission volatility, but still allowed GDUFA and BsUFA fees to skyrocket.
Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies and secure the supply of generics and biosimilars.
Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies and secure the supply of generics and biosimilars.
Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.
Reading Hikma’s press releases and other public documents made it “at least plausible” that a physician would look to prescribe Hikma’s generic Vascepa product for any of its indications, including the highly-valued, patent-protected cardiovascular indication, the US Federal Circuit decided, reopening a lawsuit against the generics firm.
In long-running litigation over perindopril ‘pay for delay’ settlements, appeals have been refused and certain earlier findings by Europe’s general court have been set aside in a fresh ruling by the Court of Justice of the EU.
Divisional patents remain a major barrier to market entry for generics in Europe, heard attendees to Medicines for Europe’s legal affairs conference in Dublin earlier this month.
The FDA followed the EMA’s lead and declared Synapse’s trials “unacceptable” forcing drug firms that used CRO’s services to repeat studies to regain therapeutic equivalence ratings.
While the European supplementary protection certificate manufacturing waiver was once seen as a triumph for the region’s off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe’s legal affairs conference in Dublin last week heard the latest.
US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.
Four years after pleading guilty plea generic price-fixing allegations, the former Sandoz US vice-president of business contracting and analytics, Hector Armando Kellum, will serve his sentence outside a jail cell and pay a fine.
The US FDA is eager for Congress to address critical factors contributing to chronic generic drug shortages, but elected officials often are more focused on special cases like obesity drugs and ADHD treatment where the answers are very different.
The US Court of Appeals for the Second Circuit afirmed a US district court decision to dismiss purchaser and payer claims linked to so-called “pay-for-delay” agreements with generics firms over nebivolol rivals to Bystolic.
After creating a list of anticipated product-specific guidances to be published for generic sponsors and increasing PSG production, public requests for the agency to write a PSG declined.
Pink Sheet reporter and editors discuss what an upcoming listening session means for the FDA’s advisory committee reform effort, the agency’s efforts to help clinical trial modeling and simulation, and the UK’s MHRA plan to use artificial intelligence to assist in drug reviews.
The European Parliament has voted for a deal agreed with the council of ministers to ensure polluters pay for cleaning up urban wastewater.
Similar to drug master files, MMFs would allow models to be reused, but critical issues, such as protection of proprietary information, still must be resolved.