Generics

Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.

Japanese originator Takeda has agreed to settle two-year-old anticompetitive claims lodged by wholesalers in the US that it conspired with several generics manufacturers to maintain supracompetitive pricing for its Colcrys branded treatment for gout.

With multiple generic molecules experiencing treble-digit-percentage price increases in the UK in August, betahistine tablets led the month’s biggest risers, according to WaveData.

Merger reviews could take into account sponsor's Orange Book behavior. FTC's statement does not detail what would make a patent listing 'improper' but the precedents from court cases against various sponsors should offer industry some guideposts.

Generics industry trade group Medicines for Europe has met with Ukrainian government officials to discuss how to plan for any future integration process.

Accord Healthcare has been told by the FDA that its generic version of Astellas Pharma’s Prograf capsules will no longer be automatically substituted for the brand following a series of post-approval studies dating back more than a decade.

Adcock saw its profits grow by 4.2% during FY 2024 despite a challenging economic environment.

Self-labelled ‘disruptor’ Mark Cuban has brought on board yet another high-demand prescription drug, following a recent deal for biosimilar Humira.

At an extraordinary general meeting held earlier today, Novartis shareholders gave the go-ahead for the spinoff of the Sandoz generics and biosimilars business, paving the way for a formal separation on 4 October.

The IGBA has welcomed Mexican pharmaceutical industry association ANAFAM as an associate member.

Iilun Murphy said Hatch-Waxman was written with immediate-release oral drugs in mind, not the complex generics becoming more popular today. The agency is evaluating the issue.

Now in its tenth year, the Global Generics & Biosimilars Awards has received a record-breaking number of entries in 2023. Judges are now evaluating the nominees ahead of our awards ceremony on Wednesday 25 October at the Hotel Porta Fira in Barcelona.

Amphastar is looking to tidy up its balance sheet after the company’s landmark acquisition of Eli Lilly’s Baqsimi (glucagon) emergency nasal spray.

Generic drug sponsors are on pace to submit the second-fewest number of ANDAs in a fiscal year in the history of GDUFA.

Amneal has marked its entry into China after receiving its first product approval in the market. Meanwhile, the firm has also outlined US approvals for two generics currently suffering from shortages.

After PEs, Torrent Pharma is speculated to be in the fray for a stake in Cipla. Experts weigh in on the contours of the product and cultural alignment of the two firms, should things move forward and also whether other Indian players could take a shot at the 'once in a lifetime opportunity'.