Generics

In an acquisition said by both US-based companies to be highly complementary, Azurity Pharmaceuticals has taken control of Slayback Pharma for an undisclosed fee.

Ahead of the Global Generics & Biosimilars Awards, which are this year being held on Wednesday 25 October at the Hotel Porta Fira in Barcelona, we reveal our final shortlist of entrants across all 14 categories.

Despite winning a landmark multi-billion-dollar antitrust suit earlier this year, Gilead Sciences has seen a US court give an initial green light allowing it to shell out nearly $250m to settle antitrust claims from direct purchasers of its two major HIV drugs.

While it currently sits in fourth place, Amneal’s co-CEO Chirag Patel has laid out ambitions for the firm to become the number one supplier of affordable medicines in the US.

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.