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Generics

Set Alert for Generics

Hybrid Specialist Azurity Snaps Up Complex Generics Firm Slayback Pharma

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.

M & A Deals

Shortlist Revealed Ahead Of October Awards

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.

Generic Drugs Biosimilars

US Court Says Yes To Gilead’s Quarter Billion Dollar Settlement On Truvada, Atripla

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.

Legal Issues Deals

Amneal Outlines Ambitions To Become Leading Affordable Medicines Supplier In US

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.

Strategy Generic Drugs

US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage

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.

Manufacturing Generic Drugs

Takeda Pens Mid-Trial Settlement To Dismiss US Colcrys Antitrust Suit

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.

Legal Issues Deals

Betahistine Leads A Raft Of UK Rises In August

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.

Market Intelligence Pricing Strategies

FTC Set To Take Enforcement Action Against Drugmakers Over Orange Book Patent Listings

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.

Generic Drugs Enforcement

Generics Industry Preps For Potential Entry Of Ukraine Into EU

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

Ukraine Generic Drugs

Accord’s 12-Year-Old Prograf Generic Has US Equivalence Rating Pulled

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.

FDA Drug Approval Standards

Adcock Remains Resilient In Tough Business Environment

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

Sales & Earnings South Africa

Lupin And Mark Cuban Shake Hands On Spiriva Alliance In US

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

Deals Generic Drugs

Novartis Shareholders Give Green Light To Sandoz Spinoff

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.

Strategy Generic Drugs

IGBA Welcomes Mexican Membership

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

Mexico Generic Drugs

US FDA’s New Generics Chief: We Need More Flexibility For Complex Products

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.

Generic Drugs FDA

Judges Weigh Record Entries Ahead Of October’s GGB Awards

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.

Generic Drugs Biosimilars
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