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Generics

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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

Amphastar Taps Private Financing After Major Eli Lilly Acquisition

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

Financing Complete Response Letters

ANDA Submissions Lagging As FY2023 Nears Its End

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

Generic Drugs Review Pathway

Amneal Kicks Off China Business With First Approval

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.

Approvals China

More Interest In Speculated Cipla Stake Sale: Portfolio, Cultural Fit Will Matter

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'.

Deals M & A
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