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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
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Alvotech’s Japanese Ustekinumab Nod Is ‘First For Global Markets’

Following the formation of their partnership nearly five years ago, Alvotech and Fuji have together welcomed approval in Japan for Alvotech’s biosimilar to Stelara (ustekinumab).

Biosimilars Approvals

Not In 2023 After All? FDA Turns Down Approval For Coherus’ On-Body Pegfilgrastim

Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”

Biosimilars Value-Added Medicines

Sandoz Prepares For European Natalizumab Launch As Approval Arrives

As it announced the formal European Commission approval of its partnered Polpharma Biologics-developed Tyruko natalizumab biosimilar to Tysabri, Sandoz offered Generics Bulletin a timeframe for its expected launch in Europe.

Biosimilars Approvals

‘There Is Always Room For Improvement’: Celltrion Reflects On A Decade Of European Biosimilars

Marking a decade since Celltrion’s Remsima version of infliximab became the first monoclonal antibody biosimilar approved in Europe, Kevin Byoung Seo Choi, senior vice president and head of the marketing division at Celltrion Healthcare, talks to Generics Bulletin about the firm’s progress so far and the “room for improvement” that the company perceives in areas such as regulation, market access and pricing, supply chain and procurement – as well as what the future holds for the Korean biosimilars giant.

Biosimilars Europe
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Not In 2023 After All? FDA Turns Down Approval For Coherus’ On-Body Pegfilgrastim

Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”

Biosimilars Value-Added Medicines

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

Teva’s Francis: I Looked At All The Sexy Stuff And Overlooked Olanzapine

After launching the Uzedy long-acting formulation of risperidone in partnership with MedinCell earlier this year, Teva has stressed the “really exciting” product profile of another long-acting antipsychotic from the partnership, olanzapine, while discussing how it will avoid the safety pitfalls of legacy products in the space.

Value-Added Medicines Strategy

What’s Next? Five Things To Look Out For In September

Generics Bulletin previews the most notable and anticipated events for September 2023.

Biosimilars Generic Drugs
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