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Generics

Set Alert for Generics

Sandoz Canada Expands Its Portfolio With Generic Vyvanse Launch

Sandoz Canada brings a lisdexamfetamine generic to the market, while its US filing still has tentative approval. Meanwhile, off-patent group CGPA launches a social media campaign to tackle misinformation surrounding generics.

Generic Drugs Launches

Opioid Overdose Reversal Drug Manufacturers Commit To Increased Naloxone Capacities

Hikma, Teva, and other drug manufacturers have committed to increased supply of naloxone and nalmefene as part of a meeting with the White House Office of National Drug Control.

United States Generic Drugs

Amneal Launches Six Injectables With Some To Aid US Drug Shortage

Amneal aims to address the ongoing drug shortage crisis in the US with injectable additions to its portfolio. Meanwhile, the FDA states that it has “made a significant impact” to mitigate shortages, preventing 236 shortages in 2023.

Generic Drugs Market Access

UK Pregabalin Prices Skyrocket In May

Pregabalin topped our table of Biggest Risers in May, in another month of multiple treble-digit-percentage average price increases for the UK generics market.

Generic Drugs Pricing Strategies

The Generics Bulletin Podcast: Teva, Sandoz, Sawai and US Orange Book patents

Generics Bulletin’s editorial team discusses the latest strategic developments for major industry players Teva, Sandoz and Sawai, as well as explaining the recent debate over US patent listings in the FDA’s Orange Book.

Strategy Generic Drugs

IGBA Celebrates ICH Re-Election And CEO Committee Progress

In a busy month for the IGBA, the global off-patent industry association has celebrated re-election to the ICH’s management committee and has held a meeting of its own CEO advisory committee.

Generic Drugs Biosimilars

Aurobindo’s Eugia Prepares For ‘Muted’ Growth In FY2025

While Eugia continues to look for ways to solve the future challenges amidst temporary plant closure, parent Aurobindo reported a “good” performance in FY2024, with expected continued growth, and gave an update on its Auro Peptides business and GLP-1s.

Generic Drugs Strategy

France Threatens To Block Servier Sale Of Biogaran To Outside Owner

“We have been very clear with Servier that we do not want it to sell Biogaran,” France’s prime minister has indicated, suggesting that a foreign purchaser would face “drastic conditions” attached to any deal.

Deals M & A

Hikma Opens UK Office To Strengthen Ties With NHS

Just weeks after announcing the establishment of a Spanish subsidiary, Hikma has crossed the English Channel to strengthen its position in Europe by opening a commercial office in the UK.

United Kingdom Generic Drugs

Sun-Taro Merger Nearing Completion As Shareholders Vote Yes

Sun Pharma will finally merge with Taro as a single company, after failed attempts to absorb the firm over a decade ago. Also, the firm hints about its upcoming generic portfolio, including GLP-1 products, as well as increasing investment into its specialty business.

Deals M & A

ANDA Suitability Petitions: The Timelines They Are A-Changin'

US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.

Regulation Generic Drugs

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

Generics Bulletin previews the most noteworthy and anticipated events for June 2024.

Biosimilars Generic Drugs

Sandoz And Bio-Thera Get EU Nod For Bevacizumab

At its May meeting, the EMA’s CHMP has issued positive opinions for Sandoz and Bio-Thera’s Avzivi partnered biosimilar rival to Avastin, as well as five generics that included a trio of pomalidomide products.

Approvals Biosimilars

Key UK Xarelto Patent Knocked Out Again In Boost For Generics Manufacturers

Bayer has been left reeling after the UK Court of Appeal found in favor of generics manufactures and reaffirmed a decision to revoke a key patent shielding its blood-thinner blockbuster Xarelto (rivaroxaban). Challenges to Xarelto’s IP are continuing apace across Europe.

Legal Issues Intellectual Property

Irish Body Calls For Urgent Action To Tackle Drug Shortages

Medicines for Ireland has called for action that would alleviate drug shortages affecting every fifth patient in the country after recently urging strategic reform in the EU.

Biosimilars Generic Drugs

Who’s Hired? Dr Reddy’s Names New North America Chief

A busy couple of weeks for executive appointments in the generics and biosimilars industry has seen Dr Reddy’s name a new North American CEO, Fresenius Kabi appoint a new biopharma chief, Teva recruit a new head of global operations, and more.

Executive Changes Leadership
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