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'Potential Blockbuster' Dupixent Set For EU Eczema OK

While Dupixent looks set for use in Europe for treating moderate-to-severe atopic dermatitis, analysts believe the biologic has a great future in other indications and could eventually become a blockbuster.

Approvals Biologics Commercial
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Uphill Climb For Gedeon Richter's Cariprazine After Delayed EU OK

Gedeon Richter has finally had its antipsychotic cariprazine approved in the EU for treating schizophrenia - but its delay to market could dampen demand for the drug unless it can differentiate itself from rivals.

Approvals Business Strategies

AMR Roundtable Part 2: The Need For Patient Perspectives To Reinforce Urgency Of Antimicrobial Drug Development

Scrip spoke with the CEOs of Zavante and Amplyx as well as a BARDA official during a roundtable discussion at BIO about the challenges of antimicrobial drug development. This second part of the roundtable centers on the lack of patient advocates in the area of antimicrobial-resistant infections.

Market Access Infectious Diseases

Amgen's Ofman On Value-Based Contracts And Reimbursement Challenges

Amgen has negotiated 75 value-based contracts – agreements that SVP Josh Ofman sees as one area where biopharma and payer views are aligned. However, tension between the two sides remains high in pricing and reimbursement negotiations when it comes to rebates and other issues.

Market Access Pricing Strategies

Otsuka Ties Up With Mylan To Advance MDR-TB Drug In India?

Otsuka, which has been under fire over delayed access to delamanid in India, appears to have allied with Mylan, which has now secured a key clearance for the novel multidrug-resistant TB therapy in the country.

Commercial Market Access

Pfizer, Cipla Pledge Better Access To Affordable Cancer Therapies In Africa

Pfizer and Cipla have separately committed to expanding access to affordable oncology drugs in sub-Saharan Africa in collaboration with the American Cancer Society and the Clinton Health Access Initiative. The public-private alliances are expected to enable procurement of these medicines for the African nations at significant savings, which Cipla tells Scrip could be in the region of 20-30% initially.

Middle East and Africa Market Access

CHMP OK Puts Merck KGaA's Cladribine Pill On EU Home Stretch After Long Trek

Merck of Germany's oral multiple sclerosis medicine cladribine looks set to finally get EU approval. But the long, slow race it has had to endure - and time lost getting there - may curb sales.

Advisory Committees Approvals
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