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Latest From ViiV Healthcare

Merck’s Anti-PCSK9 Pill Sets Up Convenience Battle Against Infrequently Dosed Injectables

The drug maker announced the start of a Phase III program for its oral PCSK9 inhibitor MK-0616, including a 14,550-patient outcomes trial set to start later in the year.

Clinical Trials Business Strategies

Aurobindo’s Pediatric AIDS Combo Generic Approved; Eugia Restructuring Back On Cards

A US FDA tentative approval for Aurobindo’s dolutegravir combination generic for children should increase access under the PEPFAR program and aid sales. On a Q1 earnings call, renewed efforts to restructure Eugia, biosimilar launch plans and fallouts of oral drug shortages and damage to Pfizer’s US injectables warehouse were discussed.

Approvals Strategy

Aurobindo’s Pediatric AIDS Combo Generic Approved; Eugia Restructuring Back On Cards

A US FDA tentative approval for Aurobindo’s dolutegravir combination generic for children should increase access under the PEPFAR program and aid sales. On a Q1 earnings call, renewed efforts to restructure Eugia, biosimilar launch plans and fallouts of oral drug shortages and damage to Pfizer’s US injectables warehouse were discussed

Commercial Approvals

Nilotinib Patent Expiry Leaves Door Open For India Generics, Other Markets Could Face Longer Wait

The expiry of Novartis’ nilotinib compound patent in July leaves the door open for Tasigna generics in India. Medicines Patent Pool sub-licensees like Hetero and Dr. Reddy’s are also free to launch their generics as the agreement doesn’t include the Indian market. However, MPP sub-licensee plans for other markets involve a tougher regulatory path

Commercial Business Strategies
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