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.

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.

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

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