Latest From Akriti Seth
New Jersey-based Teligent reported a low quarter as the company continues to focus on remediation measures to lift the FDA warning letter hanging over its Buena New Jersey manufacturing facilty. Teligent has also recently recalled a batch of its 4% lidocaine hydrochloride topical solution because the firm’s testing found it to be super potent.
The AAM has applauded US proposals to lower drug prices, following the development of the HHS’s 45-day plan in response to president Joe Biden’s executive order on promoting competition. However, AAM chief executive Dan Leonard has criticized Congressional proposals to weaken the 180-day incentive for first generics and curtail patent settlement agreements as “misguided.”
India’s Alkem has delivered a strong quarter with a boost in its domestic business on the back of “strong volume-led growth in the acute therapies and faster than market growth in chronic therapies.” However, the company saw a slight YoY decline in the US.
Lupin and non-profit organization TB Alliance have entered into a partnership for a new therapy for highly drug-resistant tuberculosis, pretomanid, to be distributed in 140 countries and territories.
South Korea’s Celltrion has delivered a strong second quarter on the back of high-margin US sales, as its Truxima rituximab biosimilar recovered. The company is on track to launch at least one biosimilar every year by 2030. Meanwhile, the company and partner Icure have filed a donepezil patch with the Korean Ministry of Food and Drug Safety.
The American Academy of Ophthalmology has criticized healthcare insurers for pushing bevacizumab biosimilar alternatives to Avastin, like Pfizer’s Zirabev and Amgen’s Mvasi, that have not been subjected to clinical trials in eye disease or testing for retinal toxicity.