More bad news for Sarepta; Novartis, Microsoft join forces in AI pact
→ Sarepta $SRPT is still feeling the heat. A little more than a month after the FDA threw an unexpected surprise rejection for the company’s application for an accelerated approval of its Duchenne MD drug, golodirsen, the company faced more bad news today. A rival company in Japan, NS Pharma, said that it had submitted the necessary paperwork needed for approval of their new drug, viltolarsen, to treat Duchenne MD for children born with the disorder caused by a mutation in the DNA sequence exon 53. According to a STAT report, NS Pharma expects viltolarsen to be approved in the US by the middle of 2020, if not sooner — barring any setbacks.
→ Novartis $NVS is “reimagining medicine” by tapping into technology that is now firmly entrenched across the biopharma industry: artificial intelligence. Its partner of choice for its AI innovation lab is the tech titan Microsoft $MSFT — and the collaboration is broad, although sparse in detail. The idea is to 1) “bring the power of AI to the desktop of every Novartis associate…to take on the next wave of challenges in medicine” and 2) to “tackle some of the hardest computational challenges within the life sciences,” including the optimization of cell and gene therapies at scale. Recall, Novartis has had some trouble with the manufacturing of its CAR-T therapy Kymriah.
→ Another win to add to the books for Merck‘s $MRK blockbuster, Keytruda, which has been approved as a monotherapy in China for first-line treatment of certain patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors that express PD-L1. The approval was based upon overall survival findings from the Phase III KEYNOTE-042 trial, including data from an extension of the global study in Chinese patients. This approval makes Keytruda the “first anti-PD-1 therapy approved in China as both monotherapy and in combination with chemotherapy for the first-line treatment of appropriate patients with NSCLC.”
→ In May, the FDA handed Heron Therapeutics $HRTX an unexpected rejection — relating to manufacturing concerns — for the company’s long-acting non-opioid painkiller, HTX-011, designed to treat post-surgical analgesia. The company announced today that it has resubmitted its NDA for the drug to the FDA and that they expect a 6-month review by the agency.
→ Hemophilia player BioMarin $BMRN, has opened a new headquarters in Dublin, Ireland — doubling its current team of 500 in the region. The new headquarters is just one expansion that the company has been working on. The company is continuing to work on a €38 million expansion of its plant at Shanbally in Cork, which is the company’s only manufacturing plant outside of the United States.
→ The Financial Times has reported that Chinese venture capital investment in the US has hit its lowest level since 2015. But as funds are trickling in at a slow pace in the US, China has turned to elsewhere such as India and South-East Asia for its investments. According to Refinitiv data, Chinese funds invested just $4 billion in US companies in the first nine months of 2019, which is the smallest since 2015, down from nearly $7 billion in the same time frame last year and $9 billion in the same 2017 period.