HiFiBiO, which is focused on developing immune modulators, raised $67 million in a series C round with backing from Gilead Sciences' Kite Pharma. Initially rejected by the FDA in 2008, Kyowa Kirin's add-on Parkinson's disease therapy Nourianz has finally been approved. An investigation team at India's securities agency found no merit in two allegations that Sun Pharmaceutical violated regulations, local media reports. And more.
HiFiBiO Therapeutics, which has offices near Boston, Paris and Shanghai, has raised a $67 million series C round to help advance its pipeline of immunotherapies in oncology and autoimmune disease. The financing was led by IDG Capital, which boasts a strong presence in China. Other investors old and new, including Sequoia Capital China and Gilead’s Kite Pharma, also contributed.
Kyowa Kirin’s long-awaited FDA nod for add-on Parkinson’s disease therapy istradefylline is finally here. The drug, to be sold as Nourianz, was in 2008 rejected in the U.S. but launched in Japan in 2013. To be used on top of levodopa/carbidopa, the adenosine A2A receptor antagonist is designed to help Parkinson’s patients who are experiencing “off” episodes.
A preliminary probe by the Securities and Exchange Board of India (SEBI) found no violation of securities laws at Sun Pharma on two main whistleblower allegations. Pending final approval, the recommendation to close the investigation would be a major relief for the Indian drugmaker. Allegations of dubious corporate operations have weighed on its shares since they first surfaced in late 2018.
South Korea prosecutors raided local biotech SillaJen’s offices in Busan and Seoul after accusations its management used undisclosed information to sell their stocks. SillaJen’s chief science officer allegedly sold all of his 167,777 shares, raking in about 8.8 billion won ($7.25 million), shortly before a data committee dubbed its oncolytic virus Pexa-Vec a failure in phase 3.
Shanghai biotech Harbour Biomed has teamed up with CRO PPD to work on creating new oncology and immunology drugs. The company is working on several drugs, including a HER2-CD3 bispecific antibody, an anti-PD-L1 and an in-licensed anti-FcRn autoimmune therapy.
Glenmark Pharmaceuticals is recalling more than 31,000 tubes of clotrimazole and betamethasone dipropionate cream because of consumer complaints the fungal fighter had a runny texture. The voluntary recall came shortly after the Indian firm recalled tubes of mometasone furoate cream because it was found to be gritty.
India’s Strides Pharma has picked up a softgel manufacturing facility in Florida from Micelle BioPharma. Though the purchase price of $500,000 is quite low, Strides said it intends to invest another $10 million to add other capabilities.
In a warning letter sent to CTX Life Sciences’ API manufacturing facility in Surat, India, the FDA says the plant “failed to monitor and control the water used in the rinse steps for endotoxins” even though the company knew its API was for a sterile injectable drug. The FDA also took issue with how the facility didn’t fully investigate out-of-spec test results.
CDMO Ajinomoto Bio-Pharma continues to expand. It said it’s buying the 50% share of the joint venture still owned by Indian partner Granules OmniChem. The JV, established in 2011, makes small-molecule intermediates and APIs.