Industry News

Sun Pharma and includes its subsidiaries and/or associate companies) announced that one of its wholly-owned subsidiaries has received approval from the Ministry of Health, Labour and Welfare (MHLW), Japan for ILUMYA (tildrakizumab) for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies. Japan has approximately 430,000 people currently suffering from psoriasis.

Hindustan Unilever Limited (HUL) announced that it has completed the acquisition of intimate hygiene brand VWash from Glenmark Pharmaceuticals Ltd. This acquisition was announced on March 23, 2020 and was subject to certain closing conditions, which have now been fulfilled.

Cipla Limited announced the launch of remdesivir under its brand name CIPREMI. The U.S. FDA issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc. for emergency use of remdesivir for the treatment of hospitalized 2019 coronavirus disease (COVID-19) patients. It is the only U.S. FDA approved Emergency Use Authorisation (EUA) treatment for adult and paediatric patients hospitalized with suspected or laboratory confirmed COVID-19 infection. In May, Gilead Sciences Inc. extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla’s generic version of remedisvir called CIPREMI.

Dr. Reddy's Laboratories has entered into a non-exclusive Licensing Agreement with Gilead Sciences that will grant Dr. Reddy’s the right to register, manufacture and sell Gilead’s investigational drug, Remdesivir, a potential treatment for Covid-19, in 127 countries including India.

Sun Pharma's wholly-owned subsidiaries and Hikma Pharmaceuticals PLC (Hikma) have entered into an exclusive licensing and distribution agreement for ILUMYA™, an innovative biologic product, for the Middle East & North Africa (MENA) region.

Johnson & Johnson announced that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July.

Bristol Myers Squibb announced results from the open-label switch period of Early AMPLE, a Phase IV exploratory biomarker study assessing the differences by which Orencia (abatacept) and another treatment, adalimumab, interfere with disease progression in moderate-to-severe early rheumatoid arthritis (RA) patients who tested positive (seropositive) for certain autoantibodies. Findings of the open-label switch period showed that early seropositive RA patients treated with Orencia demonstrated substantial clinical improvements at week 48, sustaining the level of responses achieved at week 24 compared to adalimumab. In seropositive patients switching from adalimumab to Orencia, the efficacy responses generally increased over the open-label period to week 48. These results are featured in a poster presentation at the European E-Congress of Rheumatology (EULAR) 2020.

Roche announced the initiation of a global phase III, randomised, double-blind, multicentre study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalised patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc.