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  • Lupin and DKSH inks to market five biosimilar candidates in Philippines

    Lupin and DKSH have signed an exclusive license and supply agreement to commercialize five of Alvotechs proposed biosimilars in the Philippines. The biosimilars planned under this agreement include biosimilar Prolia, Xgeva, Simponi, and Eylea as well as two undisclosed proposed biosimilars for immunology and oncology.

  • FIrst AI enabled Cath lab launched by Wipro GE Healthcare

    GE Healthcare, a leading global medical technology, diagnostics and digital solutions innovator, has announced the launch of its first Made in India, AI-powered Cath lab - Optima IGS 320 to advance cardiac care in India.

  • Indian pharma market bloomed 12.1 percent in August

    ​​​​The overall Indian pharmaceutical market grown around 12.1 percent by value and 4.8 percent by volume in month of August as per the market research firm AWACS.

    Almost all the therapy areas have shown a robust double-digit growth or in case of units the growth may be single digit due to NLEM permission to hike price come into the picture and number of companies have shown a good price driven growth for the month of August.

  • Typhoid vaccine of Zydus marks additional indication from CDSCO panel

    ​Subject Expert Committee of CDSCO recommended amendment of indication of Typhoid Vi conjugate vaccine of Zydus Lifesciences to include the age group of 45-65 years for single dose only.

    Earlier, Zydus Lifesciences had presented its proposal for grant of permission for the additional indication of Typhoid Vi conjugate vaccine for age group 45-65 years along with the Phase III clinical trial report.

  • Bayer to pay USD 40 million over whistleblowers bribe claims

    Bayer Corporation and its related entities have agreed to pay USD 40 million to resolve alleged violations of the False Claims Act in connection with the drugs Trasylol, Avelox and Baycol.

    The settlement announced yesterday arose from two whistleblower lawsuits filed and pursued by Laurie Simpson, a former employee of Bayer who worked in its marketing department. 

  • Psoriasis drug of Boehringer Ingelheim gets FDA nod

    The U.S. Food and Drug Administration is the first regulatory authority to approve spesolimab as a treatment option for generalized pustular psoriasis (GPP) flares in adults, Boehringer Ingelheim announced today.

    Spesolimab, marketed in the U.S. as SPEVIGO, is a novel, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogenesis of GPP.

  • Amneal submits NDA for Parkinsons Disease

    Amneal Pharmaceuticals has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for IPX203, a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinsons disease (PD).

    IPX203 is a novel, oral formulation of CD/LD extended-release capsules designed for the treatment of Parkinson’s disease.

  • Zydus receives USFDA approval for Venlafaxine and Pregabalin ER Tablets

    Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Venlafaxine Extended-Release Tablets and Pregabalin Extended-Release Tablets.

    USFDA has approved Venlafaxine Extended-Release Tablets, USP 37.5 mg, 75 mg, 150 mg and 225 mg Extended-Release (ER) Tablets and Pregabalin ER Tablets, USP 82.5 mg, 165 mg and 330 mg which is generic of Lyrica CR.

  • BE receives CDSCO Panel nod to manufacture pneumococcal conjugate Vaccine

    Biological E. Limited (BE)'s 14-valent paediatric vaccine (investigational pneumococcal polysaccharide conjugate vaccine PCV14) is approved by the Subject Expert Committee of CDSCO  against S. pneumoniae infection in infants.

    Streptococcus pneumoniae infection continues to be a leading cause of child mortality under 5 years of age in India and in developing countries. With the PCV14 vaccine, Biological E hopes to contribute to the prevention of invasive pneumococcal disease and protect millions of lives globally.

  • Aurobindo Pharma to add Rs. 300 crores in manufacturing facility

    Aurobindo Pharma to invest Rs. 300 crores for expanding its mammalian cell culture manufacturing facility of CuraTeQ Biologics which is a fully owned subsidiary of the Drug maker.

    There was a meeting held on 1st september where all the board members agreed to expand its operations by establishing another mammalian cell culture manufacturing facility of higher capacity to cater to the future requirements. The capital expenditure for ramping up capacities is estimated to be around Rs.300 crores.

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