Drug DiscoveryResearch & Development April 18, 2019 LabCorp to buy Envigo’s non-clinical research services business in $485m deal By PBR Staff Writer LabCorp said that the proposed deals will make the company to pay a net cash of $485m and will add an incremental $156m to revenues on a pro
Clinical TrialsHuman Trials April 12, 2019 Janssen’s HIV drug SYMTUZA yields positive results in DIAMOND trial By PBR Staff Writer The trial, called DIAMOND, is the first prospective phase 3 trial which is assessing the rapid initiation of a single-tablet regimen (STR) SYMTUZA for the treatment of human
RegulationApprovals April 9, 2019 ViiV Healthcare gets FDA approval for HIV drug Dovato By PBR Staff Writer The approval has been granted for a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50mg and lamivudine (3TC) 300mg to treat HIV-1 infection in adults with no antiretroviral
RegulationDrug Filing April 8, 2019 Gilead seeks FDA approval for once-daily Descovy to treat HIV pre-exposure prophylaxis By PBR Staff Writer The company has submitted a supplemental new drug application (sNDA) to the FDA for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) for PrEP to reduce
Drug DiscoveryResearch & Development April 3, 2019 Xencor, Astellas Pharma collaborate on novel bispecific antibody program By PBR Staff Writer As part of a research and license agreement, Astellas Pharma will be able to use Xencor’s bispecific technology to advance a novel bispecific antibody program in oncology. The
RegulationApprovals April 2, 2019 AstraZeneca, Merck secure FDA breakthrough therapy status for selumetinib By PBR Staff Writer The designation has been provided based on Phase II data from the Sprint trial, which evaluated selumetinib as an oral monotherapy in pediatric patients aged three years or
Drug DiscoveryResearch & Development April 1, 2019 Boehringer Ingelheim buys MacroDel platform developer ICD Therapeutics By PBR Staff Writer Boehringer Ingelheim, along with nanoPET Pharma, will use the MacroDel biologics-delivery platform to develop novel therapeutics. nanoPET Pharma is a former shareholder of ICD Therapeutics. nanoPET Pharma managing
RegulationApprovals March 20, 2019 Sage Therapeutics gets FDA nod for Zulresso to treat postpartum depression By PBR Staff Writer Zulresso is claimed to be the first and only medicine secured approval to treat PPD, which is the most common medical complication of childbirth. The medicine is an
RegulationMarketing Authorisation March 11, 2019 Roche gets EC nod for Tecentriq and Avastin combo for first-line lung cancer By PBR Staff Writer The EC has approved Tecentriq in combination with Avastin, paclitaxel and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC). Tecentriq, in
RegulationApprovals February 20, 2019 Merck gets FDA nod for Keytruda as adjuvant treatment for melanoma By PBR Staff Writer The recommended dose of Keytruda for the adjuvant treatment of adult patients with melanoma is 200 mg administered as an intravenous infusion over 30 minutes every three weeks