January 2019 | PharmaShots

Eli Lilly’s Alimta (pemetrexed) + Keytruda (pembrolizumab) Receives FDA’s Expanded Label Approval for 1L Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

January 31, 2019April 24, 2019Shiwani Sharma

Shots: The expanded label approval is based on P-III KEYNOTE-189 study results assessing Alimta + pembrolizumab + Pt-based CT vs Alimta + Pt-based [...]

Columbia’s Zuckerman Institute Develops an AI-based Brain-Computer Interface (BCI) for People with Aphasia & Amyotrophic Lateral Sclerosis (ALS)

January 31, 2019April 24, 2019Shiwani Sharma

Shots: The BCI application focuses on human auditory cortex for the reconstruction of unspoken thoughts into speech for patients have who lost their [...]

Merck’s V114 Receives FDA’s Breakthrough Therapy Designation to Prevent Invasive Pneumococcal Disease

January 31, 2019April 24, 2019Shiwani Sharma

Shots: The BT designation is based on P-I/II and P-II results assessing four lots of V114 in healthy adults and infants, demonstrating non-inferiority [...]

Janssen (J&J) Reports Results of Erleada (apalutamide) in P-III TITAN Study for Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

January 31, 2019April 24, 2019Shiwani Sharma

Janssen, J&J, Reports, Results, Erleada, apalutamide, P-III, TITAN Study, Metastatic Castration-Sensitive Prostate Cancer [...]

Roche Discontinues P-III CREAD-1 and 2 Trials of Crenezumab in Patients with Early Alzheimer’s Disease (AD)

January 31, 2019April 24, 2019Shiwani Sharma

Shots: The P-III CREAD-1 and 2 study involves assessing of Crenezumab vs PBO in 1500 patients with early AD with confirmed evidence of [...]

EMA Shifts its Headquarters from London to Amsterdam, The Netherlands

January 30, 2019April 24, 2019Shiwani Sharma

Shots: Post decision of UK moving out from EU with the announcement of Brexit in 2016, EMA initiated shifting of its headquarters (HQs) [...]

Neurocrine and Voyager Collaborate to Develop and Commercialize VY-AADC & VY-FXN01 for Parkinson’s & Friedreich’s Ataxia Disease

January 30, 2019April 24, 2019Shiwani Sharma

Shots: Voyager to receive $165M upfront including $115M in cash, $50M equity investment at $11.96/share and $1.7B milestones for its four gene therapy [...]

Sumitomo Dainippon’s Latuda (lurasidone HCl) Receives NMPA’s (CFDA) Approval for Schizophrenia

January 30, 2019April 24, 2019Shiwani Sharma

Shots: The approval is based on P-III clinical studies results assessing Latuda (n=245) vs Placebo (n=233) in 483 patients with schizophrenia The study [...]

Takeda Reports Results of TAK-003 in P-III TIDES (DEN-301) Trial for Dengue

January 30, 2019April 24, 2019Shiwani Sharma

Shots: The P-III TIDES study contains three parts assessing TAK-003 (0.5ml, SC) vs PBO in patients for the prevention of dengue fever of [...]

Pfizer and Eli Lilly Report Results of Tanezumab in P-III OA study (A4091057) for Moderate-To-Severe Osteoarthritis (OA) Pain

January 30, 2019April 24, 2019Shiwani Sharma

Shots: The P-III OA study involves assessing of tanezumab (2.5mg/5mg, SC) vs PBO in 849 patients in the ratio (1:1:1) with moderate-to-severe OA [...]