July 2018 | PharmaShots

Shionogi’s Mulpleta (lusutrombopag) Receives FDA Approval for Chronic Liver Patients in Adults

July 31, 2018April 26, 2019Shiwani Sharma

Shots: Mulpleta is approved based on two randomized, placebo-controlled trials (L-PLUS 1 & 2) involving 312 patients with platelets ≤50 x 109/L randomized [...]

Pfizer receives EU approval for Trazimera(Trastuzumab), the First Oncology Biosimilar

July 31, 2018April 26, 2019Shiwani Sharma

Shots: Trazimera is a biosimilar of Herceptin indicated for treatment of HER2 overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma The [...]

Pernix Therapeutics Buys Orexigen’s Contrave for $73.5Mn

July 30, 2018April 26, 2019Shiwani Sharma

Shots: Nalpropion buys global commercialization rights of Orexigen’s Contrave a weight loss drug. Nalpropion is an investor group which includes Pernix Contrave has [...]

Progenies Receives FDA approval of first-and-only Azerda (iobenguane I 131) to treat Unresectable, LA/M Pheochromocytoma/Paraganglioma

July 30, 2018April 26, 2019Shiwani Sharma

Shots: AZEDRA radio therapeutic indicated to treat adult and pediatric patients ≥12yrs with iobenguane scan positive Has shown reduction rate in need of [...]

Novartis Announces the EU Approval of first-in-class Aimovig®️(erenumab) for Migraine Prevention

July 30, 2018April 26, 2019Shiwani Sharma

Shots: Results of 2600 patients trial reported significant i.e. ≥50% reduction in migraine days with comparable safety and tolerability to PBO [...]

BioLineRx Annouces Expansion of 2016 Collaboration with Merck&Co. in Immuno-Oncology in pancreatic cancer

July 30, 2018April 26, 2019Shiwani Sharma

Shots: Under the expansion collaboration, new arm of assessment is added assessing BL-8040, Keytruda and chemo in 2L patient in COMBAT/KEYNOTE-202 study Results [...]

Lilly Announces an Extension to 2015 Research Collaboration deal with Dana Farber Cancer Institute

July 30, 2018April 26, 2019Shiwani Sharma

Shots: The extension provides a better understanding to clinicians and initial funding discoveries, molecular analyses, design and conduct of samples for new discoveries [...]

Sun Pharma to Recall 2500 bottles of Riomet from Arizona

July 30, 2018April 26, 2019Shiwani Sharma

Shots: U.S. FDA announces recalling of over 2,508 bottles of Metformin hydrochloride with an extended release tablets of 500 mg, packaged in a [...]

ChemBio Annouces the Collaboration with FIND Moving to Development of HCV Point-Of-Care Diagnostic-Test

July 28, 2018April 26, 2019Shiwani Sharma

Shots: ChemBio will be using its patented DPP® technology platform to test rapid HCV core antigen assay Parallely, FIND is conducting pilot studies [...]

Imfinzi (durvalumab) Receives Positive CHMP Opinion in EU for PD-L1 expressing LA NSCLC patients

July 27, 2018April 26, 2019Shiwani Sharma

Shots: Imfinzi has been approved in unresectable PD-L1 expressing LA NSCLC patients treated with platinum-based CRT Approval is based post-hoc subgroup analyses by PD-L1 [...]