Month: September 2019

Biosimilars

Celltrion Signs an Exclusive Co-Marketing Agreement with Juno in Australia

Shots: Juno to provide sales promotion and hospital contracting services to Australian Hospital market customers and will co-market Herzuma (biosimilar, trastuzumab) and Truxima (biosimilar, rituximab) with Celltrion in Australia  The focus of the agreement is to market globally biosimilar brands to Australian Healthcare professionals and patients Herzuma (CT-P6, biosimilar, trastuzumab) is a mAb targeting the […]Read More

Pharma

Merck Reports Results of Recarbrio (imipenem/cilastatin/relebactam) in P-III RESTORE-IMI 2

Shots: The P-III RESTORE-IMI 2 study involves assessing of Recarbrio (imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg) vs Piperacillin/Tazobactam in adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) The P-III RESTORE-IMI 2 study resulted in meeting its 1EPs & 2EPs of statistical non-inferiority           in Day 28 all-cause mortality and […]Read More

Biotech

GSK Reports Results of Nucala (mepolizumab) in REALITI-A Study for

Shots: The REALITI-A study involves assessing of Nucala (100mg, SC) in 368 patients with severe eosinophilic asthma, being conducted in a routine care setting, compared to the prior 12mos. The REALITI-A study results: annual reduction rate in exacerbations (69%); reduction in exacerbations requiring hospitalization/emergency room visits (77%); reduction in m-oral corticosteroid (OCS) dose 10 mg/day […]Read More

Regulatory

Roche’s Rituxan (rituximab) Receives the US FDA’s Approval for Two

Shots: The FDA’s approval is based on P-IIa PePRS study assessing MabThera/Rituxan (IV) + glucocorticoids in 25 pediatric patients with active granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) aged 6-17yrs. The P-IIa PePRS study results: the achievement of PVAS remission @6mos. (56%); @12mos. (92%); @18mos. (100%); safety profile in pediatric patients with GPA & […]Read More

M&A

Sobi to Acquire Dova Pharmaceuticals for $915M

Shots: Sobi acquires Dova Pharmaceutical in cash & stock transaction making a total deal value as $915M.  Dova to receive upfront of $27.50/share in cash, $1.50/share on approval of Doptelet as CVR, representing a total consideration of up to $29.00/share with a premium of 36% to Dova’s closing price on Sept 27, 2019 The focus […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (September 23– 27, 2019)

1. Incyte Reports Updated Results of Pemigatinib in P-II FIGHT-202 Trial for Patients with Previously Treated Advanced Cholangiocarcinoma Published: Sept 27, 2019 | Tags: Incyte, Reports, Updated, Results, Pemigatinib, P-II, FIGHT-202 Trial, Patients, Previously, Treated, Advanced, Cholangiocarcinoma 2.Pfizer Reports Results of Abrocitinib in P-III JADE MONO-2 Study for Moderate to Severe Atopic Dermatitis Published: Sept 27, 2019 […]Read More

Pharma

Incyte Reports Updated Results of Pemigatinib in P-II FIGHT-202 Trial

Shots: The P-II FIGHT-202 (NCT02924376) study involves assessing of pemigatinib (13.5 mg, qd) as monothx in adults patients previously treated, LA or metastatic cholangiocarcinoma with documented FGF/FGFR status divided into 3 cohorts: Cohort A (N=107, FGFR2 fusions or rearrangements), Cohort B (N=20, other FGF/FGFR genetic alterations) or Cohort C (N=18, no FGF/FGFR genetic alterations)   […]Read More

Top 20

Top 20 Biopharma Acquisitions of 2018 Based on the Total

Biopharma acquisition activity in 2018 shows a significant increase over the previous year. Takeda proved to be on top with the acquisition of Shire among the top 20 acquisitions with a total deal value of $57.17B strengthening its capabilities in gastroenterology, neuroscience, oncology, rare diseases, and plasma-derived therapies. This article is based on the 2018 […]Read More