Top Pharma News of the Week

Daiichi Sankyo and Puma Biotechnology Announce Research Collaboration with Major Cancer Center in HER2-Mutated Cancer

Dec. 12, 2017

Daiichi Sankyo Company, Limited and Puma Biotechnology, Inc. have announced a preclinical research collaboration with Memorial Sloan Kettering Cancer Center (MSK) to explore the combination of Daiichi Sankyo’s investigational antibody drug conjugate DS-8201 and Puma Biotechnology’s irreversible pan-HER tyrosine kinase inhibitor neratinib (NERLYNX®) in HER2-mutated or HER2-positive solid tumors.

FDA Approves New Pfizer Biosimilar

December 13, 2017

Pfizer Inc. has announced that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab) for all eligible indications of the reference product.  The FDA has approved IXIFI as a treatment for patients with rheumatoid arthritis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

U.S. FDA Accepts Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Intermediate- and Poor-Risk Patients with Advanced Renal Cell Carcinoma and Grants Priority Review

December 13, 2017

Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The FDA also previously granted Breakthrough Therapy Designation for this application.

Bristol-Myers Squibb Granted Exclusive License by Ono Pharmaceutical for Multiple Programs Targeting Immuno-Suppressive Factors in the Tumor Microenvironment

December 13, 2017

Bristol-Myers Squibb Company and Ono Pharmaceutical Co., Ltd. announced an agreement that grants Bristol-Myers Squibb an exclusive license for the development and commercialization of ONO-4578, Ono’s selective Prostaglandin E2 (PGE2) receptor 4 (EP4) antagonist. The companies will also collaborate on discovery efforts to identify additional compounds from Ono’s PGE2 receptor antagonist programs.

Pfizer Announces FDA Approval of Xeljanz® (Tofacitinib) and Xeljanz® XR for the Treatment of Active Psoriatic Arthritis

December 14, 2017

Pfizer Inc. has announced that the United States Food and Drug Administration (FDA) has approved XELJANZ® 5 mg twice daily (BID) and XELJANZ® XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). XELJANZ/XELJANZ XR is the first and only Janus kinase (JAK) inhibitor approved by the FDA for both moderate to severe rheumatoid arthritis (RA) and active PsA.

Merck Provides Update on KEYNOTE-061, a Phase 3 Study of KEYTRUDA® (pembrolizumab) in Previously Treated Patients with Gastric or Gastroesophageal Junction Adenocarcinoma

December 14, 2017

Merck has announced that the pivotal phase 3 KEYNOTE-061 trial investigating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, as a second-line treatment for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma, did not meet its primary endpoint of overall survival (OS) (HR, 0.82 [95% CI, 0.66-1.03]; p=0.042 [one-sided]) in patients whose tumors expressed PD-L1 [Combined Positive Score (CPS)]. Additionally, progression free survival (PFS) in the PD-L1 positive population did not show statistical significance. The safety profile observed in KEYNOTE-061 was consistent with that observed in previously reported studies of KEYTRUDA; no new safety signals were identified.

Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Yervoy (ipilimumab) for the Treatment of Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma

December 18, 2017

Bristol-Myers Squibb Company has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Yervoy (ipilimumab) for pediatric patients 12 years of age and older who have unresectable or metastatic melanoma. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

US FDA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated non-small cell lung cancer

December 18, 2017

AstraZeneca has announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations). The FDA has granted Tagrisso Priority Review status and previously granted Breakthrough Therapy Designation in the 1st-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC.

Top Pharma News of the Week last edit: 2017-12-18T18:44:21+00:00 da Luca
1 Comment
  • LUKALAPU LOKESWARARAO
    Posted 19 December 2017 5:54 0Likes

    Accurate data.

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