Top Pharma News of the Week – August 6th

All The Most Important Pharmaceutical News Stories Of The Week – August 2018 – Week # 1

Pfizer Receives European Approval for Oncology Biosimilar, Trazimera™ (Trastuzumab)

July 31, 2018

Pfizer Inc. has announced that the European Commission (EC) has approved TRAZIMERA™, a biosimilar to Herceptin®* (trastuzumab), for the treatment of human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric
or gastroesophageal junction adenocarcinoma. This approval follows the recommendation from the Committee for Medicinal Products for Human Use in May 2018.

European Commission Approves Bristol-Myers Squibb’s Opdivo (nivolumab) for the Adjuvant Treatment of Adult Patients with Melanoma with Involvement of Lymph Nodes or Metastatic Disease Who Have Undergone Complete Resection

July 31, 2018

Bristol-Myers Squibb Company has announced that the European Commission (EC) has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. This indication is for both BRAF mutant and wild-type melanoma patients. With this decision, Opdivo becomes the first and only PD-1 therapy to receive an EC approval in the adjuvant setting and has gained its eighth indication across six distinct tumor types in the European Union (EU).

Eisai and Merck Announce FDA Grants Breakthrough Therapy Designation for LENVIMA® (lenvatinib) in Combination with KEYTRUDA® (pembrolizumab) as Therapy for Previously Treated Patients with Advanced and/or Metastatic non-MSI-H/pMMR Endometrial Carcinoma

July 31, 2018

Eisai Co., Ltd. and Merck, known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for LENVIMA® (lenvatinib), the orally available kinase inhibitor discovered by Eisai, in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the potential treatment of patients with advanced and/or metastatic non-microsatellite instability high (MSI-H)/proficient mismatch repair (pMMR) endometrial carcinoma (EC) who have progressed following at least one prior systemic therapy. The LENVIMA/KEYTRUDA combination therapy is being jointly developed by Eisai and Merck as part of the strategic collaboration announced in March 2018.

Xeljanz® (Tofacitinib Citrate) Receives Marketing Authorization in The European Union for Moderately to Severely Active Ulcerative Colitis

August 1, 2018

Pfizer Inc. has announced that the European Commission (EC) has approved XELJANZ® (tofacitinib citrate) 10 mg twice-daily (BID) for at least eight weeks, followed by XELJANZ 5 mg BID or 10 mg BID, for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. XELJANZ is the first and only oral therapy and Janus kinase (JAK) inhibitor to be approved for this patient population.

FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo’s FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML

August 1, 2018

Daiichi Sankyo Company, Limited has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).

Selumetinib granted orphan designation in Europe for neurofibromatosis type 1

August 3, 2018

AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) have announced that the European Medicines Agency (EMA) has granted orphan designation to selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1). NF1 is an incurable genetic condition that affects one in 3,000 newborns worldwide. The severity of signs and symptoms associated with NF1 can be highly variable, are often mild-to-moderate and may include skin, nerve and skeletal manifestations. Plexiform neurofibromas (PNs) are benign tumors on nerve sheaths that develop in 20-50% of patients, and as they continue to increase in number and size, cause moderate-to-severe morbidities such as pain, motor dysfunction and disfigurement.

PRIME designation granted by European Medicines Agency for RG6042 for treatment of Huntington’s disease

August 3, 2018

Roche has announced that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation for the company’s investigational medicine RG6042 (formerly known as IONIS-HTTRx) for the treatment of people with Huntington’s disease (HD). RG6042 has demonstrated its ability to reduce the toxic mutant huntingtin protein (mHTT), which is believed to be the underlying cause of HD, in a Phase I/IIa study. PRIME is a designation implemented by the EMA to support data generation and development plans for promising medicines, providing a pathway for accelerated evaluation by the agency, and thus potentially enable them to reach patients earlier.

Regeneron And Bluebird Bio Announce Collaboration to Discover, Develop and Commercialize New Cell Therapies for Cancer

August 6, 2018

Regeneron Pharmaceuticals, Inc. and bluebird bio, Inc. have announced a collaboration to apply their respective technology platforms to the discovery, development and commercialization of novel immune cell therapies for cancer. The collaborators will specifically leverage Regeneron’s VelociSuite® platform technologies for the discovery and characterization of fully human antibodies as well as T cell receptors (TCRs) directed against tumor-specific proteins and peptides, and bluebird bio will contribute its field-leading expertise in gene transfer and cell therapy.

Top Pharma News of the Week – August 6th last edit: 2018-08-06T18:28:18+00:00 da Luca

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