Top Pharma News of the Week – September 17th

All The Most Important Pharmaceutical News Stories Of The Week – September 2018 – Week # 3

Gilead and Galapagos Announce Filgotinib Meets Primary and All Key Secondary Endpoints in First Phase 3 Study in Rheumatoid Arthritis

September 11, 2018

Gilead Sciences, Inc. and Galapagos NV have announced that FINCH 2, a global, randomized, placebo-controlled, Phase 3 study of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response/intolerance to biologic agents, achieved its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20 percent response (ACR20) at Week 12. Also at Weeks 12 and 24, the proportion of patients achieving ACR50 and ACR70, low disease activity (LDA, DAS28(CRP) < 3.2), and clinical remission (DAS28(CRP) < 2.6) were significantly higher for patients receiving once-daily filgotinib 100 mg or 200 mg compared to patients receiving placebo.

Merck’s ZERBAXA® (ceftolozane and tazobactam) Met Primary Endpoints of Non-Inferiority Compared to Meropenem in Pivotal Phase 3 Study of Adult Patients with Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia

September 11, 2018

Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 clinical study evaluating the company’s antibiotic ZERBAXA® (ceftolozane and tazobactam) at an investigational dose for the treatment of adult patients with either ventilated hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) met the pre-specified primary endpoints, demonstrating non-inferiority to meropenem, the active comparator, in Day 28 all-cause mortality and in clinical cure rate at the test-of-cure visit. In the U.S., ZERBAXA is currently indicated in adult patients for the treatment of complicated urinary tract infections, including pyelonephritis, caused by certain Gram-negative microorganisms, and is indicated, in combination with metronidazole, in adult patients for the treatment of complicated intra-abdominal infections caused by certain Gram-negative and Gram-positive microorganisms.

FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Monotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Patients Whose Tumors Express PD-L1 (TPS >1%)

September 12, 2018

Merck, known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has accepted for review and granted priority review to a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 (tumor proportion score [TPS] >1%) without EGFR or ALK genomic tumor aberrations. The application is based on data from the pivotal Phase 3 KEYNOTE-042 trial, one of five Phase 3 clinical trials with KEYTRUDA in NSCLC to demonstrate a significant improvement in overall survival. Data from the trial were presented earlier this year at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Jan. 11, 2019.

Bristol-Myers Squibb’s Novel, Oral, Selective TYK2 Inhibitor Delivered Significant Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis in Phase 2 Trial

September 12, 2018

Bristol-Myers Squibb Company has announced results from a Phase 2 study of BMS-986165, an investigational oral, selective tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate to severe plaque psoriasis. Efficacy endpoints including 75% and 90% reduction in the Psoriasis Area and Severity Index (PASI 75, PASI 90) were achieved following 12 weeks of treatment with 3 mg daily of BMS-986165, with a favorable risk-benefit profile. Nasopharyngitis, headache, diarrhea, nausea and upper respiratory tract infection were the most common adverse events (AEs) reported.

Gilead Sciences and Precision BioSciences Announce Collaboration to Develop Therapies Against Hepatitis B Virus Using ARCUS Genome Editing

September 12, 2018

Gilead Sciences and Precision BioSciences have announced that the companies have entered into a strategic collaboration to develop therapies targeting the in vivo elimination of hepatitis B virus (HBV) with Precision’s proprietary genome editing platform, ARCUS.

Boehringer Ingelheim Acquires All ViraTherapeutics Shares to Develop Next Generation Viral-Based Immuno-Oncology Therapies 

September 13, 2018

Boehringer Ingelheim has announced that it has acquired all shares of ViraTherapeutics, a biopharmaceutical company specializing in the development of oncolytic viral therapies. ViraTherapeutics developed the lead candidate VSV-GP (Vesicular Stomatitis Virus (VSV) with modified glycoprotein (GP)), which is being investigated alone and in combination with other therapies. The total transaction value of EUR 210 million is based on an option and share purchase agreement signed between the companies in August 2016.

US FDA approves Lumoxiti (moxetumomab pasudotox-tdfk) for certain patients with relapsed or refractory hairy cell leukaemia

September 14, 2018

AstraZeneca and MedImmune, its global biologics research and development arm, announced that the US Food and Drug Administration (FDA) has approved Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is not recommended in patients with severe renal impairment (CrCl < 29 mL/min). The Phase III trial results demonstrated 75% (95% confidence interval [CI]: 64, 84) of patients receiving Lumoxiti achieved an overall response; 30% (95% CI: 20, 41) had a durable complete response.

Allergan to Acquire Bonti Adding New Neurotoxin Programs to Medical Aesthetics Pipeline

September 14, 2018

Allergan plc, a leading global pharmaceutical company, has announced it has agreed to acquire Bonti, Inc., a privately held clinical-stage biotechnology company focused on the development and commercialization of novel, fast-acting neurotoxin programs for aesthetic and therapeutic applications.

Top Pharma News of the Week – September 17th last edit: 2018-09-17T17:25:10+00:00 da Luca

Leave a Reply

*The views and opinions expressed on IgeaHub belong to the authors only. They do not represent the views or opinions of any company or organization.

Follow Us

Join us

All rights reserved. Terms of use and Privacy Policy

Design by PT Webmaster

%d bloggers like this:
Skip to toolbar