Top Pharma News of the Week

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

US, EU, and Japan Health Authorities Accept Regulatory Submissions for Review of Pfizer’s Third-Generation ALK Inhibitor Lorlatinib

 

February 12, 2018

Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to the company’s New Drug Application for lorlatinib. Lorlatinib is an investigational, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC), previously treated with one or more ALK TKIs. The European Medicines Agency and the Japan Pharmaceutical and Medical Devices Agency have also accepted marketing applications for the use of lorlatinib.

Sandoz announces US FDA approval and launch of Glatopa® 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis

 

February 13, 2018

Sandoz, a Novartis division, has announced the US FDA approval and launch of Glatopa® (glatiramer acetate injection) 40 mg/mL. Glatopa is a fully-substitutable, AP-rated generic version of Copaxone® (glatiramer acetate injection) 40 mg/mL three times-a-week therapy for relapsing forms of multiple sclerosis (MS). Glatopa was developed under a collaboration agreement between Momenta Pharmaceuticals, Inc. and Sandoz and is produced in the US.

ERLEADA (apalutamide), a Next-Generation Androgen Receptor Inhibitor, Granted U.S. FDA Approval for the Treatment of Patients with Non-Metastatic Castration-Resistant Prostate Cancer

 

February 14, 2018

Janssen has announced that the U.S. Food and Drug Administration (FDA) has approved ERLEADA™ (apalutamide), a next-generation androgen receptor inhibitor, for the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). ERLEADA™ is the first FDA-approved treatment for these patients. Today’s approval follows an FDA Priority Review designation based upon data from the Phase 3 SPARTAN study, which demonstrated a 72 percent reduction in risk of distant metastasis or death, and an increase in median metastasis-free survival (MFS) by more than two years (difference of 24.31 months) in patients with NM-CRPC.

Pfizer receives breakthrough therapy designation from FDA for PF-04965842, an oral JAK1 inhibitor, for the treatment of patients with moderate-to-severe atopic dermatitis

 

February 14, 2018

Pfizer Inc. has announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the US FDA for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The Phase 3 program for PF-04965842 initiated in December and is the first trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program.

Novartis forms alliance to develop medicines for treating infectious diarrheal disease

 

February 14, 2018

Novartis and the Bill & Melinda Gates Foundation have formed an alliance to advance development of Novartis’ drug candidate KDU731 for the treatment of cryptosporidiosis. Diarrheal diseases are one of the leading causes of childhood mortality globally, resulting in approximately 525,000 deaths each year and cryptosporidiosis is the second leading cause of infectious diarrhea in children under 2 years of age.

Selumetinib granted Orphan Drug Designation by the US FDA for neurofibromatosis type 1

 

February 15, 2018

AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) have announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1).

Merck KGaA and Pfizer Provide Update on Phase III JAVELIN Lung 200 Trial of Avelumab Monotherapy in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer

February 15, 2018

Merck KGaA and Pfizer Inc. have announced results from the Phase III JAVELIN Lung 200 trial comparing avelumab to docetaxel in patients with unresectable, recurrent or metastatic non-small cell lung cancer (NSCLC) whose disease progressed after treatment with a platinum-containing doublet therapy. While the trial did not meet its prespecified endpoint of improving overall survival (OS) in patients with programmed death ligand-1-positive (PD-L1+) (1% or higher) tumors (HR: 0.90 [96% CI: 0.72–1.12], p-value 0.1627, one-sided), the proportion of patients in the chemotherapy arm crossing over to immune checkpoint inhibitors outside the study was higher than previously reported in post-platinum immunotherapy clinical trials, and this may have confounded this trial outcome (percentage of patients receiving subsequent checkpoint inhibitor therapy: docetaxel arm 26.4%; avelumab arm 5.7%).

Oxford BioMedica Announces Collaboration and Licence Agreement with Bioverativ in the Field of Haemophilia Gene Therapy

February 15, 2018

Oxford BioMedica plc (OXB), a leading gene and cell therapy group, has announced that it has completed a major new collaboration & licence agreement with Bioverativ Inc. for the development and manufacturing of lentiviral vectors to treat haemophilia. The agreement includes a licence to use OXB’s LentiVector Enabled technology and access to its industrial-scale manufacturing technology. Under the terms of the agreement, Oxford BioMedica will receive a $5 million upfront payment from Bioverativ. Oxford BioMedica is also eligible to receive various milestone payments, potentially worth in excess of $100 million, and undisclosed royalties on net sales of Bioverativ’s lentiviral vector haemophilia products.

Roche to acquire Flatiron Health to accelerate industry-wide development and delivery of breakthrough medicines for patients with cancer

 

February 15, 2018

Roche and Flatiron Health, Inc. have announced that the two partners have signed a definitive agreement under which Roche will acquire all shares of Flatiron Health, following on from an existing equity stake of 12.6%. The transaction is expected to close in the first half of 2018.

Novartis new Cosentyx® data confirms robust efficacy and quality of life improvements in scalp psoriasis

 

February 16, 2018

Novartis has presented new Cosentyx® (secukinumab) data from the prospective Phase III SCALP study which showed significant improvement in skin clearance with Cosentyx in patients with scalp psoriasis. Due to the presence of hair, scalp psoriasis is particularly difficult to treat with common topical and phototherapy options. These study results were presented at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California.

US FDA approves Imfinzi for unresectable Stage III non-small cell lung cancer

 

February 17, 2018

AstraZeneca and MedImmune, its global biologics research and development arm, have announced that the US Food and Drug Administration (FDA) has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).

Top Pharma News of the Week last edit: 2018-02-19T18:35:57+00:00 da Luca

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