February 2, 2017
Amgen has announced that the FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial evaluating whether Repatha® (evolocumab) minimizes the risk of cardiovascular events in patients with clinically evident atherosclerotic cardiovascular disease (ASCVD) met its primary composite endpoint (cardiovascular death, non-fatal stroke, non-fatal myocardial infarction (MI), coronary revascularization or hospitalization for unstable angina) and the key secondary composite endpoint (cardiovascular death, non-fatal stroke or non-fatal MI). No new safety issues were observed. Detailed results from the Repatha FOURIER outcomes trial will be presented at the American College of Cardiology(ACC) 66th Annual Scientific Session Late-Breaking Clinical Trials session in Washington, D.C. on Friday, March 17.
Abbvie Gets U.S. FDA Priority Review for Its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for Treating Chronic Hepatitis C
February 2, 2017
AbbVie, a global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority review for its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), being evaluated for treating all major genotypes (GT1-6) of chronic hepatitis C virus (HCV). The FDA grants priority review designation to medicines that it determines have the potential to deliver substantial improvements in the effectiveness and safety of the treatment of a serious disease. The NDA is supported by data from eight registrational studies in the G/P clinical development program of Abbvie, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes and for special populations.
FDA Accepts Two SBLAs for The Keytruda® (Pembrolizumab) Of Merck for Locally Advanced or Metastatic Urothelial Cancer
February 3, 2017
Merck has announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental Biologics License Applications (sBLAs) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer. In particular, the application for first-line use was accepted and granted Priority Review for the treatment of these patients who are not eligible for cisplatin-containing therapy. The application for second-line use was also accepted and granted Priority Review for these patients with disease progression on or after platinum-containing chemotherapy.
February 7, 2017
Cellectis, the Paris-based biotech, has received an Investigational New Drug, or IND, approval from the U.S. Food and Drug Administration (FDA) for conducting phase I clinical trials with UCART123, the gene-edited product candidate of the biotech, in patients with acute myeloid leukemia, or AML, and blastic plasmacytoid dendritic cell neoplasm, or BPDCN. This is the first “off the shelf” allogeneic gene-edited CAR T-cell product candidate that the FDA has approved for clinical trials. Cellectis anticipates to initiate phase I trials in the first half of 2017.
February 8, 2017
Bayer and its partners at J&J, back in the fall of 2012, started a massive study to see if the drug Xarelto (rivaroxaban) could help prevent major cardiovascular events like myocardial infarction, stroke, and death in high risk patients with coronary artery disease or peripheral artery disease.
February 10, 2017
Seattle Genetics has become the new flag carrier for the solid tumor drug IMMU-132 of Immunomedics. In order to claim global rights on the drug, Seattle Genetics is paying $300 million, and also committing up to $1.7 billion more in milestones. The biotech will now take the lead on a Phase III study for metastatic triple negative breast cancer. And once the BLA is filed, it’s obligated to pay over the first of its milestone money as Seattle Genetics looks to vault to an approval as early as late 2017.
European Commission Approves Once-Daily Olumiant Tablets for Treating Adults with Moderate-To-Severe Active Rheumatoid Arthritis
Feb. 13, 2017
Eli Lilly and Company and Incyte Corporation have announced that the European Commission has granted marketing authorisation for Olumiant® (baricitinib) 4 mg and 2 mg film-coated tablets in Europe for treating moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs).
Feb 15, 2017
Integra Lifesciences, a prominent medical device maker, has announced that it will acquire the Codman Neurosurgery business of Johnson & Johnson’s (JNJ) for $1.05 billion. The Codman unit of JNJ includes a portfolio of medical devices focusing on advanced hydrocephalus, operative neurosurgery, and neuro-critical care, according to the company. During 2016, the acquired products generated approximately $370 million in revenue, the company stated.
17 February 2017
AstraZeneca has announced positive results from its Phase III OLYMPIAD trial comparing Lynparza (olaparib) tablets (300mg twice daily) to physician’s choice of a standard of care chemotherapy in the treatment of patients with HER2-negative metastatic breast cancer harbouring germline BRCA1 or BRCA2 mutations. It was found that patients treated with Lynparza showed a clinically-meaningful and statistically-significant improvement in progression-free survival (PFS) compared with those who received chemotherapy (capecitabine, vinorelbine or eribulin).
Celgene Announces Positive Results from Phase III Sunbeam Trial of Oral Ozanimod in Patients with Relapsing Multiple Sclerosis
Feb 17, 2017
Celgene Corporation has announced that its phase III SUNBEAM trial that evaluates the safety and efficacy of ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis (RMS), met the primary endpoint in reducing annualized relapse rate (ARR), compared to weekly interferon (IFN) β-1a (Avonex®).
Roche Receives EU Approval of Alecensa (Alectinib) for People with Previously Treated ALK-Positive Non-Small Cell Lung Cancer
21 February 2017
Roche has announced that the European Commission has granted a conditional marketing authorisation for Alecensa® (alectinib) as monotherapy for treating adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. Within one year of treatment, most people with ALK-positive NSCLC develop resistance to the current standard of care, and approximately 60% develop metastases in the central nervous system (CNS).
February 23, 2017
Incyte Corporation has signed off on a multi-year deal for collaborating with scientists at the University of Pennsylvania on its next-gen combos and cancer therapies.
Novartis Drug Zykadia Receives FDA Priority Review for First-Line Use in Patients with ALK+ Metastatic NSCLC
February 23, 2017
Novartis has announced that the US Food and Drug Administration (FDA) accepted the supplemental New Drug Application (sNDA) of the company for filing, and granted Priority Review for the expanded use of Zykadia® (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The FDA also granted Breakthrough Therapy designation to Zykadia for the first-line treatment of patients with ALK+ metastatic NSCLC with metastases to the brain.
Revlimid® (Lenalidomide) Approved by The European Commission as Monotherapy for The Maintenance Treatment of Patients with Newly Diagnosed Multiple Myeloma
Feb 24, 2017
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, has announced that the European Commission (EC) has approved REVLIMID® (lenalidomide) as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation (ASCT). REVLIMID® is the first and only licensed maintenance treatment available to these patients.
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The International Federation of Health Plans, the leading global network of the health insurance industry, developed a report on the comparison of health care costs across different countries. The 2015’s survey includes pricing for several specialty prescription drugs, common diagnostic evaluations, and a selection of typical medical procedures.
9 February 2017
Prominent pharmaceutical companies are renowned for their commitment toward innovation, and they spend heavily on R&D. The list of top 20 pharmaceutical companies in the world investing the largest sums in R&D in the fiscal year 2015-16 is provided in this article.
Reputation is extremely important for Pharmaceutical Companies. Like every year, Fortune collaborated with Korn Ferry Hay Group on the survey of corporate reputations. To determine the best-regarded companies in 51 industries, Korn Ferry Hay Group evaluated 680 companies in 28 countries. Executives, directors, and analysts have been asked to rate enterprises in their own industry. The list of Pharmaceutical Companies that made it to the top is given in this article.
In 2016, Novartis stood at USD 36.2 billion, a decrease of 2%, as compared to 2015 fiscal nine months sales. The fiscal third quarter (Q3) sales were USD 12.1 billion, a decrease of 1% compared to 2015 Q3 sales with earnings per share at USD 0.8. The company recorded a total pharmaceutical sales of fiscal nine months at USD 24.3 billion in 2016.
The company specializes in Cardiovascular and Metabolic disease (CVMD); Oncology; and Respiratory, Inflammation and Autoimmunity (RIA) along with Infection, Neuroscience and Gastrointestinal (ING) disease areas. The London based company operates in 100+ countries globally. The company recorded sales of USD 23 billion in 2016, a decrease by 5% compared to USD 24.7 billion in 2015. The earnings per share in 2016 was USD 2.77.
The company is involved research and development of a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. The company recorded sales of £28 billion in 2016 an increase by 6% compared to £24 billion in 2015. The earnings per share in 2016 was 18.8p. The pharmaceutical division sales £16 billion in 2016 an increase of 3% in comparison with 2015. The growth can be attributed to the HIV products which increase by grew 37% in the year.
The company develops prevention to treatment-based products in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare segments. The company has three operating segments: Pharmaceuticals, Human Vaccines (Vaccines) and Animal Health. Its pharmaceuticals portfolio consists of a range of prescription medicines, generic medicines and consumer health products. The company recorded sales of € 33.8 billion in 2016, a decrease by 0.7% compared to € 34 billion in 2015. The earnings per share in 2016 was € 5.68. The pharmaceutical segment revenue was recorded at € 29.2 billion.