… investor, but the announcement was seen as insufficient to dispel concern over the high-tech conglomerate’s financial health.
Category: Biotech
Mylan launches generic Zovia in U.S.
Mylan has announced the launch of a generic version of Zovia , a pregnancy preventative, in the U.S. The product — Ethyniol Diacetate and Ethinyl Estradiol tablets — was found to be bioequivalent to Zovia, and subsidiary Jai Pharma got FDA approval for its abbreviated new drug application.
Insulin Market – Global and China Industry Detailed Analysis to 2019
Diabetes, growing at an exponential rate worldwide, has become a serious health concern. The disease has emerged as a major cause of death of people between 20 years and 80 years of age.
FDA puts Seattle Genetics drug trials on hold after 4 deaths
Seattle Genetics Inc said four people had died in trials testing its experimental cancer drug, prompting the U.S. Food and Drug Administration to impose a clinical hold on several early-stage studies. Six patients with acute myeloid leukemia , a type of blood cancer, have been identified with liver toxicity and four have died, the company said on Tuesday.
Seaward Management Limited Partnership Holds Position in Novo Nordisk A/S
Seaward Management Limited Partnership maintained its stake in Novo Nordisk A/S during the third quarter, Holdings Channel reports. The firm owned 47,650 shares of the company’s stock at the end of the third quarter.
Novo Nordisk A/S (NVO) Receives Consensus Rating of “Hold” from Brokerages
Shares of Novo Nordisk A/S have been assigned a consensus rating of “Hold” from the seventeen brokerages that are presently covering the stock. Two equities research analysts have rated the stock with a sell recommendation, nine have issued a hold recommendation, five have given a buy recommendation and one has assigned a strong buy recommendation to the company.
Teva bribery settlement raises questions on Argentina, Romania probes
A half-billion dollar settlement reached between Teva Pharmaceutical Industries Ltd. and the US government last week for the resolution of criminal charges in the bribery of officials in Russia, Ukraine and Mexico raises questions about the fate of other Teva bribery probes, in Argentina and Romania. Teva and the US Department of Justice said in separate statements on Thursday that they had reached a settlement over the charges relating to Russia, Ukraine and Mexico, and that Teva would pay a combined total of US criminal and regulatory penalties of almost $520 million.
Consumer Confidential: Insulin price hikes aren’t sweet – Sun, 25 Dec 2016 PST
A key feature of Republican plans to replace Obamacare is allowing market forces to boost innovation and competition among health care providers. “Unleashing the power of choice and competition is the best way to lower health care costs and improve quality,” declares House Speaker Paul Ryan in his conservative manifesto “A Better Way.”
Top Insider Buys of the Week
… share. The price of the stock has decreased by 0.13% since. Abbott Laboratories is an American-based international health care company. It has more than 74,000 employees in 150 countries. Some products include pharmaceutical drugs, medical devices …
Migraine drugs may repeat rheumatoid arthritis success
… its first human infection of the strain since the former Portuguese colony returned to China in 1999. – – Children are more likely to become overweight or obese during summer vacation than during the school year, a U.S. study …
PTAB Upholds Validity of BMS Patent
The PTAB issued a Final Written Decision upholding the validity of Bristol-Myers Squibb’s U.S. Patent 8,476,239, which had been challenged by Momenta in IPR2015-01537. According to documents filed with the PTAB during the IPR, the ‘239 patent covers stable formulations of a protein called “CTLA4Ig.”
Impax Laboratories Is Undervalued
Investors in the company have been let down time and again. Some factors for the continued weakness in shares include: A poor acquisition, whereby the company acquired a portfolio of generic drugs from Teva and Allergan for $586 million, only to then take an impairment charge of $285.2 million after failing to calculate the extent of the price reductions it would have to make on the products it acquired to retain key clients.
The Most Expensive Drugs of 2016
Prescription drug prices have gotten out of control for many Americans and many insurers, with some medications costing as much as premium sports cars, according to health-care investments analyst Keith Speights, writing for The Motley Fool. Speights recently reviewed the five most expensive drugs of 2016.
Gilead Sciences Has Bought Back $10 Billion of Stock in 2016. Should Investors Be Happy?
The stock has lost about 25% of its value in 2016, and management has taken advantage of the plunge by repurchasing about 100 million shares of its own stock. While it’s nice to know the shares were purchased at knockdown prices, it’s hard to remain cheerful when your stock price is sinking.
ContraVir expands mid-stage study of tenofovir prodrug analog into higher dose
ContraVir Pharmaceuticals broadens its ongoing Phase 2a study evaluating tenofovir exalidex against Gilead Sciences’ tenofovir disoproxil fumarate in patients with chronic hepatitis B virus infection by increasing the highest planned dose to 150 mg/day from 100 mg/day. The 84-subject sequential dose escalation study is assessing once-daily doses of TXL for four weeks against 300 mg of TDF once daily.
Ironwood’s Linzess OK’d in Japan to treat IBS-C; shares up 3%
Ironwood Pharmaceuticals announces that the Japanese Ministry of Health, Labor and Welfare has approved LINZESS for the treatment of adults with irritable bowel syndrome.
Therapy Focus – Immunotherapy Closes In On Triple-Negative Tumors
Celgene admitted as much last week by saying it would not push a promising Abraxane-containing chemotherapy regimen into pivotal trials in this Several studies are already under way, most notably a large first-line phase III trial of Abraxane plus Roche’s anti-PD-L1 antibody Tecentriq. Early data are encouraging, and hopes are high that meaningful survival benefits will emerge in the next couple of years.
DPP IV Inhibitors
… Global Diabetes Expenditure: Opportunity Indicator for DPP-IV Inhibitor Market………….. II-5 Table 3: Global Health Expenditure on Diabetes by Region (2015): Spending (in US$ Billion) by People Diagnosed with Diabetes in the Age Group 20-79 …
Press release distribution, EDGAR filing, XBRL, regulatory filings
Pfizer Receives Approval in the European Union for Nimenrix in Infants Six Weeks of Age and Older )–Pfizer Inc. announced today the European Commission has approved an expanded indication for Nimenrixa Approved as First Anti-PD-1 Therapy in Japan for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer Whose Tumors Express High Levels of PD-L1 )–KEYTRUDA Approved as First Anti-PD-1 Therapy in Japan for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer Whose Tumors Express H… )–Madame Tussauds and country superstar Brad Paisley joined forces to pay tribute to Grand Ole Opry legend Little Jimmy Dickens by unveiling his wax figure on the R… )–Manitowoc Foodservice announces SVP, General Counsel and Secretary Maurice Jones retirement; promotes Joel Horn to SVP, General Counsel and Secretary effecti… )–Mitsubishi UFJ Capital, a … (more)
Press release distribution, EDGAR filing, XBRL, regulatory filings
Hypertension is… )–Research and Markets has announced the addition of the “Haemophagocytic lymphohistiocytosis Forecast in 14 Major Markets 2016-2026” report to their offering. Haemopha… )–Research and Markets has announced the addition of the “Manufacturing in the Cloud” report to their offering.
GSK starts phase III study of once-daily closed triple combination…
… endpoint is the annualised rate of moderate/severe asthma exacerbations. Other secondary endpoints are assessing health-related quality of life and symptom control. Despite the availability of treatments, many patients have asthma that is …
SK Chemicals’ hemophilia drug approved in Canada
SK Chemicals, the biopharmaceuticals unit of South Korea’s SK Group, has obtained regulatory approval to sell its hemophilia treatment in Canada, marking another step forward in breaking into overseas markets. SK Chemicals said Sunday that Health Canada, the country’s drug regulator, has granted marketing and sales approval for Afstyla, a biologic drug for hemophilia developed by SK Chemicals and licensed out to Australian biotech firm CSL Ltd. in 2009.
View Press Release
A Once-Daily Treatment that Demonstrated Comparable Efficacy with Improved Renal and Bone Laboratory Safety Parameters Compared to Tenofovir Disoproxil Fumarate — )–Gilead Sciences, Inc. today announced that the Japanese Ministry of Health, Labour and Welfare has approved Vemlidy 25mg, a once-daily treatment for suppression of viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function. Vemlidy is a novel targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of tenofovir disoproxil fumarate 300mg.
Johnson & Johnson Completes Acquisition of Abbott Medical Optics
The all-cash , and includes ophthalmic products in three areas of patient care: cataract surgery, laser refractive surgery and consumer eye health. These product lines will now join with the world-leading ACUVUEA Brand Contact Lenses business, and the combined organization will operate under the brand name Johnson & Johnson Vision .
FDA warns Pfizer over contaminated drugs at Kansas plant
… that your company’s oversight and control over the manufacturer of drugs is inadequate,” the FDA said. – Most people aren’t aware that surgeons are sometimes involved in multiple operations happening at the same time, and many …