AmerisourceBergen Corporation today reported that in its fiscal year 2014 fourth quarter ended September 30, 2014, adjusted diluted earnings per share from continuing operations increased 35.8 percent to $1.10. Revenue increased 29.1 percent to $31.6 billion in the quarter. We delivered exceptional performance in our September quarter, completin
Dublin- Research and Markets has announced the addition of the "Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices" report to their offering. In this report, biopharmaceutical manufacturer decision-makers share their perspectives on:. -Expected outsourcing of commercial biosimilar manufacturing- Comfort level with...
The following statement can be attributed to BayBio, the Biotechnology Industry Organization, the Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Association and the Consumer Healthcare Products Association:. However, there is no rationale for mandating new, costly and redundant disposal options when both the Food a
ENP Newswire- 30 October 2014. Release date- 29102014- The European Medicines Agency has published its revised overarching guideline on biosimilars. This document, together with a series of complementary guidelines that were subsequently developed by EMA, have led to the approval of 19 biosimilars in the European Union to date, including the first
This is especially important given the rapid increase of expensive oral cancer therapies,' said study leader Dawn L. Hershman, MD, MS, associate professor of medicine at the College of Physicians and Surgeons, and associate professor of epidemiology at the Mailman School of Public Health, Columbia University Medical Center. Dr. Hershman is also lea
The first plant for the manufacturing of biosimilar medicines will be launched in 2016 in Algeria, by Jordanian laboratory El Kendi, said Wednesday in Algiers, CEO of the laboratory Farouk Aissam. "The laboratory El Kendi will launch in 2016 a biosimilars plant, the first one in Algeria which still doesn't manufacture this class of molecules," sai
Teva Pharmaceutical Industries Ltd. today reported results for the quarter ended September 30, 2014. We also remain fully committed to transform and simplify our operational network and make quality a competitive competency for us, stated Erez Vigodman, President& CEO of Teva. Erez Vigodman continued, We are well positioned to achieve our goa
TWi Pharmaceuticals, Inc. today announced that it has received final approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for Donepezil Hydrochloride Tablets USP, 23 mg, the generic equivalent to Eisai Inc.' s Aricept 23 mg. TWi Pharmaceuticals is preparing to launch the product in the US via its
Robert A. Bradway, chairman and chief executive officer at Amgen, opened the meeting by affirming that the Company's strategy will continue to focus on discovery and development of innovative medicines to address serious illnesses, development of branded biosimilars, next-generation biomanufacturing of high quality biologics, developing improved...
The European Union's Medicines Agency issued the following news:. The European Medicines Agency has published its revised overarching guideline on biosimilars. This document, together with a series of complementary guidelines that were subsequently developed by EMA, have led to the approval of 19 biosimilars in the European Union to date, including
US pharmaceutical giant Pfizer sold some 300 million doses of Viagra worldwide by 2013. The company applied for the patent in China in 1994 and was granted 20- year exclusive rights in 2001.. There are about 140 million patients with erectile dysfunction in China, according to a report released by Guosen Securities in May. And though its exclusive
Senators Amy Klobuchar and Chuck Grassley today urged the Federal Trade Commission to release data on pay-for-delay settlements. In a letter to FTC Chairwoman Edith Ramirez, the senators requested the prompt release of the agency's annual report summarizing agreements where brand-name drug companies pay generic drug companies to delay marketing low
Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Letrozole Tablets USP, 2.5 mg, the therapeutic equivalent to the reference listed drug, Femara Tablets, 2.5 mg, of Novartis Pharmaceuticals Corporation. Letrozole Tablets USP, 2.5 mg, repre
Mumbai: Generic drug manufacturer Lupin plans to out-license its three new chemical entities which are currently under clinical trials in Europe. The company posted a 55% growth in its profit for the quarter ended September to Rs 630 crore on the back of increase in other income and strong sales in the US and India. "Three of our NCEs are under cl
Pius Hornstein, Sanofi vice president for Turkey and the Middle East, right, with Jerome Silvestre, SVP, Sanofi Global Generics Division, Khalid bin Kalban, MD& CEO of Dubai Investments, and Jamil Akhtar, GM of Globalpharma, at the press conference. Sanofi, a global and diversified health care leader, has commenced the first phase of local generic
Notably, the NSCLC market will grow despite the generic/biosimilar erosion of key branded current therapies, including Eli Lilly's Alimta, Genentech/ Roche/Astellas/Chugai's Tarceva and Genentech/ Roche/Chugai's Avastin. Sequential treatment of tyrosine kinase inhibitor- refractory patients: Novartis' Zykadia became the first agent to be approved f
This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products, if all other legal and regulatory requirements are met. The 1984 amendments include what is now section 505 of the F
Reddy s Laboratories announced today that it has launched Sirolimus Tablets 1 mg and 2 mg, a therapeutic equivalent generic version of RAPAMUNE tablets in the US market on October 27, 2014, following the approval by the United States Food& Drug Administration. The RAPAMUNE tablets brand had U.S. sales of approximately $206 Million MAT for
EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, today announced that the Medicines Control Council of South Africa has successfully used EXTEDO's reviewing and validation tool for registering pharmaceutical submissions prepared in eCTD format for the first time ever. The successful registrations of an NCE and a generic
IGI Laboratories posted its financial results for the third quarter ended September 30. -Total net revenues generated from the sale of IGI-label generic topical pharmaceutical products for the three and nine months ended September 30, were $3.0 million and $9.3 million, respectively, increases of 117 percent and 123 percent over the same periods in
Such inspections are carried out on a regular basis by the FDA, and an "acceptable" classification is necessary to permit the Company to be in a position to receive final approvals for Abbreviated New Drug Applications and for New Drug Applications, and to permit manufacturing of drug products intended for commercial sales in the United States afte
Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that its affiliate, Iroko Pharmaceuticals Inc., signed a licensing agreement with Aspen Pharma Pty Ltd, a company incorporated in Australia, for the exclusive rights to register and market ZORVOLEX capsules in...
The National Community Pharmacists Association issued the following news release:. Independent community pharmacies are increasingly providing services to support patient compliance with their prescribed drug regimen and set a new record high in the proportion of prescriptions filled with typically lower-cost generic drugs, according to the...
Pfizer Inc. reported financial results for third-quarter 2014. At the beginning of fiscal year 2014, the company began managing its commercial operations through a new global commercial structure consisting of three operating segments: the Global Innovative Pharmaceutical segment; the Global Vaccines, Oncology and Consumer Healthcare segment; and..
There's buzz in the market that Hospira, the Illinois- based injectable generic drugs maker, is eyeing Poonawalla's equity interests in Orchid. Orchid recently concluded the sale of its antibiotics manufacturing complex and pharmaceutical R&D facility to Hospira, two years after they entered into an agreement. He told TOI that it was in the best in