Allergan plc, a leading global pharmaceutical company, today announced that the Committee for Medicinal Products for Human Use has adopted a Positive Opinion for the Marketing Authorisation of ENZEPI in the European Union. 1 ENZEPI is a pancreatic enzyme replacement therapy for patients with exocrine pancreatic insufficiency due to cystic f
The Stork OTC is the only FDA- cleared over-the-counter conception device that helps women and couples with getting pregnant in the privacy of home. The interview is scheduled to air live at 7:45 A.M. PT on KOVR-TV/ KMAX-TV. The FDA- cleared, over-the-counter device utilizes cervical cap insemination.
For further information regarding management's assessment of internal control over financial reporting, refer to Item 9 A "Controls and Procedures" in this Form 10- K. INTRODUCTION The following Management's Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the audited consolidated financial
Our revenues increased by 9% for the three months ended March 31, 2016 as a result of higher Opdivo, Eliquis and Daklinza product sales. These impacts were partially offset by the expiration of our U.S. commercialization rights to Abilify*, the transfer of Erbitux* rights in North America and competitive pressures resulting from exclusivity losses
WASHINGTON, April 28 The Department of Health and Human Services published the following notice in the Federal Register from the Food and Drug Administration:. A Notice by the Food and Drug Administration on 04/27/2016. Dates: The public meeting will be held on September 27, 2016, from 9 a.m. to 5 p.m. Please register here for the meeting by Sept
Care Dimensions will hold an eight-week volunteer training course from 9 a.m. to noon Fridays beginning May 6 at the Care Dimensions Kaplan Family Hospice House, 78 Liberty St., Danvers. Lahey Medical Center, Peabody will be holding an informational session for community residents on a state-of-the-art weight loss procedure on Thursday, May 5.
ORLANDO, Fla.- April 27, 2016- Immune Therapeutics, Inc., a clinical-stage biotech company providing immunotherapy solutions for the treatment of autoimmune disease and cancer with a focus on emerging nations, today announced that Nigeria's National Agency for Food and Drug Administration and Control has approved its patented Lodonal as an over the
The receipt of NAFDACs approval will enable the Companys distribution partner, AHAR Pharma, and GB Pharma Holdings, to launch a nationwide marketing and sales program that is expected to generate new and significant revenue channels for the Company. Its approval for the Company to exclusively market and distribute Lodonal in Nigeria clears the way
OPKO Health, Inc., announced that additional data on RAYALDEE as a treatment for secondary hyperparathyroidism will be highlighted later today in a poster presentation at the National Kidney Foundation Spring Clinical Meetings, underway in Boston, MA.. OPKO s poster presentation entitled Modified-release Calcifediol Treatment of SHPT Indicate
OPKO Health, Inc. today announced the U.S. Food and Drug Administration has accepted OPKO s resubmission on April 22, 2016 of the New Drug Application for RAYALDEE for the treatment of secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency. OPKO resubmitted the NDA following receipt of a
The receipt of NAFDAC s approval will enable the Company s distribution partner, AHAR Pharma, and GB Pharma Holdings, to launch a nationwide marketing and sales program that is expected to generate new and significant revenue channels for the Company. Its approval for the Company to exclusively market and distribute Lodonal in Nigeria clears
The public meeting is intended to allow FDA to obtain patient perspectives on the impact of receiving an organ transplant on daily life and patient views on treatment approaches; the input from this public meeting will help in developing topics for further discussion. FDA is also interested in discussing issues related to scientific challenges in..
The OTC Drugs Market: Commercial Trends and Rx-to-OTC Switch Prospects Summary GBI Research's latest report, "The OTC Drugs Market: Commercial Trends and Rx-to-OTC Switch Prospects" discusses trends in the over-the-counter pharmaceuticals market and the commercial prospects for switching drugs from prescription-only to OTC status.
Acura Pharmaceuticals, Inc., a specialty pharmaceutical company innovating abuse deterrent drugs, today announced that the Company has been issued U.S. Patent No. 9,320,796 by the United States Patent and Trademark Office pertaining to the Company's Limitx? Technology platform. About Acura Pharmaceuticals Acura Pharmaceuticals is a specialty...
BioPharmX Corporation, a specialty pharmaceutical company focusing on dermatology and women's health, today announced its financial results for the fourth quarter and fiscal year ended January 31, 2016.. Announced the U.S. FDA approved the company's Investigational New Drug application for BPX-01, a novel topical gel to treat acne. Commenced Phas
Transparency Market Research Report Added "Noscapine Base Market" to its database.Albany, NY 04/26/2016 Transparency Market Research is a leading provider of the latest market intelligence on a diverse array of industries, including the global pharmaceutical industry. A new report in this data pool is the " Noscapine Base Market- Global Indus
Perrigo Company plc today announced that its Board of Directors declared a quarterly dividend of $0.145 per share, payable on June 14, 2016 to shareholders of record on May 27, 2016. Perrigo Company plc, a top five global over-the-counter consumer goods and pharmaceutical company, offers consumers and customers high quality products at affordable
Lex Machina, a LexisNexis company and creator of Legal Analytics , today announced the release of its second Hatch-Waxman/ANDA Report, which surveys the landscape of patent litigation related to Abbreviated New Drug Applications submitted to the FDA under the Hatch-Waxman Act. The two U.S. districts that have received an overwhelming majority o
AbbVie, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for the use of VIEKIRA PAK without ribavirin in patients with genotype 1 b chronic hepatitis C virus infection and compensated cirrhosis. The Centers for Disease Control and Prevention estimate
Active pharmaceutical ingredients are bulk drug products that are used as raw materials for formulations. APIs of good quality are essential for the manufacture of effective and safe medicines. However, not all pharmaceutical companies possess in-house API manufacturing capabilities.
BioPharmX Corporation, a specialty pharmaceutical company developing products for the dermatology market, today announced that it has completed enrollment for its Phase 2 a study of the novel topical minocycline gel BPX-01. "This research is important to the dermatology community, which has been searching for an effective alternative to current
Enanta Pharmaceuticals, Inc.,, a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced today that the U.S. Food and Drug Administration has approved AbbVie s supplemental New Drug Application for the use of VIEKIRA PAK without ribavirin in patients
Ipsen is pleased to announce that its partner Exelixis, Inc. received approval from the U.S. Food and Drug Administration for CABOMETYX? tablets earlier today for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. On February 29, 2016, Exelixis and Ipsen jointly announced an exclusive lic
Antares Pharma, Inc. today announced that the Company s OTREXUP.COM website has been awarded a 2015 Bronze Horizon Interactive Award in the category of Consumer Information Websites. The Horizon Interactive Awards are among the most prestigious awards in the field of interactive and creative media. The annual international competition, now in
By a News Reporter-Staff News Editor at Pharma Business Week A patent by the inventors Agisim, Gary Robert; Friedline, Robert Alan; Patel, Shivangi Akash; Sertzen, Cesar Ivan; Shepperson, Vanessa Rose, filed on February 27, 2014, was published online on April 12, 2016, according to news reporting originating from Alexandria, Virginia, by NewsRx c