Alembic Pharmaceuticals has received approval from the US health regulator for Zolmitriptan orally disintegrating tablets, used for the treatment of migraine, in the American market. The company has received approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Zolmitriptan Orally Disintegrating Tablets, 2.5
Alembic now has a total of 51 ANDA approvals from USFDA. Alembic Pharmaceuticals Limited announced that the company has received approval from the US Food& Drug Administration for its Abbreviated New Drug Application for Zolmitriptan Orally Disintegrating Tablets, 2.5 mg and 5 mg. Alembic Pharmaceuticals Ltd is currently trading at Rs 631.9, down b
Alembic Pharmaceuticals Limited announced that the company has received approval from the US Food& Drug Administration for its Abbreviated New Drug Application for Zolmitriptan Orally Disintegrating Tablets. Alembic Pharmaceuticals Ltd ended at Rs 624.45 down by Rs 7.80 or 1.23% from its previous closing of Rs 632.25 on the BSE. The scrip opened at
Americans are used to negotiating prices- some call it haggling- for bigticket items like cars and houses. Sometimes parents arm-wrestle colleges over tuition aid. The authors investigated prices of generic drugs to treat heart failure in the city of St. Louis.
HYDERABAD, India& PRINCETON, N.J. Dr. Reddy s Laboratories Ltd announced today that it has launched Nystatin and Triamcinolone Acetonide Cream, USP, in the United States market, approved by the U.S. Food& Drug Administration. The generic had U.S. sales of approximately $119 million MAT for the most recent twelve months ended in October 2016
New interim data demonstrate Sandoz proposed biosimilar rituximab has equivalent efficacy to reference product. Novartis International AG/ New interim data demonstrate Sandoz proposed biosimilar rituximab has equivalent efficacy to reference product. Holzkirchen, December 5, 2016- Sandoz, a Novartis division, and the pioneer and global leader in...
By a News Reporter-Staff News Editor at Clinical Trials Week- International Isotopes Inc. announces that it has submitted an abbreviated new drug application to the U.S. Food and Drug Administration for its I3odine/MAX? sodium iodide radiopharmaceutical product. This is the first application submitted to the FDA by any company for a generic sod
On December 5, 2016, Kadmon Holdings, Inc. issued a press release announcing that it has submitted an Abbreviated New Drug Application for KD034, to the U.S. Food and Drug Administration. This is the first application submitted to the FDA by any company for a generic trientine hydrochloride product for the treatment of Wilson's disease in patients
Kadmon Holdings, Inc. today announced that it has submitted an Abbreviated New Drug Application for KD034, to the U.S. Food and Drug Administration. Trientine hydrochloride is an important therapeutic option for Wilson s disease patients, based on its tolerability profile, particularly for newly diagnosed and pediatric populations, said Ha
Novartis International AG/ New interim data demonstrate Sandoz proposed biosimilar rituximab has equivalent efficacy to reference product. *ASSIST-FL trial demonstrates equivalent safety, efficacy, pharmacokinetics and pharmacodynamics of Sandoz proposed biosimilar rituximab to the reference product* Interim data in over 600 adults show potential..
Teva Pharmaceutical Industries Ltd. today announced that Dipankar Bhattacharjee has been appointed President and Chief Executive Officer, Global Generic Medicines Group, effective today. Mr. Bhattacharjee will be based in the U.S.. I am honored to lead the Global Generic Medicines Group, a business with a robust R&D pipeline, a talented team of
VANC Pharmaceuticals Inc., a pharmaceutical company focused on the Canadian generic drug and over-the-counter markets, announces today it has signed a non-binding term sheet to acquire all outstanding common shares of HealthTab Inc., a proven point-of-care solution provider to Canadian pharmacies. The strategic acquisition of HealthTab will provide
Amgen and Allergan plc. today announced the submission of a Marketing Authorization Application to the European Medicines Agency for ABP 215, a biosimilar candidate to Avastin . "The submission of ABP 215 to the EMA is an important milestone as Amgen seeks to expand our oncology portfolio," said Sean E. Harper, M.D., executive vice president o
"Enbrel Biosimilars Clinical Trial Insight" report by PNS Pharma gives comprehensive clinical insight on 36 biosimilars version of Enbrel drug in clinical pipeline. Currently 5 biosimilar version of Enbrel are commercially available in Iran, Mexico, India, UK and Australia. The patent on Enbrel was originally set to expire on October 23, 2012, b
When Andrew Witty became CEO of one of the biggest pharmaceutical firms in the world, GlaxoSmithKline, his industry was so unpopular that campaigners threw red paint at company stands during conferences to represent the blood of those who died because they could not afford medicines. Two years into his tenure, with Big Pharma s reputation in the
The US Food and Drug Administration has granted its final approval for Lupin Ltds armodafinil tablet, which is used for treating sleep disorder. The companys US subsidiary Lupin Pharmaceuticals Inc is expected to commence promotion of this approved product, a generic version of Cephalon Incs Nuvigil tablet, in the US shortly. Nuvigil tablet had US
Momenta Pharmaceuticals, Inc. is a biotechnology company focused on the development of generic versions of complex drugs. Although the drug has been developed and commercialized by both MNTA and Baxter Bioscience, now part of Shire, MNTA is expected to take over M923 in order for Shire to continue its focus on treating patients with rare diseases.
New Psoriasis Study Findings Have Been Reported by Researchers at University of Turin. According to news reporting originating from Turin, Italy, by NewsRx correspondents, research stated, "The infliximab originator's patent recently expired, leading to the production of biosimilar versions of the drug. Our news editors obtained a quote from the re
By a News Reporter-Staff News Editor at Drug Week NEW ORLEANS, Prices for generic drugs to treat heart failure can vary so widely that uninsured patients may not be able to afford them, according to preliminary research presented at the American Heart Association's Scientific Sessions 2016. Researchers surveyed 175 pharmacies in the greater St. L
Sun Pharmaceutical Industries is currently trading at Rs. 718.25, up by 11.95 points or 1.69% from its previous closing of Rs. 706.30 on the BSE. The scrip opened at Rs. 709.80 and has touched a high and low of Rs. 718.50 and Rs. 707.75 respectively. The BSE group `A` stock of face value Rs. 1 has touched a 52 week high of Rs. 898.00 on 23- Feb-201
Altasciences Clinical Research, a leading early phase drug development contract research organization, is delighted to have been named Best Contract Research Organization Niche at the 12 th Annual Scrip Awards held November 30 th in London. We continuously innovate to meet the evolving and increasingly complex needs of our clients, while m
Dec. 01 Lupin Pharmaceuticals Inc., the Baltimore- based subsidiary of Indian drug maker Lupin Ltd., has received final regulatory approval for a generic sleep disorder medication. Lupin's Armodafinil is a generic version of Cephalon Inc.' s Nuvigil, used to treat narcolepsy, sleep apnea and shift work disorder among adults. The final regulatory
Release date- 30112016- Pfizer Inc. today announced that the pivotal REFLECTIONS B3271002 study, a comparative safety and efficacy study of PF-05280014 versus Herceptin, met its primary endpoint. PF-05280014 is being developed by Pfizer as a potential biosimilar to Herceptin. 'As the leading global biosimilars company, we are committed to advancing
Equities in today's lineup are: Mylan N.V., Horizon Pharma PLC, Allergan PLC, and Catalent Inc.. Shares in Hertfordshire, the UK- based Mylan N.V. ended Wednesday's session at $36.61, rising 1.53% from the last trading session. On November 18 th, 2016, research firm Mizuho reiterated its' Buy' rating on the Company's stock with a decrease of the ta
Vensun Pharmaceuticals, Inc., a privately held generic pharmaceuticals company, today announced the completion of $22.5 million Series C preferred financing with a consortium of investors led by Perceptive Advisors, LLC. Deerfield Management Company, L.P. also joins Perceptive Advisors as a new investor in the Company. Joseph Edelman, Founder and C