By a News Reporter-Staff News Editor at Pharma Business Week Amneal Pharmaceuticals LLC and Impax Laboratories, Inc., announced that Andrew S. Boyer, 52, has joined Amneal as Executive Vice President, Commercial Operations and is expected to serve in the same capacity for the new combined company following the consummation of the combination with
Gottlieb also said he wants to speed up the U.S. approval process for generic and biosimilar versions of biologic drugs, which are drugs comprised of living organisms, such as plant or animal cells. He deflected questions about whether the FDA approves drugs of questionable value that have exorbitant prices. The Food and Drug Administration,
Hyderabad, India 02/19/2018 According to a new market research report "Biosimilars Market By Type, By Technology, By Application, By Region- Global Industry Analysis, Size, Share, Growth, Trends, And Forecasts 2017-2022", published by MarketDataForecast. The Global Biosimilars Market was priced USD 4,760.0 million in 2016 and calculable to be
By a News Reporter-Staff News Editor at Pharma Business Week Indivior PLC announced that its U.S. subsidiary, Indivior Inc., has filed patent lawsuits against Dr. Reddy's, Actavis, Par, Alvogen and Teva for infringement of United States Patent No. 9,855,221 relating to their respective proposed generic versions of the Company's SUBOXONE Sublin
Isofol Medical AB today announce that the company will in the future be adopting the generic name arfolitixorin for its lead candidate, up to now referred to as Modufolin . This is an important step towards bringing a new drug to market, "said Anders Rabbe, Chief Executive Officer at Isofol Medical AB. The generic name arfolitixorin for Modufol
By a News Reporter-Staff News Editor at Pharma Business Week Knobbe Martens, one of the leading intellectual property law firms in the United States, has received a U.S. District Court ruling in Iceutica Pty Ltd., et al. v. Lupin Limited, et al. dismissing all claims of patent infringement against client Lupin Limited and Lupin Pharmaceuticals, I
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week Washington, DC- In its response to the U.S. Department of Health and Human Services' latest Request for Information on Promoting Health Care Choice and Competition Across the United States, the American College of Rheumatology urged HHS to reform its prior authorization polic
Albany, NY 02/17/2018 Doxorubicin is the generic drug name for anti-cancer chemotherapy drug Adriamycin and Rubex. Doxorubicin is an anthracycline antibiotic and belongs to the group of anti-cancer medication known as antineoplastic and is made from the natural product produced by bacterium Streptomyces peucetius var. caesius. It is used for
The following should be read in conjunction with our consolidated financial statements and related notes beginning on page F 1 of this Annual Report. The following discussion contains forward looking statements. We earn revenue on net sales of VIVITROL and ARISTADA, which are proprietary products that we manufacture, market and sell in the U.S.
Biosimilars have been available in Europe for over a decade, and have offered the opportunity to vastly reduce the cost of treatment for a large number of biologic agents. This analysis summarizes key information on the process of biosimilar approval in Europe, along with associated challenges, and provides highlights on country-specific market acc
Celltrion Healthcare has announced that the European Commission has approved Herzuma for all indications of reference trastuzumab in the European Union. The approval of Herzuma marks the third Celltrion Healthcare product approved in the EU and builds on the companys expanding biosimilar portfolio. Man Hoon Kim, President and CEO of Celltrion...
This determination will allow FDA to approve abbreviated new drug applications for benazepril hydrochloride; hydrochlorothiazide oral tablets, 5 mg and 6.25 mg, if all other legal and regulatory requirements are met. The 1984 amendments include what is now section 505 of the Federal Food, Drug, and Cosmetic Act, which requires FDA to publish a list
The "Biosimilar Insulin Market Access" report has been added to ResearchAndMarkets.com' s offering. Biosimilar competition is providing payers with opportunities to contain costs in a category that accounts for a significant proportion of total drug expenditure. The launch of the biosimilar insulin Basaglar is a threat to the insulin-based produc
The National Multiple Sclerosis Society issued the following news:. The approval means that Sandoz provided evidence that the generic medication is equivalent to the brand-name Copaxone. More Details: The FDA has approved a generic glatiramer acetate medication that has been shown to be equivalent to the 40 mg Copaxone taken three days per week by.
By a News Reporter-Staff News Editor at Health& Medicine Week A new study on Health and Medicine- Health Services Management is now available. According to news reporting originating from Thessaloniki, Greece, by NewsRx correspondents, research stated, "The increase in the consumption of generic drugs to reduce pharmaceutical expenditure is a cha
The European Commission has approved Celltrion Healthcares Herzuma, a biosimilar of Roche/ Genentechs blockbuster Herceptin. Herceptin, a biologic drug developed by Genentech and marketed by Roche, pulled in worldwide sales of $6.8 billion in 2016, of which $2.1 billion stemmed from Europe. Subsequently, the approval of Herzuma will be greatly welc
Our preliminary focus is on the development of therapies for skin, lung and prostate cancers in the United States of America market, with the first indication targeting basal cell carcinoma in patients with Basal Cell Carcinoma Nevus Syndrome for which we commenced a Phase 2 trial in the third quarter of 2015 and completed enrollment in the fourth
TORONTO, ON/ ACCESSWIRE/ February 16, 2018/ Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today reported the results of operations for the year ended November 30, 2017.
Mumbai, Baltimore- Pharma major Lupin announced the launch of its Oseltamivir Phosphate Capsules, USP having received an approval from the United States Food and Drug Administration earlier. Lupin's Oseltamivir Phosphate Capsules, USP, 30 mg, 45 mg, and 75 mg are the generic equivalent of Hoffman-La Roche, Inc.' s Tamiflu Capsules, 30 mg, 45 mg, an
By a News Reporter-Staff News Editor at Drug Week Global pharmaceutical leader Mylan N.V. announced the U.S. launch of Efavirenz Tablets USP, 600 mg, the first generic version of Bristol-Myers Squibb's Sustiva . In the U.S., there are an estimated 1.1 million people living with HIV. Keywords for this news article include: Pharmaceutical Compani
Albany, NY 02/16/2018 Inhalation based drug products are typically water based solutions or suspensions of drug containing additional excipients. However, introduction of dry powder inhalers eliminated the chances of degradation of therapeutically active ingredient in the solution form. Inhalation based dosage forms are intended for direct de
Pernix Therapeutics Holdings, Inc., a specialty pharmaceutical company, today announced the launch of an authorized generic version of Treximet in the U.S. by the Company s subsidiary, Macoven Pharmaceuticals, LLC. Treximet is a prescription medicine that contains sumatriptan and naproxen sodium and is indicated for the treatment of acute m
Studies from O. Kayikci and Co-Researchers in the Area of Biosimilars Reported[ Biosimilar filgrastim (leucostim ) have similar efficacy in steady-state hematopoietic progenitor cell mobilization compared to original filgrastim (neupogen ).. By a News Reporter-Staff News Editor at Drug Week Fresh data on Drugs and Therapies- Biosimilars are p
Mumbai- Sun Pharmaceutical Industries Ltd. reported financials for the third quarter& nine month ending December 31st, 2017. India sales at Rs. 2,085 crores, growth of 6% over Q3 last year. US finished dosage sales at US$ 328 million down by 35% over Q3 last year.
On February 15, 2018, United Therapeutics Corporation and Actavis Laboratories FL, Inc. entered into a Settlement Agreement to settle their ongoing litigation concerning certain patents relating to Orenitram Extended-Release Tablets and Actavis' Abbreviated New Drug Application seeking approval by the U.S. Food and Drug Administration to market