Analyst Ratings For Amneal Pharmaceuticals Inc (NYSE:AMRX) Today, Canaccord Genuity raised its price target on Amneal Pharmaceuticals Inc (NYSE:AMRX) to $21.00 per share. There are 4 Hold Ratings, 4 Buy Ratings, no Strong Buy Ratings, no Sell Ratings on the stock. The current consensus rating on Amneal Pharmaceuticals Inc (NYSE:AMRX) is Buy with a
BAUDETTE- ANI Pharmaceuticals, Inc. ANIP, -1.74% today reported its financial results for the three and six months ended June 30, 2018 and updated its 2018 financial guidance. Arthur S. Przybyl, President and CEO, stated,' In the second quarter of 2018 ANI continued to successfully execute on its strategy to grow the brand and generic business plat
New York, NY 08/14/2018 Global Biosimilars Market. WiseGuyRerports.com Presents "Global Biosimilars Market 2016-2020" New Document to its Studies Database. The market is divided into the following segments based on geography:- Americas- APAC- EMEA.
Elite Pharmaceuticals, Inc. a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today reported positive topline results from pivotal bioequivalence studies conducted for an undisclosed immediate-release antibiotic generic product being co-developed with SunGen Pharma. IQVIA reported annual...
NORTHVALE- Elite Pharmaceuticals, Inc., a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today announced that it received approval from the U.S. Food and Drug Administration for the Company's abbreviated new drug application for methadone hydrochloride 5 mg and 10 mg tablets. Based on QuintilesIMS...
Koreas Samsung Bioepis has begun clinical development of its first ever novel biologic a protein intended to treat severe acute pancreatitis. A joint venture between Samsung and Biogen, Samsung Bioepis has made its name producing biosimilars in the last few years. Chul Kim, senior vice president and head of clinical sciences division at Samsung Bio
-Teligent, Inc., a specialty generic pharmaceutical company, averted a national sterile water and sodium chloride crisis by securing inventory to cover 100% of the Canadian Market following a breakdown in the global supply chain. "As a company, we knew we had to mobilize ourselves to mitigate the effects of this crisis on Canadians," said Mark Man
AIDS Healthcare Foundation has filed a petition for writ of certiorari with the Supreme Court of the United States last week seeking the Court s review of the dismissal of a federal lawsuit filed by AHF in January 2016 against Gilead Sciences Inc. and other defendants alleging its patent for a key HIV/AIDS drug, tenofovir alafenamide is invalid
JHL Biotech has announced it received a positive Scientific Advice from the Committee for Medicinal Products for Human Use of the European Medicines Agency related to the EU approval pathway for its proposed trastuzumab biosimilar, JHL1188, to treat breast cancer. The reference innovator biologic achieved approximately US $7 billion in sales global
Agency: " Food and Drug Administration, HHS." FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, Trang.Tran@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The holders of the applications listed in the t
EVENT: Health and Human Services Department; Food and Drug Administration holds a hearing on FDA's approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products. LOCATION: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31
By a News Reporter-Staff News Editor at Pharma Business Week Lannett Company, Inc. announced that it has entered into an exclusive perpetual licensing agreement with Andor Pharmaceuticals, LLC for Methylphenidate Hydrochloride Extended Release tablets USP in 18 mg, 27 mg, 36 mg and 54 mg strengths. Andor's pending Abbreviated New Drug Application
-Medicure Inc., a cardiovascular pharmaceutical company, is pleased to announce that the United States Food and Drug Administration has approved its Abbreviated New Drug Application for Sodium Nitroprusside Injection 50 mg/2 mL single dose vial, a generic intravenous cardiovascular drug product. Medicure' s newly approved product was determined by
HERTFORDSHIRE, England and PITTSBURGH, Aug. 13, 2018/ PRNewswire/ Global pharmaceutical company Mylan N.V. today announced the U.S. launch of Tadalafil Tablets USP, 20 mg, the first generic version of the reference listed drug, Eli Lilly and Company's Adcirca . "Mylan offers more than 650 products in the U.S., and the addition of Tadalafil Tab
By a News Reporter-Staff News Editor at Pharma Business Week Plagued by regulatory delays, the FDA finally granted approval for Retacrit in May 2018, making it the first biosimilar erythropoietin-stimulating agent to become available in the US market. Vifor Pharma, which also holds exclusive US commercialization rights to Roche's Mircera, a long-
By a News Reporter-Staff News Editor at Clinical Trials Week Current study results on Drugs and Therapies- Biosimilars have been published. According to news reporting from Boston, Massachusetts, by NewsRx editors, the research stated, "Biologic drugs are notoriously expensive. Our news journalists report that additional information may be obtain
Studies from University of Coimbra Have Provided New Information about Pharmaceutical Research. By a News Reporter-Staff News Editor at Clinical Trials Week Investigators publish new report on Drugs and Therapies- Pharmaceutical Research. The news correspondents obtained a quote from the research from the University of Coimbra, "The first strateg
The US Food and Drug Administration has granted its first competitive generic therapy designation to Apotexs potassium chloride oral solution for hypokalemia in patients on diuretics. CGT designation was introduced under the FDA Reauthorisation Act and is granted to generic drugs that have no adequate generic competition. FDA commissioner Scott...
Even as the Trump Administration has grabbed headlines in recent months with efforts to control drug prices, another program at the FDA has yielded early results with a generic drug approval. The FDA has approved the first generic under a new pathway created to streamline approval for generics in drug classes with little or no competition.
The FDA approved Apotex Inc.' s potassium chloride oral solution USP, 10%; and 20% on August 8 as the first generic drugs to receive a Competitive Generic Therapy designation. Annovera, the vaginal contraceptive system, developed by the Population Council, and licensed to TherapeuticsMD Inc., was greenlighted by the FDA on August 10, becoming the f
In a brief filed in FTC v. WLF further argues that the about-to-violate standard requires the FTC to provide evidence of the defendant's near-term plans. But the FTC did not file its lawsuit until 2017, five years after the drug company had ceased its petitioning activity and five years after generic competition began.
Analyst Ratings For Amneal Pharmaceuticals Inc (NYSE:AMRX) Today, BMO Capital Markets raised its price target on Amneal Pharmaceuticals Inc (NYSE:AMRX) to $20.00 per share. There are 3 Hold Ratings, 3 Buy Ratings, no Strong Buy Ratings, no Sell Ratings on the stock. The current consensus rating on Amneal Pharmaceuticals Inc (NYSE:AMRX) is Buy with
Analyst Ratings For Amphastar Pharmaceuticals Inc (NASDAQ:AMPH) Today, Needham & Company LLC lowered its price target on Amphastar Pharmaceuticals Inc (NASDAQ:AMPH) to $22.00 per share. There are 4 Buy Ratings, 2 Hold Ratings, no Strong Buy Ratings, no Sell Ratings on the stock. The current consensus rating on Amphastar Pharmaceuticals Inc (NASDAQ:
BAUDETTE- ANI Pharmaceuticals, Inc. announced today that it will present on Thursday, August 9, 2018 at 2:30 PM ET at the Canaccord Genuity 38th Annual Growth Conference. Arthur S. Przybyl, President and CEO and Stephen P. Carey, Vice President, Finance and CFO, will present on behalf of ANI Pharmaceuticals, Inc. The presentation will be webcast li
Completed Phase 1 clinical trial in June, planning to launch Phase 3 clinical trial across 20 nations beginning with Portugal. Further, it recently submitted its Clinical Trial Application for Phase 3 clinical study to the National Authority of Medicines and Health Products, I.P. of Portugal. Beginning with Portugal, Celltrion is set to conduct Pha