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 The leading web portal for pharmacy resources, news, education and careers August 19, 2018
Pharmacy Choice - News - Generic Drugs - August 19, 2018

Pharmacy News

 Generic Drugs
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8/19/18 - FDA approves Teva's generic of Mylan's EpiPen [Jerusalem Post (Israel)]
The US Food and Drug Administration has approved Teva Pharmaceutical Industries Ltd. s generic version of Mylan NV s life-saving allergy injection, EpiPen, at a time when regulators are looking to lower healthcare costs. There has also been a shortage of EpiPen in North America, Europe and Canada since earlier this year due to manufacturing d
8/18/18 - EpiPen: NJ consumers squeezed by cost to get generic option from Teva [Asbury Park Press, N.J.]
Aug. 17 Families who rely on the expensive EpiPen to save their children during a severe allergy attack may soon have a lower-cost generic option thanks to a pharmaceutical company moving to New Jersey. "I think it's fantastic," said Amy McVey, 40, of Long Branch, whose 11- year-old son uses the injectable drug. Teva Pharmaceuticals Inc., the Is
8/18/18 - FDA approves first generic competitor to EpiPen [T-break Tech (Middle East)]
It was approved after the FDA issued new guidance for generic copies of products like the EpiPen, which combines a drug with a specialized device to deliver it fast when people have life-threatening allergic reactions. This approval means patients living with severe allergies who require constant access to lifesaving epinephrine should have a lower
8/18/18 - Ophthalmology Devices Market: Global Product Intelligence, Analysis, Opportunities and Forecast to 2024: Some of the prominent participants in the Global Ophthalmology Devices Market are Carl Zeiss Meditec AG, Abbott Medical Optics, Inc., Bausch & Lo
Pune, Maharashatra 08/17/2018 " Infinium Global Research has produced a new premium report Ophthalmology Devices Market. The report also deep dives into the sub-segments of Ophthalmology Devices Market by devices and application through main geographies in the Global Market such as North America, Europe, Asia-Pacific and RoW. Some of the prom
8/18/18 - Samsung looks to expand CDMO biz with $22bn investment [Tehran Times (Iran)]
Samsung plans to invest KRW 180 trillion into its various businesses over the next three years, including in biomanufacturing-focused Samsung BioLogics. According to the firm, both its contract development and manufacturing organisation Samsung BioLogics and biosimilar business Samsung Bioepis have seen strong growth. Samsung BioLogics will benefit
8/18/18 - Supply Of Generic Drugs For A Period Of Two Years [TendersInfo (India)]
Tenders are invited for Supply of Generic Drugs for a Period of Two Years Eligibility Criteria: The following bidders are eligible to participate in the tender:- Domestic Manufacturers having valid own manufacturing license or loan license are eligible to quote the drugs manufactured at their manufacturing units duly inspected and registered with M
8/18/18 - US-China trade war offers window of opportunity for Indian pharma sector, says GlobalData [Sport360]
Vikas Bedi, Head of APAC Healthcare Research at GlobalData, opines: This exemption may not be India specific but Indian pharma companies can benefit from this move as they are already manufacturing and marketing many of the required products at significantly lower prices and with high quality. However, a huge trade gap exists between the two nation
8/17/18 - 'Pharma Wholesale and Distribution Market Worth $1,195bn in 2021' Says Visiongain Report
Visiongain, a independent media company, issued the following news release:. Visiongain's new report Pharma Wholesale and Distribution Market Forecasts 2017-2027: Branded and Generic Drug Distribution, Leading National Markets, Leading Wholesalers, US, Europe, Japan and China indicates that the pharma wholesale and distribution market will see $1,1
8/17/18 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Controlled Correspondence Related to Generic Drug Development
Agency: " Food and Drug Administration, HHS." SUMMARY: The Food and Drug Administration is announcing that a proposed collection of information has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995.. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Dr
8/17/18 - Antares Pharma Announces FDA Approval of Generic EpiPen Utilizing VIBEX Auto Injector
Antares Pharma announced that the U.S. Food and Drug Administration has approved Teva Pharmaceutical, epinephrine auto injector drug-device combination product indicated for emergency treatment of severe allergic reactions including those that are life threatening in adults and certain pediatric patients. We are extremely pleased with the FDA
8/17/18 - As Big Pharma Rakes In Profits at Patients' Expense, Durbin Calls for Action on Skyrocketing Prescription Drug Cost
As the costs of prescription drugs continue to soar for patients under the Trump Administration, U.S. Senator Dick Durbin today called for action on several pieces of legislation that would hold the pharmaceutical industry accountable, curb price hikes, and bring much-needed transparency to price setting for prescription drugs in the U.S. Durbin wa
8/17/18 - Auditor's Report: Pharmacy Benefit Managers Take Fees of 31% on Generic Drugs Worth $208M in One-Year Period
Ohio's Pharmacy Benefit Managers charged the state a "spread" of more than 31 percent for generic drugs- nearly four times as much as the previously reported average spread across all drugs, according to a new report by Ohio Auditor of State Dave Yost. An analysis conducted by Auditor Yost's staff found PBMs collected $208 million in fees on generi
8/17/18 - BioCentury - Management tracks: Achillion, Navidea
Rare disease company Achillion Pharmaceuticals Inc. hired Anthony Gibney as EVP and CBO. Immunotherapy company Navidea Biopharmaceuticals Inc. said CEO Michael Goldberg has resigned to become CEO of the immunotherapy company's Macrophage Therapeutics Inc. subsidiary. Hikma Pharmaceuticals plc hired Kristy Ronco as EVP of sales and marketing for the
8/17/18 - Cataract Surgery Device Market 2022 Snapshot : Key Players Strategies, Upcoming Opportunities and Industry Analysis by MRFR: Market Research Future announced the Report with Titled Cataract Surgery Device Market. Analyses all the Segments and S
Pune, India 08/17/2018 The Globally for Cataract Surgery Device Market is growing steadily. Some of the key players in this market are: Alcon, Inc., Abbott Laboratories, Carl Zeiss Meditech AG, Essilor International S.A., Opcon Corporation, Allergan, Inc., Bausch& Lomb, Inc., NIDEK Co., Ltd., STAAR Surgical Company and others. On 17 Th July 2
8/17/18 - Cipher Pharmaceuticals Reports Q2 2018 Results
MISSISSAUGA- Cipher Pharmaceuticals Inc. today announced its financial and operational results for the three and six months ended June 30, 2018. In 2018, Cipher has launched one new product in Canada and completed five transactions that demonstrate meaningful progress in the execution of its growth strategy to assemble a diversified portfolio of...
8/17/18 - Cipla partners with MSN Laboratories for marketing and distribution of generic Xeloda
Mumbai- Cipla USA, Inc., a subsidiary of Cipla Limited, today announced that it has secured rights from MSN Laboratories Private Limited to market& distribute Capecitabine 150 mg and 500 mg tablets in the United States of America. Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics
8/17/18 - Cipla Receives Final Approval for Generic Reyataz
Mumbai- Cipla Limited today announced that it has received final approval for its Abbreviated New Drug Application for Atazanavir Caps 100 mg, 150 mg, 200 mg, 300 mg from the United States Food and Drug Administration. Cipla's Atazanavir Caps 100 mg, 150 mg, 200 mg, 300 mg is AB-rated generic therapeutic equivalent version of Bristol-Myers Squibb P
8/17/18 - Data from National Institute of Biology Advance Knowledge in Antineoplastic Monoclonal Antibodies [Quality assurance of rituximab (anti-CD 20)...
According to news reporting from Noida, India, by NewsRx journalists, research stated, "A validated and robust bioassay is of paramount importance in the various stages of biosimilar development to ensure efficacy, quality and potency. For more information on this research see: Quality assurance of rituximab antibodies by potency testing: determini
8/17/18 - Elite Pharmaceuticals, Inc. Reports Financial Results for the First Quarter of Fiscal Year 2019 Ended June 30, 2018 and Provides Conference Call Information
NORTHVALE- Elite Pharmaceuticals, Inc., a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, announced results for the first quarter of fiscal year 2019 ended June 30, 2018. Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological...
8/17/18 - FDA Approves First Generic Version of EpiPen
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening, in adults and pediatric
8/17/18 - FDA approves first generic version of lifesaving EpiPen
FDA Commissioner Scott Gottlieb, insurers and advocates said the copycat device from Teva Pharmaceuticals, an Israeli company, could be a lifeline for patients looking to save money and access vital medication, after Mylan reported supply shortages with its manufacturing partner, Pfizer. Under pressure from Congress, Mylan didn't slash prices, but
8/17/18 - FDA OKs Teva product as 1st generic version of EpiPen
WASHINGTON- The Food and Drug Administration approved the first generic version of EpiPen on Thursday, a move that will bring new competition for the lifesaving allergy injection that helped spark public furor over high drug prices. There has been "limited availability of EpiPen in certain areas in the U.S., including both pharmacy-level supply dis
8/17/18 - Korean biotechs drug candidates in phase 3 clinical trials [Tehran Times (Iran)]
A growing number of Koreas biotech and pharmaceutical companies are pushing the boundaries of conventional product portfolios that depend heavily on imported therapies and generic drugs. Encouraged by a series of out-licensing deals and development of biosimilars, more than four companies take aim to go beyond the Korean market with drug candidates
8/17/18 - Nation/world business briefs
U.S. regulators have approved a new generic version ofEpipen, the emergency allergy medication. TheFood and Drug Administrationapproval comes two years after EpiPen maker Mylan was berated by Congress for hiking the price of its product by more than 500 percent. The company lowered its full-year guidance, but it managed a 0.3 percent same-store sal
8/17/18 - New cell lines produce NIST monoclonal antibody for improved biologic drugs
By a News Reporter-Staff News Editor at Drug Week When the National Institute of Standards and Technology issued the world's first standardized monoclonal antibody in July 2016, the exhaustively analyzed protein known as NISTmAb was intended as a valuable tool for biopharmaceutical companies. In a new paper in the journal mAbs, researchers at the
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