This strategic direction will involve a focus on the Company's strong Canadian business, supported by Toprol-XL and its authorized generic as well as Vimovo royalties, and the discontinuation of the remaining U.S. commercial business. Despite a successful launch of Zontivity in the U.S., the Company has concluded that the momentum from Zontivity
By a News Reporter-Staff News Editor at Pharma Business Week Lannett Company, Inc. announced that it has acquired 23 approved and one pending drug product applications from a subsidiary of Endo International plc for an upfront payment plus future milestone payments. For the 12 months ended March 2018, combined sales of the acquired products were
By a News Reporter-Staff News Editor at Clinical Trials Week Biopharmaceutical company NeuClone has announced positive preclinical results of its biosimilar to Johnson& Johnson's Stelara , including 3- dimensional structure confirmation through X-ray crystallography analysis. NeuClone's Stelara biosimilar is co-developed with Serum...
According to news reporting originating in Munich, Germany, by NewsRx journalists, research stated, "Biosimilars are biological products similar to, but not the same as, the innovator products. Both the European Medicines Agency and the Food and Drug Administration have released detailed guidance on the development of biosimilars. " Our news corres
According to news reporting out of Silver Spring, Maryland, by NewsRx editors, research stated, "The objective of this report is to summarize common deficiencies identified in the filing reviews of abbreviated new drug applications with clinical endpoint bioequivalence studies and skin irritation, sensitization, and adhesion studies received by the
By a News Reporter-Staff News Editor at Pharma Business Week SOHM, Inc. is a global generic pharmaceutical manufacturer, developer and marketer. Indian subsidiary of SOHM, Inc., was appreciated and facilitated at 30th All India Conference of National Integrated Medical Association in the presence of Honorable Mr. Jay Narayan Vyas, Minister, Healt
My 74- year-old mother, who lives primarily on her Social Security, takes several high-priced drugs that sap her income even with her Medicare drug plan.- Looking for Assistance. If she qualifies for help, she'll pay no more than $3.35 for a generic drug and $8.35 for a brand-name drug in 2018.. To get the subsidy, your mom's assets can't be more t
Heritage Pharmaceuticals, a generic pharmaceuticals company, issued the following news release:. Heritage Pharmaceuticals Inc. announced the immediate availability of Acyclovir 200 mg Capsules. According to IMS data for the twelve-months ended May 2018, the U.S. market for Acyclovir Capsules approximated $6.9 million.
SOUTH SAN FRANCISCO- Another week has gone by, and it was raining FDA approvals. This drug developed by Amgen Inc. is the first FDA- approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks. Pfizer Inc.' s RETACRIT, a biosimi
AstraZeneca saw profits in the first quarter of the year tumble 46 per cent as it comes to terms with generic versions of the one of its biggest drugs hitting the market. The pharmaceutical firm reported core operating profit for the first three months of the year of $896 m, 46 per cent lower than 12 months ago, revenue fell four per cent, to $5.1
Mallinckrodt PLC is expected to release Phase 4 interim Acthar data for multiple sclerosis at the end of May, rheumatoid arthritis in June and systemic lupus erythematosus at some point in the second quarter. Mylan NV' s Neulasta and Advair biosimilars have June 4 and June 27 Target Action Dates, respectively. Cantor forecast June oral arguments fo
New Findings from Cairo University in Biosimilars Provides New Insights. Our news editors obtained a quote from the research from Cairo University, "There is a need for regional recommendations for healthcare professionals to ensure that biosimilar drugs can be used safely. The news editors report that additional information may be obtained by cont
While the traditional pharmaceutical and biotechnology leaders like Japan, Russia and the U.S. have reached a saturation level, newer regions of South Asia, particularly the Indian subcontinent, are playing a vital role in changing the face of pharma and biotech market across the globe. Today, India and China lead the generics segment. Third world
By a News Reporter-Staff News Editor at Drug Week Amneal Pharmaceuticals has launched vigabatrin for oral solution USP, a generic equivalent for Sabril . Amneal has also filed an ANDA with US FDA for the tablet form of vigabatrin. Annual U.S. sales of vigabatrin for oral solution were $318 million, according to March 2018 IQVIA? market data.
Amneal Pharmaceuticals, Inc., an integrated specialty pharmaceutical company, today announced that its founders along with members of management will ring the opening bell at the New York Stock Exchange this morning at 9:30 a.m. ET. Amneal Pharmaceuticals, Inc., headquartered in Bridgewater, NJ, is an integrated specialty pharmaceutical company f
The FDA approval comes after the review of a comprehensive data package submitted by Pfizer indicating high similarity between Retacrit and its reference products, Epogen and Procrit. Pfizer has already signed an agreement with Vifor Pharma for the commercialisation of the biosimilar in select channels across the US. Previously, the company secured
Johnson& Johnsons Actelion Pharmaceuticals, Celgene, and Gilead Life Sciences are all potentially blocking generic drug makers from accessing samples of their products, along with three dozen other drug companies according to new data out Thursday from the FDA intended to publicly shame them for what it calls gaming tactics. Thursdays announcement
The FDA published the names of dozens of companies that have potentially been blocking access, saying sunshine is need to change their behavior. The FDA said companies are using a variety of tactics to stall the sale of generics. They may cite the presence of a Risk Evaluation and Mitigation Strategy a program the FDA applies to certain drugs to
The "Global Generic Drug Litigation Updates 2018: Opportunities for Generic Companies Based on the Latest Para IV Events" report has been added to ResearchAndMarkets.com' s offering. The report highlights all important opportunities for generic companies based on the latest Para IV litigation updates. The analyses provides an insight into each prod
The "Global Generic Drug Litigation Updates 2018: Opportunities for Generic Companies Based on the Latest Para IV Events" report has been added to ResearchAndMarkets.com' s offering. The report highlights all important opportunities for generic companies based on the latest Para IV litigation updates. US Courts documents Company SEC filings/Annual.
SAINT LAURENT- IntelGenx Corp. today announced that all patent litigation between the Company, Par Pharmaceutical, Inc., Indivior, Inc., Indivior UK Limited, and Aquestive Therapeutics, Inc. related to Suboxone film has been settled. Par is IntelGenx's commercial and development partner for a generic version of Suboxone sublingual film product, whi
Investigators from School of Pharmacy Have Reported New Data on Toxicology and Pharmacology. According to news reporting originating from Taipei, Taiwan, by NewsRx correspondents, research stated, "Generic drugs are accounted for majority of medicinal products. Our news editors obtained a quote from the research from the School of Pharmacy, "The pr
According to news reporting originating from Genolier, Switzerland, by NewsRx correspondents, research stated, "Patent expirations for several biological products have prompted the development of alternative versions, termed' biosimilars', which have comparable quality, safety and efficacy to a licensed biological medicine. This was followed by a..
New Biosimilars Study Findings Recently Were Reported by D. Sampey and Co-Researchers. By a News Reporter-Staff News Editor at Drug Week A new study on Drugs and Therapies- Biosimilars is now available. According to news reporting from Frederick, Maryland, by NewsRx journalists, research stated, "The precise product quality and lower cost of good
DUBLIN- Perrigo Company plc today announced that Sun Pharmaceutical Industries, Inc. and MiCal Pharmaceuticals LLC initiated patent litigations on May 9 and 10, 2018, in the U.S.. District Court for the District of Delawareand in the U.S. District Court for the Western District of Michigan regarding Perrigo' s Paragraph IV Abbreviated New Drug Appl