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 The leading web portal for pharmacy resources, news, education and careers October 20, 2017
Pharmacy Choice - News - Generic Drugs - October 20, 2017

Pharmacy News

 Generic Drugs
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 250     Next >>     Go To Page:

10/12/17 - Amgen Wins Reprieve on Its 2nd-Best-Selling Drug [Arab News (Saudi Arabia)]
That may mean it`s only a matter of time before generic drug companies, including Mylan, win FDA approval of biosimilar copycats. Last year, Novartis received an FDA rejection for its Neulasta biosimilar, which prompted it to withdraw its application for approval in Europe earlier this year. Today, Mylan became the latest upstart to stumble at the
10/12/17 - BioDelivery Sciences Announces Patent Litigation Settlement Agreement with Teva
BioDelivery Sciences International, Inc., a specialty pharmaceutical company with a focus in pain management and addiction medicine, today announced that it has entered into a Settlement Agreement with Teva Pharmaceuticals USA, Inc., Actavis Laboratories UT, Inc. and Teva Pharmaceuticals Industries, Ltd. that resolves BDSI's previously reported..
10/12/17 - Cambrex Invests in Generic API Development and Manufacturing Capabilities at Its Milan Site
East Rutherford, NJ Cambrex Corporation, the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients, today announced that it has made a number of investments, in both R&D and manufacturing capabilities to support the development and production of generic APIs, at its site in Paullo, Milan, Italy.
10/12/17 - China Grand's glaucoma generics drug approved for production [ET Net News (China)]
China Grand Pharmaceutical and Healthcare. production approval issued by the China Food and Drug Administration. approval from CFDA in March 2017 and already made contributions to the results of the.
10/12/17 - Cipher Pharmaceuticals Comments on Supply Chain Impact from Hurricane Maria
Release date- 11102017- MISSISSAUGA, ON- Cipher Pharmaceuticals Inc. today commented on the impact from Hurricane Maria to its manufacturing partner's facilities in Puerto Rico. Galephar Pharmaceutical Research operates two manufacturing facilities in Puerto Rico. Galephar expects to have the Humacao facility operational by mid- to late-November 20
10/12/17 - Federal Register Extracts
SUMMARY: The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Requests for Reconsideration at the Division Level Under GDUFA." This guidance provides recommendations for industry on the procedures for resolving scientific and/or regulatory issues or matters between FDA and applicants of...
10/12/17 - Intellipharmaceutics Announces US$4 Million Registered Direct Offering [Syrian Arab News Agency]
-Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled- and targeted-release oral solid dosage drugs, today announced that it entered into securities purchaseagreements with certain institutional investors providing for the purchase and sale of...
10/12/17 - Investigators from London School of Economics Release New Data on Health Policy and Law (Comparing Generic Drug Markets in Europe and the United...
According to news reporting originating in London, United Kingdom, by VerticalNews journalists, research stated, "Our study indicates that there are opportunities for cost savings in generic drug markets in Europe and the United States. The news reporters obtained a quote from the research from the London School of Economics, "Regulators and payers
10/12/17 - Lupin launches generic Norco tablets in the US
Mumbai, Baltimore- Pharma Major Lupin announced the launch of its Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg having received an approval from the United States Food and Drug Administration earlier. Lupin's Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/325 mg, 7.5 mg/325 mg and 10 m
10/12/17 - Pharma Industry Needs to Prepare for Increasing Entry of Generics [Sudan Tribune]
Major pharma players will need to shrewdly navigate generic headwinds as mid- to long-term growth prospects continue to be tempered by important patent expiries with global regulatory and payer systems focusing on price competition to reduce spending. In fact, weathering the biosimilar entry to multi-billion-dollar reference biologics in the U.S. w
10/12/17 - Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability
SUMMARY: The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Requests for Reconsideration at the Division Level Under GDUFA." This guidance provides recommendations for industry on the procedures for resolving scientific and/or regulatory issues or matters between FDA and applicants of...
10/12/17 - US FDA Issues Complete Response Letter for Proposed Biosimilar Pegfilgrastim
Release date- 11102017- The U.S. Food and Drug Administration has issued a Complete Response Letter for Mylan's Biologics License Application for MYL-1401H, a proposed biosimilar pegfilgrastim. This product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan. The CRL relates to the pending update of the BLA with certa
10/12/17 - Why Kenya must debunk generic drug myths [Business Daily (Kenya)]
Medical professionals at the launch of partnership between Kenya s ACE Pharmaceuticals and a Bangladeshi firm for the supply of generic drugs. As reported in The East African on August 17, 2017, Kenya leads in the use of branded drugs, even as the region shifts towards the use of generics. READ: Africa to get state-of-art HIV drugs for Sh7, 000
10/11/17 - Amgen And Simcere Announce Strategic Collaboration To Co-Develop And Commercialize Biosimilars In China
By a News Reporter-Staff News Editor at Biotech Week Amgen and Simcere Pharmaceutical Group announced the execution of an exclusive agreement to co-develop and commercialize four biosimilars in China. Simcere will be responsible for distribution and commercialization in China, while Amgen will have a limited right to co-promote the products.
10/11/17 - At 10.8 % CAGR, Global Generic Drug Market Size & Share Will Reach $380.60 Billion by 2021: Zion Market Research
Zion Market Research has published a new report titled Generic Drug Market by Brand for Central Nervous System, Cardiovascular, Dermatology, Oncology, Respiratory and Others Therapeutic Applications- Global Industry Perspective, Comprehensive Analysis and Forecast, 2015 2021. According to the report, the global generic drug market accoun
10/11/17 - Biocon gets complete response letter from US drug authority for anti-cancer drug [Arab Times (Kuwait)]
Biotechnology firm Biocon on Tuesday said the United States health regulator has issued complete response letter for proposed biosimilar Pegfilgrastim, indicated for use in cancer treatment. The company, however said it does not expect this CRL to impact the commercial launch timing of biosimilar Pegfilgrastim in the U.S. This product is a part of
10/11/17 - Celltrion taps Oracle Health Sciences Safety Solutions to Help Bring Cost-Effective Life-Saving and Biosimilar Drugs to Market
By a News Reporter-Staff News Editor at Biotech Week Oracle announced that Celltrion, a global leading biopharmaceutical company, has selected Oracle Health Sciences Argus and Oracle Health Sciences Empirica Signal to streamline its pharmacovigilance case management and patient safety initiatives- helping to bring more chronic disease and...
10/11/17 - Eli Lilly patent covering Alimta lung cancer treatment upheld in final written decision from PTAB [Syrian Arab News Agency]
On Thursday, October 5th, a final written decision issued by the Patent Trial and Appeal Board upheld a series of 22 claims from a patent owned by Indianapolis, IN- based drugmaker Eli Lilly& Company. This decision ends an inter partes review, which was initially petitioned by Chicago, IL- based generic pharmaceutical firm Neptune Generics to chall
10/11/17 - FDA Rejects Mylan and Biocon`s Pegfilgrastim Biosimilar [Sudan Tribune]
Indian drug maker Biocon announced today that the FDA has issued a Complete Response Letter for BioconMylans proposed pegfilgrastim biosimilar, MYL-1401H, referenced on Neulasta. BioconMylan had previously withdrawn an application for the same drug from the European Medicines Agency after a French National Agency for Medicines and Health Products..
10/11/17 - Inhalation & Nasal Spray Generic Drugs Market | 2017 Global Leading Players Analysis & Industry Forecast to 2022
Inhalation & Nasal Spray Generic Drugs MarketReport offered by DecisionDatabases.com gives a market overview of the Inhalation & Nasal Spray Generic Drugs industry which covers product scope, market revenue, opportunities, ...
10/11/17 - Intellipharmaceutics Announces US$4 Million Registered Direct Offering
Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled- and targeted-release oral solid dosage drugs, today announced that it entered into securities purchase agreements with certain institutional investors providing for the purchase and sale of..
10/11/17 - Kowa Pharmaceuticals America, Inc. Announces Court Decision to Uphold Patent Protection for Livalo (pitavastatin calcium)
Kowa Pharmaceuticals America, Inc. announced today that the U.S. District Court, Southern District of New York, has found that the U.S. Patent 8,557,993 protecting Livalo is valid, and that generic drug manufacturer Apotex, Inc. and Apotex Corp. s proposed Abbreviated New Drug Application product would infringe the 993 patent. Kowa Company
10/11/17 - Lupin Acquires Symbiomix Therapeutics LLC
Pharma major Lupin announced that its US subsidiary, Lupin, Inc., has acquired Symbiomix Therapeutics, LLC. The acquisition has been made for a cash consideration of USD 150 million including a USD 50 million upfront and other time-based payments. On September 15, 2017, the US FDA approved Symbiomix s lead product, Solosec? oral granules, for
10/11/17 - Medicare Q & A
A: If you are a Medicare beneficiary with a maximum gross income of $1,377 for a single person, you may be eligible to receive a credit for your Medicare Part B premium, which is generally deducted from your monthly Social Security check. Generic drug costs range from $1.20 to $3.30. If your gross income is more than $1,377 with a maximum of $1,505
10/11/17 - Mylan and Biocon biosimilar of Amgens Neulasta hit with manufacturing-related CRL [Sport360]
The FDA, which had already criticized the plant where Biocon is producing biosimilars for the U.S. market, has now issued it and partner Mylan a complete response letter tied to manufacturing for one of them. The Indian company Tuesday said the FDA had issued the CRL for their proposed biosimilar pegfilgrastim, a copy of Amgens chemotherapy compani
Articles(s): 1 - 25 of 250     Next >>     Go To Page:


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