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.
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
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
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...
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
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 BioconMylan had previously withdrawn an application for the same drug from the European Medicines Agency after a French National Agency for Medicines and Health Products..
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..
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
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
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
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
Upsher-Smith Laboratories, LLC. today announced the launch of Exemestane Tablets, 25 mg. "We are pleased to offer physicians and patients a cost-effective alternative to Aromasin ," said Rusty Field, President and CEO of Upsher-Smith. The NDC number for Exemestane Tablets, 25 mg is 0832-0595-30. For questions about ordering, please call Upsher
Charles Haviland Mize, MD, and the Bhutan Emergency Aeromedical Retrieval team for their volunteer efforts in helping save lives in Bhutan, on October 2nd, 2017. In addition to the award, and in response to the Bhutan Foundation "s campaign for funding, BEAR will be receiving a donation from Boston Biopharma to help further expand the program with
The US Food and Drug Administration has issued a Complete Response Letter for Mylan's Biologics License Application for MYL-1401H, a proposed biosimilar pegfilgrastim. The US Food and Drug Administration has issued a Complete Response Letter for Mylan's Biologics License Application for MYL-1401H, a proposed biosimilar pegfilgrastim.
The US Food and Drug Administration has issued a complete response letter for Mylan's biologics license application, a proposed biosimilar pegfilgrastim. Shares of Bioconrose 3% after the company said that the delay in approval for its biosimilar pegfilgrastim from the US Food and Drug Administration will not impact its launch date for the drug in
INGELHEIM AM RHEIN, Germany, Sept. 15 Boehringer Ingelheim, a pharmaceutical company, issued the following news release:. Boehringer Ingelheim today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the Marketing Authorisation Application of Cyltezo, to treat mult
-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 2017.
If you want a Stock Review on CPRX, FLXN, SUPN, or AGN then come over to http://dailystocktracker.com/register/ and sign up for your free customized report. DailyStockTracker.com revisits the Generic Drugs industry, focusing on the performance of Catalyst Pharmaceuticals Inc., Flexion Therapeutics Inc., Supernus Pharmaceuticals Inc., and Allergan P
Last week the Californian-based drug company Gilead announced a voluntary licensing agreement for bictegravir to the UN-backed Medicines Patent Pool. Essentially this will allow four Indian companies to make the important HIV drug and sell it to 116 poor to mid-income countries. Gilead retains the rights for rich nations where it will make the vast
Synthons prefilled syringe with 40 mg/ml of glatiramer acetate the generic version of Teva Pharmaceuticals Copaxone 40 mg has received regulatory clearance in all 28 member states of the European Union plus Iceland, Liechtenstein and Norway to treat relapsing-remitting multiple sclerosis. This regulatory decision comes after the European Patent...
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 three and nine months ended August 31, 2017. Isa Odidi, CEO of Intellipharmaceutics. W
TheLatin America (LATAM) adalimumab marketfeatures the dominance of few companies operating amid a lackluster market, a limited set of growth opportunities, and the looming threat of biosimilars, observes Transparency Market Resea...
For the financial year ending in March 2017, the company s consolidated sales stood at Rs.171, 198 Million, while the profits grossed Rs. 25,575 Million. Lupin Ltd closed at Rs 1060.5, up by Rs 20.7 or 1.99% from its previous closing of Rs 1039.8 on the BSE. The scrip opened at Rs 1050.95 and has touched a high and low of Rs 1070.95 and Rs 1044.
Mycenax announced that the of Australian Government Department of Health and Ageing has approved the phase I application for LusiNEX, Mycenaxs biosimilar product of Actemra/ RoActemra being developed to treat autoimmune diseases. LusiNEX, is a biosimilar acting as interleukin-6 receptor antagonist. In addition to the approval from TGA, CTA submissi