"Over the past five years, Fred has played an essential role in our evolution from a primarily generics company to a leading specialty pharmaceutical company," said Paul M. Bisaro, Chairman and CEO of Actavis. He was also instrumental in establishing our biosimilar strategy, which today includes five products in development, including four under th
Actavis plc, a global specialty pharmaceutical company, announced that it has entered into agreements with Akorn, Inc. and Hi-Tech Pharmacal Co. Inc. to purchase four currently marketed products and one product under development for cash consideration. The closing of the purchase agreements are contingent upon the consummation of Akorn's acquisitio
Akorn, Inc., a niche pharmaceutical company, announced that it has completed its previously announced acquisition of Hi-Tech Pharmacal Co., Inc. for $640 million in cash. According to a release, the combination of Akorn and Hi-Tech will transform the Company into a larger, more diversified generic player. This combination also brings critical mass
April 22 The Supreme Court's decision against Teva Pharmaceutical Industries Ltd.' s request to block a potential launch of generic Copaxone pending the outcome of the hearing on the patent later this year is not surprising, says Citi Research in response to the Supreme Court's decision on Friday, adding that it's investment thesis remains unchan
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-796-3601.. SUPPLEMENTARY INFORMATION: The holders of the applications listed in table 1 in this document have informed FDA that these drug products
Flood Law Group today announced that they have added updated content to their informational webpage dedicated to lawsuits related to the prescription drug Actos. Roughly 2,700 lawsuits against Takeda Pharmaceutical Co. and Eli Lilly& Co. have been consolidated under MDL No. 2299 at the U.S. District Court for the Western District of Louisiana.
Novartis International AG/ Novartis announces portfolio transformation, focusing company on leading businesses with innovation power and global scale: Pharmaceuticals, Eye Care and Generics. *Acquires GSK oncology products, strengthening Novartis' leading Oncology business with novel therapies and becomes GSK's preferred commercialization partner..
Research and Markets has announced the addition of the "Public Knowledge, Perceptions, and Intentions for Biologic and Biosimilar Medicines" report to its offerings. In a release, Research and Markets noted that report highlights include:. This research was designed to provide pharmaceutical sales, marketing, and brand management with data to bette
Decision Resources Group finds that the number of publically disclosed biosimilar development projects has increased by more than 40 percent in the last 12 months. The majority of these development projects are yet to enter clinical development, but the 20 percent annual increase in the number of biosimilars in clinical trials indicates substantial
Ampio Pharmaceuticals' Vyrix Enters into an Agreement with Paladin Labs for Exclusive Rights to Zertane? in Canada and Other Territories to Broaden its International Footprint. By a News Reporter-Staff News Editor at Clinical Trials Week Ampio Pharmaceuticals Inc. announced that its wholly-owned subsidiary Vyrix Pharmaceuticals, a specialty...
By a News Reporter-Staff News Editor at Pharma Business Week TherapeuticsMD, Inc., parent company of BocaGreenMD, Inc., announced the launch of Prena1 Pearl, BocaGreen's generic formulation of vitaMedMD, Inc.' s newest prescription prenatal multivitamin, vitaPearl. vitaPearl is a pearl-shaped softgel that is currently the smallest complete prescr
By a News Reporter-Staff News Editor at Pharma Business Week Mylan Inc. confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an Abbreviated New Drug Application with the U.S. Food and Drug Administrat
Prior to joining Lupin, Theresa was with Aptalis pharma as the Chief Corporate Development Officer responsible for Mergers& Acquisitions, Strategy and Global Business Development. Before Aptalis, Theresa was with Novartis for 9+ years and held positions of increasing responsibility including Head, Global BD&L for General Medicines, Executive Direct
By a News Reporter-Staff News Editor at Pharma Business Week Par Pharmaceutical Companies, Inc. announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for potassium chloride extended-release capsules, USP, in 600 mg and 750 mg strengths. According to IMS Health data, annua
Teva believes it is first-to-file and thus far is the only Company to receive an approval from FDA. Teva plans to commence shipping immediately. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries.
By a News Reporter-Staff News Editor at Gastroenterology Week Research and Markets has announced the addition of the "PharmaPoint: Crohn's Disease- US Drug Forecast and Market Analysis to 2022" report to their offering. The loss of patent protection of the anti-TNF marketed brands will allow for the emergence of biosimilars, such as Hospira's Inf
By a News Reporter-Staff News Editor at Marketing Weekly News Particle Sciences, a drug delivery Contract Development and Manufacturing Organization, announced that they have entered into an exclusive agreement with Actavis plc, a leading specialty pharmaceutical company, to develop an unnamed complex generic product. Actavis will have responsibi
April 19 Pharmacist Larry Cowan can flip through his records and spot the generic drugs that have taken big price jumps in the past year or so. "Now the price is close to 10 times that," said Cowan, owner of Glenview Professional Pharmacy in Richland Hills. While the FDA in the past month removed doxycyline from its shortage list, it still costs
Teva Pharmaceutical Industries Ltd. announced that while the Chief Justice of the United States found that Teva had demonstrated a fair prospect of success on the merits in its appeal of a decision from the United States Court of Appeals for the Federal Circuit that invalidated the claim of U.S. Teva will continue pursuing its appeal in the S
By a News Reporter-Staff News Editor at Health& Medicine Week Actavis plc confirmed that the United States Court of Appeals for the Federal Circuit has reversed a lower court ruling that Actavis' generic version of Shire's Lialda infringes United States Patent No. 6,773,720. Actavis' Abbreviated New Drug Application for its generic version of Lia
WASHINGTON The Supreme Court has declined to temporarily block a lower court ruling that opens the world's best-selling multiple sclerosis drug to competition from generic rivals. Teva claims the U.S. Court of Appeals for the Federal Circuit wrongly overturned five of its patents for the drug. That ruling allows rivals Mylan Inc., Momenta Pharma
Lannett Company, Inc. said that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Diazepam Oral Solution, 5 mg/ mL, a Schedule C-IV controlled drug. "We believe our ANDA for Diazepam Oral Solution, 5 mg/mL was the first bioequivalent Diazepam Oral Solution product approved by the FDA,"
By a News Reporter-Staff News Editor at Health& Medicine Week Perrigo Company plc announced that it has initiated market launch and made its first shipments of the authorized generic version of LEO Pharma A/S' Taclonex Ointment. >From its beginnings as a packager of generic home remedies in 1887, Perrigo Company plc, headquartered in Ireland,
Teva Pharmaceutical Industries announced the launch of the generic equivalent to Lunesta, 1, 2 and 3 mg, in the United States. According to a release, Lunesta Tablets, marketed by Sunovion Pharmaceuticals, had annual sales of approximately $852 million in the United States, according to IMS data as of December 2013. Teva Pharmaceutical Industries i
Teva Pharmaceutical Industries Ltd has settled a patent lawsuit with Pfizer Inc. In Mar 2014, a US court invalidated a patent covering Celebrex, giving Pfizer's rivals a chance to sell cheaper versions. With the settlement of the patent lawsuit, Teva can now launch a generic version of Pfizer's Celebrex in Dec 2014. According to Pfizer, Celebrex ge