Mesalamine (generic), Asacol, Pentasa Newswire

Mesalamine (generic), Asacol, Pentasa Newswire

Comprehensive Real-Time News Feed for Mesalamine (generic), Asacol, Pentasa.

Results 1 - 20 of 41 in Mesalamine (generic), Asacol, Pentasa

  1. US regulatory nod for Zydus drug to treat ulcerRead the original story

    12 hrs ago | Nerve News

    Ahmedabad, July 25 - Zydus Cadila on Tuesday said it has received final approval of the US Food and Drug Administration for its Mesalamine delayed-release tablets to treat a bowel disease that causes inflammation in the digestive tract . The drug will be manufactured in our formulation manufacturing plant at Moraiya near Ahmedabad, a company statement said.


  2. Innovate Biopharmaceuticals Submits Orphan Drug Application To FDA...Read the original story

    Tuesday Jul 11 | BioSpace

    Innovate Biopharmaceuticals, Inc ., a clinical stage biotechnology company focused on developing novel medicines for autoimmune and inflammatory disorders, announced today it has submitted an application to the U.S. Food and Drug Administration seeking orphan drug designation for INN-108 as an oral therapy proposed for the treatment of pediatric ulcerative colitis. "Orphan drug designation would expedite our development of a therapy that we believe could bring relief to children and teenagers suffering from active ulcerative colitis," said Innovate's CEO Chris Prior, Ph.D. "There is an unmet need for an effective treatment for this disease, and INN-108 is a promising potential therapy.


  3. Shire Investors Have Overreacted To Lialda NewsRead the original story w/Photo

    Jun 13, 2017 | Seeking Alpha

    But I think the market has overreacted to this event, and I would use the recent weakness as an attractive entry point for Shire. On June 7 , Zydus Cadila announced it has received approval for its generic formulation of Shire's Lialda, opening the door to a potential launch in July/August 2017 in the US market.


  4. Ulcerative colitis flares: Managing and easing symptomsRead the original story w/Photo

    Jun 10, 2017 | Medical News Today

    Ulcerative colitis is a chronic inflammatory bowel disease. This disease causes the lining of the large intestine and rectum to swell and develop sores.


  5. Shire Development, LLC v. Mylan Pharms., Inc.Read the original story w/Photo

    May 23, 2017 | JD Supra

    Shire Development, LLC v. Mylan Pharms., Inc ., No: 12-1190-T-36AEP, 2017 U.S. Dist.


  6. Tofacitinib as Induction and Maintenance Therapy for Ulcerative ColitisRead the original story

    May 21, 2017 | CiteULike

    To insert individual citation into a bibliography in a word-processor, select your preferred citation style below and drag-and-drop it into the document. Ulcerative colitis is characterized by an increased frequency of bowel movements and bloody diarrhea, which has a negative effect on quality of life.1 Current therapies for ulcerative colitis include mesalamine, glucocorticoids, thiopurines, and antagonists to tumor necrosis factor and 4?7 integrin.1?5 Many patients do not have a response to these therapies or have a response that is not sustained.


  7. GeneriCo, LLC Prevails in Inter Partes Review of United States Patent 8,865,688Read the original story

    May 19, 2017 | World News Report

    LOUIS, May 19, 2017 -- GeneriCo, LLC , a global specialty generic drug company, today announced that the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office ruled in favor of its petition for Inter Partes Review of the Valeant Pharmaceuticals International, Inc. U.S. Patent 8,865,688 .  The PTAB's decision invalidates all of the disputed claims of the '688 Patent that previously provided Apriso® FDA Orange Book exclusivity through May 1, 2030.


  8. Valeant: Et Tu Mylan?Read the original story w/Photo

    May 19, 2017 | Seeking Alpha

    According to reports Mylan just prevailed in challenging Valeant's patent covering ulcerative colitis medicine, Apriso: Valeant Pharmaceuticals is hovering over session lows on the news that Mylan has prevailed in challenging Valeant's U.S. Patent No. 8,865,688 covering UC med Apriso .


  9. Salix Announces The Publication Of A Study Evaluating The Safety And...Read the original story

    May 17, 2017 | BioSpace

    Salix Announces The Publication Of A Study Evaluating The Safety And Efficacy Of UCERIS Tablets For Induction Of Remission In Patients With Active Mild To Moderate Ulcerative Colitis Refractory To Mesalamine Therapy /PRNewswire/ -- Salix Pharmaceuticals today announced the peer-reviewed publication of a study in the Journal of Crohn's & Colitis evaluating the safety and efficacy of budesonide multimatrix , which was examined for induction of remission in patients with mild to moderate ulcerative colitis refractory to baseline mesalamine therapy. Budesonide MMX or UCERIS tablets, is a prescription corticosteroid medicine used to help get mild to moderate UC under control.


  10. Global Mesalazine Market Forecasted for Progressive Growth During 2016-2022Read the original story w/Photo

    May 12, 2017 | SBWire

    Growing number of diseases on the global level has been the catalyst for the market growth of mesalazine drug, which is the main component for treating various bowel problems. To elaborate further Market Research Hub has recently added an analyzed report titled as " Global Mesalazine Market Research Report 2017" to its vast database.


  11. Allergan Stock Falls on Declining U.S. Medicine Revenue, Goldman DowngradeRead the original story w/Photo

    May 10, 2017 |

    Shares of Allergan were down about 3.5% during morning trading on Wednesday after the firm reported declining U.S. general medicine net revenue, and receiving a downgrade at Goldman Sachs. The Dublin-based pharmaceutical firm said that U.S. general medicine net revenues fell 7% when it reported first quarter financial results on Tuesday.


  12. US court rules in favour of Zydus Cadila in patent caseRead the original story w/Photo

    May 10, 2017 | The Times of India

    NEW DELHI: Drug firm Zydus Cadila , on Wednesday, said it has received a favourable judgement from a US federal court in a patent infringement case paving the way for company to launch its generic product in the American market. The US Court of Appeals for the Federal Circuit has affirmed judgement in favour of Zydus Pharmaceuticals Inc, holding that its proposed generic version of Lialda does not infringe a US Patent, the company said in a statement.


  13. Allergan Starts Off 'Pivotal' 2017 With a Beat as Shares Stand Pat, Plus Jim Cramer's TakeRead the original story w/Photo

    May 9, 2017 |

    Shares of Allergan have been on a rollercoaster over the past year as the company executes its stepping stone M&A strategy and continues to focus on driving revenues and building products. Unlike in quarters past, the company's shares, were relatively unchanged on Tuesday, following reporting of its first quarter earnings for 2017.


  14. Allergan Must Show Mergers, Drug Pipeline Can Make Up For Lost SalesRead the original story w/Photo

    May 8, 2017 |

    With sales drops in several of Allergan's core products, analysts will scrutinize the performance of its recent acquisitions and strength of the company's pipeline when it reports first quarter earnings prior to the market's opening Tuesday. Analysts estimate that Allergan's total revenue will fall 6.9% to $3.53 billion in in the quarter, according to FactSet, due to the loss of patent exclusivity of Asacol HD, which is used to treat adults with moderately active ulcerative colitis, and two products in its Namenda Alzheimer's franchise.


  15. Markush Madness: Watson Avoids Infringement by Adding an Element to a FormulationRead the original story w/Photo

    Apr 5, 2017 | JD Supra

    On February 1, 2017, in Shire Development, LLC v . Watson Pharmaceuticals, Inc ., the U.S. Court of Appeals for the Federal Circuit held that Watson's proposed generic version of Shire's LIALDA did not infringe claims 1 and 3 of Shire's U.S. Patent No.


  16. Mesalamine enemas for induction of remission in oral mesalamine...Read the original story

    Apr 5, 2017 | CiteULike

    Paediatric Ulcerative Colitis is more extensive than adult disease, and more often refractory to mesalamine. However, no prospective trials have evaluated mesalamine enemas for inducing remission in children.


  17. Sigmoid Pharma Announces A Strategic Collaboration With Dr. Falk Pharma GmbHRead the original story

    Apr 3, 2017 | BioSpace

    SIGMOID PHARMA LIMITED, a privately-owned pharmaceutical company developing innovative therapeutics for gastrointestinal and immunological diseases using its proprietary SmPillA solid oral drug delivery platform, announced today that it has entered into an agreement with Dr. Falk Pharma GmbH to advance Sigmoid's SmPillA cyclosporine franchise for ulcerative colitis, graft versus host disease and other gastrointestinal diseases. The terms of the agreement include an upfront equity investment in Sigmoid, development funding, milestone payments as well as tiered double-digit royalties for the future development and commercialization of CyColA , AlloColA and related products in Europe.


  18. Sigmoid Pharma Limited Announces a Strategic Collaboration with Dr. Falk Pharma GmBHRead the original story

    Apr 3, 2017 | Customer Interaction Solutions

    SIGMOID and Dr. Falk have entered into an exclusive license, development and option agreement to advance Sigmoid's SmPillA cyclosporine franchise in Europe Dr. Falk has made an up-front equity investment in SIGMOID in connection with the signing of the license agreement SIGMOID to receive significant development funding, clinical, regulatory and sales milestone payments plus double-digit tiered royalties under the agreement as well as clinical and operational support DUBLIN, Ireland, April 04, 2017 -- SIGMOID PHARMA LIMITED, a privately-owned pharmaceutical company developing innovative therapeutics for gastrointestinal and immunological diseases using its proprietary SmPillA solid oral drug delivery platform, announced today that it has entered into an agreement with Dr. Falk Pharma GmbH to advance Sigmoid's SmPillA cyclosporine franchise for ulcerative colitis, graft versus host ... (more)


  19. The Carillion plc (CLLN) Receives "Sell" Rating from Canaccord GenuityRead the original story

    Mar 10, 2017 | The Oak Ridge Observer

    In the duration of 12 months Lookers PLC's share price has decreased by -21.86% to 124 from 158.69. Societe Generale initiated coverage on Shire PLC in a research report on Friday, December 2nd.


  20. "Consisting Of" Creates Closed Group and Provides Avenue to Avoid InfringementRead the original story

    Feb 10, 2017 | Patently Obvious

    In a short opinion, the Federal Circuit has reversed a lower court infringement claim - holding instead that Watson's generic product does not infringe. In U.S. Patent law, it is an act of infringement to file an Abbreviated New Drug Application with the Food and Drug Administration seeking to market a generic version of a patented drug listed in the FDA Orange Book.