Amgen reported that that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for the investigational bispecific T cell engager antibody construct, blinatumomab. Amgen said that a Marketing Authorization Application has also been submitted to the European Medicines Agency via the centralized procedure for.
Release date- 22102014- WILMINGTON, Del.- On September 30, Ashland Specialty Ingredients, a commercial unit of Ashland Inc., opened a state-of-the-art pharmaceutical center of excellence in Wilmington. One way of accomplishing this is by investing in leading-edge facilities and laboratories,' said Luis Fernandez-Moreno, president, Ashland Specialty
Dexcom has received U.S. Food and Drug Administration approval for its CGM remote mobile communications device: Dexcom SHARE. According to a release from the company, Dexcom SHARE, an accessory to the Dexcom G4 PLATINUM Continuous Glucose Monitoring System, uses a secure wireless connection to transmit the glucose levels of a person with diabetes t
Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, reported that the U.S. Food and Drug Administration has approved Velcade for injection for use in previously untreated patients with mantle cell lymphoma. "Mantle cell lymphoma is a subtype of non-Hodgkin lymphoma that is usually a clinically...
FDA announced October 10, 2014 that Gilead Sciences Harvoni product was approved for the treatment of chronic hepatitis C, genotype 1 infection in adults. Sofosbuvir was approved by the FDA under the trade name Sovaldi in December 2013. Harvoni is a product of Gilead Sciences, based in Foster City, California.======================== TapIm
Release date- 22102014- New Brunswick, N.J.,- Johnson& Johnson today announced that it has made a commitment of up to $200 million to accelerate and significantly expand the production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies. The vaccine regimen, which was discovered in a collaborative research program wit
Today's docket includes a woman convicted of public intoxication, an accused trafficker of painkillers, and a procedural matter involving Purdue Pharma, a multibillion-dollar pharmaceutical company based in Stamford, Conn., that's effectively accused of laying waste to this Appalachian coal town. In this county courthouse in southeastern Kentucky,
By a News Reporter-Staff News Editor at Women's Health Weekly According to news reporting originating from Washington, D.C., by NewsRx journalists, a patent application by the inventors Simon, Werner; Lutz, Christian; Muller, Christoph; Anderl, Jan, filed on March 9, 2012, was made available online on October 9, 2014. The assignee for this patent
By a News Reporter-Staff News Editor at Politics& Government Week According to news reporting originating from Washington, D.C., by VerticalNews journalists, a patent application by the inventors Kan, Pei; Hung, ChiaHung; Hong, Kee-lung; Tseng, Yun-Long; Chan, Yun-Hsu, filed on November 2, 2012, was made available online on October 9, 2014. No as
Reflexonic LLC, developer of the Viberect non-pharmaceutical device for treating erectile dysfunction in men, has achieved Food and Drug Administration clearance to market the product over the counter in the US. Viberect is already registered for sale so far in the US, European Union, Australia, Canada and India. Now, with support from Austin, Tex.
ALEXANDRIA, Va., Oct. 23 Regeneron Pharmaceuticals, Tarrytown, New York, has been assigned a patent developed by four co-inventors for "fusion polypeptides capable of activating receptors." The co-inventors are James P. Fandl, Lagrangeville, New York, Gang Chen, Yorktown Heights, New York, Nicholas J. Papadopoulos, Lagrangeville, New York, and Th
By a News Reporter-Staff News Editor at Biotech Week A patent application by the inventors Brittain, Harry G.; Felice, Philip V., filed on May 21, 2014, was made available online on October 9, 2014, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This patent application is assigned to Theaprin Pharmaceutic
DUBLIN and BOSTON, Oct. 22, 2014/ PRNewswire/ Actavis plc, a leading global specialty pharmaceutical company, and Rhythm, a biopharmaceutical company, today announced that Actavis has been granted an exclusive option to acquire Rhythm's wholly owned subsidiary, Rhythm Health, Inc., which is developing relamorelin, a peptide ghrelin agonist, for t
Alkermes plc today announced that the U.S. Food and Drug Administration has accepted for filing the New Drug Application for aripiprazole lauroxil, the company s investigational, novel, once-monthly injectable atypical antipsychotic for the treatment of schizophrenia. Under the Prescription Drug User Fee Act, the FDA s target action date for
WASHINGTON, Oct. 22, 2014/ PRNewswire-USNewswire/ ALS ACT, The ALS Association, and the T ranslational Re search A dvancing T herapy ALS Northeast ALS Consortium clinical trials network are pleased to announce a call for phase II clinical trial applications for novel, high-potential treatments in amyotrophic lateral sclerosis. The call for clinic
AVACEN Medical announced today that its AVACEN 100 Class II medical device received 510 OTC clearance by the U.S. Food and Drug Administration. This clearance allows the AVACEN 100 to be marketed over the Internet for: the temporary relief of joint pain associated with arthritis; muscle spasms; and minor strains and sprains. In' Game Mode,' the t
Under the terms of the agreement, Bavarian Nordic will grant Janssen an exclusive license for its multivalent MVA-BN Filovirus vaccine, designed to protect against Ebola Zaire, Ebola Sudan and Marburg virus. In addition, Bavarian Nordic will scale up its production and is targeting to manufacture more than 1 million doses of the vaccine valued at U
*Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson& Johnson licenses MVA-BN-based Ebola/ Marburg vaccine from Bavarian Nordic* Bavarian Nordic will scale up and is targeting to manufacture more than 1 million doses of the prophylactic vaccine in 2015 for clinical trials and emergency use in the current Ebola outbreak in W
?Biocon's partner Mylan begins multicenter phase III clinical trials for insulin glargine in the United States.? Biocon, through its subsidiary Biocon Research Limited, buys back GE Equity International Mauritius' s 7.69% stake in Syngene for Rs. 215.38 Crore. Subsequently, it enters into an agreement to sell 10% to Silve r Leaf Oak Limited, va
Oct. 22 Cecil- based generic drug giant Mylan Inc. said in a government filing today that it still plans to complete its deal to buy a chunk of Abbott Laboratories' overseas generics business in the first quarter next year and reincorporate in the Netherlands, but the two companies have slightly adjusted the terms of the transaction. Under the ne
By a News Reporter-Staff News Editor at Biotech Week Given the rapidly evolving hepatitis C treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue U.S. Food and Drug Administration approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1 b patients in the United States and
Cempra, Inc., a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that it will report third quarter 2014 financial results after the close of U.S. financial markets on October 29, 2014. Cempra management will host a webcast and.
Centric Medical, a new division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today that the U.S. Food and Drug Administration has given 510 marketing clearance to its TARSA-LINK system, for internal bone fixation of fractures, fusions, and osteotomies in the foot and a
By a News Reporter-Staff News Editor at Biotech Week A researcher at the Cancer Therapy& Research Center is the leader on a study receiving a special $1.62 million orphan disease grant from the Food& Drug Administration. The FDA's four-year grant will allow Andrew Brenner, M.D., Ph.D. to continue the study how the drug TH-302 may help people with
Data on Head and Neck Cancer Reported by Researchers at Department of Surgery. According to news originating from New York City, New York, by NewsRx correspondents, research stated, "We previously reported inferior outcomes for locally-advanced head and neck squamous cell carcinoma patients treated with concurrent cetuximab vs. high-dose cisplatin