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Valeant enters into definitive agreement to acquire Sprout Pharmaceuticals

Valeant enters into definitive agreement to acquire Sprout Pharmaceuticals

Valeant Pharmaceuticals International, Inc. and Sprout Pharmaceuticals, Inc. today announced that they have entered into a definitive agreement under which a wholly-owned subsidiary of Valeant will acquire Sprout, on a debt-free basis, for approximately $1 billion in cash, plus a share of future profits based upon the achievement of certain milestones. [More]
Hospira announces TGA approval of Inflectra (infliximab) for treatment of eight inflammatory conditions

Hospira announces TGA approval of Inflectra (infliximab) for treatment of eight inflammatory conditions

Hospira today announced that Inflectra (infliximab), the first monoclonal antibody (mAb) biosimilar therapy, has been registered in Australia. This registration paves the way for the Federal Government to reduce the cost of some of the most expensive medicines on the Pharmaceutical Benefits Scheme (PBS). [More]
Unituxin (dinutuximab) granted EC Marketing Authorisation for treatment of childhood neuroblastoma

Unituxin (dinutuximab) granted EC Marketing Authorisation for treatment of childhood neuroblastoma

United Therapeutics Corporation announced today that the European Commission (EC) has granted Marketing Authorisation for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT). [More]
BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BioDelivery Sciences International, Inc. announced the approval by the U.S. Food and Drug Administration of a Supplemental New Drug Application (sNDA) for a new formulation of ONSOLIS (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant. [More]
FDA accepts sNDA to review Brintellix clinical trial data for treatment of major depressive disorder

FDA accepts sNDA to review Brintellix clinical trial data for treatment of major depressive disorder

Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) announced today the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for review to add clinical data regarding the effect of Brintellix (vortioxetine) on certain aspects of cognitive function in adults with Major Depressive Disorder (MDD) to the current product label. [More]
Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Astellas today announced topline results from the Phase 3 ACTIVE study evaluating the efficacy and safety of intravenous (IV) and oral isavuconazole, commercially known as CRESEMBA (isavuconazonium sulfate), under development for adults with candidemia and other invasive Candida infections. [More]
Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis (carfilzomib)

Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis (carfilzomib)

Amgen today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for Kyprolis (carfilzomib) for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. [More]
New TCR therapy demonstrates encouraging clinical responses in patients with multiple myeloma

New TCR therapy demonstrates encouraging clinical responses in patients with multiple myeloma

Results from a clinical trial investigating a new T cell receptor (TCR) therapy that uses a person's own immune system to recognize and destroy cancer cells demonstrated a clinical response in 80 percent of multiple myeloma patients with advanced disease after undergoing autologous stem cell transplants (ASCT). [More]
Nonmotor features may predict PD progression

Nonmotor features may predict PD progression

The presence of mild cognitive impairment, orthostatic hypotension, and rapid eye movement sleep behaviour disorder may identify a subset of Parkinson’s disease patients with a poor prognosis, research suggests. [More]
The Lancet Oncology publishes results of CYRAMZA (ramucirumab) Phase III trial for HCC treatment

The Lancet Oncology publishes results of CYRAMZA (ramucirumab) Phase III trial for HCC treatment

Eli Lilly and Company announced that The Lancet Oncology has published results of the Phase III REACH trial that evaluated CYRAMZA (ramucirumab) as a second-line treatment for people with hepatocellular carcinoma (HCC), also known as liver cancer. While the REACH trial's primary endpoint of overall survival favored the CYRAMZA arm, it was not statistically significant. [More]
Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Amgen today announced that a Phase 3 study evaluating Vectibix (panitumumab) and best supportive care (BSC) met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) compared to those patients treated with BSC alone. [More]
Amgen starts Phase 3 study assessing the benefit of Kyprolis in patients with relapsed/refractory multiple myeloma

Amgen starts Phase 3 study assessing the benefit of Kyprolis in patients with relapsed/refractory multiple myeloma

Amgen today announced the initiation of the ARROW trial, a global Phase 3 study evaluating the benefit of Kyprolis® (carfilzomib) for Injection administered once-weekly with dexamethasone versus the current U.S. Food and Drug Administration (FDA) approved twice-weekly administration schedule in patients with relapsed and refractory multiple myeloma who have received prior treatment with bortezomib and an immunomodulatory agent (IMiD). [More]
Updated data from PROCLAIM national patient registry presented at 51st ASCO

Updated data from PROCLAIM national patient registry presented at 51st ASCO

Prometheus Laboratories, Inc. announced today the presentation of updated data from the PROCLAIM national patient registry in which first-line Proleukin® (aldesleukin for injection) therapy improved survival in patients with metastatic renal cell carcinoma (mRCC), compared to patients previously treated with targeted therapies. [More]
RPCI-led research team to share clinical results of entolimod drug at ASCO 2015

RPCI-led research team to share clinical results of entolimod drug at ASCO 2015

A collaborative team of researchers led by Alex A. Adjei, MD, PhD, FACP, of Roswell Park Cancer Institute (RPCI) will share results from the first clinical study of the anticancer effects of the novel agent entolimod at the American Society of Clinical Oncology (ASCO) 51st Annual Meeting in Chicago. [More]
Amgen to present clinical data on multiple blood cancer treatments at EHA 2015

Amgen to present clinical data on multiple blood cancer treatments at EHA 2015

Amgen today announced that it will present data from multiple Kyprolis (carfilzomib) for Injection, BLINCYTO (blinatumomab), oprozomib and Nplate (romiplostim)‎ studies at the 20th Congress of the European Hematology Association taking place in Vienna, June 11 - 14, 2015. [More]
UCB sponsoring several presentations on Cimzia for Crohn's disease at DDW 2015

UCB sponsoring several presentations on Cimzia for Crohn's disease at DDW 2015

UCB, a global biopharmaceutical company focusing on immunology and neurology treatment and research, is sponsoring several data presentations on Cimzia (certolizumab pegol) at Digestive Disease Week 2015, taking place in Washington, DC from May 16-19. [More]
Lilly receives fourth FDA approval for CYRAMZA (ramucirumab)

Lilly receives fourth FDA approval for CYRAMZA (ramucirumab)

Eli Lilly and Company has received its fourth U.S. Food and Drug Administration approval for CYRAMZA (ramucirumab). CYRAMZA (ramucirumab injection 10 mg/mL solution) is now also indicated in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. [More]
Hospira announces availability of INFLECTRA (infliximab) in Canada

Hospira announces availability of INFLECTRA (infliximab) in Canada

Hospira, Inc., a global leader in biosimilars and the world's leading provider of injectable drugs and infusion technologies, announces the availability of INFLECTRA (infliximab) in Canada, the country's first subsequent entry biologic (SEB) monoclonal antibody (mAb) therapy. [More]
Amgen receives FDA priority review designation for Kyprolis to treat relapsed multiple myeloma

Amgen receives FDA priority review designation for Kyprolis to treat relapsed multiple myeloma

Amgen today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. [More]
Egalet announces plans to commercialize SPRIX Nasal Spray and OXAYDO tablets

Egalet announces plans to commercialize SPRIX Nasal Spray and OXAYDO tablets

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain treatments, today announced its plans for the commercialization of SPRIX (ketorolac tromethamine) Nasal Spray and OXAYDO (oxycodone HCI, USP) tablets for oral use only –CII. [More]
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