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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.

13 Aug 2015

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.

11 Aug 2015

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.

30 Jul 2015

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.

23 Jul 2015

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).

22 Jul 2015

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.

19 Jun 2015

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.

19 Jun 2015

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

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.

19 Jun 2015

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

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).

1 Jun 2015

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.

1 Jun 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.

30 May 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.

28 May 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.

17 May 2015

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.

25 Apr 2015

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.

30 Mar 2015

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.

30 Mar 2015

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.

25 Mar 2015

New global study on Acute Kidney Injury (AKI) shows the way to eliminating preventable deaths by 2025 – early detection and management are key

The International Society of Nephrology (ISN) will present the findings of a new global study on Acute Kidney Injury (AKI), seen by experts as a key step forward in their efforts to eliminate preventable deaths from the condition by 2025 (0by25).

16 Mar 2015

Egalet announces net revenues of $1.9 million for 2014

Egalet Corporation today reported financial results for the year ended December 31, 2014.

16 Mar 2015

United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics Corporation announced today that the United States Food and Drug Administration has approved Unituxin (dinutuximab) Injection (formerly called ch14.18), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

10 Mar 2015

Hypotension News and Research

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

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

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

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

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

Nonmotor features may predict PD progression

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

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

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

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

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

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

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

Lilly receives fourth FDA approval for CYRAMZA (ramucirumab)

Hospira announces availability of INFLECTRA (infliximab) in Canada

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

Egalet announces plans to commercialize SPRIX Nasal Spray and OXAYDO tablets

New global study on Acute Kidney Injury (AKI) shows the way to eliminating preventable deaths by 2025 – early detection and management are key

Egalet announces net revenues of $1.9 million for 2014

United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

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