Hypotension News and Research

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Tresiba and Ryzodeg approved to improve blood sugar control in adults with diabetes mellitus

The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.

9 Oct 2015

FDA grants 12-year exclusivity to RUCONEST (C1 esterase inhibitor [recombinant])

Salix Pharmaceuticals and Pharming Group NV announced today that the U.S. Food and Drug Administration has granted 12 years of exclusivity to RUCONEST (C1 esterase inhibitor [recombinant]) 50 IU/kg.

8 Oct 2015

Amgen gets positive CHMP opinions for Kyprolis (carfilzomib) and BLINCYTO (blinatumomab)

"We are pleased to receive positive CHMP opinions for Kyprolis and BLINCYTO as this is an important step in providing new treatment options for patients in Europe with rare forms of cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

25 Sep 2015

Feeling dizzy after standing up may signal serious conditions, increased risk of death

People who get dizzy several minutes after standing up may be at risk of more serious conditions and even an increased risk of death, according to new research published in the September 23, 2015, online issue of Neurology, the medical journal of the American Academy of Neurology.

24 Sep 2015

Higher doses of hydrocortisone not linked to neurodevelopmental impairments in low birth weight infants

Hydrocortisone is one of the 15 most frequently prescribed medications in extremely low birth weight (?1000 g) infants in the newborn intensive care unit (NICU).

21 Sep 2015

Amgen, Xencor partner to develop and commercialize new therapeutics for cancer immunotherapy, inflammation

Amgen and Xencor, Inc. announced today that the two companies have entered into a research and license agreement to develop and commercialize novel therapeutics in the areas of cancer immunotherapy and inflammation.

16 Sep 2015

Egalet announces launch of OXAYDO (oxycodone HCI, USP) Tablets and IMPACT-Rx initiative

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on discovering, developing and commercializing innovative pain treatments, today announced the launch of OXAYDO (oxycodone HCI, USP) tablets -CII in the United States.

9 Sep 2015

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.

20 Aug 2015

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).

20 Aug 2015

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).

17 Aug 2015

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

Hypotension News and Research

Tresiba and Ryzodeg approved to improve blood sugar control in adults with diabetes mellitus

FDA grants 12-year exclusivity to RUCONEST (C1 esterase inhibitor [recombinant])

Amgen gets positive CHMP opinions for Kyprolis (carfilzomib) and BLINCYTO (blinatumomab)

Feeling dizzy after standing up may signal serious conditions, increased risk of death

Higher doses of hydrocortisone not linked to neurodevelopmental impairments in low birth weight infants

Amgen, Xencor partner to develop and commercialize new therapeutics for cancer immunotherapy, inflammation

Egalet announces launch of OXAYDO (oxycodone HCI, USP) Tablets and IMPACT-Rx initiative

Valeant enters into definitive agreement to acquire Sprout Pharmaceuticals

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

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

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

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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