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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]
STIOLTO RESPIMAT Inhalation Spray now available for treatment of COPD across the U.S.

STIOLTO RESPIMAT Inhalation Spray now available for treatment of COPD across the U.S.

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that STIOLTO RESPIMAT (tiotropium bromide and olodaterol) Inhalation Spray is now available by prescription at pharmacies across the United States. [More]
MSD announces EC approval of SIMPONI (golimumab) for treatment of adult patients with nr-axial SpA

MSD announces EC approval of SIMPONI (golimumab) for treatment of adult patients with nr-axial SpA

MSD (Merck & Co., Inc., Kenilworth, New Jersey, USA) today announced that on 22 June the European Commission approved SIMPONI (golimumab) for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA). [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]
Alexza updates, amends ADASUVE (Staccato loxapine) commercial partnerships with Ferrer and Teva

Alexza updates, amends ADASUVE (Staccato loxapine) commercial partnerships with Ferrer and Teva

Alexza Pharmaceuticals, Inc. today announced that it has updated and amended its ADASUVE (Staccato loxapine) commercial partnerships with Grupo Ferrer Internacional, S.A. and Teva Pharmaceutical Industries Ltd. Ferrer is Alexza's commercial partner for ADASUVE in the European Union, Latin America, the Commonwealth of Independent States and other countries in Europe. [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]
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]
United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

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. [More]
Lilly receives FDA approval for CYRAMZA (ramucirumab)

Lilly receives FDA approval for CYRAMZA (ramucirumab)

Eli Lilly and Company has received its third U.S. Food and Drug Administration approval for CYRAMZA (ramucirumab). [More]

Study indicates major added benefit of propranolol in some children with haemangioma

The Institute for Quality and Efficiency in Health Care (IQWiG)investigated in a dossier assessment whether propranolol offers an added benefit in comparison with the appropriate comparator therapy in infants with proliferating infantile haemangioma (sometimes called "strawberry mark"). [More]
FDA approves CYRAMZA in combination with paclitaxel for advanced adenocarcinoma

FDA approves CYRAMZA in combination with paclitaxel for advanced adenocarcinoma

Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA (ramucirumab) in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. [More]
Study: Tonsil removal for children with sleep apnea decreases asthma severity

Study: Tonsil removal for children with sleep apnea decreases asthma severity

Surgical removal of the tonsils and adenoids in children suffering from sleep apnea is associated with decreased asthma severity, according to the first large study of the connection, published in the journal PLOS Medicine. [More]
Ethnicity may play role in occurrence of surgery-related breathing problems in children

Ethnicity may play role in occurrence of surgery-related breathing problems in children

Ethnicity may play a role in the occurrence of breathing problems during and after surgery, suggests preliminary results from a new study presented at the ANESTHESIOLOGY 2014 annual meeting. [More]
Boehringer Ingelheim announces availability of Striverdi Respimat Inhalation Spray 5 mcg in the U.S.

Boehringer Ingelheim announces availability of Striverdi Respimat Inhalation Spray 5 mcg in the U.S.

Boehringer Ingelheim today announced that Striverdi Respimat (olodaterol) Inhalation Spray 5 mcg is now available by prescription in pharmacies across the United States. [More]
Ramucirumab Phase III study meets primary endpoint in patients with metastatic colorectal cancer

Ramucirumab Phase III study meets primary endpoint in patients with metastatic colorectal cancer

Eli Lilly and Company today announced that the RAISE trial, a Phase III study of ramucirumab (CYRAMZA) in combination with chemotherapy in patients with metastatic colorectal cancer (mCRC), met its primary endpoint of overall survival. [More]
Boehringer Ingelheim announces FDA acceptance of NDA filing for tiotropium and olodaterol FDC

Boehringer Ingelheim announces FDA acceptance of NDA filing for tiotropium and olodaterol FDC

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration accepted for review the New Drug Application (NDA) for the fixed-dose combination (FDC) of tiotropium and olodaterol delivered via the Respimat inhaler for the proposed indication of long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. [More]
FDA approves GlaxoSmithKline’s Arnuity Ellipta for treatment of asthma

FDA approves GlaxoSmithKline’s Arnuity Ellipta for treatment of asthma

GlaxoSmithKline plc today announced that the FDA has approved Arnuity™ Ellipta® (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm. [More]
Sanofi, MannKind sign licensing agreement to develop and commercialize Afrezza Inhalation Powder

Sanofi, MannKind sign licensing agreement to develop and commercialize Afrezza Inhalation Powder

Sanofi and MannKind Corporation announced today that they have entered into a worldwide exclusive licensing agreement for development and commercialization of Afrezza (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes. [More]
Alexza Pharmaceuticals announces availability of ADASUVE inhalation powder in Guatemala

Alexza Pharmaceuticals announces availability of ADASUVE inhalation powder in Guatemala

Alexza Pharmaceuticals, Inc. today announced that ADASUVE inhalation powder, pre-dispensed (loxapine) is now available in Guatemala. This approval represents the first ADASUVE approval in Latin America for Ferrer and Alexza. [More]
Afrezza gets FDA approval to improve glycemic control in adults with diabetes mellitus

Afrezza gets FDA approval to improve glycemic control in adults with diabetes mellitus

The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal. [More]
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