SHANGHAI, April 21, 2016 /PRNewswire/ -- The Health Industry Summit (tHIS) 2016 opened in Shanghai at the National Exhibition and Convention Center on April 17.
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AbbVie, a global biopharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion in favor of the use of IMBRUVICA® (ibrutinib) for the treatment of adult patients with previously-untreated chronic lymphocytic leukemia (CLL) in the European Union (EU). The positive CHMP recommendation follows the March 4, 2016 U.S. Food and Drug Administration (FDA) approval of IMBRUVICA for the first-line treatment of patients with CLL.1 If approved by the European Commission (EC), this would be the fifth treatment indication for IMBRUVICA in the EU to date.
AstraZeneca and its global biologics research and development arm, MedImmune, today announced an integrated genomics initiative to transform drug discovery and development across its entire research and development pipeline.
CPhI Istanbul 2016, organised by UBM EMEA, returns for the third consecutive year to Turkey, co-located with InnoPack, ICSE and P-MEC. The four-in-one event will take place at the Istanbul Congress Center (ICC), Turkey, from the 1st to the 3rd of June 2016, and is heavily supported by the Ministry of Health (Turkish Medicines and Medical Devices Agency)and the Pharmaceutical Manufacturers Association of Turkey (IEIS) – highlighting the integral role it is playing in stimulating regional growth. In total, the event is forecasted to attract over 4,200 attendees and over 200 exhibitors, with attendance from regional heavyweights such as DEVA, Nobel Ilac, and Pharmactive.
New Data Reaffirm Positive Benefit-Risk Balance of Bayer’s Xarelto® in Patients with Atrial Fibrillation in Daily Clinical Practice
Bayer AG and its development partner Janssen Pharmaceuticals, Inc. today announced results from a new real-world study, REVISIT-US. In REVISIT-US reduced rates of ischemic stroke accompanied by reduced rates of intracranial haemorrhage (ICH) were seen with Xarelto® (rivaroxaban) versus warfarin in patients with non-valvular atrial fibrillation (AF). These results complement and reaffirm findings from the Phase III ROCKET AF clinical trial as well as the non-interventional XANTUS study. Results from REVISIT-US, which analysed nearly 23,000 real-world patients in the United States, were presented at the 12th Annual Congress of the European Cardiac Arrhythmia Society.
Merck Receives Breakthrough Therapy Designation from U.S. FDA for KEYTRUDA® in Classical Hodgkin Lymphoma (cHL)
Merck known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL). This is the fourth Breakthrough Therapy Designation granted for KEYTRUDA.
Lilly's Taltz® (Ixekizumab) Receives U.S. FDA Approval For The Treatment Of Moderate-To-Severe Plaque Psoriasis
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Taltz should not be used in patients with a previous hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz is designed to specifically target IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.
Phase 3 Study Findings Demonstrate Treatment With Baricitinib Results In Significant Improvements For Patients With Rheumatoid Arthritis Who Had Inadequate Response To Biologics
Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced that detailed results of RA-BEACON — a pivotal phase 3 global study of baricitinib, a once-daily oral treatment currently under regulatory review for the treatment of moderate-to-severe rheumatoid arthritis (RA) — were published today in the New England Journal of Medicine.
New 2016 ACC/AHA Guideline Focused Update States That It Is Reasonable To Choose Effient® (Prasugrel) Over Clopidogrel For Certain ACS-PCI Patients With ST-Elevation Myocardial Infarction And NSTE-ACS
A new guideline focused update provided oral antiplatelet therapy Effient® (prasugrel) with a Class IIa recommendation, meaning that it is reasonable to choose Effient over clopidogrel for the maintenance therapy of patients with acute coronary syndrome (ACS) who experience an ST-elevation myocardial infarction (STEMI) – the most severe form of a heart attack1 – or non–ST-segment elevation (NSTE) who are treated with dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). This recommendation applies to patients who are not at a high risk for bleeding complications and do not have a prior history of stroke or transient ischemic attack (TIA).
Proteostasis Therapeutics, Inc. Presents New Data Demonstrating Potential for Genotype-Agnostic and Combination Therapies for People with Cystic Fibrosis
Proteostasis Therapeutics, Inc. (NASDAQ: PTI), a biopharmaceutical company developing small molecule therapeutics to treat diseases caused by dysfunctional protein processing, such as cystic fibrosis (CF), today announced new preclinical data on the company’s first-in-class genotype-agnostic amplifier and novel corrector at the 13th Annual European Cystic Fibrosis Society (ECFS) Basic Science Conference near Pisa, Italy from March 30-April 2. The company will hold a conference call and webcast today at 4:00 p.m. ET to discuss the data being presented at the conference and the company’s outlook for 2016.
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