Industry news

• Drug Labeling Session Was Held in Russia

  20 March 2019 GMP News

  Minpromtorg of Russia and SID & GP held an extended session of the marking working group at the International Economic Forum of CIS Member States «CIS: Digital Economy – Integration Platform». The status of manufacturers and regions readiness for drugs marking, including the 12 high-cost nosologies, as well as the understanding by the industry that marking is inevitable and the cases of the «pioneers» engaged in printing and aggregation of marking codes – all these topics were discussed today during a 3-hour meeting of the key players at the domestic pharmaceutical market. 

• ACC: BMS, Pfizer's Eliquis tops warfarin in high-risk afib subgroup

  20 March 2019 Carly Helfand / FiercePharma

  Pfizer and Bristol-Myers Squibb’s next-gen anticoagulant Eliquis has been stealing warfarin market share for years, but that doesn't mean it's slowing down. The drug now has new data showing it's the safer option for a tough-to-treat group of atrial fibrillation patients.

• Patient Input and Patient Preference Studies

  20 March 2019 Nick Hicks / Pharmaceutical Executive

  Gaining regulatory approval and reimbursement of new treatments in many therapeutic areas such as rare diseases is not easy and reflects in part the lack of demonstration of improvement in meaningful health outcomes for patients.²  The U.S. Institute for Clinical and Economic Review (ICER) value framework states the problem so clearly “all too often what matters most to patients is poorly captured in the available clinical trial data”.

• Patient Support Programs: Cost, Benefit, and Resourcing

  19 March 2019 Susan Darrah-Reilly, Tyla Sosa Hager, Louise Jebson / Pharmaceutical Executive

  Patient support programs (PSPs) and market research programs (MRPs) are popular and, in some areas, expected services of the pharmaceutical industry that place a significant burden on pharmacovigilance (PV) resources. PSPs are designed to enhance patient safety and help patients and/or healthcare professionals to better manage disease and optimize treatment. 

• Phase 4 Results of BMS-Pfizer Trial

  19 March 2019 GMP News

  The Bristol-Myers Squibb-Pfizer Alliance announced results from the Phase 4 AUGUSTUS trial evaluating Eliquis® (apixaban) versus vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) and recent acute coronary syndrome (ACS) and/or undergoing percutaneous coronary intervention (PCI). Results show that in patients receiving a P2Y12 inhibitor with or without aspirin (antiplatelet therapies), the proportion of patients with major or clinically relevant non-major (CRNM) bleeding at six months was significantly lower for those treated with Eliquis compared to those treated with a VKA (10.5% vs. 14.7%, respectively; hazard ratio [HR]: 0.69, 95% confidence interval [CI]: 0.58-0.81; p-superiority).

• EMA now operating from Amsterdam

  15 March 2019 EMA

  As of today, EMA is operating from Amsterdam. EMA left its London premises on 1 March, and following a transitional week of teleworking, its staff will gradually move throughout this week into the Spark building in Amsterdam Sloterdijk.

• China to Ensure Vaccines Safety

  14 March 2019 GMP News

  China will strengthen management and supervision of vaccines to ensure their safety, the country’s top drug regulator said Monday.  Chinese lawmakers have finished their first reading of a draft law on vaccine management, and solicited public opinions, Jiao Hong, head of the National Medical Products Administration, told a press conference on the sidelines of the annual legislative session.

• WHO Released New Influenza Straregy

  14 March 2019 GMP News

  WHO released a Global Influenza Strategy for 2019-2030 aimed at protecting people in all countries from the threat of influenza. The goal of the strategy is to prevent seasonal influenza, control the spread of influenza from animals to humans, and prepare for the next influenza pandemic.

• Facebook to Fight against Vaccine Misinformation

  13 March 2019 GMP News

  Facebook announced this week that it’s going to reduce the reach of anti-vaccine content on the world’s largest social network. Such content will no longer be allowed to be promoted through recommendations or advertisements and will also be made less prominent in search results. These are the actions that it’s taking short of taking down anti-vaccine posts entirely.

• Collaboration for Development and Selling Liver Drug in Asia

  12 March 2019 GMP News

  TaiwanJ Pharmaceuticals has signed a US$26 million contract with Newsoara Biopharma to license out its drug candidate JKB-122 for further development in Asia. On March 2nd, 2019, TaiwanJ announced that its JKB-122, an effective phase 2 nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) drug candidate, had been successfully licensed out to Newsoara Biopharma Co. Ltd, a company located in Shanghai. Newsoara Biopharma, known for its capability of drug developments, will be responsible for the clinical development and market commercialization of JKB-122 in Asia, except Taiwan.