Industry news

• Optimising wet granulation manufacturing with advanced technologies

  03 October 2024 Catherine Eckford / European Pharmaceutical Review

  The approach proposed in the paper suggests how artificial intelligence (AI) and machine learning (ML) could enhance process efficiency and product quality during complex manufacturing.

• First-in-class therapy approved for schizophrenia

  03 October 2024 Catherine Eckford / European Pharmaceutical Review

  The “landmark” approval represents the first new class of medicine in several decades for treating schizophrenia.

• The Russian Ministry of Health proposed changes to essential drug lists

  02 October 2024 GxP news

  A draft proposal for amendments to the Russian Government Order No. 2406-r, dated October 12, 2019, has been released on the official website of the Russian Ministry of Health. The amendments were prepared following the meetings of the Ministry of Health commission held in late August 2024.

• WHO guidance aims to strengthen clinical trial ecosystem

  02 October 2024 Catherine Eckford / European Pharmaceutical Review

  The new recommendations are applicable to clinical trials in countries of all income levels and seek to make trials more effective and supportive for a diverse range of participants.

• Russia’s Constitutional Court has mandated a new system for providing drugs to patients with rare diseases

  01 October 2024 GxP news

  The The Constitutional Court of the Russian Federation has endorsed the initiative put forth by members of the State Council of the Republic of Tatarstan to reevaluate the process of delivering medications to adults suffering from orphan diseases. It is essential to establish a mechanism for reserve financing to cover purchases and deliveries in situations where regions are unable to independently manage the costs.

• From January to August 2024, Russia’s medicinal product production totaled 530.7 billion rubles

  30 September 2024 GxP news

  RNC Pharma unveiled insights regarding drug production activities in Russia for August 2024. In total, pharmaceutical companies produced 329 million packages of finished drugs this month. The natural dynamics show a decline of 6.1% in packages compared to August 2023.

• The first bioanalogue of the rheumatoid arthritis drug Actemra is OK’ed in Russia

  30 September 2024 GxP news

  The Russian Ministry of Health has announced the registration of Russia’s first bioanalogue of the Swiss medication “Actemra” (tocilizumab, Roche), developed by the company “Generium,” for the treatment of rheumatoid arthritis. The trade name of the domestic drug is “Complarate”.

• From January to August 2024, Russia’s medicinal product production totaled 530.7 billion rubles

  27 September 2024 GxP news

  RNC Pharma unveiled insights regarding drug production activities in Russia for August 2024. In total, pharmaceutical companies produced 329 million packages of finished drugs this month. The natural dynamics show a decline of 6.1% in packages compared to August 2023.

• The government has expanded medicine sales in villages without pharmacies

  27 September 2024 GxP news

  Russian Prime Minister Mikhail Mishustin has enacted a government decree allowing medical facilities in rural areas without pharmacies to engage in the retail sale of medications. Now these institutions will be able to obtain a license for such activities. Information about this appeared on the government website.

• FDA issues draft guidance to help industry conduct global cancer clinical trials

  26 September 2024 Darren Incorvaia / FierceBiotech

  To help clinical trial sponsors who are planning global cancer studies best position themselves for FDA approval, the agency has released draft guidance for conducting multiregional clinical trials in oncology. The draft includes considerations for selecting clinical trial sites, analyzing data and incorporating regional information about the disease and available treatments.