Industry news

• Hand-held ultrasound developer Butterfly Network to go public through $1.5B acquisition deal

  30 November 2020 Conor Hale / FierceBiotech

  Hand-held ultrasound developer Butterfly Network is going public through a $1.5 billion acquisition deal backed by the hedge fund Glenview Capital Management.

• The Expert Spoke about Contraindications to Vaccination against Coronavirus

  27 November 2020 GMP News

  Asthmatics, diabetics and former cancer patients may have contraindications from a coronavirus vaccine, Head of the Department of General Virology of the Chumakov Federal Scientific Center for Research and Development of Immune and Biological Products of the Russian Academy of Sciences Georgy Ignatyev said at a press conference at TASS.

• Cancer-killing virus escapes immune destruction and fights metastatic lung tumors in mice

  27 November 2020 Arlene Weintraub / FiercePharma

  Several viruses have a natural ability to kill cancer, but translating them into treatments has proven challenging, partly because the immune system tends to eradicate them before they can reach cancer cells. Researchers from Emory and Case Western Reserve say they’ve found a way to overcome that challenge with a specially engineered virus.

• The European Union is planning tough measures to boost its access to drugs

  26 November 2020 GMP News

  The European Commission has adopted a Pharmaceutical Strategy for Europe to ensure patients have access to innovative and affordable medicines and to support the competitiveness, innovative capacity and sustainability of the EU’s pharmaceutical industry. The Strategy will allow Europe to cover its pharmaceutical needs, including in times of crisis, through robust supply chains. The Strategy will help to establish a future-proof and crisis-resilient EU pharmaceutical system.

• Production of Russian COVID-19 Vaccine May Be Organized in Germany

  26 November 2020 GMP News

  The Russian Direct Investment Fund (RDIF) is looking at possible production of the Russian Sputnik V anti-coronavirus vaccine in Germany, RDIF’s CEO Kirill Dmitriev said.

• New Contract Allows EU to Buy up to 160 Million Doses of Moderna’s Vaccine

  25 November 2020 GMP News

  The European Union has struck a deal for up to 160 million doses of U.S. firm Moderna’s COVID-19 vaccine candidate, the head of the European Commission said on Tuesday (24 November), taking the EU’s potential stock of COVID-19 shots to nearly 2 billion.

• FDA Approves First Drug to Treat Rare Metabolic Disorder

  25 November 2020 GMP News

  The U.S. Food and Drug Administration approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disorder. This approval is a cumulation of the work of experts and community members coordinated by the Oxalosis & Hyperoxaluria Foundation and the Kidney Health Initiative.

• EC Wants to Make it Easier for Patients to Access Cheaper, Generic Medicines

  24 November 2020 GMP News

  The European Commission wants to make it easier for patients to access cheaper, generic medicines, a draft EU document seen by Reuters shows, in a move that could cut the revenues of big pharmaceutical firms.

• HMA/EMA Statement on Approval of Vaccines

  24 November 2020 GMP News

  According to EU legislation (Regulation 726/2004) most COVID-19 vaccines fall under the scope of the centralised procedure since they are produced by biotechnological processes for which the centralised procedure is mandatory (as listed in Annex 1 to the Regulation). For other types of vaccines currently under development, such as those composed of whole-inactivated virus or live attenuated virus, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) network encourage marketing authorisation holders to submit their applications through the centralised procedure in order to ensure that those vaccines reach all Member States at the same time, with no unfair access in the Union.

• Pharma Supply Chain Still Highly Vulnerable to COVID-19 Pandemic

  23 November 2020 GMP News

  New industry research reveals 75 percent of pharma supply chain leaders believe the COVID-19 will greatly increase problems with drug diversion, including theft and counterfeiting of critical products (such as test kits, vaccines and anti-viral medicines). The report found that COVID-19 has also caused significant challenges with drug shortages and increased production costs.