Industry news

• FDA Publishes COVID-19 Pandemic Recovery and Preparedness Plan Summary Report

  18 January 2021 BioPharm International

  FDA announced on Jan. 13, 2021 that it had published a report summarizing the work to date of the COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative, which was launched in August 2020 to strengthen the Agency’s response to the current pandemic and to future public health emergencies.

• Research How a gene linked to the circadian clock could point to new prostate cancer treatments

  18 January 2021 Arlene Weintraub / FiercePharma

  Studies have shown that disruptions in circadian rhythms caused by chronic sleep deprivation and other lifestyle-related issues are linked to an increased incidence of some cancers, including prostate cancer.

• 2021 in Focus: Pharm Exec’s Annual Industry Outlook

  15 January 2021 Pharmaceutical Executive

  With a complicated and challenging global picture greeting the new year, driven by the continuing pandemic and historic political and regulatory changes in the US and Europe, we outline eight diverse trends critical to biopharma’s future health and growth.

• Research Eye stem cell transplant to treat blindness bolsters retinal function in monkeys

  15 January 2021 Angus Liu / FiercePharma

  An international research team of scientists from Singapore’s Agency for Science, Technology and Research (A*STAR), the Icahn School of Medicine at Mount Sinai in New York and Germany’s Eye Clinic Sulzbach is using a type of stem cell in the eye to grow the pigmented layer of retina that’s essential for vision. The approach is showing promise in monkeys.

• Harnessing the power of a digital assistant to accelerate patient access

  14 January 2021 FiercePharma

  Technology in the healthcare landscape is evolving, and leading hub services providers are implementing solutions that help accelerate speed to therapy for patients. One crucial portion of accessing medication is being able to receive benefit verification information in a timely manner.

• A COVID-19 treatment candidate that fuses tiny antibodies from llamas and alpacas shows promise

  14 January 2021 Angus Liu / FiercePharma

  The immune systems of camelids such as llamas and alpacas make tiny “nanobodies” many scientists believe could inspire treatments that offer advantages over traditional antibodies. Now, researchers from the University of Bonn, the Karolinska Institutet and Scripps Research Institute have designed a nanobody-based drug for COVID-19.

• Fierce JPM Week: Will the first COVID-19 vaccines deter future launches? Not at all, experts say

  13 January 2021 Eric Sagonowsky / FirecePharma

  Typically in drug and vaccine development, first-to-market products command a big advantage that can deter follow-up products. Not so with COVID-19 vaccines, experts said Tuesday. There’s still plenty of need for new entrants.

• Look out, pharma. A 'tidal wave' of side effect reports is coming amid COVID-19 vaccine rollouts

  12 January 2021 Eric Sagonowsky / FirecePharma

  With COVID-19 vaccine launches gaining steam—and an unprecedented level of media coverage zeroed in—pharma companies of all stripes should brace not only for a wave of adverse event reports, experts say, but for lawsuits that could follow.

• Despite Pandemic, FDA Ramps Up New Drug Approvals

  12 January 2021 Jill Wechsler / BioPharm International

  The vetting and authorizing of important new therapies remained productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies.

• NEWS First COVID-19 patient enrolled in acute kidney injury drug trial

  11 January 2021 Hannah Balfour / European Pharmaceutical Review

  The first patients with COVID-19 infection and sepsis-associated acute kidney injury (SA-AKI) have been enrolled in AM-Pharma’s Phase III REVIVAL trial as an additional cohort. This sub-study will assess the safety, tolerability and clinical benefit of recombinant alkaline phosphatase in these patients.