Industry news

• EMA’s new guide to implementing IDMP data standards triggers the countdown to change

  04 March 2021 Remco Munnik / European Pharmaceutical Review

  The IDMP data standards aim to standardise the submission of data on medicinal products. Remco Munnik, Associate Director at Iperion, has been working with the EU focus group creating the EU IDMP Implementation Guide version 2, published late February. He explains why pharma companies need to act now in response to the new guidance and provides practical recommendations for action.

• What does it take to supply COVID-19 vaccines across the globe? Here's how the leading players are working it

  04 March 2021 Fraiser Kansteiner, Eric Sagonowsky / FiercePharma

  As COVID-19 gained steam worldwide last spring, little was known about the disease and the havoc it would wreak on the world. A year later, vaccines offer hope in the global fight against the virus, but it will be a monumental task to produce them and deliver them around the planet.

• COVID-19 Vaccine Makers Overcome Challenges to Ramp Up Production

  03 March 2021 Jill Wechsler / BioPharm International

  To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health.

• FDA greenlights home COVID-19 testing kits from Quidel, Eurofins

  03 March 2021 Conor Hale / FierceBiotech

  After one year and hundreds of individual diagnostic authorizations for COVID-19, the FDA is now greenlighting more tests that can be performed or started at home, and on a much broader scale. 

• EMA’s transformative treatments of 2020

  01 March 2021 Hannah Balfour / European Pharmaceutical Review

  Despite the challenges presented by COVID-19, 2020 was a bumper year for approvals by the European Medicines Agency (EMA). According to their latest report, the EMA recommended a total of 97 human medications for approval in 2020, including 22 orphan drugs and 39 new active substances.

• MedTech Have a case of a COVID variant? No one is going to tell you

  01 March 2021 Christina Jewett, Rachana Pradhan, JoNel Aleccia / FierceBiotech

  COVID-19 infections from variant strains are quickly spreading across the U.S., but there’s one big problem: Lab officials say they can’t tell patients or their doctors whether someone has been infected by a variant.

• Insights into how coronavirus changes shape could aid development of COVID-19 vaccines, drugs

  26 February 2021 Angus Liu / FiercePharma

  Scientists continue to search for vaccines and drugs to add to the anti-COVID-19 arsenal. Now two research groups have announced discoveries related to the changing structure of the SARS-CoV-2 coronavirus that caused the pandemic, and they believe their insights could aid in the development of new weapons to fight the virus.

• Three-shot combo? Pfizer, BioNTech roll COVID-19 booster trial as real world data back first vaccine

  26 February 2021 Beth Snyder Bulik / FiercePharma

  As Pfizer and BioNTech start testing whether a third dose of their COVID-19 shot can help fend off new coronavirus variants, a massive real-world study has confirmed that its first, two-dose regimen is 94% effective.

• Breaking Big Pharma's AI barrier: Insilico Medicine uncovers novel target, new drug for pulmonary fibrosis in 18 months

  26 February 2021 Conor Hale / FierceBiotech

  For years, artificial intelligence has promised to shave months, if not years, off the total amount of time needed to develop a brand-new drug—and for potentially millions of dollars less, to boot. But by exactly how much has typically been left up to the imagination, though perhaps coming into clearer focus with each occasional breakthrough.

• Want to bet on Big Pharma? M&A hunger, pricing pressure increase the risk, ratings agency says

  25 February 2021 Angus Liu / FiercePharma

  Big Pharma companies have been steadily dropping in the eyes of credit ratings agencies since 2014—and the downward spiral won’t likely end this year.