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- PMLiVE

Qtern

- PMLiVE

FDA’s director and deputy director of its Office of Vaccines Research & Review resign

The departure of director Marion Gruber and deputy director Philip Krause is unexpected

- PMLiVE

Boehringer Ingelheim/Lilly’s empagliflozin is first drug to show clear benefit in heart failure

Results presented at the European Society of Cardiology Congress from the phase 3 trial demonstrated a 27% drop in hospitalisation risk

- PMLiVE

AZ’s new rare disease unit wins in Wilson disease

Alexion purchase looks increasingly ‘copper-bottomed’ as AstraZeneca prepares to submit data for ALXN1840 in Wilson disease

AstraZeneca AZ

AstraZeneca’s Forxiga approved in Japan for the treatment of CKD

Approval was based on positive data from the phase 3 trial for chronic kidney disease

- PMLiVE

Lilly to target difficult-to-treat disease through tie-up with Lycia

Lilly will use Lycia Therapeutics’ novel technology to inhibit “intractable” targets in its therapeutic areas of focus, including immunology and pain

- PMLiVE

FDA’s approval of Pfizer/BioNTech’s COVID-19 vaccine “is a milestone” says acting FDA commissioner Janet Woodcock

After more than a billion doses have been given worldwide, Comirnaty is now officially approved for people aged 16 and over in the US

- PMLiVE

FDA to consider BMS’ Orencia for graft versus host disease

Leukaemia patients who receive stem cell transplant may gain access to Orencia by the end of the year

- PMLiVE

AZ to seek approval for “long-acting” COVID-19 antibodies

AZD7442 significantly reduced the risk of developing symptomatic COVID-19 in phase 3 trial and is a one-dose treatment that can be given via an intramuscular injection

- PMLiVE

COVID-19 vaccine protection wanes over time, backing up the need for boosters

While both Pfizer/BioNTech and AstraZeneca’s vaccines offer good protection, a new UK study shows the protection reduces over time and the UK's booster campaign is likely to begin in September

Roche Basel Switzerland

FDA approval for Roche diagnostic solid tumour test

Test will identify which patients could benefit from GSK immunotherapy.

Roche Basel Switzerland

FDA approval for Roche diagnostic solid tumour test

Test will identify which patients could benefit from GSK immunotherapy.

- PMLiVE

CureVac to push ahead with first- and second-generation COVID-19 vaccines

The biotech will seek EMA approval for first-generation jab while trials are due to start for second-generation jabs in Q4

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