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- PMLiVE

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- PMLiVE

Janssen’s RSV vaccine provides high protection against respiratory infections

The phase 2b data showed the RSV vaccine provided 80% protection against lower respiratory infections in adults aged 65 and older

Biogen Idec building

Biogen’s Vumerity recommended by CHMP in MS

A thumbs up for Vumerity in the EU could ease the way for Biogen’s follow-up to Tecfidera in multiple sclerosis

- PMLiVE

Future of MHRA uncertain amid Brexit-fuelled shake up

Trade unions and regulatory experts warn that budget and staff cuts may lead to drug approval delays or the UK regulator simply rubber-stamping EMA decisions

- PMLiVE

FDA nod for Janssen schizophrenia treatment Invega Hafyera

The phase 3 study results showed that 92% of patients were relapse-free after 12 months

- 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

- PMLiVE

EMA to evaluate Roche arthritis drug RoActemra for severe COVID-19

FDA approval has already been granted following positive phase 3 trials

- PMLiVE

Merck & Co’s sales bounce back in ‘ongoing recovery from COVID-19’

Sales grew by 19% in the second quarter as key products begin to recover from the impact of the pandemic

- PMLiVE

CHMP rejects Kyowa Kirin’s Parkinson’s disease drug

Results of eight main studies of drug were 'inconsistent', according to the CHMP

- PMLiVE

Keytruda scores a win in treating early-stage breast cancer pre- and post-surgery

The FDA had previously rejected a supplemental biologics licence application in this indication

- PMLiVE

Merck & Co withdraws Keytruda’s US approval in third-line stomach cancer

The FDA initially approved Keytruda in 2017 for stomach cancer based on overall response rate data

- PMLiVE

CHMP recommends eight new medicines for EU approval

BMS’ CAR T therapy Abecma and BioMarin’s dwarfism drug Voxzogo among positive recommendations

- PMLiVE

Positive results for AZ, Merck & Co’s Lynparza in early breast cancer presented at ASCO

Lynparza reduced the risk of invasive breast cancer recurrence, second cancers or death by 42% in the overall trial population

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