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- PMLiVE

Pharma and biotech leaders back ’no deal’ Brexit warning

Ongoing division in Conservative party means 'no deal' remains a possibility

- PMLiVE

EMA starts rapid review of Shire’s HAE antibody

The EU medicines regulator is expected to make a verdict in 150 days

- PMLiVE

ViiV’s two-drug HIV combo backed by CHMP

The committee also backs two biosimilar medicines

- PMLiVE

EMA starts review of Xtandi in non-metastatic prostate cancer

The evaluation is based on positive results from the PROSPER trial

Gilead Sciences

Gilead says switching studies back new HIV therapy Biktarvy

Patients who switched from rival Triumeq could maintain viral suppression over the trial period

- PMLiVE

Gilead’s triple HIV drug approval prompts GSK lawsuit

ViiV claims bictegravir infringes its patent estate

- PMLiVE

EMA’s Amsterdam home will not be ready in time

Staff will initially move to a temporary building in the city after Brexit

- PMLiVE

EMA hands UniQure orphan status first in Huntington’s

The Dutch biotech expects to file the treatment for approval later this year

- PMLiVE

Novartis gets speedy reviews for new Kymriah filings

US and EU regulatory agencies will review the drug for DLBCL patients

- PMLiVE

ViiV starts trial of HIV-preventing injections for women

Cabotegravir could provide a new way for women to protect themselves

AstraZeneca AZ

AZ speeds first-line lung cancer filing for Tagrisso to EMA

As FLAURA trial results show boosted progression-free survival

- PMLiVE

GSK’s ViiV gets US okay for two-drug HIV regimen

Juluca is a combination of ViiV’s Tivicay and Janssen’s Edurant

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