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AstraZeneca Plc (AZN)

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idpickering
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AstraZeneca - Forxiga receives positive EU CHMP opinion

#198202

Postby idpickering » February 1st, 2019, 3:57 pm

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a new indication for the marketing authorisation of Forxiga (dapagliflozin), after adopting a positive opinion for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).


https://www.investegate.co.uk/astrazene ... 17558703O/

moorfield
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Re: AstraZeneca - Forxiga receives positive EU CHMP opinion

#198208

Postby moorfield » February 1st, 2019, 4:12 pm

Good news (I think). :?

For the next 57 days at least, after which it becomes illegal I wonder ... :shock:

idpickering
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AstraZeneca - EMA grants PRIME eligibility for MEDI8897

#198979

Postby idpickering » February 5th, 2019, 7:20 am

AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the European Medicines Agency (EMA) has granted access to its PRIME (PRIority MEdicines) scheme for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (mAb) being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV.



The PRIME initiative, launched by the EMA in 2016, offers early, proactive and enhanced support to developers of promising medicines to optimise development plans and accelerate evaluation so these medicines can reach patients faster. To be eligible for PRIME, medicines must target an unmet medical need and show potential benefit for patients based on early clinical data.



Mene Pangalos, Executive Vice-President, R&D BioPharmaceuticals, said: "We are excited to receive PRIME eligibility for MEDI8897, our next-generation monoclonal antibody targeting respiratory syncytial virus in infants. We will work closely with the European Medicines Agency to optimise our development plan and help us bring MEDI8897 to patients as quickly as possible."



This is the first EMA PRIME eligibility that AstraZeneca has received since the programme's initiation. It is based on the primary analysis of the Phase IIb trial to evaluate the safety and efficacy of MEDI8897, which met its primary endpoint defined as a statistically-significant reduction in the incidence of medically-attended LRTI caused by reverse transcriptase polymerase chain reaction-confirmed RSV for 150 days after dosing in healthy preterm infants. Full results from the Phase IIb trial will be presented at a forthcoming medical meeting.

https://www.investegate.co.uk/astrazene ... 00070836P/

moorfield
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Re: AstraZeneca - EMA grants PRIME eligibility for MEDI8897

#199037

Postby moorfield » February 5th, 2019, 11:26 am

Thanks Ian.

More temporary good news for AZN shareholders.

52 days to go. :o

idpickering
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AstraZeneca Plc (AZN)

#199213

Postby idpickering » February 6th, 2019, 7:06 am

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Fasenra (benralizumab) for the treatment of hypereosinophilic syndrome (HES).

HES is a group of rare, potentially fatal disorders characterised by high numbers of eosinophils in blood and tissues, which can cause progressive damage to any organ in the body.1,2 The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.


https://www.investegate.co.uk/astrazene ... 00021778P/


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