Smart Immune announces FDA orphan drug status, IND acceptance and fast track designation to commence Phase 1/2 clinical trial of proprietary allogeneic T cell progenitor product SMART 101 (ProTcell) for AML and ALL

10 May 2021 - Phase 1/2 trial to begin by fall 2021 at a top US cancer centre. ...

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Amgen announces tezepelumab biologics license application submitted to U.S. FDA

10 May 2021 - Potential first in class medicine blocking TSLP, an epithelial sytokine. ...

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Positive CHMP opinion for self-administered Crysvita

10 May 2021 - The EMA's CHMP has recommended Kyowa Kirin’s Crysvita for a new self-administration option to treat the ...

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China NMPA approves PARP inhibitor pamiparib for patients with previously treated advanced ovarian cancer

7 May 2021 - This marks the first approval of pamiparib and the third BeiGene discovered medicine to receive regulatory approval. ...

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‘In their own bubble’: How a cancer center promoted an exclusive experimental drug to attract patients

6 May 2021 - A new medication for children with a rare and life-threatening cancer called neuroblastoma had a curious ...

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Protest calls for more drug spending

9 May 2021 - Patients’ rights advocates will lie down on the job, as part of a nationwide day of ...

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Families plead for PBS listing for ‘life-saving’ cystic fibrosis drug

8 May 2021 - A new drug is being hailed as a “game-changer” for cystic fibrosis sufferers as the government is ...

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UK medicines regulator issues its first authorisation under Project Orbis

7 May 2021 - UK medicines regulator issues its first authorisation under Project Orbis for osimertinib (Tagrisso), a post-surgery treatment for ...

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Medicare beneficiaries can't wait for lower drug prices

7 May 2021 - Medicare beneficiaries have been among the hardest-hit populations by the pandemic for the last 13 months — ...

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High Council for Health calls for reimbursement for ADHD medication

5 May 2021 - The High Council for Health has issued a formal opinion calling for medication used in the treatment ...

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Rather than turning its back on the QALY, pharma should collaborate on efforts to improve it

7 May 2021 - A key element in the long-simmering debate on reining in drug prices in the United States ...

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The National Audit Office's review can contribute to strengthening TLV's work

7 May 2021 - On 6 May, the National Audit Office published its report on the Government's and TLV's work ...

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EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19

7 May 2021 - EMA’s CHMP has started a ‘rolling review’ of data on sotrovimab (also known as VIR-7831 and ...

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Updated agenda for the July 2021 PBAC meeting

7 May 2021 - The agenda for the July 2021 PBAC meeting has been updated.  ...

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ICER to assess treatment for severe asthma

6 May 2021 - Report will be subject of Midwest CEPAC meeting in November 2021; draft scoping document open to ...

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