Nivolumab in skin cancer: additional benefit upgraded on the basis of an indirect comparison

16 September 2021 - For nivolumab (Opdivo), the pharmaceutical company was able to achieve a significantly better result in a second ...

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Controversy over using quality adjusted life years in cost effectiveness analyses: a systematic literature review

8 September 2021 - Researchers and policy makers in the US are exploring the implementation of health technology assessment and value ...

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Albireo receives UK MHRA approval of Bylvay (odevixibat)

8 September 2021 - Bylvay now approved in U.S., EU and UK as first drug treatment for patients with progressive familial intrahepatic ...

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COVID-19 vaccine weekly safety report (9 September 2021)

9 September 2021 - To 5 September 2021, approximately 21 million vaccine doses have been given in Australia – 13.1 million ...

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Albireo sells priority review voucher for $105 million

7 September 2021 - PRV was granted to Albireo with the FDA approval of Bylvay (odevixibat) in July. ...

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Consumers to have more say on medicine access issues

7 September 2021 - Consumer involvement in Australia’s medicines choices has been further strengthened under a new strategic agreement Medicines ...

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MSD Australia endorses new medicines strategic agreement

8 September 2021 - MSD Australia has today welcomed the signing of a new Medicines Strategic Agreement between Medicines Australia ...

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Withdrawals from pharmaceutical benefits on 1 October 2021

8 September 2021 - Suboxone is among the medicines that will be withdrawn from the drug benefits at the companies' ...

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Nivolumab scores a rare 'no' from NICE

8 September 2021 - Nivolumab scores only its second final rejection to date from NICE. ...

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Ultragenyx Canada announces Health Canada approval of a second indication for Crysvita (burosumab injection) for the treatment of tumour induced osteomalacia in adults

7 September 2021 - Ultragenyx Pharmaceutical today announced that Crysvita (burosumab Injection) has been approved by Health Canada for the treatment ...

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Intelivation Technologies received FDA approval for the Advantage-C PEEK cervical interbody fusion device

8 September 2021 - Intelivation Technologies announced today that they have achieved FDA 510(k) Clearance of the Advantage-C PEEK cervical ...

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Phathom Pharmaceuticals submits two NDAs to U.S. FDA for vonoprazan-based treatment regimens for the treatment of H. pylori infection

8 September 2021 - Phathom Pharmaceuticals announced today that it has submitted two new drug applications to the U.S. FDA for ...

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FDA grants Madorra breakthrough device designation status for treatment of moderate to severe vulvovaginal atrophy

8 September 2021 - Clinical trials of Madorra therapy system show promising results for treatment of vulvovaginal atrophy. ...

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HiberCell receives fast track designation from FDA for first in human studies of PERK inhibitor (PERKi) HC-5404-FU

8 September 2021 - C-5404-FU PERKi program is currently in a Phase 1a clinical trial for the treatment of solid ...

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Congress is ready to dig into drug prices

7 September 2021 - After months of drama and procedural votes, Congress is about to dive into the legislative process on ...

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NICE draft guidance recommends apalutamide for treating prostate cancer

8 September 2021 - NICE has today published final draft guidance which now recommends apalutamide (Erleada; Janssen) plus androgen deprivation therapy ...

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