Last Week in Review: 2/15/2021 – 2/19/2021

COVID-19

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has initiated a rolling review of CureVac’s COVID-19 vaccine candidate CVnCoV.

The Ministry of Health, Labor and Welfare (MHLW) has approved Pfizer’s vaccine against COVID-19 for people aged 16 or older, reported the local press. Pfizer originally applied for fast-track approval of its vaccine in mid-December.

The Russian Direct Investment Fund (RDIF) announced the approval of Russian Sputnik V vaccine against COVID-19 in Saint Vincent and the Grenadines, an island nation of the Caribbean, and in Montenegro.

The European Commission has approved a second contract with Moderna to ensure up to an additional 300 million doses of its COVID-19 vaccine, and another contract with Pfizer and BioNTech for 200 million doses of its vaccine Comirnaty.

The Canadian Government has expanded its confirmed order commitment of Moderna’s COVID-19 Vaccine by 4 million doses, meaning the country is now committed to a total of 44 million doses.

The Therapeutic Goods Administration (TGA) has granted provisional approval to AstraZeneca for its COVID-19 vaccine. The product is the second COVID-19 vaccine to thus far receive Australian regulatory approval after the vaccine developed by Pfizer and BioNTech.

Novavax and SK Bioscience have announced an expanded collaboration and license agreement for Novavax’ COVID-19 vaccine, NVX-CoV2373.

The World Health Organization (WHO) has given Emergency Use Listing to AstraZeneca for its COVID-19 vaccine, in a move that paves the way for the jab to be used globally.

The European Medicines Agency (EMA) has received Janssen’s application for conditional marketing authorization (CMA) for its COVID-19 vaccine.

The Chinese-developed vaccine Sinovac was approved on Thursday by Hong Kong’s government for emergency use against COVID-19, even while its demonstrated efficacy is low compared to other available vaccines.

BIOSIMILAR

Viatris announced that Health Canada has approved Hulio, a biosimilar to AbbVie’s Humira (adalimumab).

Hulio, which is licensed from Fujifilm Kyowa Kirin Biologics, is now available on the market in Canada.

Fujifilm Kyowa Kirin Biologics and Mylan EDP GK of the Viatris group also announced the Japan launch of the biosimilar, Hulio, marking the first launch of a biosimilar to AbbVie’s Humira in Japan.

Sandoz Canada has announced the launch of Hyrimoz (adalimumab injection), a Humira biosimilar authorized for sale by Health Canada on November 4, 2020.

The European Commission has approved Celltrion’s Humira (adalimumab) biosimilar, “Yuflyma.”

POLICY 

Swissmedic has been a part of the U.S. Food and Drug Administration’s (FDA) project Orbis since the beginning of 2020, when it was able to approve a new active substance (tucatinib) for the treatment of breast cancer as part of Orbis for the first time. Now, Swissmedic has expressed full support of the project in accordance with its strategic goals, following its participation in the project in 2020 as a pilot. As such, Switzerland is now confirmed to be a full-time participant of Project Orbis.

Russian Prime Minister Mikhail Mishustin has signed a decree allocating 10 billion rubles for the purchase of medicines for children with rare diseases under the Circle of Kindness Program.

Minnesota Democratic lawmakers have called for the establishment of an independent board to regulate prescription drug prices after last year’s bipartisan push to lower insulin prices.

Novartis has entered into a grant agreement with the Bill & Melinda Gates Foundation in order to facilitate the discovery and development of a single-administration, in vivo gene therapy to cure sickle cell disease (SCD).

DRUG LAUNCH

Bluebird bio has suspended sales of Zynteglo (betibeglogene autotemcel) pending investigation of a safety concern, according to the European Medicines Agency (EMA).

HTA

Germany’s Federal Joint Committee (G-BA) has concluded that Vertex’s triple-combination therapy Kaftrio (ivacaftor/tezacaftor/elexacaftor) plus Kalydeco (ivacaftor) offers significant benefit versus other therapeutic options for patients with cystic fibrosis (CF).

PRICING & REIMBURSEMENT

The Netherlands’ Zorginstituut (ZIN) has issued advice on whether five treatment combinations for multiple myeloma (MM) should be included in the basic package all in one go.

The Ministry of Health, Labor and Welfare (MHLW) has approved over 190 generic products for the next round of reimbursement listings in June, reported Pharma Japan.