- The U.S. Food and Drug Administration (FDA) has approved the first ophthalmology biosimilar, Samsung Bioepis and Biogen’s ranibizumab biosimilar, Byooviz.
- The Pan American Health Organization (PAHO) selected FIOCRUZ in Brazil and Sinergium Biotech in Argentina as regional hubs for the development and production of mRNA-based vaccines in Latin America to fight COVID-19 and future infectious-disease challenges.
- The new “EUnetHTA21” consortium includes 13 organizations from EUnetHTA and will be led by ZIN (The Netherlands). It also includes the following HTA agencies: AEMPS (Spain), AIFA (Italy), AIHTA (Austria), GBA (Germany), HAS (France), INFARMED (Portugal), IQWIG (Germany), KCE (Belgium), NCPE (Ireland), NIPN (Hungary), NOMA (Norway) and TLV (Sweden).
The United States and European Union (EU) partnered to further efforts toward vaccinating the world by expanding the supply and delivery of vaccines and other therapeutics for COVID-19. The initiative is composed of five pillars covering vaccine sharing, vaccine readiness, global vaccine supply and therapeutics, global health security, and regional vaccine production.
The U.S. Food and Drug Administration (FDA) amended its emergency use authorization (EUA) for Pfizer & BioNTech’s COVID-19 vaccine, adding a booster dose for certain groups.
The Director of the Centers for Disease Control and Prevention (CDC) recommended the use of a third (booster) shot of Pfizer and BioNTech’s COVID-19 vaccine for individuals who are 65 and older, nursing home residents and those aged 50 to 64 who have risky underlying health problems.
The Pan American Health Organization (PAHO) selected FIOCRUZ in Brazil and Sinergium Biotech in Argentina as regional hubs for the development and production of mRNA-based vaccines in Latin America to fight COVID-19 and future infectious-disease challenges.
Johnson & Johnson announced news today that shows its COVID-19 vaccine protection against COVID-19 increases when a booster shot is administered. The Phase 3 ENSEMBLE 2 study showed that a booster shot of the Johnson & Johnson COVID-19 vaccine given 56 days after the first led to 100% protection against severe/critical COVID-19, 75% protection against moderate to severe/critical COVID-19 globally, and 94% protection against moderate to severe/critical COVID-19 in the U.S.
Valneva began recruiting adolescents for the Phase 3 Clinical Trial of its inactivated COVID-19 vaccine candidate VLA2001 in the United Kingdom.
U.S. Senators Susan Collins (R-ME) and Bob Casey (D-PA) introduced the Prescription Drug Pricing Dashboard Act that would make readily available information about the price of prescription drugs.
U.S. Senators Bill Cassidy (R-LA) and Sherrod Brown (D-OH) introduced the bipartisan Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act of 2021 to create an emergency stockpile of key APIs used in essential generic medicines and incentivize domestic production of these ingredients to shore up the supply chain.
The French Ministry of Health has announced that healthcare and pharmaceutical product spending in France will be increased by EUR 1 billion in the 2022 Social Security financing bill (PLFSS).
Bavaria’s Health Minister, Klaus Holetschek, announced that he wants to expand production facilities in Europe in order to re-localize production and mitigate supply bottlenecks.
The Ukrainian Verkhovna Rada adopted Bill No. 4662, which improves patients’ access to innovative medicines by utilizing managed access agreements.
Amidst parliamentary budget talks, Latvia’s Minister of Health, Ilmārs Dūrītis, requested more than 101 million euros for cancer treatment in Latvia.
A new report commissioned by the UK government found that 10% of the volume of prescriptions are either “inappropriate” for the patient’s needs or the patients could be better treated with alternative methods.
PRICING & REIMBURSEMENT
The Italian Medicines Agency (EMA) has clarified the reimbursement conditions for Novartis’s Zolgensma (onasemnogene abeparvovec) in a letter sent to the president of the Puglia Region, Michele Emiliano, regarding the case of two children with spinal muscular atrophy (SMA) type 1.
Malta’s Nationalist Party (PN) pledged to offer free cancer medicines, which are currently unavailable in Malta, through the establishment of a dedicated drug fund, as part of the party’s 13 proposals on cancer treatment.
The Board of Trustees of Russia’s Circle of Kindness Foundation approved adding 10 more drugs to the list of products funded by the foundation.
Vertex Pharmaceuticals announced it has signed a Letter of Intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA), which represents an agreement in principle regarding the public reimbursement of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for eligible patients with cystic fibrosis (CF).
The Health Insurance Review and Assessment Service (HIRA) has begun exploring the possibility of reimbursing digital therapeutics, having determined it feasible to cover “low-risk medical devices.”
On 17 September 2021, the European Health and Digital Executive Agency (HaDEA) signed the Service Contract for the Provision of Joint Health Technology Assessment (HTA) Work Supporting the Continuation of EU Cooperation on HTA. The new “EUnetHTA21” consortium includes 13 organizations from EUnetHTA and will be led by ZIN (The Netherlands). It also includes the following HTA agencies: AEMPS (Spain), AIFA (Italy), AIHTA (Austria), GBA (Germany), HAS (France), INFARMED (Portugal), IQWIG (Germany), KCE (Belgium), NCPE (Ireland), NIPN (Hungary), NOMA (Norway) and TLV (Sweden).
The National Institute for Health and Care Excellence (NICE) recommended MSD’s Keytruda (pembrolizumab) for the treatment of relapsed or refractory classical Hodgkin lymphoma in people aged 3 and older.
NICE also recommended Keytruda with platinum- and fluoropyrimidine-based chemotherapy for untreated, locally advanced unresectable or metastatic carcinoma of the esophagus or HER-2 negative gastro-esophageal junction adenocarcinoma in adults whose tumors express PD-L1 with a combined positive score (CPS) of 10 or more.
NICE also turned down coverage of Albireo’s Bylvay (odevixibat) for the treatment of all subtypes of progressive familial intrahepatic cholestasis (PFIC) in an evaluation consultation document.
With Gilead’s Veklury (remdesivir), the Federal Joint Committee (G-BA) has completed its first assessment of a therapeutic for COVID-19.
bluebird bio completed its rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for betibeglogene autotemcel (beti-cel) – branded as “Zynteglo” in Europe – for adult, adolescent and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions, across all genotypes.
The U.S. Food and Drug Administration (FDA) has approved the first ophthalmology biosimilar, Samsung Bioepis and Biogen’s ranibizumab biosimilar, Byooviz.
Under Project Orbis, Singapore’s Health Sciences Authority (HSA) provisionally approved PharmaMar’s Zepzelca (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) who have progressed after prior platinum-containing chemotherapy.
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