German Health Insurance Uproar as Costs Set to Rise in…

More than 57 million members of statutory health insurance (GKV) will face a significantly higher contribution in 2023 Federal Health Minister Karl Lauterbach said in a tweet: “Unfortunately, the contribution rate must increase by 0.3%. The deficit is too large: EUR 17 billion” “Nevertheless, the promise remains that there will be no cuts in performance. The pharmaceutical industry makes the largest contribution to solidarity. Their sales increased very rapidly,” adds Lauterbach

DCGI Approves India's First Homegrown mRNA Vaccine…

India's drug regulator, the Drugs Controller General of India (DCGI), has approved the country's first-ever indigenously developed messenger RNA (mRNA) vaccine, dubbed Gemcovac-19, against COVID-19The vaccine is developed and manufactured by Pune-based Gennova Biopharmaceuticals and is approved for restricted emergency use for those aged 18 years and aboveThe company has conducted Phase 2 and Phase 3 data trials on 4,000 participants to evaluate vaccine safety, immunogenicity, and tolerability. The Subject Expert Committee (SEC) under India's DCGI has found the data submitted by Gennova satisfactory

Voxzogo Available in Boao Lecheng

Ruijin Hospital in the Boao Lecheng International Medical Tourism Pilot Zone has started administering the world’s first achondroplasia treatment, Voxzogo (vosoritide) from BioMarinIn total, five children average 5.8 years of age with achondroplasia have so far been treated with Voxzogo under the first drug project launched by Ruijin HospitalVoxzogo has been approved by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA)

Pfizer and Roivant Unveil Priovant Therapeutics

Roivant Sciences and Pfizer have unveiled Priovant Therapeutics, which was established by both companies in September 2021 to develop and commercialize novel therapeutics for autoimmune diseasesPfizer licensed oral and topical brepocitinib’s global development rights and U.S. and Japan rights to Priovant, and licensed ropsacitinib, a selective TYK2 inhibitor, to PriovantBrepocitinib is a potential first-in-class dual TYK2 and JAK1—Priovant is developing the oral version of the drug for use across multiple orphan and specialty autoimmune diseases including psoriatic arthritis, plaque psoriasis, ulcerative colitis, alopecia areata, and hidradenitis suppurativa, dermatomyositis, and systemic lupus erythematosus (SLE)

Boao Lecheng Taps Fosun for Medical Device RWE Pilot

The Boao Lecheng International Medical Tourism Pilot Zone has tapped Fosun Pharma as its partner for a medical device real-world evidence (RWE) collection pilot projectBoth parties will work to improve policies on using imported products in the pilot zone, with a specific focus on medical devices and diagnostics—Moreover, Fosun and the local authority will oversee testing and evidence generation to ultimately garner approval for any products under the pilotJia Ning, Director of the Lecheng Pioneer District Administration Bureau, said, “In the future, both parties will rely on their respective resource advantages to accelerate the transformation and application of scientific research achievements in innovative drugs, medical devices, diagnostic technologies and products, and promote the accumulation of high-quality medical resources and medical technology innovation resources”

NewAmsterdam and Menarini Strike Obicetrapib…

Under an agreement with NewAmsterdam Pharma, Italy-based Menarini will market obicetrapib, pending approval, in Europe, either as monotherapy or as part of a fixed dose combination with ezetimibe, for cardiovascular diseasesNewAmsterdam will retain rights to commercialize its oral, low-dose, once-daily cholesteryl ester transfer protein (CETP) inhibitor in the rest of the world, along with rights to develop some forms of obicetrapib for other diseases, including Alzheimer’sIn Phase 2b trials, obicetrapib as an LDL-lowering adjunct to maximally tolerated statin therapy has demonstrated promising efficacy in patients with dyslipidemia

Following CHMP Decision, BioMarin Could Use…

Earlier this month, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting conditional marketing authorization for Roctavian (valoctocogene roxaparvovec) as the first gene therapy to treat severe hemophilia A - If the European Commission chooses to embrace the CHMP’s positive recommendation, BioMarin could turn to an outcomes-based payment agreement to ensure “success or your money back,” according to CEO, Jean-Jacques BienaiméSpeaking to Business Insider before the committee’s decision, Bienaimé suggested that the company is in discussions to use a pay-for-performance model in both the U.S. and Europe, should the drug gain marketing authorization. "A lot of companies have talked about it. They haven't really done it," he said to the publication, adding: "We are doing it”According to Dr. Magdi Stino, Vice President, NAVLIN Data, the challenge for these types of therapies is their "high cost, coupled with the fact that they do not work for all patients. Payers fear the high cost given the uncertainty, which is why such outcomes-based agreements are needed. Even if these therapies were successful for all patients, they still require a financing arrangement to actually pay for them. These types of agreements will grow in number as new gene therapies are approved,” he added, “and it is still not clear how well they will work in practice as we are still in the early stages of the gene therapy revolution"

NICE Launches Living RWE Framework

On Thursday, the National Institute for Health and Care Excellence (NICE) hosted a webinar to announce the launch of its real-world evidence framework, which aims to identify when real-world data can be used to reduce uncertainties and improve guidance, and clearly describe best practices for planning, conducting and reporting real-world evidence studies to improve the quality and transparency of evidenceKicking off the launch, Dr. Samantha Roberts, CEO of NICE explained that the document is a “first draft, and as you can imagine it’s a living document. There is a ubiquity of data unlike anything we have seen before and health systems are under increasing pressure. It is not unreasonable to believe that RWE will have a real role in solving these tricky problems… It can help us with monitoring the uptake of new technologies to make sure patients are benefitting to the extent we’ve seen in clinical trialsThe framework aims to improve the quality of real-world evidence informing NICE’s guidance but does not set the minimum acceptable standards for the quality of evidence

Harnessing the Golden Age of Innovation with NICE

Speaking at the 2022 VWV PING Conference, Dr Samantha Roberts, Chief Executive at the National Institute for Health and Care Excellence (NICE) offered a view into her “emerging thinking” on NICE’s current capabilities and future goals, having now held the role for five monthsLast year NICE launched its 5-year strategy with an aim to keep ahead of the challenges of a “rapidly changing” health and care landscape, allowing NICE to evolve from producing full guidelines to adopting a more modular, living style of recommendations, enabling rapid updates that incorporate the latest evidence to reach healthcare professionals faster than ever before –Speaking at the event, Dr Roberts confirmed that NICE was “not going to rewrite” the plan, despite the disruption of COVID-19, noting “I completely agree with the direction of travel laid out in the plan"NICE has its job cut out for it at the moment, given the record pressures placed on NHS England: “I’ve worked in healthcare for 35 years I’ve never seen anything like this,” Dr Roberts added, “We currently have an incredibly overstretched NHS. We all need to be doing things in a very slick way where the patient benefit is clear. We at NICE need to adapt to accommodate these changes – we don’t want to be an analog service in a digital world"

Valneva Announces Settlement With UK Govt. Regarding…

Valneva announced it has entered into a settlement agreement with the Government of the United Kingdom (HMG) regarding the terminated supply agreement for the company’s COVID-19 vaccine candidate, VLA2001HMG ended its deal with Valneva in September 2021 after accusing the company of breaching its obligations outlined in the agreement, but Valneva denied the allegationsThe government had initially entered into a five-year deal with the company for the supply of 190 million doses of the vaccine (60 million doses at first, followed by another 130 million doses between 2022 and 2025), which also included an increased manufacturing deal