The revenue boost Evusheld has given AstraZeneca over the past year will grind to a halt now that the FDA, as expected, has pulled approval for the antibody combo on the grounds it is ineffective against most SARS-CoV-2 variants circulating in the US.
JAMA reports on the COVID-19 Prevention Network’s efforts. Also, Inhibikase said the US FDA lifted a hold on its drug for Parkinson’s disease, while Astellas Pharma said the agency lifted a clinical hold on its gene therapy for Pompe disease. And Trefoil, Theriva Biologics and Nektar initiated new trials.
Bayer pharmaceuticals executive Marianne De Backer will succeed Scangos at Vir, tasked with advancing several mid-stage programs in areas like hepatitis B and influenza to late-stage development.
After a comparatively subdued 2022 in terms of M&A and other deal-making, a strengthening currency and interest in new areas such as digital tools and cell and gene therapy might see a rebound in activity this year, which should also see domestic approvals of several potential blockbusters and more support for bioventures.
Recent antibody mega-deals are providing a rare bright spot for the embattled China biotech sector, amid sharply rising COVID-19 deaths in the country that indicate rebound and recovery could take longer than previously expected.
CureVac, formerly a cheerleader of the unmodified mRNA approach, is embracing the modified version for its vaccine portfolio, a move that has gone down well with the investment community.
Headwinds of political instability, violent conflict, inflation and recession accompany us into 2023. Scrip surveyed industry leaders on the impacts for biopharma.
The short-notice reopening of the country made 2022 a tough year for the health sector in China, where divestments, cash crunches and commercial challenges abounded. Throughout the year, despite clinical trial activity continuing to blossom, multiple Chinese innovative drug developers faced setbacks in the US from regulatory rejections of oncology products. Meanwhile, others quietly scaled back their operations in China, hit by the negative impact of deep price cuts.
The past couple of years have generated important growth for the pharma industry thanks to its drugs and vaccines for COVID-19. But with the IRA, high inflation, rising interest rates and chilly public markets, biopharma faces challenges this year. Here, we summarize key messages from In Vivo’s Outlook 2023.
China has rejected extending insurance coverage for Pfizer’s Paxlovid despite the US company's plans to continue supplying the oral COVID-19 antiviral, including through local manufacturing, amid strong demand and increasing severe infections in the country.
Moderna has made its first-ever acquisition with the $85m purchase of OriCiro Genomics, a Japanese bioventure with DNA synthesis and amplification technology. The deal is expected to contribute to Moderna’s capabilities in both manufacturing and R&D.
From being little known to sought after by millions, Pfizer’s oral antiviral Paxlovid is fast becoming the most pursued medicine in China, amid the largest outbreak of COVID-19 infections the world has yet seen.
It’s been a year since Paxlovid was launched and The Medicines Patent Pool licensed Pfizer’s nirmatrelvir. Scrip looks at a few likely reasons for authorized generics of Paxlovid not turning up and what lies ahead in 2023 as Hetero's version becomes the first with WHO Prequalification while two Chinese and a Korean company wait in the wings.
Incoming visitors won't be required to be centrally quarantined in designated facilities starting 8 January while the national health authority also calls to stockpile three months supply of antivirals to tackle acute shortages across the nation.
After China eased its "COVID Zero" policies, infections have surged in Beijing, Guangzhou and other cities, likely prompting the National Health Security Administration to delay the closely-watched annual drug reimbursement pricing negotiations. Meanwhile, Pfizer has signed a new distribution deal with state-owned Meheco to meet surging demand for its oral antiviral Paxlovid in the country, while at least two domestically developed mRNA vaccines are now awaiting approval. Also, Chinese biotechs are looking at three main methods of surviving and thriving.
As citizens in China grapple with the virtual end of pandemic restrictions and rush for medicines from cold remedies to traditional options, even some prescription antivirals such as Paxlovid are appearing online, while cheaper but unauthorized Indian generic versions have quickly sold out. Meanwhile, a renewed vaccination effort is targeting high-risk individuals and second booster shots as the country faces a huge surge in cases.
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