New Covid-19 vaccine booster shots are coming and they’ll include protection against the omicron variant. The U.S. government agreed to a purchasing contract covering 105 million doses of the Pfizer/BioNTech vaccine for a planned vaccination campaign in the fall.
Biopharmaceutical companies and public health officials have learned a great deal about pandemic response in the last two years. A panel discussion during the annual meeting of the Biotechnology Innovation Organization explored some of the lessons from Covid-19 and how they can prepare us for the next pandemic.
Pfizer and Merck have each won FDA approvals in the past year for new pneumococcal vaccines, but GSK aims to top both of them with its $2.1 billion acquisition of Affinivax. That biotech’s Phase 3-ready vaccine candidate addresses more bacterial strains than any pneumococcal vaccines currently available.
Pfizer and BioNTech reported positive clinical data for a Covid-19 booster in children younger than 5, results released ahead of a June FDA advisory committee meeting scheduled to discuss the use of that vaccine and Moderna’s in kids. In other Covid news this week, the CDC issued a health advisory for Pfizer’s antiviral Paxlovid and a respiratory failure drug for Covid-19 flunked its clinical trial.
Takeda Pharmaceutical spinout HilleVax broke the biotech IPO drought with a $200 million stock market debut for clinical development of a norovirus vaccine. Two eye health companies marked the other IPO activity: Belite Bio went public while Bausch + Lomb set financial terms for what could become one of the biggest IPOs of the year.
While Covid-19 has had a significant impact on drug spending, IQVIA projects that its effect will moderate in coming years. IQVIA’s new report on U.S. medicines spending projects that immunology, oncology, and neurology will continue to drive the growth in drug spending.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Alnylam Pharmaceuticals has proprietary lipid nanoparticle technology used in its FDA-approved RNA therapies. The biotech company claims that the messenger RNA Covid-19 vaccines from Moderna and Pfizer infringe on a patent covering this LNP technology.
Sanofi and GlaxoSmithKline weathered clinical trial delays for their Covid-19 vaccine, but the partners now have data to support filings seeking regulatory authorizations. Key features of the vaccine may be able to persuade the vaccine hesitant; it may also be well-suited for use as a booster.
Pfizer is paying BioNTech $225 million to kick off a new alliance aiming to develop a shingles vaccine based on the same messenger RNA technology that is the basis of the partners' Covid-19 vaccine. It’s the third alliance between the two companies, but this time Pfizer brings something more to the table.
The FDA has expanded emergency authorization of Covid-19 boosters to include children 12 to 15 vaccinated with the Pfizer and BioNTech messenger RNA shot. The decision is based on a study that found boosting reduced deaths by 90%, but that Israeli analysis only evaluated these shots in people 50 and older.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The new Covid-19 variant, named Omicron, has mutations that could help it evade antibodies produced by the immune system. Scientists are conducting lab tests to better understand this new variant and pharmaceutical companies are testing how existing vaccines, as well as those in development, measure up the new mutations.
Vaxxinity, a clinical-stage biotech with vaccine technology that gets the body to produce therapeutic or protective antibodies, raised $78 million from an IPO that priced below the targeted price range. In addition to its lead Alzheimer’s disease program, Vaxxinity’s pipeline includes product candidates for Parkinson’s disease, migraine, and Covid-19.
Vaccine biotech Inventprise has developed technology that offers broader protection than currently available products. Its lead program, a pneumococcal vaccine candidate, is being readied for tests in humans and it now has a financial commitment of up to $90 million from the Bill & Melinda Gates Foundation.
Johnson & Johnson won the support of an FDA advisory panel, which unanimously recommended a booster shot for adults. The backing comes one day after the panel’s affirmative vote on a Moderna vaccine in a busy week of regulatory developments for Covid-19 vaccines, therapies, and diagnostics.
Life sciences companies are using “digital twins” for everything from drug discovery to manufacturing. A panel of experts at MedCity News’ INVEST Digital Health conference discussed how this capability to run virtual simulations is changing practices now while also shaping the industry for the years to come.
