- Seqirus begins shipping 2020/21 influenza vaccines to U.S. market (chaindrugreview.com)Vaccine sales driven down by pandemic's effects on doctor visits Vaccine sales driven down by pandemic's effects on doctor visits (biopharmadive.com)
Seqirus announced Thursday it has begun shipping its portfolio of seasonal influenza vaccines to customers in the U.S. for the 2020/21 influenza season. Seqirus is one of the world’s largest influenza vaccine companies and is well-positioned to supply up to 60 million doses* for the U.S. market this year, depending on demand...“Influenza vaccination is critical every year, and it is more important than ever this season as it can help reduce the risk of co-infection from seasonal influenza and COVID-19 and minimize the burden of flu on the healthcare system to preserve capacity for patients with COVID-19 and other serious disorders,” said Gregg Sylvester, MD, Chief Medical Officer at Seqirus. “Our cell-based and adjuvant vaccine technologies are designed to address influenza prevention challenges...against seasonal influenza.”...READ MORE
- AstraZeneca to be exempt from coronavirus vaccine liability claims in most countries (reuters.com)
AstraZeneca has been granted protection from future product liability claims related to its COVID-19 vaccine hopeful by most of the countries with which it has struck supply agreements...With 25 companies testing their vaccine candidates on humans and getting ready to immunise hundred millions of people once the products are shown to work, the question of who pays for any claims for damages in case of side effects has been a tricky point in supply negotiations...“This is a unique situation where we as a company simply cannot take the risk if in ... four years the vaccine is showing side effects,” Ruud Dobber, a member of Astra’s senior executive team, told Reuters...READ MORE
- On eve of first big coronavirus vaccine study, trial leaders brace for ‘unprecedented’ task (biopharmadive.com)Moderna's COVID-19 vaccine candidate moves into late-stage trial (reuters.com)
...Moderna will begin the first clinical trial of its kind, a massive placebo-controlled study to definitively determine whether an experimental vaccine can thwart the disease caused by the novel coronavirus...four other like-sized trials from other coronavirus vaccine developers are also expected to begin in the U.S. Combined, they are looking for a specific group of about 150,000 total volunteers, and aiming to amass enough information from them within months to back potential approvals for emergency use...Other, similarly large trials have been run before to test vaccines. But never have so many been done, simultaneously, for the same disease during a pandemic. Those factors make for one of the most logistically challenging research initiatives in history...READ MORE
- Industry Welcomes Global AMR Action Fund (biopharminternational.com)
Industry has welcomed the launch of the Global AMR Action Fund, which aims to bring two to four new antibiotics to patients by 2030 to tackle antimicrobial resistance...More than 20 biopharmaceutical companies are involved in the fund and have raised US$1 billion so far in new funding to support the clinical research of innovative new antibiotics to address the most resistant bacteria and life-threatening infections. The fund is an initiative of the International Federation of Pharmaceutical Manufacturers and Associations...“Unlike COVID-19, AMR is a predictable and preventable crisis. We must act together to rebuild the pipeline and ensure that the most promising and innovative antibiotics make it from the lab to patients,” said Thomas Cueni, director general of IFPMA...READ MORE
- A huge experiment’: How the world made so much progress on a Covid-19 vaccine so fast (statnews.com)The coronavirus vaccine frontrunners are advancing quickly. Here's where they stand (biopharmadive.com)
Never before have prospective vaccines for a pathogen entered final-stage clinical trials as rapidly as candidates for Covid-19...The colossal impact of the coronavirus is motivating the speed, opening a spigot of funding and inspiring research teams around the world to join the hunt. But the astonishing pace of the progress is also a consequence of the virus itself: It is, scientifically speaking, an easier target for potential vaccines than other pathogens, and a prime candidate for cutting-edge vaccine platforms new to scientists’ toolkits...Vaccines typically take years, if not decades, to reach people; the record now is four years for the mumps vaccine. Here’s what has propelled the Covid-19 endeavor to eclipse prior efforts so far...READ MORE
A familiar family
An acute, not chronic infection
Cutting-edge approaches
Money, money, money
Regulatory nimbleness
The challenges ahead - Pfizer lays out COVID-19 vaccine commercial strategy for pandemic and beyond (fiercepharma.com)
Pfizer's COVID-19 vaccine strategy includes two phases, plus a broader mandate to develop more mRNA platform vaccines...With its trials and pricing set, Pfizer has pulled back the curtain on the long-range commercial strategy for its COVID-19 vaccine. During its earnings call...execs laid out two phases, pandemic and seasonal, with some combination of the two likely to play out over the next several years...READ MORE
- AHA: Half of U.S. hospitals could be operating in the red by end of year (fiercehealthcare.com)
A new report from the hospital industry predicts half of all U.S. hospitals will be operating in the red by the end of the year unless more federal relief is approved...The report...prepared on behalf of the American Hospital Association, paints a grim picture of the impact of the COVID-19 pandemic on hospital operating margins...Hospital margins could sink to negative 7% in the second half of 2020, and half of all hospitals are likely to operate with a negative margin...Hospitals were slammed financially by low patient volume and cancellation of elective procedures to preserve capacity to combat COVID-19...Normally, hospitals overall operate with a 3.5% operating margin. But margins are expected to drop to negative 3% in the second quarter of this year...That drop would have been negative 15% without funding from Congress, which gave providers $175 billion a few months ago...READ MORE
- Kodak Pharmaceuticals lands $765m US loan (outsourcing-pharma.com)
The Eastman Kodak Co. (traditionally associated with cameras, film, printers and other imaging technology) announced the launch of its new Kodak Pharmaceuticals arm, which will produce various pharmaceutical ingredients. The $765m funding is the first action occurring under the president’s executive order, which authors the International Development Finance Corp. (DFC) and Department of Defense (DoD) to collaborate on COVID-19 response...”Kodak is stepping up to help onshore pharmaceutical production and this DPA action will allow the modernized Strategic National Stockpile to have domestic resiliency. Once Kodak ramps up we will have the ability to tap into that capacity for domestic use."...READ MORE
- Pfizer CEO says it’s ‘radical’ to suggest pharma should forgo profits on COVID-19 vaccine: report (fiercepharma.com)
Pfizer could make a 60% to 80% profit margin on its COVID-19 vaccine, one analyst estimates...Pfizer’s chief business officer John Young said the company wasn’t thinking about a return on investment for its rapidly developed COVID-19 vaccine. Instead, he said, “finding medical solutions to this crisis" was a Pfizer priority...But now that the company has moved into phase 3 trials of its BioNTech-partnered vaccine and scored a $1.95 billion supply deal with the U.S. government, Pfizer seems to be changing its tune....READ MORE
- AstraZeneca confirms Russia vaccine deal days after COVID-19 hacking accusations surface (fiercepharma.com)
...Western intelligence officials pegged Russian hackers with an attempt to rip off leading research for a COVID-19 vaccine, linking the would-be thieves with the country's intelligence services...Russia itself denies involvement in any of those attacks—and with a new licensing deal for AstraZeneca's COVID-19 shot, the country says it doesn't need the secrets anyway...Russian drugmaker R-Pharm has signed a licensing deal with Britain's AstraZeneca to produce and distribute doses of its University of Oxford-partnered adenovirus-based COVID-19 shot, AZD1222...READ MORE