- Baxter’s CDMO arm will add 100 new positions in $50M fill-finish expansion of Indiana plant (fiercepharma.com)
...the contract manufacturing market has seen a wave of investment in the U.S. amid the COVID-19 pandemic and a call for "onshore" drug production...Baxter Biopharma Solutions, the CDMO arm of healthcare giant Baxter, will shell out $50 million in an expansion to its fill-finish manufacturing plant in Bloomington, Indiana, that will eventually bring 100 new positions on board...The expansion will add a 25,000-square-foot warehouse; a new filling line for flexible plastic containers; a high-speed automated syringe fill line capable of filling up to 600 units per minute; and a new high-speed, automated visual inspection line...READ MORE
- Track-and-trace requirements go into effect on Friday (pharmacist.com)
Starting Friday, November 27, 2020, pharmacies must buy and sell only products with a required “product identifier” on their packages. This requirement is part of the phased-in implementation of the Drug Supply Chain Security Act of 2013, also known as the “track-and-trace” law. By Friday, dispensers should be familiar with this requirement and know what to do if a product identifier is not on the package when they receive products that require it. The product identifier is on most drug packages in both human-readable format and on a machine-readable 2D data matrix barcode...“The challenge for dispensers is that not all drug product packages are required to have a product identifier, and there is no central database to check if a product should have one,”...READ MORE
- AstraZeneca hopes warmer storage needs for COVID-19 vaccine will be an advantage against mRNA competitors (fiercepharma.com)AstraZeneca, Oxford Coronavirus Vaccine Up to 90 Percent Effective (nationalreview.com)3rd major COVID-19 vaccine shown to be effective and cheaper (apnews.com)
AstraZeneca is the latest player to unveil early COVID-19 vaccine data, and results seem to show an efficacy gap between at least one of its vaccine regimens and those of its two mRNA-based peers. But while investors may be less than enthused with the data, the vaccine does sport a major advantage in logistics given its much warmer storage needs...AstraZeneca's COVID-19 vaccine candidate, dubbed AZD1222, can be stored and transported at normal refrigerated temps of 2 degrees to 8 degrees Celsius (36 degrees to 46 degrees Fahrenheit) for at least six months and can be administered in "existing healthcare settings," giving the shot a major logistics leg up over a leading mRNA-based competitor that requires ultra-cold storage...READ MORE
- Hey, pharma: When it comes to influencers, forget lifestyle gurus and stick to patient advocates, study says (fiercepharma.com)
When it comes to influencers in pharma marketing, companies should skip trendy avocado toast and aerial yoga guru types and rely on lesser-known patient advocates—at least, according to data gathered by WeGo Health...Its recent network survey found that only 14% percent of the WeGo users surveyed mostly or completely trust lifestyle influencers, while 51% completely or mostly trust patient influencers. When it comes to branded pharma products, the survey was even more positive for patient influencers: 85% said they would be very or somewhat receptive to an ad from a patient influencer promoting a drug-related to the patient’s condition...READ MORE
- Suspicious timing of Pfizer vaccine announcement (americanthinker.com)
On November 9, Pfizer announced that its COVID-19 vaccine candidate demonstrated efficacy of over 90% based on the mix of 94 cases between the placebo and vaccine groups in its Phase 3 clinical trial...Some of us had wondered about the timing of the announcement, given that the results far exceeded the primary efficacy endpoint of only 50% (with appropriate statistical confidence intervals) set by the FDA for a successful vaccine, and Dr. Fauci's concurrence that 50% would be acceptable...READ MORE
- The Latest: India seeks more cold storage for vaccine push (apnews.com)
Indian Prime Minister Narendra Modi has urged states that are witnessing a surge in coronavirus cases to establish cold storage facilities for COVID-19 vaccines...India is home to some of the world’s biggest vaccine makers and there are five vaccine candidates under different phases of trial here. But the state-run cold chain facilities used to keep some vaccines consistently refrigerated would be inadequate for the enormous challenge of rolling out a COVID-19 vaccine...READ MORE
- Moderna to file COVID-19 shot for emergency nod in November, with Pfizer rollout pegged for early next month: Slaoui (fiercepharma.com)COVID-19 shots could reach first Americans by mid-December, top health official says (reuters.com)
As a tide of late-stage data rolls in on COVID-19 vaccines from Pfizer, Moderna and AstraZeneca, the U.S. is gearing up for reviews that could see a vaccine authorized and deployed before the year is out. On Saturday, the chief of the White House's Operation Warp Speed effort laid out a definitive timeline, setting expectations for when the public could expect at least two shots to become available...Moderna will file for an emergency nod for its mRNA-based vaccine candidate before the month is out, Moncef Slaoui, Ph.D., head of "Warp Speed" and former vaccine chief at GlaxoSmithKline, said...That submission will segue straight into a Dec .17 data review, with the aim to ship vaccines to distributors within 24 hours of approval and potentially start vaccinations two days after the advisory panel makes its call, Slaoui said...READ MORE
- Aetna pilot harnesses CVS pharmacists to address Medicaid members’ social needs (fiercehealthcare.com)
A new Aetna pilot program aims to harness its parent company's pharmacy reach to help address members' social needs...Through the HealthTag initiative, CVS Health pharmacists and pharmacy employees are empowered to offer more personalized information when Aetna Medicaid members come to pick up prescriptions, providing the members with health information beyond how to take their medications appropriately...Inside the prescription bag, members are provided additional details on how to access community services to address social concerns like food, housing or transportation. The network of these organizations is backed by Unite Us, a social care coordination program...Aetna will pilot the program at CVS pharmacies in West Virginia and Louisiana...READ MORE
- Regeneron, following in Lilly’s footsteps, wins FDA emergency nod for COVID-19 antibody cocktail (fiercepharma.com)
Regeneron’s COVID-19 antibody cocktail, one of the drugs President Donald Trump was given after he was infected with the SARS-CoV-02 virus, has been cleared for emergency use by the FDA. And, despite looming rollout of vaccines, one analyst still sees the therapy as a steady $1 billion-plus business...The emergency use authorization for REGN-COV2, a combination of monoclonal antibodies casirivimab and imdevimab, marks the second for an antibody therapy. The first one went to Eli Lilly’s bamlanivimab, which was given an EUA a few days ago...READ MORE
- COVID-19 vaccine delivery will need as many community pharmacy vaccinators as possible (pharmaceutical-journal.com)Ambulatory Pharmacists Provide Value During Pandemic (pharmacypracticenews.com)
NHS England is preparing for the huge task of delivering COVID-19 vaccines, including through community pharmacies...Delivery of a COVID-19 vaccine to the public will require the participation of “as many of the workforce who are trained in vaccination as possible” from community pharmacy...Jill Loader, deputy director of pharmacy commissioning at NHS England and NHS Improvement, said there were “a number of different ways community pharmacy can get involved” in the COVID-19 vaccine delivery programme, with some community pharmacies expected to be commissioned as a vaccination site through a locally enhanced service...“We anticipate that we are going to need to use as many of the workforce who are trained in vaccination as possible,” she said...READ MORE