- Coronavirus (COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection (fda.gov)SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) Kit (RUO) (genscript.com)
...the U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. The FDA issued an emergency use authorization for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects this type of antibody...Although the FDA has previously issued EUAs to more than 50 antibody tests, those tests only detect the presence of binding antibodies. Binding antibodies bind to a pathogen, such as a virus, but do not necessarily decrease the infection and destruction of cells...READ MORE
- Takeda, Moderna partner up to bring 50M coronavirus shots to Japan (fiercepharma.com)
Japanese drugmaker Takeda has quickly emerged as one of the leading forces in the fight against COVID-19 as a vaccine manufacturing partner and R&D lead on a convalescent plasma-based therapy. Now, Takeda will help another biotech distribute its potential COVID-19 vaccine in the drugmaker's home country...Moderna has tapped Takeda to bring 50 million doses of its mRNA-based COVID-19 shots to Japanese shores as part of a government-backed vaccine distribution effort...Takeda will import and distribute Moderna's shot, dubbed mRNA-1273, starting in the first half of next year, as well as handle local regulatory approvals...READ MORE
- FiercePharmaPolitics—Pfizer Vyndaqel copay lawsuit could bring drug pricing shockwaves (fiercepharma.com)
Pfizer’s fast-growing and costly heart meds Vyndaqel and Vyndamax have been the subject of drug pricing scrutiny since their launch in 2018. Now, they’re at the center of a Medicare copay lawsuit that could reverberate around the industry...meds list with prices of $225,000 per year, the company is suing the U.S. Department of Health and Human Services in an attempt to help with Medicare patients with their copays...kickbacks laws prohibit drugmakers from assisting with Medicare patient copays; companies can financially help patients on commercial insurance. The laws are designed to keep a check on drug prices, and one expert told Barron’s a ruling in Pfizer's favor “would be a major earthquake” for the industry...READ MORE
- Eli Lilly faces FDA crackdown for manufacturing issues at plant handling COVID-19 antibody (fiercepharma.com)
Just days after Eli Lilly sent an COVID-19 antibody ahead for FDA scrutiny, the drugmaker's immediate chances were halted by a damaging trial stop for the therapy. Now, the FDA has knocked Lilly for its manufacturing controls at a New Jersey site producing the antibody...The FDA cited Lilly's Branchburg, New Jersey, facility on two counts of inadequate "control of computer systems," Lilly confirmed in an email. Those two findings included deleted data on the company's manufacturing processes and failed quality control over audit paper trails...FDA investigators flagged the quality control deficiencies in a notice...The investigators' findings qualified as official action indicated (OAI) in the notice, the highest enforcement priority level from the FDA for its observations...READ MORE
- GSK pledges renewed environmental commitment with aggressive climate change and nature targets (fiercepharma.com)
GlaxoSmithKline is committing to a new environmental plan with two ambitions: eliminate its impact on climate change and neutralize its impact on nature by 2030...In environmental parlance, the goal is a net zero impact on climate change and a net positive impact on nature by the end of the decade...The twofold approach means GSK will reduce its environmental footprint as much as possible—and where it can’t reduce, implement restoration programs—while also contributing more to nature than it takes out...READ MORE
- FDA won’t require manufacturing inspections for emergency COVID-19 vaccine use: Bloomberg (fiercepharma.com)
As the leading COVID-19 vaccines move closer to potential emergency use, the research and regulatory processes have been intensely scrutinized. But there’s one area that hasn’t seen as much attention so far—manufacturing facility inspections...COVID-19 vaccine developers seeking FDA emergency use authorizations won’t have to undergo pre-approval site inspections...The FDA conducts thousands of facility inspections per year, and some find flaws that drug or vaccine companies must remedy before launching new products...READ MORE
- The Booming Biosimilar Market of 2020 (drugchannels.net)
The biosimilar market is finally beginning to fulfill its promise...The latest data show that provider-administered biosimilar drugs are successfully displacing their reference biological products...manufacturers of reference products are cutting drug prices to defend their market shares...Twenty of the 28 FDA-approved biosimilars are provider-administered products covered primarily under a patient’s medical benefit. Many innovator drugs now compete with multiple biosimilar versions, including Herceptin and Remicade...READ MORE
- FDA Identifies “Essential Medicines” for US (pharmtech.com)
As part of the administration’s campaign to reduce the United States’ reliance on an increasingly global pharmaceutical supply chain and to minimize potential shortages for critical drugs, FDA has published a list of those drugs and medical products considered critical for addressing public health emergencies. The list will provide a basis for bolstering biopharmaceutical production at home of essential medicines and medical products and for addressing supply chain vulnerabilities...READ MORE
- Health Systems Keep Pushing into Specialty, But Roadblocks Remain (pharmacypracticenews.com)
Hospitals and health systems are building and expanding their own specialty pharmacies, and with good reason, according to several veterans of specialty rollouts...more than 75% of hospitals with at least 600 beds operate a specialty pharmacy, allowing them to directly prescribe patients critical medications for various chronic and often life-threatening diseases...An in-house specialty pharmacy provides many financial and clinical advantages over external specialty pharmacies for both patients and providers...significant roadblocks, and time and effort needed, to successfully launch a specialty pharmacy...READ MORE
- Gilead signs remdesivir agreement with European Commission (outsourcing-pharma.com)
...Gilead will supply the EC with up to half a million treatment courses of Veklury to treat COVID-19 patients...The European Commission has signed a joint procurement contract from the EC’s Emergency Support Instrument, worth a total of EUR 70 million with pharma giant Gilead, with the opportunity to extend the supply beyond the initial 500,000-treatment level if necessary. Participating countries now can place orders to procure the drug directly with the company...READ MORE