2 More Drugs Recommended To Treat Covid In UK, But Not In US

FiercePharma: Roche's Actemra, Regeneron's Kevzara Win U.K.'s Favor In COVID-19 After Study Shows 24% Drop In Death Risk 
The question of whether seriously ill COVID-19 patients can benefit from anti-inflammatories like Roche’s Actemra and Sanofi and Regeneron’s Kevzara has dogged practitioners in the United States thanks to conflicting clinical trial results. The United Kingdom, on the other hand, has reached a definitive answer on the two drugs, both of which are IL-6 inhibitors: They significantly reduce the risk of death in COVID-19 patients needing intensive care, and they should be used to ease the pressure hospitals are now facing as the coronavirus pandemic continues to intensify, the country’s National Institute for Health Research (NIHR) said Thursday. The recommendation came after data from an NIHR-sponsored study showed that Actemra and Kevzara can cut hospital stays for COVID-19 patients admitted to intensive care by 10 days and can lower the risk of death by 24% in patients who receive either drug within a day of admission. (Weintraub, 1/8)

Albuquerque Journal: NM Providers Slow To Prescribe Coronavirus Antibody Drugs
New antibody drugs are available around the state that, if given early, can dramatically reduce the chance of at-risk COVID-19 patients getting so sick they end up in the hospital. But there haven’t been a lot of takers in New Mexico – despite a near-record of 43 daily deaths one day last week related to COVID-19. Now the push is on to educate patients and medical providers about the availability and effectiveness of the two IV-administered antibody therapies. (Heild, 1/10)

Fortune: Bayer Strikes Deal To Aid CureVac In COVID-19 Vaccine Rollout 
The German biopharma firm CureVac has announced a tie-up with the country's biggest pharmaceutical beast, Bayer, for the development and supply of CureVac's candidate COVID-19 vaccine. The companies did not disclose the financial terms of the deal. Bayer's stock jumped more than 2% on the news Thursday morning. The collaboration and services agreement should aid the supply of "several hundred million" vaccine doses, the companies said. CureVac said in November that it intends to produce up to 300 million doses this year, and up to 600 million doses in 2022. (Meyer, 1/7)

FiercePharma: Look Out, Pharma. A 'Tidal Wave' Of Side Effect Reports Is Coming Amid COVID-19 Vaccine Rollouts
With COVID-19 vaccine launches gaining steam—and an unprecedented level of media coverage zeroed in—pharma companies of all stripes should brace not only for a wave of adverse event reports, experts say, but for lawsuits that could follow. With tens of millions of Americans set to be vaccinated, including many people at high risk of severe COVID-19, it's not just vaccine makers who need to actively look out for potential adverse events or drug interactions, lawyers with Sidley Austin said. All pharma companies—not just those involved in COVID-19 vaccine deliveries—can expect “a significant increase in volume of reports over the coming months,” Torrey Cope, a partner in the firm's Food, Drug and Medical Device Regulatory practice, said in an interview. (Sagonowsky, 1/7)

ProPublica: CDC Shut Down A Lab Involved In Making Faulty Coronavirus Tests 
With no public notice, the Centers for Disease Control and Prevention in October shut down a key lab involved in making faulty COVID-19 tests for state and local health authorities early in the pandemic. The move came less than six hours after ProPublica published an investigation that detailed for the first time the chain of mistakes and disputes that unfolded inside CDC labs, which culminated in one of the biggest fumbles in the agency’s 74-year history. A CDC acting branch chief told the staff of the Respiratory Viruses Diagnostics Team lab on Oct. 15 that the closure would be for two to four weeks while the CDC investigated and the staff worked on corrective action plans, according to internal sources. But more than two months later, the lab still is not performing tests. (Bandler, Callahan and Rotella, 1/8)

In other pharmaceutical industry news —

FiercePharma: FDA Extends Immunodeficiency Drug's Shelf Life As Pandemic Exacerbates Shortages 
The U.S. immunoglobulin supply just got a little more secure, thanks to a label change enabling one of Octapharma's chief rare disease meds to sit in the fridge for up to three years. The FDA has stretched the expiration date of 42 existing lots of Octapharma’s subcutaneous immune deficiency drug cutaquig and granted a 12-month shelf life extension on future lots stored at 36 degrees to 46 degrees Fahrenheit. The drug was previously cleared to last 24 months when refrigerated. Cutaquig’s six-month shelf life at room temperature remains unchanged, Octapharma said Tuesday. (Kansteiner, 1/6)

Stat: FDA Advisory Panel Meetings Became "Rarer And Tougher" In 2020
Among the myriad changes wrought by the Covid-19 pandemic, Food and Drug Administration advisory committee meetings to review medicines are “rarer and tougher” now, according to one Wall Street analyst. Over the past year, just half of new drug applications taken to advisory committees were recommended for regulatory approval. That compares with 78% in 2019 and a rate of more than 80% in three of the four years before that, according to Cowen analyst Rick Weissenstein, who cited an analysis by the Prevision Policy consulting firm in an investor note. (Silverman, 1/8)

FiercePharma: Should Pharma Charity Contributions Be Publicly Disclosed, Just Like Doctor Payments? Senators Say Yes
Pharma companies have inked a series of federal settlements over payments to charity organizations, which the federal government argues are a “conduit” to boosting drug sales. Now, after an opioid investigation, two Senators want all those charity payments disclosed publicly. And they have just the mechanism for it. Sens. Chuck Grassley and Ron Wyden have called for an expansion of the Centers for Medicare and Medicaid Services Open Payments database. That database now includes payments from pharma companies to doctors and other medical providers, but the senators propose adding payments to tax-exempt groups, too. Further, the senators have called for a new requirement that the HHS secretary formulate guidelines to boost transparency around research organizations and others contracted by the health agency.  (Sagonowsky, 1/8)

CIDRAP: Nations Facing Drug Shortages Use Registries, Other Steps 
Drug supply chain vulnerabilities have achieved greater visibility with the COVID-19 pandemic, but they have increasingly plagued countries in the past few years. A survey published in Health Policy's December issue found that 20 of 24 countries used drug registries to combat them, 20 simplified regulatory procedures during shortages, 18 regularly talked with stakeholders, and 15 had financial sanctions in place for when manufacturers missed notification or supply requirements. Even with these practices in place, multiple countries expressed an interest in increasing management strategies, and for good reason. Finland, the researchers report, experienced an 18-fold increase in shortages from 2010 to 2018, with instances doubling from 2016 to 2018 alone. (McLernon, 1/8)