Drugmakers kick off 2021 with 500 U.S. price hikes

 

Drugmakers including Abbvie Inc and Bristol Myers Squibb raised U.S. list prices on more than 500 drugs to kick off 2021, according to an analysis by health care research firm 46brooklyn.

The hikes come as drugmakers are reeling from effects of the COVID-19 pandemic, which has reduced doctor visits and demand for some drugs. They are also fighting new drug price-cutting rules from the Trump administration, which would reduce the industry's profitability.

They include more than 300 price increases from companies like Pfizer and GlaxoSmithKline reported by Reuters late last week.

Nearly all the increases were below 10%, and the median hike was 4.8%, down slightly from last year, 46brooklyn said https://www.46brooklyn.com/branddrug-boxscore. The firm's analysis is based on data from Elsevier's Gold Standard Drug Database.

Abbvie raised prices on around 40 drugs including a 7.4% hike on rheumatoid arthritis treatment Humira, the world's top-selling drug. Revenue from Humira is expected to top $20 billion next year.

Bristol Myers hiked prices on around a dozen drugs, including cancer drugs Revlimid and Opdivo by 4.5 percent and 1.5 percent, respectively. It hiked the price of blood thinner Eliquis by 6 percent.

It said in a statement that it only raised prices on drugs with ongoing clinical research. It expects net prices, which include rebates and other discounts, to fall this year.

Drug price increases have slowed substantially since 2015, both in terms of the size of the hikes and the number of drugs affected.

However, 46brooklyn said its analysis of Medicaid data shows the average cost per branded drug is still ticking up.

    "Over time, we end up cycling out cheaper brands designed to treat large populations, and replacing them with expensive brands designed to treat smaller populations," wrote Eric Pachman, president of 46brooklyn. "With price increases losing their impact, launch prices will be the primary driver of U.S. drug list price inflation."

https://www.marketscreener.com/quote/stock/GLAXOSMITHKLINE-PLC-9590199/news/GlaxoSmithKline-Drugmakers-kick-off-2021-with-500-U-S-price-hikes-32119381/

BioNTech, Pfizer: No data to support delayed vaccine booster

 BioNTech and partner Pfizer warned on Monday that they had no evidence that their jointly developed vaccine will continue to protect against COVID-19 if the booster shot is given later than tested in trials.

“The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design,” the companies said in a joint statement, referring to prime and a booster shots given three weeks apart.

“There is no data to demonstrate that protection after the first dose is sustained after 21 days.”

Germany was considering on Monday whether to allow a delay in administering the second dose to make scarce supplies go further after a similar move by Britain last week. Separately, Denmark approved a delay of up to six weeks between the first and second shots of the vaccine.

https://www.reuters.com/article/us-health-coronavirus-germany-biontech/biontech-says-no-data-to-support-delayed-vaccine-booster-shot-idUSKBN2991XX

Spain will administer two doses of BioNTech-Pfizer vaccine

 Spain’s central health authority will continue to recommend administering two doses of the BioNTech-Pfizer vaccine in the period indicated by its manufacturers, health minister Salvador Illa said on Monday.

The decision goes against the United Kingdom’s recent policy shift to no longer reserve doses for a second round three weeks after the first, instead choosing to administer a single dose to more people. Germany is also considering this option.

BioNTech-Pfizer say immunity is only guaranteed one week after receiving the second dose.

Some 82,834 people in Spain have received a vaccine so far, amid criticism the campaign has gotten off to a slow start.

https://www.reuters.com/article/us-health-coronavirus-spain-vaccine/spain-will-administer-two-doses-of-biontech-pfizer-vaccine-minister-says-idUSKBN29924R

Major U.S. airlines back 'global' COVID-19 testing requirements

 A group representing major U.S. airlines on Monday backed a proposal by public health officials to implement a global testing program requiring negative tests before most international air passengers return to the United States, according to a letter seen by Reuters.

Airlines for America, a group that represents American Airlines, United Airlines, Delta Air Lines and other major carriers also urged the Trump administration in a letter to Vice President Mike Pence “to move ahead with recommendations to rescind current entry restrictions on travelers from Europe, the United Kingdom and Brazil as soon as possible. These entry restrictions should be removed concurrently with the testing program.”

In November, Reuters reported that the White House was considering rescinding restrictions that ban most non U.S. citizens from traveling to the United States from the 26 members of the Schengen area that allow travel across open borders, the United Kingdom, Ireland and Brazil.

“We believe a well-planned program focused on increasing testing of travelers to the United States will further these objectives in a much more effective way than the blanket travel restrictions currently in place,” the airlines’ letter said.

Airlines support a Centers Disease Control and Prevention (CDC) proposal to implement “a global program to require testing for travelers to the United States,” the letter added.

A senior administration official said the CDC proposal to expand international testing requirements faces significant opposition from people at senior levels of the administration, including in Pence’s office.

The CDC on Dec. 28 began requiring all airline passengers arriving from Britain - including U.S. citizens - to test negative for COVID-19 within 72 hours of departure.

Airlines are seeking at least 14 days before new requirements take effect and “consideration of inadequate testing and results availability in specific countries rather than a blanket worldwide requirement is also needed,” the letter said.

https://www.reuters.com/article/us-health-coronavirus-airlines-testing/major-u-s-airlines-back-global-covid-19-testing-requirements-letter-idUSKBN29929H

Initial Guidance on Use of Monoclonal Antibodies for Covid Treatment in Children, Teens

 This article was originally published here

J Pediatric Infect Dis Soc. 2021 Jan 3:piaa175. doi: 10.1093/jpids/piaa175. Online ahead of print.

ABSTRACT

BACKGROUND: In November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for two novel virus-neutralizing monoclonal antibody therapies, bamlanivimab, and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate COVID-19 in adolescents and adults in specified high-risk groups. This has challenged clinicians to determine the best approach to use of these products.

METHODS: A panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacy, pediatric intensive care medicine, and pediatric hematology from 29 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on review of the best available evidence and expert opinion.

RESULTS: The course of COVID-19 in children and adolescents is typically mild and there is no high-quality evidence supporting any high risk groups. There is no evidence for safety and efficacy of monoclonal antibody therapy for treatment of COVID-19 in children or adolescents, limited evidence of modest benefit in adults, and evidence for potential harm associated with infusion reactions or anaphylaxis.

CONCLUSIONS: Based on evidence available as of December 20, 2020, the panel suggests against routine administration of monoclonal antibody therapy (bamlanivimab, or casirivimab and imdevimab), for treatment of COVID-19 in children or adolescents, including those designated by the FDA as at high risk of progression to hospitalization or severe disease. Clinicians and health systems choosing to use these agents on an individualized basis should consider risk factors supported by pediatric-specific evidence, and ensure implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.

PMID:33388760 | DOI:10.1093/jpids/piaa175

https://www.docwirenews.com/abstracts/journal-abstracts/initial-guidance-on-use-of-monoclonal-antibody-therapy-for-treatment-of-covid-19-in-children-and-adolescents-4/

Inovio expects to begin late-stage COVID-19 vaccine study in 2Q

 

Inovio Pharmaceuticals Inc expects to start a late-stage U.S. study of its experimental COVID-19 vaccine candidate in the second quarter of 2021, the drug developer's chief executive officer said on Monday.

Inovio's vaccine, INO-4800, is being tested in two trials - a mid-stage study in China in partnership with Advaccine Biopharmaceuticals Suzhou Co Ltd and a mid-to-late stage trial in the United States.

The U.S. Food and Drug Administration had put the Phase III portion of the study on hold in September, as the agency sought more information, including details of a delivery device used to inject INO-4800 into skin cells.

Inovio expects to answer all regulatory questions raised by the FDA regarding its vaccine delivery system by the second quarter, Dr. Joseph Kim, the company's chief executive officer, told Reuters.

"We expect to complete mid-stage trials in March and project we will be able to start late-stage trials in second quarter of this year," Dr. Kim said.

The regulatory delay has resulted in Inovio lagging behind other developers in the race to develop a vaccine, as shots from Pfizer-BioNTech and Moderna have already gained authorization for emergency use in the United States.

On Monday, Inovio also entered a licensing agreement with Advaccine for manufacturing and selling INO-4800 in China.

Under the deal, Advaccine will get exclusive rights to Inovio's vaccine candidate in China, and Inovio will receive an upfront payment of $3 million, an aggregate of $108 million upon achieving milestones, and will also be entitled to sales royalty.

Advaccine is scaling up its manufacturing capability and expects to produce 100 million doses of the vaccine this year for China, Inovio said.

https://www.marketscreener.com/quote/stock/INOVIO-PHARMACEUTICALS-I-17937428/news/Inovio-expects-to-begin-late-stage-COVID-19-vaccine-study-in-second-quarter-32116334/

New York, Florida tell hospitals to speed COVID-19 vaccinations or lose supply

 The governors of New York and Florida sought to accelerate the slower-than-expected rollout of coronavirus vaccines by warning hospitals on Monday that they would reduce future allocations to those that fail to dispense shots quickly enough.

In New York, hospitals must administer vaccines within a week of receiving them or face a fine and loss of future supplies, Governor Andrew Cuomo said.

"I don't want the vaccine in a fridge or a freezer, I want it in somebody's arm," the governor said. "If you're not performing this function, it does raise questions about the operating efficiency of the hospital."

The U.S. federal government has distributed more than 15 million vaccine doses to states and territories around the country, but only around 4.5 million have been administered so far, according to data from the U.S. Centers for Disease Control and Prevention (CDC) released on Monday.

The U.S. government has fallen far short of its target of vaccinating 20 million people by the end of 2020. Officials said they expect the rollout will pick up significantly this month.

Surgeon General Jerome Adams told CBS News that there are 15 million to 20 million doses of vaccine available.

"We should be hopeful about that while acknowledging we have got to do better and we are going to keep doing better," Adams said. "And I promise you, you will see in these next two weeks numbers increase substantially."

The United States had reported a total of 20.5 million COVID-19 cases and 351,480 deaths as of midnight on Sunday. On a seven-day rolling average, it is reporting 210,190 cases and 2,636 coronavirus deaths per day.

In Florida, where officials have put senior citizens ahead of many essential workers for getting the vaccine, Governor Ron DeSantis announced a policy under which the state would allocate doses to hospitals that dispense them most quickly,

"Hospitals that do not do a good job of getting the vaccine out will have their allocations transferred to hospitals that are doing a good job at getting the vaccine out," DeSantis said at a briefing.

"We do not want vaccine to just be idle at some hospital system," he added, though he did not say they would face fines.

Florida will also deploy an additional 1,000 nurses to administer vaccines and will keep state-run vaccination sites open seven days a week, he said.

New York has dispensed about 175,000 doses of the 896,000 it has received since mid-December, according to CDC data. Florida has dispensed 265,000 of the 1.14 million doses it received.

In New York City, Mayor Bill de Blasio said obstacles were slowing his goal to have 1 million residents receive a first of two vaccine doses by the end of January. A little over 110,000 residents have received their first dose so far, according to city data.

De Blasio urged the state to broaden early eligible groups beyond healthcare workers and nursing home residents to include essential workers such as teachers, police officers, fire fighters, grocery store personnel and people who are more than 75 years old.

New York City currently has 125 vaccination sites and plans to double that by the end of the month, the mayor said.

"This has got to be a seven-day-a-week, 24-hour reality going forward," de Blasio said.

Monday also marked the first day when some Americans were due to receive their second vaccine shot, three weeks after getting the first dose. Among them was Maritza Beniquez, a healthcare worker in Newark, New Jersey.

"I now have body armor," she said after receiving the dose in a video posted on Facebook by New Jersey Governor Phil Murphy, who was part of a small gathering that witnessed the event. 

https://www.marketscreener.com/quote/stock/FACEBOOK-INC-10547141/news/New-York-Florida-tell-hospitals-to-speed-COVID-19-vaccinations-or-lose-supply-32118615/