GlaxoSmithKline and U.S. partner Vir Biotechnology will boost production of their antibody-based COVID-19 treatment by adding a second manufacturing plant to help meet soaring demand in the United States.
The U.S. government last week signed a deal with the drugmakers to buy 600,000 more doses of the therapy, sotrovimab, for an undisclosed sum.
The GSK-Vir therapy has shown more promise against the Omicron variant in lab studies than treatments from major rivals Eli Lilly and Regeneron.
"GSK had been planning to introduce another production facility to our manufacturing network in advance of Omicron," a GSK spokesperson told Reuters on Friday.
"The second site provides GSK additional scale and diversity given the pandemic uncertainty."
Deliveries of the 600,000 additional doses will be carried out through the first quarter of 2022, the spokesperson said.
The Wall Street Journal reported on Friday that GSK and Vir were expected to make the first deliveries in February.
The United States is reporting an average of 752,698 new coronavirus infections a day, according to a Reuters analysis of official data, fuelling the urgent need for effective solutions.
The Biden administration in November signed contracts worth about $1 billion for an unknown number of doses of sotrovimab before the rapid spread of Omicron, and has said it would control the distribution of the drug in the country.
The White House on Friday launched a new phone line that Americans can use to order free at-home coronavirus tests, in an effort to reach those who cannot easily access the internet.
Starting Friday, Americans who cannot put in an order for the COVID-19 tests on the website launched by the White House earlier this week can call 1-800-232-0233 to do so, the White House said. The call line, which serves those speaking English, Spanish and over 150 additional languages, is open 8 a.m. until midnight EST, seven days a week.
The Biden administration has also set up a text-based line for hearing impaired callers at 1-888-720-7489.
The White House said the resources are meant to make the process of ordering the free tests as easy as possible and ensure that Americans with low literacy, those who have challenges accessing the internet and those who need additional support can access the tests.
The White House also said that the administration is working with national and local organizations that serve communities of color, those with disabilities and other high-risk communities to raise awareness about the free COVID-19 tests and help Americans order them.
Additionally, the White House said that 20 percent of the test orders processed each day will be from high Social Vulnerability Index zip codes, or those that are being hardest hit by the pandemic.
“We want to make sure those communities are, instead of being the afterthought, first in line in so many ways,” Cameron Webb, Biden’s COVID-19 adviser for equity, told NBC News, which was first to report Friday’s launch of the hotline.
The White House test website, COVIDTests.gov, went live on Tuesday. Americans can use the website to order free rapid COVID-19 tests, limited to four per household, that will be delivered by the Postal Service. The tests are expected to take between seven and 12 days to ship.
Americans are required to provide minimal information — their name and mailing address — to receive the tests.
The Biden administration announced plans to offer free COVID-19 tests last month, amid criticism over a high demand and shortage of rapid coronavirus tests as the omicron variant made its way through the United States.
The Biden administration is using the website and phone line to distribute 500 million COVID-19 rapid tests to individuals across the country.
Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today announced that it has filed a Form 10 registration statement with the United States Securities and Exchange Commission ("SEC") in connection with the intended spinoff of its Dental and Spine businesses into a standalone, publicly traded company, ZimVie.
The Form 10 includes detailed information about ZimVie, such as historic financial information, a description of ZimVie's business and strategy, and other legal and financial disclosures. A copy of the Form 10 is available on the SEC website atwww.sec.gov.
In addition, ZimVie will host a virtual Investor Day on Monday, February 7, 2022 from 11:00 a.m. to approximately 3:00 p.m. Eastern Time. The virtual event will feature presentations from ZimVie leaders outlining its Dental and Spine offerings, addressable market opportunity, financial outlook, business strategy, and the broader organizations supporting these businesses. The event will feature a live Q&A panel following speaker presentations.
A live and archived webcast of the event can be accessed via Zimmer Biomet's Investor Relations website at https://investor.zimmerbiomet.com.
Zimmer Biomet announced in February 2021 its intent to form a new independent, publicly traded company to optimize resource allocation and drive toward market leadership. That transaction process remains on track, with an expected close in the first quarter of 2022.
Alzheimer's patient groups, disappointed by Medicare's plan to sharply limit coverage of new drugs for the brain-wasting disease, are planning publicity and lobbying campaigns to protest a proposal they say could delay their use for 10 years.
"Congress has to know how bad this will be for patients," said John Dwyer, president of Global Alzheimer's Platform Foundation (GAP) advocacy group.
In a preliminary decision https://www.reuters.com/business/healthcare-pharmaceuticals/future-biogens-aduhelm-hinges-us-medicare-alzheimers-coverage-2022-01-11 last week, the U.S. Centers for Medicaid and Medicare Services (CMS), which runs the government health plan for people age 65 and older, said it would cover Biogen Inc's already approved Aduhelm, and similar Alzheimer's disease treatments in development, only for patients enrolled in approved clinical trials.
That plan would severely limit the number of patients receiving the treatment, undercutting the Food and Drug Administration's accelerated approval of Aduhelm for patients in the early stages of the memory-robbing condition.
The public disagreement over the drug's use is unusual for the agencies, both part of the U.S. Department of Health and Human Services.
Alzheimer's Association Chief Executive Harry Johns said Medicare's plan "usurps FDA's role in drug approvals," calling it "an unprecedented and terrible draft decision."
His group, as well as UsAgainstAlzheimer's and GAP - three of the biggest Alzheimer patient organizations - said they plan to fight the decision by appealing to lawmakers, the Biden administration and the U.S. Health Secretary.
The Alzheimer's Association said it is using "all avenues of communication" to make its case.
Biogen is also fighting the decision and in a statement said it is "supportive of the community in raising their voices on this important issue of access."
The Medicare agency could alter its plan before it is finalized in April, but it is unclear what new evidence or facts would cause it to soften its stance.
"There are only two clinical studies ... There isn't any real-world experience to convince CMS," said James Chambers, a researcher at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center in Boston. "They will receive a lot of outrage as opposed to new information."
Medicare has opened a 30-day comment period with a final decision due by April 11.
"If the (CMS) decision changes, it will be because of political pressure," said Raymond James analyst Chris Meekins.
CONTROVERSIAL DECISION
The FDA's June decision https://www.reuters.com/article/biogen-alzheimers-fda-idCNL2N2NP12J was the first approval of an Alzheimer's drug in nearly two decades, but was a controversial one not supported by the agency's outside advisers. It relied on evidence that the drug can reduce amyloid brain plaques, a likely contributor to Alzheimer's, rather than proof that it slows progression of the disease.
Only one of Biogen's two large-scale trials showed that Aduhelm had an impact on cognition.
The three Alzheimer's patient groups said Medicare's plan unfairly penalizes people with the disease - probably because there are so many of them and the cost could be enormous.
Aduhelm's price - cut recently to $28,200 from $56,000 per year - sparked concerns about Medicare's budget since Alzheimer's is an age-related disease and around 85% of people eligible for the drug are in the government plan.
The number of Americans with Alzheimer's is expected to rise to 13 million by 2050 from more than 6 million currently. Biogen has estimated that around 1 million would currently be eligible for Aduhelm.
Other companies, including Biogen partner Eisai Co Ltd and Eli Lilly and Co, also are pursuing accelerated approval from the FDA for similar medications.
"This decision was not about Aduhelm alone. This was a decision about drugs still in trials," said UsAgainstAlzheimer's chairman George Vradenburg. "It is stunning preemption."
Medicare typically pays for FDA-authorized medications, but by law is required to cover only products and services deemed "reasonable and necessary" for diagnosis or treatment.
Vradenburg said his organization is "communicating with Congress and the Biden Administration" about its dismay.
New Hampshire residents may soon be able to receive ivermectin from pharmacies without first getting a prescription or approval from a doctor.
Proposed legislation titled House Bill 1022 would allow pharmacists to dispense the drug, which some believe can treat COVID-19 even though it lacks approval for such use from the U.S. Food and Drug Administration (FDA), by means of standing orders.
Under the law, pharmacists would be able to "dispense ivermectin under the delegated prescriptive authority of the physician or APRN (Advanced Practice Registered Nurses), specify a mechanism to document screening performed and the prescription in the patient's medical record, and include a plan for evaluating and treating adverse events," according to the bill.
"Any such prescription shall be regarded as being issued for a legitimate medical purpose in the usual course of professional practice."
The pharmacist would also be required to provide any patients who receive ivermectin with a "standardized information sheet written in plain language" that provides health care referral information and notes the importance of follow-up care.
"Nothing on the information sheet shall discourage the recipient from using ivermectin for the treatment of COVID-19," the bill read.
According to the legislation, the measure would take effect 60 days after it was passed.
The FDA has not approved ivermectin for the treatment or prevention of COVID-19 in both humans and animals, according to its website. It is, however, "approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea."
The agency said that while clinical trials to assess the effectiveness of ivermectin against COVID-19 were taking place, current data does not indicate that is the case. It also said that taking large doses of the drug is dangerous, and instructed anyone who receives an ivermectin prescription to "fill it through a legitimate source such as a pharmacy, and take it exactly as prescribed."
New Hampshire residents may soon be able to receive ivermectin from pharmacies without first getting approval from a doctor. Above, a close-up of text reading Ivermectin on a container of veterinary medication, Lafayette, California, September, 2021.SMITH COLLECTION/GADO/GETTY IMAGES
Some are pushing back against the legislation, including Jeffrey Poirier, whose Twitter bio says he is a registered pharmacist in New Hampshire.
"This goes against the recs of NHSHP (New Hampshire Society of Health-System Pharmacists), the FDA & the CDC. Desperation is pervasive, even in the face of the advice against it from our pharmacy leaders," he wrote in a tweet Wednesday.
A number of medical experts testified in opposition to the bill during a legislative session on Tuesday.
"I'd like to believe the standard of care here in New Hampshire is that a patient could get a prescription for ivermectin, off-label, as long as that patient ideally gets put into some clinical trial, whether it's a drug company or whether it's an academic institution like Dartmouth," Dr. Nick Perencevich, a retired general surgeon, said during his testimony.
Republican State Rep. Leah Cushman, a sponsor of the bill and registered nurse, told Newsweek that she wanted to make sure residents of the state "have options for treatment of COVID-19." She also said that the burden of the virus on hospitals needs to be curbed, "and right now there are no early treatments being offered by most doctors."
In regard to some of the pushback against the bill, Cushman said that the House committee was working on a bipartisan amendment to address some of the concerns. This includes requiring that patients who receive the drug are informed that its use for COVID-19 is "off-label" and setting guidelines for tracking any adverse effects, she said.
"I think we can work together to get it an Ought to Pass recommendation from the committee," Cushman said.
The FDA has, however, stressed that even levels of ivermectin approved for human use can have potentially harmful effects when they interact with other medications, such as blood thinners. Additionally, an overdose on ivermectin can cause nausea, vomiting, diarrhea, low blood pressure, seizures, coma, and even death, according to the agency.
"There's a lot of misinformation around, and you may have heard that it's okay to take large doses of ivermectin. It is not okay," the FDA said on its website.
Newsweek has reached out to the FDA for comment on the bill.
The New Hampshire legislation is currently in committee, but the state House of Representatives is slated to vote on it in the coming weeks, WMUR reported.
UKidney™ procedure data published in the American Journal of Transplantation; the first such data published in a peer-reviewed journal
UHeart™ recipient patient reaches a two-week milestone post-transplant
UThymoKidney™ procedure represents a historic first preclinical human model study
United Therapeutics Corporation (UT) (Nasdaq: UTHR), a public benefit corporation with a purpose to provide a brighter future for patients, announced today that the world's first recipient of an investigational genetically-modified xenotransplanted organ, UT’s UHeart™, reached a two-week milestone. University of Maryland School of Medicine (UMSOM) surgeons report continued post-operative cardiovascular improvement in the patient with normal organ function. In addition, the first peer-reviewed publication of a similarly gene-edited investigational xenograft, UT’s UKidney™, in a human preclinical model at the University of Alabama at Birmingham Marnix E. Heersink School of Medicine (UAB) was published yesterday in the American Journal of Transplantation.
These major medical milestones come on the heels of the September 2021 historic transplant of UT’s UThymoKidney™ at New York University Langone Health (NYU). That human preclinical model proved for the first time that UT’s GalSafe™ pig could, as modified, transcend the most proximate immunological barriers to xenotransplantation. The GalSafe pig was approved by the U.S. Food and Drug Administration (FDA) for human food and as a potential source for biomedical use in December 2020. These achievements rely on UT’s development, through its Revivicor subsidiary, of genetically modified pigs that are designed to provide a supply of organs for people who are unable to receive human organ donations.
Also relevant to UT’s organ development efforts are:
Drone delivery of organs.UT’s historic October 2021 first-ever delivery of a transplanted lung by electric drone at Toronto General Hospital, demonstrating the feasibility of UT’s goal to deliver its transplantable organs with zero carbon footprint aircraft; and
Ex-vivo lung perfusion.More than 200 human donor lungs successfully transplanted after being saved from disposal by UT’s subsidiary Lung Bioengineering at its facilities in Silver Spring, Maryland and on the Mayo Clinic campus in Jacksonville, Florida.
