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☆ Opinion | Three Mothers’ Plea to the F.D.A.: Save Our Children
▼ + stars: | 2024-02-28 | by ( ) www.nytimes.com time to read: +1 min

To the Editor:Re “Why Can’t More Children Get the Treatment That Saved My Son’s Life?,” by Elizabeth Currid-Halkett (Opinion guest essay, Feb. 24):Our three children, ages 5 and 7, battle a rare, relentless and ultimately fatal disease called cystinosis. We recently found hope in the initial phase of a gene therapy clinical trial that was shown to be safe and yielded very promising results — a therapy that could one day save our children’s lives. Our biggest fear is that it will not be accessible to them or others in desperate need. We applaud Dr. Marks’s wisdom and perspective. reviewers’ initial rejection is a cautionary tale of how patient access to lifesaving therapies could be impeded by a narrow interpretation of efficacy.

Persons: Elizabeth Currid, Currid, Peter Marks, “ Organizations: Biologics

The Food and Drug Administration on Tuesday granted emergency use authorization to the updated COVID-19 vaccine from Novavax, marking the third new coronavirus shot that will be made available to the public ahead of the winter and the only not produced with messenger RNA technology. FDA authorized the shot for people ages 12 and older just weeks after shots from Moderna and Pfizer rolled out. “Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. Some individuals are skeptical of the new technology, instead opting for Novavax’s more traditional use of protein-based technology. “In the coming days, individuals in the U.S. can go to major pharmacies, physicians’ offices, clinics and various government entities to receive an updated Novavax vaccine.”

Persons: “, ” Peter Marks, ”, John Jacobs Organizations: Drug Administration, FDA, Moderna, Pfizer, FDA’s, Biologics, Research, Health, Covid Locations: U.S

COVID-19 deaths and hospitalizations have been on the rise in the U.S. as fall approaches. Nearly 845 coronavirus deaths were reported for the week ending Aug. 19, according to provisional data from the Centers for Disease Control and Prevention. That’s up from about 520 deaths a month prior. Meanwhile, COVID-19 hospitalizations have been increasing in the U.S. for nine weeks, reaching more than 20,500 new hospital admissions during the week ending Sept. 9 – an increase of nearly 8% from the prior week. While the totals are smaller than in previous waves of the virus in the U.S., they mark noteworthy trends heading into the fall and winter seasons.

Persons: ” Peter Marks, ” Organizations: Centers for Disease Control, CDC, ”, Food, Drug Administration’s, Biologics, Research, EG Locations: U.S, COVID

WASHINGTON (AP) — The U.S. approved updated COVID-19 vaccines Monday, hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter. It’s part of a shift to treat fall updates of the COVID-19 vaccine much like getting a yearly flu shot. A CDC advisory panel is set to issue recommendations Tuesday on who most needs the updated shots. The FDA pointedly isn’t calling this latest round a “booster” but instead a vaccine updated to better match the currently circulating virus. But while the FDA's decision allows for wide use of the updated shots, the CDC will decide how strongly different groups are urged to get them.

Persons: BioNTech, they’ve, There’s, Novavax, It’s, Peter Marks Organizations: WASHINGTON, Drug Administration, Moderna, Pfizer, Disease Control, CDC, FDA, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP

The Food and Drug Administration on Monday authorized updated COVID-19 shots that could roll out as soon as this week. “Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. The fall booster shot campaign comes as the U.S. sees its seventh straight week of rising COVID-19 hospitalizations. COVID-19 deaths appear to be rising slightly, but the provisional data from the CDC is prone to amendments and delays.

Persons: ”, Peter Marks Organizations: Drug Administration, FDA’s, Biologics, Centers for Disease Control, EG Locations: U.S

☆ FDA approves Pfizer maternal RSV vaccine for infants
▼ + stars: | 2023-08-21 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

It's now the second treatment approved by the FDA to prevent RSV in infants and the first vaccine. It uses maternal immunization, which refers to vaccinating pregnant mothers so they can pass protective antibodies to their fetuses. "When you think globally, this vaccine could potentially have a huge public health impact," Gurtman told CNBC. The FDA in mid-July approved an RSV monoclonal antibody from Sanofi and AstraZeneca that is directly administered to infants. The shot would help the U.S. combat the upcoming RSV season as it comes off an unusually severe year.

Persons: It's, Alejandra Gurtman, Gurtman, Dr, Peter Marks Organizations: Drug Administration, Pfizer, FDA, Centers for Disease Control, Prevention, CNBC, Sanofi, AstraZeneca, CDC Locations: U.S

☆ FDA advisors raise doubts about seasonal updates to Covid vaccines as with flu shots
▼ + stars: | 2023-06-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The U.S. Food and Drug Administration's independent panel of advisors raised doubts about the need to "periodically" update Covid vaccines, noting that it's unclear if the virus is seasonal like the flu. But the original voting question included language about whether the panel recommends a "periodic update" to Covid shots. But several advisors cautioned against calling Covid seasonal like the flu. "It's not clear to me that this is a seasonal virus yet," said Henry Bernstein, a pediatrician at Cohen Children's Medical Center. In response to the advisors, FDA's Marks emphasized that Covid shots will likely require another update "at some point."

Persons: Peter Marks, Arthur Reingold, Henry Bernstein, Mark Sawyer, Sawyer, FDA's Marks Organizations: Union Station, The U.S . Food, University of California, Children's Medical Locations: Los Angeles , California, The U.S, Berkeley, U.S, San Diego

☆ FDA recommends that updated Covid shots target omicron subvariant XBB.1.5 this fall
▼ + stars: | 2023-06-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

The U.S. Food and Drug Administration on Friday recommended that Covid vaccine manufacturers make single-strain shots for the fall that target omicron subvariant XBB.1.5, the dominant strain of the virus nationwide. XBB.1.5 is a descendant of the omicron variant, which caused cases in the U.S. to spike to record levels early last year. That panel unanimously voted that new jabs should be monovalent and target a member of the XBB family. The three companies have already been developing updated versions of their shots that target XBB.1.5. Dr. Peter Marks, head of the FDA's vaccine division, suggested Thursday that the updated vaccines could be available to the public around September.

Persons: Novavax, Peter Marks Organizations: . Food, Drug Administration, FDA, Pfizer, Moderna, Centers for Disease Control, Advisors, CNBC Locations: U.S

☆ F.D.A. Panel Advises Vaccine Makers to Aim at Only One Covid Variant
▼ + stars: | 2023-06-15 | by ( Christina Jewett | ) www.nytimes.com time to read: +2 min

The bivalent shots offered last fall included protection against the Omicron variant and an early Covid variant. is expected to make a more official recommendation to vaccine makers soon. The manufacturers will be expected to study the new formulas and submit data to the agency. spokesman said it expected that an updated vaccine would be available by late September, assuming the data support safe and effective vaccines. It remains unclear whether or when the vaccine makers or the F.D.A.

Persons: ”, Peter Marks, Natalie Thornburg Organizations: Pfizer, Moderna, Centers for Disease Control, World Health Organization, Agency Locations: United States

☆ FDA advisors recommend that new Covid vaccines target an omicron XBB variant this fall
▼ + stars: | 2023-06-15 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

The committee unanimously voted that the new jabs should be monovalent — meaning they are designed to protect against one variant of Covid — and target a member of the XBB family. Those strains of Covid are descendants of the omicron variant, which caused cases to surge to record levels early last year. Advisors also generally agreed that the new shots should specifically target a variant called XBB.1.5. There is also uncertainty about which age groups the FDA and CDC will advise to receive the updated shots this fall. But it's unclear how many Americans will roll up their sleeves to take the updated shots later this year.

Persons: Melinda Wharton, Novavax, John Jacobs, Peter Marks, David Kaslow Organizations: . Food, Centers for Disease Control, Advisors, Pfizer, Moderna, National Center, FDA, CDC, Novavax, omicron Locations: U.S, Novavax

☆ Iiu Susiraja: She Has Issues? No, You Have Issues
▼ + stars: | 2023-05-31 | by ( Roberta Smith | ) www.nytimes.com time to read: +1 min

The strange, discomfiting photographs and videos of the Finnish artist Iiu Susiraja push so many buttons that her provocative exhibition at MoMA PS1 should have been staged in an elevator — to paraphrase the theater critic Peter Marks. Ambiguously titled “Iiu Susiraja: A Style Called a Dead Fish,” the show features 49 photographs and 13 short videos dating from 2008 to 2022. Like most artists whose work matters, Susiraja has no shame. Born in 1975 in Turku, Finland, where she still lives, Susiraja (pronounced ee-you susi-rah-yah) started out as a textile designer. Easy resolution of their meanings is impossible, which creates a rich internal narrative in the viewer, often starting with one’s feelings about one’s own body.

Persons: Iiu, Peter Marks, Susiraja Organizations: MoMA Locations: Turku, Finland

☆ Sarepta surges after FDA panel backs Duchenne gene therapy
▼ + stars: | 2023-05-15 | by ( ) www.reuters.com time to read: +2 min

May 15 (Reuters) - Shares of Sarepta Therapeutics (SRPT.O) soared 29% premarket on Monday as a backing by the U.S. health regulator's advisers increased the certainty of an accelerated approval for the company's gene therapy for a muscle-wasting genetic disorder. Eight of the 14 advisers to the Food and Drug Administration late Friday voted that the company had enough data to support an accelerated approval for its gene therapy for Duchenne muscular dystrophy (DMD). The vote came after FDA staff had earlier last week voiced concerns that the data from the company's mid-stage trial lacked "unambiguous evidence" about benefits from the therapy. TD Cowen analyst Ritu Baral expects an approval for the therapy, especially considering the FDA leadership's interest in promoting biomarker-based accelerated approvals for gene therapies. The FDA, often follows the advice of its expert advisers but is not obligated to do so, is slated to make a decision on accelerated approval by May 29.

☆ A drug company abandoned a treatment for ‘bubble boy disease.’ After a 5-year fight, this little girl is about to get it
▼ + stars: | 2023-04-27 | by ( Elizabeth Cohen Lauren Mascarenhas | Elizabeth Cohen | Lauren Mascarenhas | ) edition.cnn.com time to read: +29 min

The Sulacks weighed their options: Have a transplant with a match that was less than ideal – far less – or wait for gene therapy to become available. The news release didn’t say anything else about the SCID gene therapy. Or was the company abandoning its plans for SCID gene therapy altogether? In February, 2021, the parents of more than 20 children who were waiting for the gene therapy treatment, including the Sulacks, wrote a letter to Gaspar. Insurance companies have sometimes balked at paying for gene therapy, which is typically given in one treatment.

☆ FDA authorizes additional omicron Covid booster for seniors and people with weak immune systems
▼ + stars: | 2023-04-18 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

(Photo by Scott Olson/Getty Images)The Food and Drug Administration on Tuesday authorized an additional dose of Pfizer and Moderna 's Covid-19 vaccines targeting the omicron variant for seniors and people with weak immune systems. People with weak immune systems can receive another omicron shot at least two months after their last dose and receive additional shots at the discretion of their doctor. Children 6 months through 5 years of age who are unvaccinated can now receive the full two-dose series of Moderna's omicron vaccine. The FDA first authorized the omicron BA.5 shots last August, but that subvariant has long since been displaced by a version of omicron called XBB.1.5. In June, the agency will likely update the variant that the Covid vaccines target, ahead of the fall respiratory virus season.

☆ Sarepta drops as report says FDA almost rejected under-review gene therapy
▼ + stars: | 2023-04-13 | by ( ) www.reuters.com time to read: +1 min

April 13 (Reuters) - Sarepta Therapeutics Inc's shares (SRPT.O) fell more than 6% on Thursday as Stat News reported that the U.S. health regulator's staff were inclined to reject the company's gene therapy which is currently under review. Some staff at the U.S. Food and Drug Administration (FDA) had reached a "non-binding conclusion" that Sarepta's gene therapy should not be given approval, prompting FDA official Peter Marks to intervene and instead schedule an advisory meeting on May 12, Stat News reported, citing sources. The company is seeking approval for its gene therapy for treating a rare muscle-wasting disorder called Duchenne muscular dystrophy under the FDA's accelerated pathway. Brokerage William Blair said it still sees a "likely" approval for the therapy. Shares of Catalent Inc (CTLT.N), which holds the contract manufacturing rights for the therapy, fell as much as 5.5% in early trade.

☆ US FDA to take steps to help gene therapies get accelerated approval
▼ + stars: | 2023-03-21 | by ( ) www.reuters.com time to read: +2 min

March 20 (Reuters) - The U.S. Food and Drug Administration is moving to optimize the development of gene therapies, including encouraging the use of biomarkers to help get accelerated approval of therapies for serious conditions, an agency official said. The FDA will support using biomarkers as substitutes for other biological indicators in gene-therapy clinical trials to help clinch "accelerated approval", the agency's Peter Marks said on Monday. The U.S. health regulator grants the so-called accelerated approval mainly for drugs and therapies targeted at rare diseases or small patient populations that have had no effective treatments available to them. "The FDA views gene therapy as an excellent opportunity to expedite the delivery of potentially life-saving therapies to patients with rare diseases," said Marks, who heads the FDA's Center for Biologics Evaluation and Research, in a statement. The company is seeking approval for its gene therapy under the FDA's accelerated pathway.

☆ FDA authorizes Pfizer's Covid omicron booster as fourth shot for kids under 5
▼ + stars: | 2023-03-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

The U.S. Food and Drug Administration on Tuesday authorized Pfizer's omicron booster shot for kids under five years old who were previously vaccinated with three doses of the company's original vaccine. The new shot is bivalent, meaning it targets the original Covid strain as well as omicron BA.4 and BA.5. Pfizer's primary series for young children consists of three doses, while rival drugmaker Moderna's primary series for that same age group is only two. Since December, children in that age group who completed two doses of Pfizer's original vaccine have been eligible to receive the omicron booster as their third shot, or last dose in their primary series. One month after the children received the omicron booster, they demonstrated an immune response to both the original Covid strain and omicron BA.5 and BA.5

An advisory committee to the Food and Drug Administration on Thursday raised doubts about shifting toward a yearly Covid booster for most adults and children, saying too many questions about the virus still remain unanswered. The FDA convened its Vaccine and Related Biology Products Advisory Committee to discuss how the Covid vaccines may change moving forward. On Monday, the agency published briefing documents proposing annual Covid shots that target the latest variants of the virus — an approach similar to the yearly flu shot. Some committee members said they would prefer to make multiple yearly meetings on the Covid vaccines the norm. In a unanimous vote, the committee recommended using the bivalent formula in all Covid vaccines moving forward, not just for booster shots.

☆ FDA proposal would allow gay men in monogamous relationships to donate blood
▼ + stars: | 2023-01-27 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Under the guidelines proposed on Friday, gay and bisexual men who are in monogamous relationships would be allowed to donate blood. The FDA had imposed a lifetime ban on men who have sex with men donating blood during the AIDS crisis in the 1980s. The agency had eased the ban in 2015, allowing gay and bisexual men to donate blood if they had not had sex in the previous year. The American Medical Association had criticized the FDA's restrictions on gay men donating as discriminatory. Those taking injections to prevent HIV would not be allowed to donate blood for two years following their most recent injection.

☆ FDA advisors recommend replacing original Covid vaccine with bivalent omicron shots for all doses
▼ + stars: | 2023-01-26 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Food and Drug Administration's independent advisory committee on Thursday unanimously recommended replacing Pfizer and Moderna's original Covid vaccine used in the U.S. for everyone's first two immunizations with the new bivalent omicron shots. Instead, the drugmakers' bivalent omicron shots that target the omicron BA.5 subvariant as well as the original strain would be used for the entire vaccination series. Currently, Pfizer's and Moderna's omicron shots are only authorized as a booster, while the first two doses are still their old shots based on the original Covid strain. The FDA has proposed moving to a system that resembles how the agency updates and rolls out flu shots every year. The agency would select a Covid vaccine formulation in June to target the variant that is expected to dominate in the fall and winter.

☆ Children as young as 6 months old are now eligible for omicron Covid vaccines
▼ + stars: | 2022-12-09 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

The Centers for Disease Control and Prevention on Friday signed off on omicron vaccines for children as young as 6 months old, giving pharmacies and physicians the green light to start administering the shots. Children ages 6 months through 5 years old who received the two-dose Moderna primary series can now get an omicron booster two months after their second dose. Meanwhile, kids ages 6 months through 4 years old who are completing their Pfizer primary series will received the omicron shot as their third dose. "Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death," Marks said. "Parents and caregivers can be assured that the FDA has taken a great deal of care in our review."

☆ FDA authorizes updated Covid booster shots for kids under 5
▼ + stars: | 2022-12-08 | by ( The Associated Press | ) www.nbcnews.com time to read: +2 min

U.S. regulators on Thursday cleared doses of the updated Covid-19 vaccines for children younger than age 5. Omicron-targeted booster shots made by Moderna and Pfizer already were open to everyone 5 and older. Children under 5 who already got all three Pfizer doses aren’t yet eligible for an updated booster. “Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant,” FDA vaccine chief Dr. Peter Marks said in a statement. The CDC last month released the first real-world data showing that an updated booster, using either company’s version, does offer added protection to adults.

☆ FDA authorizes Covid omicron vaccines for children as young as 6 months old
▼ + stars: | 2022-12-08 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

REUTERS/Shannon StapletonThe Food and Drug Administration on Thursday authorized updated Covid shots that target the omicron variant for children as young as 6 months old. The eligibility rules vary depending on whether children received Moderna's or Pfizer's original vaccines as their primary series. The new shots target the omicron BA.5 subvariant and the original Covid strain. U.S. health officials expect the new shots to provide superior protection compared to the original vaccines, which only target the original Covid strain. The FDA authorized the shots based on adult immune response data for similar vaccines developed by Pfizer and Moderna that target the original omicron BA.1 variant.

☆ U.S. FDA gives first-ever approval to fecal transplant therapy
▼ + stars: | 2022-11-30 | by ( ) www.reuters.com time to read: +2 min

The therapy, Rebyota, targets Clostridium difficile, or C. difficile – a superbug responsible for infections that can cause serious and life-threatening diarrhea. While this is the first such therapy approved by the Food and Drug Administration (FDA) for recurrent C. difficile infections, fecal microbiota transplants – classified by the regulator as investigational – have long been the standard of care in the U.S. for this condition. Approval for the therapy comes on the back of a positive vote from the regulator's advisers in September, as most on the panel sought standardization of the therapy. Ferring, which gained the therapy through its 2018 purchase of U.S.-based Rebiotix Inc, was not immediately available for a comment on pricing and availability of the therapy. Besides Ferring, other companies including Seres Therapeutics (MCRB.O), which is developing an oral treatment, are working on similar therapies based on fecal microbiota transplantation.

☆ Regulators have approved the world's most expensive medicine that costs $3.5 million per patient
▼ + stars: | 2022-11-24 | by ( Ryan Hogg | ) www.businessinsider.com time to read: +3 min

The FDA approved a treatment costing $3.5 million, making it the world's most expensive medicine. Hemgenix effectively treated several patients with the blood condition Hemophilia B in trials. An independent study said a fair price for the drug would be about $2.9 million. download the app Email address By clicking ‘Sign up’, you agree to receive marketing emails from Insider as well as other partner offers and accept our Terms of Service and Privacy PolicyUS regulators have approved a hemophilia drug that will cost $3.5 million per patient, making it the world's most expensive medicine. However, the drug will have a list price of $3.5 million per dose, Managed Healthcare Executive reported, making it the world's most expensive medicine by some distance.

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