Search Results for “ Pfizer” – Page 10 – media

Pfizer’s Paxlovid approved by FDA and Gilead’s Veklury recommended by CHMP

Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets) has been approved by the US Food and Drug Administration (FDA), and Gilead Science’s Veklury (remdesivir) recommended by the European Medicines Agency’s human medicines committee to treat certain COVID-19 patients. Pfizer’s oral antiviral, which has now been granted full approval to treat mild-to-moderate COVID-19 in adults at a high risk for progression to severe disease, has been available in the US since December 2021 under the FDA’s accelerated approval pathway. The agency’s latest decision is supported by the totality of evidence submitted by Pfizer, the company said, including efficacy data from the phase 2/3 EPIC-HR study showing an 86% reduction in risk of COVID-19-related hospitalisation or death from any cause in patients who took Paxlovid within five days of symptom onset. The drugmaker said in a statement that at this time, the US government will continue to oversee the distribution of Paxlovid, and eligible ...
- Source: drugdu
- 105
- May 30, 2023
Pfizer oral weight loss drug may be as effective as Ozempic injection by Novo Nordisk, study says

An oral drug made by Pfizer causes a similar amount of weight loss as rival Novo Nordisk’s blockbuster injection Ozempic, according to a peer-reviewed study of phase 2 clinical trial results released Monday. The results were presented at a medical conference late last year, and did not compare Pfizer’s drug with Ozempic or other weight loss medications. JAMA Network only now is releasing a peer-reviewed study. Pfizer’s trial followed 411 adults with Type 2 diabetes who either took the company’s pill, danuglipron, twice a day or a placebo. Body weight was “statistically significantly reduced” after patients took either 120-milligram or 80-milligram versions of danuglipron for 16 weeks, the study found. Patients who took a 120-milligram version lost around 10 pounds on average over that time period, the study found. Pfizer’s drug could offer an advantage as an oral treatment option rather than a frequent injection. The study results also suggest ...
- Source: drugdu
- 148
- May 24, 2023
CureVac seeks to accelerate vaccine infringement case against Pfizer and BioNTech

Paul Schloesser Associate Editor CureVac is going on the offensive against Pfizer and BioNTech, saying that it will seek to accelerate its litigation around patents related to the manufacture of the Covid-19 vaccine Comirnaty. The German biotech company announced Friday that the case, which originally launched in the US last summer, has been transferred from the federal district court of Massachusetts to the eastern district court in Virginia as part of an effort to speed up the litigation, potentially allowing for a trial as soon as next year. On top of that transfer going through, CureVac filed a 94-page document Friday, filled with a broader counterclaims that say Pfizer and BioNTech infringed on nine of its US patents — eight of which it claims are owned by CureVac and the ninth by CureVac Manufacturing. These patents range from producing mRNA to vaccine design and manufacturing. CureVac first filed a lawsuit ...
- Source: drugdu
- 114
- May 23, 2023
Pfizer puts kibosh on 4 antibiotics in India after contractor’s manufacturing issues

Global drug giant Pfizer is warning physicians and clinicians in India to immediately stop using four of its antibiotics due to manufacturing issues at a contract producer.The warning covers Magnex, Zosyn, Magnamycin and Magnex Forte. All four products treat infections, with Zosyn used to target various infections caused by bacteria including stomach infections, skin infections, pneumonia, and severe uterine infections. Magnamycin injections and Magnex Forte are also used to treat bacterial infections. The company issued the warning because of “deviations” at a manufacturing facility operated by Astral Steritech Private Limited, according to a letter shared on Twitter by Dr. Sudhir Kumar, M.D., of Apollo Hospitals in Hyderabad. “Whilst the manufacturer is currently investigating the matter, they have requested Pfizer, as an abundant precautionary measure and as per best practices, to temporarily suspend the sale/distribution/supply and use of the aforementioned products, pending the investigation by the manufacturer,” the company said in ...
- Source: drugdu
- 115
- May 20, 2023
FDA advisors recommend Pfizer’s RSV vaccine for infants but raise safety concerns

The U.S. Food and Drug Administration’s independent panel of advisors Thursday recommended full approval of Pfizer’s vaccine that protects infants from respiratory syncytial virus, but raised safety concerns over premature births that may be tied to the shot. The committee unanimously said the vaccine efficacy data was sufficient. Ten of the advisors said the safety data on Pfizer’s shot was adequate, while four said it was not. “If the vaccine actually lives up to the data we’ve seen today, I can guarantee many infants and their parents will breathe easier in the coming years,” said Dr. Jay Portnoy, medical director at the Children’s Mercy Hospital in Kansas City, after voting in favor of the safety and efficacy of the shot. Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said he doesn’t believe there is enough data that indicates the safety of the vaccine is “reassuring.” “If ...
- Source: drugdu
- 113
- May 20, 2023
Pfizer to raise $31 billion in debt offering to fund Seagen acquisition, SEC filing shows

Pfizer plans to raise $31 billion through a debt offering to fund its proposed acquisition of cancer drug maker Seagen, for what would be its largest takeover since 2009, according to a new filing with the Securities and Exchange Commission. Pfizer expects to complete the $43 billion Seagen buyout later this year or in early 2024. The debt offering is expected to close Friday, according to a prospectus supplement New York-based Pfizer filed with the SEC late Tuesday. The pharma giant’s debt offering would be the biggest since CVS Health sold $40 billion of bonds in 2018 to finance its acquisition of health insurer Aetna. Pfizer’s move comes as other corporations including Apple, T-Mobile and Merck rush to tap the U.S. bond market ahead of a potential spike in borrowing costs sparked by the debt ceiling standoff. Pfizer’s stock price dropped slightly on Wednesday. The company said it will secure ...
- Source: drugdu
- 127
- May 19, 2023
Pfizer’s maternal RSV vaccine effective at preventing severe infections in newborns, FDA says, but flags potential risk of preterm birth

By Brenda Goodman, CNN CNN — Pfizer’s vaccine to protect newborns from respiratory syncytial virus, or RSV, by vaccinating their moms late in pregnancy cuts the risk that infants will need to see a doctor or be admitted to the hospital with a moderate to severe infection before 6 months of age, according to a new analysis by government regulators. Many parents have been eagerly anticipating this news, particularly after last year’s long and severe RSV season. RSV is a major cause of hospitalization in infants and the elderly each year, and it typically hits hardest during the winter months. Scientists have been working on an effective RSV for young children for roughly 60 years, so there’s plenty of excitement around the prospect of having a candidate get so close to the finish line. But the news isn’t all rosy. Safety data published in an agency analysis Tuesday also showed ...
- Source: drugdu
- 132
- May 18, 2023
Pfizer CEO says Medicare will likely face legal action over drug price negotiations

Pfizer CEO Albert Bourla on Thursday said pharmaceutical companies will likely take legal action against Medicare drug price negotiations, which aim to cut costs for older Americans, but will likely reduce company profits. “I think that there will be legal action, but I’m not sure if we’ll be able to stop anything before 2026 or not,” Bourla said during a live-streamed interview with Reuters. Bourla referred to a provision in the Biden administration’s Inflation Reduction Act that will allow the Medicare program to negotiate prices on the costliest prescription drugs each year. The first negotiations start in September and new prices will go into effect in 2026. He said the most “certain way” to stop negotiations would be to call on Congress to introduce legislation that will revise the federal government’s plan. But Bourla noted he is “not optimistic” about that happening. Democrats control the Senate and President Joe ...
- Source: drugdu
- 115
- May 13, 2023
Pfizer Acquires COVID-Flu Test Developer Lucira Health for USD 36.4 Million

By LabMedica International staff writers Pfizer Inc. (New York, NY, USA) has acquired Lucira Health, Inc. (Emeryville, CA, USA) for USD 36.4 million in a bankruptcy auction. Lucira filed for bankruptcy in February 2023, just two days before receiving FDA Emergency Use Authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test capable of differentiating and detecting influenza A and B. The COVID-19 & Flu Home Test is a single-use at-home test kit that delivers results from self-collected nasal swab samples in about 30 minutes. Lucira had previously received the first FDA EUA for an at-home rapid self-test, the Lucira COVID-19 All-in-One Test Kit, in November 2020, and the company announced in April 2021 that it had secured OTC EUA for its Lucira Check It test kit for SARS-CoV-2. The company’s tests use a handheld battery-powered real-time testing instrument with nasal swab samples and loop-mediated isothermal amplification to provide ...
- Source: drugdu
- 120
- May 5, 2023
Pfizer CEO’s texts with European Commission chief trigger new NYT lawsuit

Twenty-two months after European Commission President Ursula von der Leyen admitted to The New York Times that she negotiated a COVID-19 vaccine deal with Pfizer CEO Albert Bourla, Ph.D., through text messages, the newspaper is suing the commission over its refusal to make the texts public. While the lawsuit was filed on Jan. 25 and listed on the European Court of Justice’s public website Monday, Feb. 13, none of the documents related to the case are available to the public. Two people familiar with the suit confirmed it to Politico. The NYT argues that the EC is required legally to turn over the messages. Last year—in response to a public information request—the commission wrote that text messages do not need to be stored because they are treated as “short-lived ephemeral documents.” Reference: https://www.politico.eu/article/new-york-times-sue-european-union-ursula-von-der-leyen-pfizer-texts/
- Source: drugdu
- 139
- May 2, 2023

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