Search Results for “ Pfizer” – Page 2 – media

FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma

Regeneron Pharmaceuticals said the FDA cited no approvability concerns for its multiple myeloma drug, linvoseltamab, other than previously identified issues with a contract manufacturer. While linvoseltamab trails bispecific antibodies currently marketed by Johnson & Johnson and Pfizer, if approved, it could bring patients an earlier treatment option. By Frank Vinluan on August 21, 2024 Regeneron Pharmaceuticals already lags companies that have launched new multiple myeloma drugs, and it will have to wait a little bit longer to join them. The FDA turned down Regeneron’s application for its drug candidate, but not for any issues with the therapy itself. The regulator cited problems with the treatment’s third party manufacturer. The FDA rejection for the drug, linvoseltamab, is not a surprise. Regeneron foreshadowed that decision earlier this month during its conference call to discuss second quarter 2024 financial results, disclosing that that the FDA flagged unresolved findings with the contract manufacturer. Those problems centered on another company’s ...
- Source: drugdu
- 76
- August 23, 2024
Pfizer and BioNTech’s Covid-19/flu combination vaccine falters in Phase III readout

Pfizer and BioNTech have announced that a Phase III trial studying their investigational combination mRNA vaccine for the treatment of influenza and Covid-19 has failed to meet one of its two primary endpoints. While the vaccine demonstrated a trend of higher responses in neutralising the influenza A strain compared to a licensed influenza vaccine, it failed to demonstrate non-inferiority against the influenza B strain in geometric mean titers (GMT) and seroconversion, as per a 16 August press release. Additionally, data indicated that the combination vaccine showed “comparable” responses for SARS-CoV-2 when compared to Pfizer’s licensed approved Covid-19 vaccine, Comirnaty (tozinameran). The randomised, parallel assignment Phase III study (NCT06178991) enrolled over 8,000 adults aged 18 to 64 years old to evaluate the safety, tolerability, and immunogenicity of a single dose of the combined vaccine for protection against influenza and Covid-19. No new safety signals were found in the Phase III study. ...
- Source: drugdu
- 69
- August 20, 2024
Pfizer’s RSV vaccine shows benefit in immuno-compromised adults in study

Pfizer said on Monday its respiratory syncytial virus (RSV) vaccine Abrysvo generated a strong immune response in a late-stage study of four groups of adults aged 18 and older with a compromised immune system. A single 120 microgram dose of the vaccine generated strong neutralising antibodies against both subtypes of RSV, called RSV-A and RSV-B, across all groups in the study, Pfizer said. Abrysvo was well-tolerated in the study and showed a safety profile consistent with findings from other studies of the vaccine, it added. The drugmaker plans to submit the data to regulatory agencies for review. The study tested two doses of Abrysvo in 203 adults across four groups – those with a type of lung cancer, end-stage kidney disease, autoimmune inflammatory disorder, and solid organ transplant recipients – all of whom have compromised immunity and are at risk of developing severe RSV-associated disease. Pfizer’s vaccine is currently approved ...
- Source: drugdu
- 99
- August 19, 2024
Pfizer touts positive topline data for RSV vaccine Abrysvo

Pfizer has announced positive topline results from a pivotal late-stage study of its respiratory syncytial virus (RSV) vaccine, Abrysvo, in adults who are immunocompromised and at risk of developing severe RSV-associated lower respiratory tract disease (LRTD). As per the 12 August press release, Abrysvo was found to be well tolerated in the substudy B portion of the pivotal Phase III MONeT study (NCT05842967). While substudy B evaluated two 120 µg dose doses of Abrysvo, Pfizer reported that a single 120 µg dose of the vaccine led to “strong neutralizing” responses against RSV-A and RSV-B. The safety profile of Abrysvo was consistent with that of previous studies. “Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the U.S.,” said senior vice president and CSO, Vaccine ...
- Source: drugdu
- 74
- August 14, 2024
FDA Approval of Alopecia Drug Positions Sun Pharma to Compete With Eli Lilly, Pfizer

Leqselvi is now FDA approved for treating severe alopecia areata. Sun Pharma added the oral drug to its pipeline via the $576 million acquisition of Concert Pharmaceuticals last year. By Frank Vinluan Hair loss caused by alopecia areata now has a new FDA-approved treatment, a third-in-class drug from Sun Pharmaceutical Industries that will compete against commercialized medicines from Eli Lilly and Pfizer. The regulatory decision announced Friday for the drug, deuruxolitinib, covers the treatment of adults with severe alopecia areata. Mumbai, India-based Sun Pharma, which has U.S. operations in Princeton, New Jersey, will market the twice-daily pill under the brand name Leqselvi. Alopecia areata is a condition in which the immune system attacks hair follicles, causing sudden hair loss. The disorder affects both males and females. While the hair loss mainly happens on the scalp, the condition can affect other parts of the body. Sun Pharma cites studies estimating that 700,000 ...
- Source: drugdu
- 126
- July 30, 2024
Pfizer Hemophilia Gene Therapy Meets Phase 3 Goals, But Its Success Matters More to Sangamo

Pfizer’s hemophilia A gene therapy reduced annualized bleeding rates in a Phase 3 clinical trial, setting the stage for discussions with regulators. However, the market for such one-time treatments is uncertain, as uptake of commercialized hemophilia gene therapies remains slow. By Frank Vinluan A Pfizer gene therapy for hemophilia A reduced bleeding rates in patients with the inherited blood disorder, meeting goals of its Phase 3 study. The preliminary results announced Wednesday are measures taken at 15 months in a study that will follow patients for up to five years, meaning the one-time treatment’s durability remains an open question. The pharmaceutical giant now plans to meet with regulators to discuss next steps for the therapy. In hemophilia A, insufficient levels of a clotting protein called factor VIII make patients susceptible to frequent bleeding events. Treatment includes regular infusions of this clotting protein to prevent these events. The Pfizer gene therapy, giroctocogene fitelparvovec, delivers ...
- Source: https://medcitynews.com/author/fvinluan/
- 114
- July 27, 2024
Pfizer investigational gene therapy for DMD fails in Phase 3 study

Pfizer announced that CIFFREO, a Phase 3 global, multicentre, randomised, double-blind, placebo-controlled study evaluating the investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD) did not meet its primary endpoint of improvement in motor function among boys 4 to 7 years of age treated with the gene therapy compared to placebo. The primary endpoint in the final analysis was assessed by change in the North Star Ambulatory Assessment (NSAA) a year after treatment. Key secondary endpoints, including 10-metre run/walk velocity and time to rise from floor velocity, also did not show a significant difference between participants treated with fordadistrogene movaparvovec and placebo. The overall safety profile of fordadistrogene movaparvovec in the CIFFREO trial was manageable, with mostly mild to moderate adverse events, and treatment-related serious adverse events generally responding to clinical management. Pfizer will continue to closely monitor all participants enrolled in the study and ...
- Source: drugdu
- 123
- June 15, 2024
Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B

The FDA has approved Beqvez, a Pfizer gene therapy developed for moderate-to-severe hemophilia B. The one-time treatment carries a $3.5 million price tag, the same as a CSL Behring gene therapy already available for treating the inherited bleeding disorder. By Frank Vinluan Pfizer’s first FDA-approved gene therapy is the second such treatment for the inherited bleeding disorder hemophilia B, introducing some competition to a therapeutic area that now has two of the most expensive medicines in the world. The FDA approval announced Friday covers the treatment of adults with moderate-to-severe hemophilia B. Known in development as fidanacogene elaparvovec, the Pfizer therapy will be marketed under the brand name Beqvez. The company expects this therapy will become available to patients later in the current quarter. Hemophilias stem from genetic mutations that lead to abnormally low levels of clotting proteins. These disorders mainly affect males and make patients susceptible to bleeding events ...
- Source: drugdu
- 73
- May 2, 2024
FDA Approves Pfizer’s Beqvez for the Treatment of Adults with Moderate to Severe Hemophilia B

Don Tracy, Associate Editor Beqvez, a one-time gene therapy, offers hope to patients with moderate to severe hemophilia B who use regular factor IX prophylaxis, suffer severe hemorrhages, or recurrent serious bleeding.Pfizer announced that the FDA has approved Beqvez (fidanacogene elaparvovec-dzkt) as a one-time gene therapy for adults with moderate to severe hemophilia B. The therapy is indicated for patients who currently use factor IX (FIX) prophylaxis therapy, have a history of severe hemorrhage, or experience frequent serious bleeding with no neutralizing antibodies to the adeno-associated virus serotype. In clinical trials, Beqvez was found to help patients to produce their own FIX, lowering the need for regular intravenous (IV) infusions. The approval was based on promising data from the Phase III open-label, single-arm BENEGENE-2 trial, which evaluated the efficacy and safety of Beqvez in 45 males aged 18 to 65 years with moderately severe to severe hemophilia B. All participants ...
- Source: drugdu
- 84
- May 1, 2024
Pfizer scores FDA nod for hemophilia B gene therapy, will charge $3.5M per dose

Pfizer will offer a warranty program for its first FDA-approved gene therapy. The hemophilia B treatment will go for $3.5M, matching the price tag on CSL and uniQure’s hemophilia B gene therapy Hemgenix. (Pfizer) Ten years after dipping its toes into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained FDA approval for the acquired treatment. The U.S. regulator has endorsed Beqvez (fidanacogene elaparvovec-dzkt) for adults with the bleeding disorder hemophilia B. It becomes the first FDA-approved gene therapy for Pfizer and the second in the indication following CSL and uniQure’s hemophilia B treatment Hemgenix, which became the world’s most expensive drug at $3.5 million when it was approved in 2022. Pfizer had the chance to undercut its rival on price but decided to charge the same $3.5 million for Beqvez. The therapy will be available to patients this quarter, a spokesperson confirmed on Friday ...
- Source: drugdu
- 86
- April 30, 2024

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