Search Results for “ Pfizer” – Page 6 – media

FDA Clears Pfizer’s Braftovi + Mektovi for Non-Small Cell Lung Cancer Treatment

Treatment indicated for patients with BRAF V600E-mutant metastatic form of disease. Image Credit: Adobe Stock Images/Tex vector Pfizer revealed that the FDA has approved Braftoni (encorafenib) + Mektovi (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. Previously, the medication was approved for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation. “Today’s approval builds on our long-standing commitment to deliver innovative, personalized medicines to patients with lung cancer. By pursuing precision medicines that target a patient’s specific type of cancer, we are leveraging our deep understanding of tumor biology to help address the underlying cause of disease,” said Chris Boshoff, MD, PhD, chief oncology research and development officer, EVP, Pfizer. “Since its initial FDA approval in 2018, Braftovi + Mektovi combination therapy has helped thousands of people living with BRAF V600E- or V600K-mutant ...
- Source: drugdu
- 108
- October 17, 2023
FDA quells Care Access misconduct concern in Pfizer’s Lyme disease vaccine trial

The US Food and Drug Administration (FDA) has found no misconduct by contract research organisation (CRO) Care Access in Pfizer and French partner Valneva’s Lyme disease vaccine trial. The FDA did not issue a Form 483 – a document sent to a company indicating violations after an inspection. The outcome comes after a nine-day for-cause FDA Good Clinical Practices (GCP) inspection into sites managed by Care Access in Pfizer’s VALOR trial. The inspection reviewed Care Access’s contributions to the trial, including GCP requirements, patient safety and data integrity, the CRO said in an 11 October statement. Care Access CEO Ahmad Namvargolian said in a company statement: “We’re very glad to have had the opportunity finally to undergo this independent, searching review by an FDA expert, which confirmed what we’ve always said about our performance on the VALOR trial and beyond.” In February 2023, Pfizer and Valneva announced it was halting ...
- Source: drugdu
- 206
- October 16, 2023
Pfizer inks another EpiPen antitrust settlement, this one worth $50M

Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief medicine.The lawsuit, which dates to 2020 and was brought in federal court in Kansas, was filed by direct purchaser plaintiffs who claimed Pfizer and its EpiPen marketing and distribution partner Mylan conspired with Teva to delay the entry of a generic version of EpiPen. The settlement was revealed in a court filing this week. The suit claimed Mylan agreed to delay entry of its generic version of Teva’s branded blockbuster drug Nuvigil in exchange for Teva delaying entry of its EpiPen generic. The direct purchasers claimed they paid more for EpiPen than they would have if Teva’s generic was on the market. Under a prior partnership with Mylan, a Pfizer subsidiary was responsible for manufacturing EpiPen ...
- Source: drugdu
- 124
- October 13, 2023
Pfizer restarts production at tornado-hit plant—but supply squeezes are expected to persist

In the aftermath of a devastating summer tornado at Pfizer’s Rocky Mount injectables plant in North Carolina, manufacturing has largely resumed. Still, the company expects supply shortfalls for some drugs produced at the plant to stretch into next year.The “majority” of the Rocky Mount facility’s manufacturing lines have restarted, Pfizer said in a Monday release. What’s more, Pfizer has launched an additional line in the site’s new sterile injectable manufacturing area, dubbed R3, the company added. The “expedited restart” comes ahead of Pfizer’s previously stated timeline. Late last month, Pfizer said it intended to restart manufacturing at the plant the fourth quarter of 2023. Pfizer is restarting production in phases, with full production across the site’s three manufacturing suites expected to come back online by the end of the year. The company has planned its production restarts based on patient need and inventory levels. There are roughly a dozen medicines ...
- Source: drugdu
- 204
- October 6, 2023
FDA approves Pfizer/BioNTech and Moderna’s adapted COVID-19 vaccines

The updated vaccines more closely target current circulating variants The US Food and Drug Administration (FDA) has granted approval for Pfizer/BioNTech and Moderna’s updated COVID-19 vaccines, to tackle currently circulating variants. As previously recommended by the FDA, both vaccines have been adapted to closely target the XBB.1.5. Omicron variant by including a monovalent component. Both companies’ mRNA vaccines are approved for use in individuals aged 12 years and older and authorised for emergency use in those aged six months to 11 years. The FDA has said that it is “confident in the safety and effectiveness” of the two updated vaccines and that its risk assessment demonstrated that the benefits of both vaccines for individuals aged six months and older outweighed the risks. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” said Peter Marks, director of the ...
- Source: drugdu
- 146
- September 20, 2023
Pfizer’s Vydura recommended by NICE for acute migraines

The treatment is the first oral GPCR receptor antagonist class recommended for NHS use The National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Vydura (rimegepant) as a cost-effective option for the treatment of acute migraines in adults. The recommendation marks Vydura as the first drug in the oral GPCR receptor antagonist class to be recommended for routine NHS use as treatment for the condition. Published in NICE’s draft guidance, Vydura is recommended for adults who have previously tried at least two triptant-based therapies that were ineffective, not tolerated, or contraindicated. It is also recommended after prior use of nonsteroidal anti-inflammatory drugs, such as ibruprofen and aspirin, and paracetamol didn’t work well enough. Triptants are a group of medicines used to treat a migraine or headache. The recommendation was based on clinical trial evidence, which showed that Vydura is more likely to reduce pain in patients within 2 ...
- Source: drugdu
- 130
- September 20, 2023
Moderna, Pfizer-BioNTech’s Updated COVID-19 Vaccines Approved by FDA

By Hayley Shasteen Pictured: Syringe drawing up vaccine/iStock, Diy13 The FDA approved two updated COVID-19 booster shots from Pfizer-BioNTech and Moderna Monday afternoon, just in time for the fall vaccination season. The reformulated mRNA vaccines are specifically tailored to provide protection against circulating Omicron-related variants, including subvariant XBB.1.5, which the FDA had recommended vaccines be updated to cover in June 2023. The CDC is anticipated to release its recommendation guidance on the boosters Tuesday. A positive endorsement by the agency could see boosters available at pharmacies and doctors’ offices by the end of the week, The New York Times reported. CDC Director Mandy Cohen is expected to recommend the updated vaccines and sign off on their use, having previously made remarks favoring an updated booster. The approval for both boosters covers individuals ages 12 years and up, with Emergency Use Authorization granted for individuals ages six months to 11 years. ...
- Source: drugdu
- 231
- September 13, 2023
Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines

Out with the old and in with the new: Monday, the U.S. FDA approved retooled mRNA shots against COVID-19 from Pfizer-BioNTech and Moderna, simultaneously bidding adieu to the companies’ bivalent shots in the U.S.The FDA has approved Pfizer-BioNTech and Moderna’s separate vaccine formulations that are more closely targeted to current variants of the disease, the agency said in a release. Specifically, each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old. The vaccines have been updated to include a monovalent component aimed at omicron variant XBB.1.5, according to the companies and the FDA. Meanwhile, Novavax’s revised shot is still pending regulatory approval. Moderna noted the COVID is “on the rise again” and warned of a “’tripledemic’” of COVID, flu and respiratory syncytial virus this winter and fall. Vaccines should remain “top of mind,” the company said. Following ...
- Source: drugdu
- 107
- September 13, 2023
Pfizer, BioNTech Challenge Moderna’s COVID-19 Patents with USPTO

By Tristan Manalac Pictured: Pfizer’s office in Belgium/iStock, Alexandros Michailidis Pfizer and German partner BioNTech on Monday asked the U.S. Patent and Trademark Office to reconsider, and ultimately invalidate, Moderna’s patents over core technologies of the COVID-19 vaccine, Reuters reported. In an 87-page document, the partner companies argued that the Moderna patents are “unimaginably broad” and seek to claim ownership of knowledge that had existed long before its asserted priority date of 2015. Pfizer and BioNTech contend that using injecting mRNA into cells to produce a protein—and in turn leveraging this process to produce vaccines that prime immune protection—had been demonstrated and documented in the scientific literature as early as the 1990s. Moderna’s patent claims over any mRNA sequence encoding any betacoronavirus spike protein or its subunit, as well as a lipid-based formulation for delivery, is an “attempt to coopt and entire field of mRNA technology,” Pfizer and BioNTech argued ...
- Source: drugdu
- 110
- September 1, 2023
Pfizer telegraphs 4th-quarter production restart at North Carolina plant damaged by tornado

With many medicines from Pfizer’s Rocky Mount, North Carolina, production plant relegated to an emergency ordering list following a devastating tornado last month, hospitals and government health officials are likely eager for the massive injectables facility to restart production. Now, Pfizer has clarified the timeline by which it expects manufacturing to resume. “There are many sequential steps and variables to restart operations and Pfizer is making significant progress,” the company said Monday. The company signaled (PDF) its intention to restart manufacturing at Rocky Mount by the fourth quarter of 2023. After the tornado struck the plant July 19, Pfizer says it reopened parts of the facility Aug. 7. Current efforts to resume production remain “on track,” the company said, with several functions—such as packaging and quality laboratories—now operational. To help with product storage, Pfizer has also locked down a temporary warehouse location and received a certificate of occupancy. The tornado ...
- Source: drugdu
- 120
- August 30, 2023

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