Clinical Trials, Research and Development
November 13, 2023
Via: Biopharma DivePandemic-era changes may have permanently altered the clinical trial landscape as decentralized clinical trials gain broader acceptance. During COVID-19, more than three-quarters (76%) of pharmaceutical companies, device manufacturers and contract research organizations conducted off-site clinical trials. These types of trials […]
November 10, 2023
Via: Drugs.comIn a sign that suggests many American parents have become dubious about the safety of childhood vaccines, new government data shows that immunization exemptions for kindergartners have reached their highest levels ever. The latest statistics continue a decline in routine […]
November 10, 2023
Via: Drugs.comThe first vaccine to prevent infection with the chikungunya virus was approved by the U.S. Food and Drug Administration on Thursday. The single-dose shot, known as Ixchiq, is approved for adults who are at increased risk of exposure to the […]
November 3, 2023
Via: Biopharm InternationalOn Oct 31, 2023, Novartis announced FDA’s approval of Cosentyx (secukinumab) as a treatment for adults with moderate to severe hidradenitis suppurativa (HS). As reported by Novartis, Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL17A), […]
November 3, 2023
Via: Biopharma DiveWaning demand for COVID vaccines has hit Moderna and Pfizer, which were previously earning tens of billions of dollars from their competing shots. Last month, Pfizer cut its financial guidance and revealed plans to lay off staff. Moderna’s vaccine sales […]
October 31, 2023
Via: PMLiVEThe deal also includes an option for an exclusive licence for its Claudin-18.2 antibody drug conjugate (ADC), SHR-A1904. Compared to first-generation PARP inhibitors, HRS-1167 has higher selectivity and affinity for PARP1 and induces DNA trapping, Merck said, adding that the […]
October 30, 2023
Via: Biopharm InternationalOn Oct. 20, 2023 Pfizer announced that PENBRAYA, its vaccine for meningococcal groups A, B, C, W, and Y, has been approved by FDA. According to Pfizer, PENBRAYA is the first and only vaccine to protect against the five most […]
October 27, 2023
Via: Kaiser Health NewsThe world is entering a new era of vaccines. Following the success of covid-19 mRNA shots, scientists have a far greater capacity to tailor shots to a virus’s structure, putting a host of new vaccines on the horizon. The most […]
October 27, 2023
Via: PMLiVEFunded by the Medical Research Council part of UK Research and Innovation, the LEGACY03 trial will contribute to future vaccine designs to enhance protection for those most vulnerable to diseases. As the immune systems changes with age, the body’s response […]
October 24, 2023
Via: Biopharm InternationalFDA announced on Oct. 19, 2023 that it had issued the final guidance, Development and Licensure of Vaccines to Prevent COVID-19, to help sponsors with the clinical development and licensure of COVID-19 vaccines. The document does not address every consideration […]
October 23, 2023
Via: Drugs.comLots of vaccine disinformation spread during the pandemic, and doctors worried that may have given some parents pause about not only the risks of the COVID shot, but of childhood vaccines as well. Now, new research puts that worry to […]
October 23, 2023
Via: Biopharma DiveTwo types of meningococcal vaccines are already available in the U.S. Some protect against serogroups A,C, W and Y, while other shots, like Trumenba, protect against serogroup B. The Centers for Disease Control and Prevention recommends children aged 11 or […]
October 19, 2023
Via: Kaiser Health NewsA Senate committee finally held a hearing Wednesday on President Joe Biden’s pick to lead the National Institutes of Health. But the panel’s chair, Sen. Bernie Sanders (I-Vt.), was focused on drug prices — an issue over which the NIH […]
October 13, 2023
Via: Biopharma DiveThe U.S. government announced Friday the selection of three “next generation” COVID-19 vaccine candidates, awarding millions of dollars to support mid-stage clinical trials of the shots as part of the Project NextGen initiative. Launched in May by the Department of […]
October 6, 2023
Via: Kaiser Health NewsIn a recent campaign video, former President Donald Trump blasted President Joe Biden for “a catastrophic increase” in drug shortages. “It’s a mess,” Trump said in the video, adding that new drug shortages were up last year by 30%, with […]
October 4, 2023
Via: Biopharm InternationalOn Oct. 2, 2023, The Nobel Prize in Physiology or Medicine was awarded jointly to Katalin Karikó and Drew Weissman for their work on nucleoside base modifications that allowed the development of effective messenger RNA (mRNA) vaccines against COVID-19. The […]
October 4, 2023
Via: Drugs.comFederal regulators on Tuesday gave the go-ahead to an updated Novavax COVID vaccine, giving Americans a more traditional alternative to two recently revamped mRNA vaccines. Adolescents and adults who have previously received a COVID vaccine, but who haven’t gotten the […]
September 27, 2023
Via: Biopharma DiveRiding high from sales of an mpox vaccine, Bavarian Nordic began 2023 with one major goal in mind: becoming one of the largest pure-play vaccine manufacturers in the world. While the Danish biotechnology company has worked on vaccines since its […]
September 22, 2023
Via: Drugs.comAmericans seeking out the new COVID boosters are finding themselves held back by insurance entanglements and supply delays. Some insurers have balked at covering the vaccines, with people arriving at shot appointments only to be told that they’ll have to […]
Cell and Gene Therapy, Industry
September 21, 2023
Via: Biopharm InternationalOn Sept. 20, 2023, Alexion, AstraZeneca’s rare disease group, completed the purchase and license agreement for a portfolio of preclinical rare disease gene therapy programs and enabling technologies from Pfizer. The acquisition cost AstraZeneca up to $1 billion, with the […]