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Tag: vaccines


Clinical Trials, Research and Development

3 ways decentralized clinical trials could help advance research on rare diseases

November 13, 2023

Via: Biopharma Dive

Pandemic-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 […]


Industry, Vaccines

Childhood Vaccine Exemptons Hit Highest Level Yet: CDC

November 10, 2023

Via: Drugs.com

In 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 […]


Industry, Vaccines

FDA Approves First Vaccine for Chikungunya Virus, Ixchiq

November 10, 2023

Via: Drugs.com

The 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 […]


FDA, Regulations

New Biologic Treatment for Hidradenitis Suppurativa Receives FDA Approval

November 3, 2023

Via: Biopharm International

On 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), […]


Industry, Vaccines

Moderna adjusts to changing outlook for COVID vaccine demand

November 3, 2023

Via: Biopharma Dive

Waning 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 […]


News

Merck KGaA and Hengrui Pharmaceuticals announce oncology partnership worth over €1.4bn

October 31, 2023

Via: PMLiVE

The 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 […]


Industry, Vaccines

FDA Approves Vaccine for Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents

October 30, 2023

Via: Biopharm International

On 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 […]


Industry, Vaccines

A New Era of Vaccines Leaves Old Questions About Prices Unanswered

October 27, 2023

Via: Kaiser Health News

The 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 […]


Industry, Vaccines

University of Oxford launches new trial to enhance flu and COVID-19 vaccines

October 27, 2023

Via: PMLiVE

Funded 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 […]


Industry, Vaccines

FDA Finalizes Guidance on Development of COVID-19 Vaccines

October 24, 2023

Via: Biopharm International

FDA 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 […]


Industry, Vaccines

Pandemic Didn’t Lower Parents’ Trust in Childhood Vaccines

October 23, 2023

Via: Drugs.com

Lots 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 […]


Industry, Vaccines

Pfizer wins FDA approval of new meningococcal vaccine

October 23, 2023

Via: Biopharma Dive

Two 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 […]


Pricing, Regulations

Biden Pick to Lead NIH Finally Has Her Day, but Still Gets Caught Up in Drug Price Debate

October 19, 2023

Via: Kaiser Health News

A 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 […]


Industry, Vaccines

‘Project NextGen’ picks new mRNA, intranasal COVID vaccines for funding

October 13, 2023

Via: Biopharma Dive

The 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 […]


News

Trump Misplaced Blame When He Said Drug Shortages Were Biden’s Fault

October 6, 2023

Via: Kaiser Health News

In 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 […]


Industry, Vaccines

2023 Nobel Prize in Medicine Awarded for Development of mRNA Vaccines Against COVID-19

October 4, 2023

Via: Biopharm International

On 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 […]


Industry, Vaccines

FDA Authorizes Updated Novavax COVID-19 Vaccine

October 4, 2023

Via: Drugs.com

Federal 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 […]


Industry, Vaccines

Inside Bavarian Nordic’s late-stage stumbles — and drive to become a vaccine giant

September 27, 2023

Via: Biopharma Dive

Riding 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 […]


Industry, Vaccines

Many Americans Frustrated in Search for Low-Cost COVID Boosters

September 22, 2023

Via: Drugs.com

Americans 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

Alexion Completes Purchase and License Agreement of Rare Disease Gene Therapy Portfolio from Pfizer

September 21, 2023

Via: Biopharm International

On 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 […]