Pharmaceutical Technology

JULY 26, 2024

Mankind Pharma has announced a definitive agreement for the acquisition of Bharat Serums and Vaccines (BSV) for Rs136.3bn ($1.6bn).

Vaccines 59

Vaccines 59

pharmaphorum

FEBRUARY 11, 2021

AstraZeneca is aiming to get a next-generation vaccine targeting emerging variants approved and into the arms of patients by the autumn, company representatives said in a press conference. While the vaccine is approved in Europe, the UK and several other countries, FDA approval hangs on a study in the US.

Vaccines 78

Vaccines FDA 78

Pharmaceutical Technology

APRIL 17, 2023

Health Canada has accepted Pfizer Canada’s new drug submission for a bivalent respiratory syncytial virus (RSV) vaccine for review. The vaccine will be used to prevent lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in adults aged 60 and above.

Vaccines 64

Vaccines FDA 64

pharmaphorum

FEBRUARY 10, 2021

This is the industry’s definitive conference specifically dedicated to advancing the development of both monotherapy and combinatorial therapies to improve the current standard of care for patients with TNBC.

Immunization 133

Immunization Vaccines 133

Hospital Pharmacy Europe

JANUARY 26, 2023

The press release relates to the ConquerRSV trial which was a randomised, double-blind trial, designed to evaluate the safety and tolerability of the mRNA-1345 vaccine. The study’s primary efficacy endpoints were based on two definitions of RSV-lower respiratory tract disease with either two or three or more symptoms.

Adverse Reactions 98

Adverse Reactions Vaccines Hospitals 98

Hospital Pharmacy Europe

FEBRUARY 28, 2023

But after widespread vaccination against the virus, uncertainty remained over whether the drug would still offer benefit to at-risk and vaccinated patients, remained unanswered. The results clearly showed that lagevrio failed to reduce the frequency of COVID associated hospitalisations or deaths in high-risk, vaccinated individuals.

Vaccines 98

Vaccines Hospitals 98

pharmaphorum

JANUARY 5, 2023

have announced they have entered into a definitive agreement for Moderna to acquire OriCiro at a cost of $85 million. Most recently, of course, Moderna developed one of the earliest vaccines against the COVID-19 pandemic to be authorised and approved. Biotech Moderna, Inc. and OriCiro Genomics K.K.

Vaccines 97

Vaccines Immunization 97

The Checkup by Singlecare

SEPTEMBER 17, 2024

Dupixent works by moderating the immune system—and that can interfere with how your body responds to certain vaccinations. Here’s why, along with which vaccines you can get and what to do if you’re on Dupixent and need a live vaccine. Can you get vaccinated while taking Dupixent? But so far, the evidence is positive.

Vaccines 52

Vaccines Immunization Adverse Reactions FDA 52

Hospital Pharmacy Europe

OCTOBER 2, 2024

Pharmacist Dr João Gonçalves PhD considers the real-world evidence of a recent study demonstrating the feasibility and efficacy of a personalised peptide vaccine for glioblastoma – one of the most malignant primary brain tumours in adults.

Vaccines 52

Vaccines Immunization Chemotherapy Hospitals 52

STAT

APRIL 5, 2024

If it is true that spring has sprung — and we are still awaiting definitive evidence — you might want to enjoy the great outdoors and watch the trees and flowers slowly come to life. The rotation will likely include this , this , this , this and this. And what about you?

Vaccines 102

Vaccines Immunization 102

European Pharmaceutical Review

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

Packaging 105

Packaging Vaccines Documentation FDA 105

Hospital Pharmacy Europe

DECEMBER 18, 2022

Vaccination against COVID-19 appears to provide a small but significant protection against the development of post-COVID-19 condition. Nevertheless, real-world evidence suggests that some vaccines, such as BNT162b2, have an effectiveness comparable to that reported in phase III clinical trials.

Vaccines 52

Vaccines Hospitals 52

The Infectious Pharmacist

MAY 19, 2021

Many of my friends are concerned about starting “normal activities” after vaccination, the possibility of breakthrough infections, and the recent CDC guidance that fully vaccinated persons can go “maskless” in most situations. What is a person’s risk of COVID-19 infection if they have been fully vaccinated? First, a definition.

Vaccines 52

Vaccines Hospitals Immunization FDA 52

Digital Pharmacist

AUGUST 8, 2023

In this blog, we will explore what pharmacies should know about the recent surge in COVID-19, the co-occurrence of Flu and RSV, and the significance of vaccinations and testing in controlling these infections. Vaccinating For Respiratory Viruses in 2023 Vaccination remains the most potent tool in combating severe illness from these viruses.

Vaccines 93

Vaccines HIPAA Communication Hospitals 93

pharmaphorum

SEPTEMBER 8, 2021

The UK should think twice before backing widespread use of COVID-19 booster vaccinations, as to do so could place unnecessary burden on the NHS over the winter, according to AstraZeneca chief executive Pascal Soriot. It has already said that at-risk people, such as those with weakened immune systems, will be in line for a third dose.

Vaccines 83

Vaccines Immunization Hospitals 83

European Pharmaceutical Review

OCTOBER 17, 2022

Sanofi has signed definitive agreements with Adragos Pharmaceutical, a German contract development and manufacturing organisation (CDMO), for the sale of its pharmaceutical manufacturing site in Kawagoe, Japan. The French pharmaceutical company will also enter into a long-term supply agreement with the CDMO.

Packaging 104

Packaging Pharmaceutical Companies Pharmaceutical Companies Vaccines 104

Pharmafile

DECEMBER 12, 2023

AstraZeneca has announced that it has entered into a definitive agreement to acquire Icosavax for approximately $15 per share or an approximate total value of $1.1bn.

Immunization 59

Immunization Vaccines 59

pharmaphorum

AUGUST 23, 2022

With COVID-19 vaccines and therapeutics developed in rapid time, Ben Hargreaves investigates why this has not been the case with the creation of a treatment for Long COVID. Once the scale of the threat was understood, the pharmaceutical industry reacted with a rapidity and agility that allowed vaccines to be developed at a record rate.

Vaccines 134

Vaccines Immunization FDA 134

The Infectious Pharmacist

AUGUST 19, 2021

At the bottom of each part in this series you will find a link to some background posts that may be helpful, as well as a list of definitions. It does not merely refer to additional doses of a vaccine, but rather a booster dose refers to a dose with specific effects that is given after a “primary series” of a vaccine.

Immunization 52

Immunization Vaccines Hospitals FDA 52

The Infectious Pharmacist

AUGUST 21, 2021

Pfizer vs. Moderna and a note on vaccine dosing and timing. You probably have read news reports about a preprint article stating that the Moderna vaccine appeared more effective than the Pfizer vaccine, at least several months after vaccination. Should I stick with the same mRNA vaccine I got for the first two doses?

Vaccines 52

Vaccines Immunization Adverse Reactions Hospitals 52

PharmaShots

MAY 24, 2023

The combined company will operate under the name “TuHURA Biosciences, Inc” & will trade on Nasdaq, advancing a personalized cancer vaccine platform & preclinical tumor microenvironment modulator The P-II/III study of IFx-Hu2.0 is expected to initiate in 2024.

Vaccines 40

Vaccines 40

The Infectious Pharmacist

AUGUST 20, 2021

At the bottom of this post is a list of some background posts and definitions that may be useful. The vaccines are still highly effective. Vaccinated people are still very unlikely to have severe disease from COVID-19. Vaccinated people are still very unlikely to have severe disease from COVID-19. Why is that?

Vaccines 52

Vaccines Immunization Nursing Homes Hospitals 52

The FDA Law Blog

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. What is noteworthy about this proposed definition is that it adds a new requirement that “[a] manufacturer must make data available to CMS to support its finding.”

Labelling 59

Labelling Vaccines FDA Immunization 59

pharmaphorum

NOVEMBER 26, 2021

of their value after the announcement, while Pfizer – already making big profits from its BioNTech-partnered COVID-19 vaccine – rose almost 6%. Shares in Merck lost 3.5% The timing of the MOVE-OUT update also comes just a couple of working days before molnupiravir is due to come in front of an FDA advisory committee.

FDA 98

FDA Hospitals Vaccines 98

pharmaphorum

MAY 27, 2021

This is definitely a time for the life sciences industry to be proud of our accomplishments. The way in which the industry came together to support the development of the COVID-19 vaccines has shown that it is equally important to determine how to apply the lessons of the last year to the future. We need to be prepared to do it again.

Vaccines 119

Vaccines 119

Pharma Tutor

NOVEMBER 19, 2021

He said that our definition of wellness is not limited by physical boundaries. We have also exported more than 65 million doses of COVID vaccines to nearly 100 countries this year. We have exported life-saving medicines and medical equipment to over 150 countries during the initial phase of the pandemic. Fri, 11/19/2021 - 16:19.

Vaccines 52

Vaccines 52

ISPE

NOVEMBER 2, 2022

He shared Pfizer’s approach to reinventing to be able to develop medicines and vaccines faster, an approach that is helping pave the way to future development. Pfizer “cleared runway to allow for large-scale vaccine manufacturing before we had a product!” while clinical trials were still underway, he said.

Vaccines 98

Vaccines Pharmaceutical Companies Pharmaceutical Companies Hospitals 98

pharmaphorum

JANUARY 27, 2023

“We’ve almost got an opportunity to take it to the next level now, because we saw this with the collaboration with the COVID vaccine development and roll-out of the vaccination programme. What I’ve seen with patient centricity over the last few years is really a broadening of the definition,” Dr Mullen explained.

Pharmaceutical Companies 111

Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 111

IDStewardship

MAY 12, 2023

Not too say it is as dramatic as the latter part of that statement, but it is a definite narrowing. For example in infectious diseases we have things like tropical medicine, travel vaccines, microbiology breakpoints, immunocompromised hosts, infection prevention, and regulatory requirements.

Communication 130

Communication Documentation Vaccines 130

Pharmaceutical Technology

AUGUST 9, 2022

Life science group Sartorius has signed a definitive agreement for the acquisition of complete outstanding shares of UK-based company Albumedix from private investors in a deal valued at nearly $501.5m (£415m). Sartorius will carry out the takeover through its French-listed subgroup Sartorius Stedim Biotech.

Vaccines 52

Vaccines 52

pharmaphorum

AUGUST 16, 2022

Following the success of LNP-mRNA vaccines, we have seen an influx of novel types of lipids based nanocarriers over the last 12 months, progress has been made to minimize immuno-toxicity challenges – from maximizing therapeutic window to fine-tuning the immune response. .

Immunization 52

Immunization Vaccines 52

pharmaphorum

APRIL 11, 2022

Medicines and vaccines are among the most powerful interventions that can help improve quality of life for people across the world. The answer to this question comes back to our definition of value. And it all fuels the debate: are medicines a cost or an investment?

Pharmaceutical Companies 115

Pharmaceutical Companies Pharmaceutical Companies Vaccines Packaging 115

pharmaphorum

JANUARY 27, 2022

The global nanopharmaceutical drugs market, catalyzed by the success of Pfizer/BioNTech and Moderna’s mRNA vaccines, is poised to reach US$82.7 With expert advice from Pfizer, Moderna, Ultragenyx, Sanofi and other leading organizations, this industry-focused summit is your definitive meeting in 2022. billion by 2027.

Vaccines 52

Vaccines 52

European Pharmaceutical Review

SEPTEMBER 29, 2023

For instance, there is no definition in the proposed Directive of when a medicinal product is to be considered launched. Neither proposal includes a definition of what constitutes unmet medical need. However, Article 81.2 The European Commission has evidently expended significant effort in developing the proposals.

Communication 98

Communication Hospitals Vaccines 98

pharmaphorum

APRIL 28, 2022

The recent success of the mRNA-LNP vaccines fueled biopharma to explore lipid-based nanoparticles for advanced drug delivery. The Next Generation Lipid-Based Nanoparticles Delivery Summit is your definitive industry-led meeting to design and engineer 2nd generation of lipid nanoparticles for emerging payloads beyond RNA into clinic.

Vaccines 52

Vaccines 52

The Infectious Pharmacist

APRIL 6, 2021

Pfizer sent out a press release on March 31 with results from a small study of their mRNA vaccine in patients 12 through 15 years of age. The study enrolled about 2,200 patients with half getting the mRNA vaccine and half getting placebo. What about the Moderna vaccine? What about the vaccines in kids younger than 12 years old?

Vaccines 52

Vaccines Pharmaceutical Companies Pharmaceutical Companies Communication 52

The Checkup by Singlecare

MAY 16, 2024

You should not get live vaccines during treatment with Remicade, and other vaccines may be less effective. The FDA has placed boxed warnings on Remicade’s drug label , calling attention to the risk of serious infections, like tuberculosis and fungal infections. There’s also a risk of cancer, like lymphoma, in children.

FDA 98

FDA Immunization Labelling Vaccines 98