The Pharma Data

NOVEMBER 12, 2020

12, 2020 — Early COVID-19 vaccine BNT162b2 trial results announced by Pfizer this week caused hopes to soar for a swift end to the pandemic that has killed more than 242,000 and infected more than 10 million in the United States alone. The cases are getting to the point where they are inundating hospitals in some states.

Vaccine 52

Vaccine Hospitals Virus Doctors 52

The Pharma Data

JANUARY 12, 2021

Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. “Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics.

Government 52

Government Hospitals Virus Clinical Trials 52

The Pharma Data

NOVEMBER 20, 2020

Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. . “The Yancopoulos, M.D.,

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

MAY 27, 2022

It is our goal to ensure that hospitals, specialty pharmacies, and retail store shelves will begin seeing adequate supplies again in the coming weeks.”. “We continue to work closely with our U.S. About 500,000 additional cans of specialized medical formula manufactured by Danone’s Nutricia business will be headed to the U.S.

FDA 52

FDA Specialty Pharmacies Pharmacy Production 52

Drug Channels

OCTOBER 19, 2020

Channel Strategy for First Medical Product – A Look at Channel Considerations for Pharmacy vs. Medical Plus – Tailored Track Options Based on Company Size : Emerging/Small Companies – Infrastructure Set-Up, License Procurement and 3PL Contracting Mid-Large Companies – How Do I Think About My Portfolio Differently Based on Product Type?

Specialty Pharmacies 52

Specialty Pharmacies Science Pharmacy Licensing 52

Drug Channels

NOVEMBER 8, 2020

Cannot be combined with special category rates, clinic/hospital rates, non-profit rates or other offers. Stuart Parker, Senior Director, Trade Relations, Mayne Pharma And more! Informa-Connect CBI will see you there! Cannot be combined with other offers or used towards a current registration. Other restrictions may apply.

Specialty Pharmacies 52

Specialty Pharmacies Science Pharmacy Pharmaceuticals 52

The Pharma Data

NOVEMBER 21, 2020

Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. . Yancopoulos , M.D.,

FDA 40

FDA Clinical Trials Hospitals Production 40

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. 1396r-8(k)(3).

Drugs 59

Drugs Regulations International Production 59

Drug Channels

OCTOBER 10, 2023

reviews the evolving specialty pharmacy industry and discusses emerging challenges from direct distribution models that bypass wholesale distribution. We provide updated, expanded, and reorganized data about the following markets: Pharmacy services administrative organizations (Section 2.2.4.) and Section 6.4.3. A new Section 6.2.2.

Pharmaceuticals 40

Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars 40

Drug Channels

JUNE 27, 2021

As you declare your vaccinated independence, celebrate with these Drug Channels fireworks: Amazon’s teeny step toward pharmacy disruption How patients view copay accumulators My $0.02 on generic and biosimilar trends Some hospitals seem to be gaming their 340B eligibility Plus, tips on effective hospital marketing.

Biosimilars 52

Biosimilars Hospitals Pharmacy Drugs 52

Drug Channels

OCTOBER 13, 2020

Three new sections address COVID-19 and its impact on wholesalers, including the potential financial effects on wholesalers of widespread distribution of one or more COVID-19 vaccines. If you would like to pay by corporate purchase order or check, please email Tamra Feldman.

Pharmaceuticals 40

Pharmaceuticals Licensing Licensing Pharmacy 40

Agency IQ

JULY 12, 2024

This process eventually resulted in a final list of eleven medicines: alteplase, amoxicillin, amoxicillin/clavulanic acid, benzathine benzylpenicillin, clonazepam, fludarabine, glucagon, hepatitis B vaccine, rifampicin, verteporfin and vincristine. The report notes that these products cover “a broad set of supply chain specifics.”

Regulations 40

Regulations Production Packaging FDA 40

Drug Target Review

SEPTEMBER 6, 2024

The increased use of lentiviral vectors in vivo delivery in gene therapy has been driven by various industry trends, including development of in vivo CAR-Ts, the use of in vivo vectors for rare diseases as well as the significant increase in their use in vaccination, both for oncology and infectious disease applications.

Therapies 59

Therapies Vaccine Marketing Disease 59

The Pharma Data

NOVEMBER 20, 2020

As Pfizer and BioNTech announced news of a possible Covid-19 vaccine on November 8 , in haste, pharma leaders are rallying to ensure supply chains will be able to support distribution. With vaccines on the horizon, these predictive and prescriptive models for opening society will continue to be valuable for the foreseeable future.”.

Pharma Companies 52

Pharma Companies Vaccine Drugs Pharmacy 52

Codon

APRIL 9, 2023

Read Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults. Read Rational design of a highly immunogenic prefusion-stabilized F glycoprotein antigen for a respiratory syncytial virus vaccine. npj Vaccines. Video explaining mRNA vaccines (h/t Morgan Cheatham ). Jerez-Longres C. Gene Therapy.

Therapies 52

Therapies RNA Engineering Vaccine 52

The Pharma Data

JANUARY 17, 2021

The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. BARCELONA, Spain , Jan. Results are expected during the first half of 2021.

Clinical Trials 52

Clinical Trials Treatment Trials Virus 52

Drug Channels

DECEMBER 1, 2020

Pharmacy and healthcare provider markets experienced unprecedented volatility. If all goes well, 2021 will begin our return to normalcy, as vaccines roll out across the country. They are now poised to play a vital role in distributing COVID-19 vaccines and therapeutics as they become available. drug wholesaling industry.

Pharmacy 40

Pharmacy Drugs Vaccine Pharmaceuticals 40

The Pharma Data

MAY 13, 2021

In this special report, I’m going to show you why researchers at Harvard University and the Massachusetts General Hospital in Boston are now praising a strange new pain treatment originally discovered on the International Space Station. And then got my Doctor of Pharmacy (Pharm. from the Massachusetts College Of Pharmacy.

Pharmacy 52

Pharmacy Doctors Production Therapies 52

The Pharma Data

MAY 14, 2021

I have a cure for hives and angioedema! It is a natural cure which means it cannot be registered as a patent thus it cannot be marketed using the regular channels (drug industry-pharmacies etc.). Let’s see a pharmacy or doctor top that! Let’s see a pharmacy or doctor top that! Let’s see a pharmacy or doctor top that!

Treatment 52

Treatment Doctors Pharmacy Production 52

The Pharma Data

JULY 29, 2021

The EUA now provides for the use of baricitinib for treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). percent (24/515) for baricitinib plus remdesivir versus 7.1

Hospitals 52

Hospitals FDA Laboratories Treatment 52

The Pharma Data

JANUARY 27, 2021

coronavirus vaccination effort, the White House COVID-19 Response team announced Wednesday. Department of Health and Human Services (HHS) is amending its rules to allow retired health professionals to administer COVID-19 vaccine shots, said Jeff Zients, the White House COVID-19 Response coordinator. . WEDNESDAY, Jan.

Nurses 52

Nurses Doctors Vaccine Pharmacy 52

The Pharma Data

DECEMBER 23, 2020

A watershed moment for Pfizer and BioNTech as they announced Covid-19 vaccine was 90 per cent efficient. In early November, Pfizer and BioNTech announced their mRNA-based vaccine candidate, BNT162b2, was more than 90 per cent effective in preventing Covid-19 in cases where participants had shown no evidence of being infected with coronavirus.

Clinical Trials 52

Clinical Trials Vaccine Trials FDA 52

The Pharma Data

SEPTEMBER 21, 2020

More people are being offered a free flu vaccine this year – anyone over 50 in England is eligible. A vaccine for coronavirus is not available yet and experts are worried the UK could see the virus rip through the population this winter. Who will be offered the flu vaccine in England? pregnant women.

Vaccine 52

Vaccine Virus Pharmacy Hospitals 52

The Pharma Data

AUGUST 27, 2020

Health officials are ramping up efforts to ensure everyone who needs a flu vaccine has one. The UK’s largest flu-immunisation programme so far will see 30 million people offered the vaccine. What is clear is a big flu season combined with coronavirus could overwhelm hospitals. Who will be offered the flu vaccine?

Vaccine 52

Vaccine Virus Nurses Pharmacy 52

The Pharma Data

DECEMBER 31, 2020

million doses of the approved Pfizer and Moderna COVID-19 vaccines had been distributed across the United States by Monday morning, just 2.1 That’s far too slow a pace, said one official charged with spearheading the vaccination of Americans. million vaccination tally — compiled by the U.S. . THURSDAY, Dec.

Vaccine 52

Vaccine Long-Term Care Facilities Virus Hospitals 52

The Pharma Data

JANUARY 19, 2021

Trump’s order came as the country experienced a post-holiday surge in cases that has overwhelmed some hospitals and led to record numbers of deaths. At the same time, the national vaccination rollout has been slow and chaotic. Biden details massive vaccination effort.

Vaccine 52

Vaccine Virus Pharmacy Packaging 52

The Pharma Data

JANUARY 13, 2021

Health Secretary Alex Azar said Tuesday that the federal government would now release all available vaccine doses and told states to vaccinate every American aged 65 and older. “Every vaccine dose that is sitting in a warehouse rather than going into an arm could mean one more life lost or one more hospital bed occupied.”

Vaccine 52

Vaccine Government Virus Hospitals 52

Drug & Device Law

JANUARY 30, 2024

The plaintiff had received her second dose of Moderna Covid-19 vaccine. A couple of days later, she was admitted to a hospital emergency room because of unusual swings in her blood sugar that “flummoxed” the doctors. It also presents questions of lower court and appellate jurisdiction. This pain appeared to result from the biopsy.

Doctors 89

Doctors Vaccine Pharmacy Government 89

Drug & Device Law

MAY 15, 2023

Suffice it to say that it covers the administration of COVID vaccines – the heart of this nation’s response to the COVID-19 pandemic. The relevant facts were quite concisely stated: In the fall of 2021, [plaintiff’s] 15-year-old [daughter] visited [defendant’s] pharmacy seeking to be vaccinated for COVID-19 without parental consent.

Vaccine 59

Vaccine Pharmacy Hospitals Licensing 59

Drug & Device Law

FEBRUARY 20, 2023

For several decades – starting with plaintiffs’ pre-Vaccine Act attacks on vaccine designs – courts have addressed FDA approval as a component of “feasibility” in states that impose this limitation on design defect claims. Or does it suffice that a vaccine design has been approved in other countries? In Bruesewitz v.

FDA 59

FDA FDA Approval Testimonials Vaccine 59