The Pharma Data

MAY 13, 2021

Indian states turn to anti-parasitic drug to fight COVID-19 against WHO advice ( Reuters ). Japan vaccine chief blames drug approval system for slow inoculation drive ( Reuters ). Vaccine waiver talks can make drug firms the heroes, US trade chief says ( Reuters ) ( Law360 ).

FDA Approval 52

FDA Approval Vaccination Vaccine Drugs 52

FDA Law Blog

JULY 5, 2023

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). See 21 U.S.C. 353b(a)(8). Section II at 2.

Drugs 52

Drugs Production Manufacturing Licensing 52

XTalks

APRIL 24, 2023

According to Dr. Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

The Pharma Data

JANUARY 24, 2021

Food and Drug Administration (“FDA”) approval. Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases. PharmaDrug Inc.

Drugs 52

Drugs Containment Development Sales 52

XTalks

NOVEMBER 28, 2023

Biosimilars offer a promising pathway to reducing healthcare costs while maintaining the efficacy and safety profiles of their reference products, the originally approved biologic drugs. Samsung Bioepis was the first company to receive FDA approval for both high-concentration and low-concentration formulations of adalimumab biosimilar.

Production 98

Production Marketing Development Pharmacy 98

Pharmacy Checkers

OCTOBER 2, 2020

In most cases, the reason is that the same drugs sold in the U.S. million Americans import drugs to save money each year. First, wholesale importation of lower cost drugs from Canada is now lawful. That is pursuant to Section 804 of the Food, Drug and Cosmetic Act. are much cheaper elsewhere.

Pharmacy 54

Pharmacy Drugs FDA Approval Cosmetics 54

The Pharma Data

NOVEMBER 8, 2020

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients.

FDA Approval 52

FDA Approval Licensing Licensing Production 52

Pharmaceutical Technology

JUNE 9, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of AstraZeneca’s and Sanofi’s respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) prophylactic nirsevimab for use in newborns and infants entering their first RSV season.

FDA Approval 147

FDA Approval Antibody Allergies Packaging 147

The Pharma Data

JULY 29, 2021

Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. Under the EUA, inpatient pharmacies in the U.S. It is approved in the U.S.

HR 52

HR Licensing Licensing FDA Approval 52

Pharmacy Checkers

DECEMBER 12, 2019

wholesale importation of lower-cost drugs. Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Food and Drug Administration exemplifies the “gold standard” in drug safety. is not the gold standard in drug safety, it would fatally weaken anti-importation arguments. If the U.S.

Drugs 71

Drugs Manufacturing Medicine Compliance 71

The Pharma Data

OCTOBER 30, 2020

Food and Drug Administration , which is currently evaluating REGN-COV2 for a potential Emergency Use Authorization in mild-to-moderate outpatients at high risk for poor outcomes. Finally, the IDMC recommends continuation of the outpatient trial without modification. Regeneron is also informing the U.S.

Production 52

Production Antibody Manufacturing Trials 52

The Pharma Data

DECEMBER 17, 2020

Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in patients 12 years of age and older and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

JANUARY 12, 2021

The companies share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations. Casirivimab and imdevimab injection is not FDA approved for any use.

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

The Pharma Data

DECEMBER 29, 2020

Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational.

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

DECEMBER 5, 2020

About the Phase 1/2 Dose-escalation Trial REGN5458 monotherapy is being investigated in an open-label, Phase 1/2 dose-escalation trial in patients with R/R multiple myeloma who are at least triple refractory to existing therapeutic options, including proteasome inhibitors, immunomodulatory drugs and CD38 antibody treatments.

Antibody 40

Antibody Production Trials Medicine 40

The Pharma Data

OCTOBER 28, 2020

“The first job of an antiviral therapeutic drug is to lower the viral load, and our initial data in 275 patients strongly suggested that the REGN-COV2 antibody cocktail could lower viral load and thereby potentially improve clinical outcomes. . Regeneron has shared these results with the U.S.

Antibody 40

Antibody Trials Production Clinical Trials 40

XTalks

MARCH 22, 2023

To celebrate this milestone, we’re taking a look back over the last 20 years in the pharmaceutical industry by highlighting some of the most talked-about mergers, blockbuster drugs, trends in FDA approvals and what’s next. How has Pfizer secured their spot? Click on the infographic to explore the data.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). The Company commenced delivery of REGN-COV2 drug product under the agreement during the third quarter of 2020. Oncology Program.

Sales 52

Sales Production Manufacturing Antibody 52

XTalks

JUNE 12, 2023

The US Food and Drug Administration (FDA) granted approval to four of Medtronic’s cardiovascular product offerings, further expanding the company’s foothold in this sector. Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals. billion ($22.83

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

The Pharma Data

NOVEMBER 20, 2020

Food and Drug Administration (FDA). The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available. Casirivimab and imdevimab injection is not FDA approved for any use.

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

Pharmacy Checkers

OCTOBER 11, 2019

The FDA has finished draft guidance on one of two of the Trump administration’s drug importation policy ideas, referred to as Pathway II. The title of this post may seem like a joke for those of you who follow the issue of drug importation in America, but it is real. Most prescription drugs sold in the U.S.

FDA Approval 55

FDA Approval Drugs Manufacturing Pharmacy 55

The Pharma Data

NOVEMBER 21, 2020

Food and Drug Administration (FDA). The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available. Casirivimab and imdevimab injection is not FDA approved for any use.

Antibody 40

Antibody Production Clinical Trials Clinical Trials 40

Pharmacy Checkers

SEPTEMBER 4, 2019

Stephen Salant, PhD, professor emeritus of economics at the University of Michigan and research professor at the University of Maryland has written a paper that I believe gives voice and pays respect to the millions of Americans who import or are on the verge of importing lower-cost medication using online pharmacies. drug prices.

Pharmacy 64

Pharmacy Drugs Manufacturing Licensing 64

Pharmacy Checkers

JANUARY 4, 2020

The FDA has drafted a proposed rule to facilitate wholesale importation of lower-cost drugs from Canada, pursuant to Section 804 of the Food, Drug and Cosmetic Act. It’s a major milestone that the FDA is willing to and on the cusp of finally providing that certification – but that’s only for wholesale importation.

Drugs 58

Drugs Pharmacy Medicine Regulation 58

Pharmacy Checkers

NOVEMBER 8, 2019

There are few people more supportive than I am of prescription drug importation as one policy to help Americans access lower drug prices. But, since I accuse Big Pharma types and the FDA of ignoring reality about the safety of personal drug imports from licensed pharmacies in Canada and other countries, I won’t ignore reality!

Drugs 48

Drugs Pharmacy FDA Approval Licensing 48

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. DRUG INTERACTIONS. TARRYTOWN, N.Y., 5 x ULN).

FDA Approval 52

FDA Approval Antibody Production Trials 52

Pharmaceutical Technology

JANUARY 6, 2023

In this most recent settlement, the drug company faced allegations of colluding with the generics company Par Pharmaceuticals to violate antitrust laws. Novartis has also been on the receiving end of litigation with the Greek health ministry, academic institutes, and more, engaging the drug company in other legal disputes.

Doctors 242

Doctors Doctor Drugs Sales 242

Pharmacy Checkers

AUGUST 2, 2019

This week, the Trump administration formally announced support for not only state prescription drug importation programs, but also HHS Secretary Alex Azar’s own importation plan. These drugs, as explained below, are safe and effective foreign brand versions of the same drugs sold here. Now, there is real movement.

Drugs 69

Drugs FDA Approval Pharmacy Cosmetics 69

Pharmacy Checkers

MARCH 11, 2020

Below is a copy of Gabriel Levitt’s comments on the FDA Notice of Proposed Rulemaking titled “Importation of Prescription Drugs” that were submitted Monday, March 9th, 2020. Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. counterparts.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41