pharmaphorum

MARCH 16, 2022

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now.

FDA Approval 59

FDA Approval Generic Drugs Marketing Drug Delivery 59

Camargo

OCTOBER 14, 2021

The new Type D meeting , which allows for quicker discussion of a narrow set of issues (no more than two focused topics) between the FDA and a sponsor, such as a follow-up question that raises a new issue after a formal meeting. Continued development of the use of complex innovative trial designs. Co-Authors: Bill Stoltman, JD.

Development 189

Development Packaging Packaging Generic Drugs 189

XTalks

FEBRUARY 5, 2024

Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. Nevertheless, Opdivo continues to hold strong and Bristol Myers Squibb filed an application with the FDA in December for Opdivo in combination with cisplatin chemotherapy as a first-line treatment in advanced urothelial carcinoma.

FDA Approval 101

FDA Approval Drugs Sales Development 101

pharmaphorum

AUGUST 28, 2020

Shares in dermatology specialist Cassiopea, which is listed on the SWX exchange in Switzerland, rose almost 17% after news of the FDA approval emerged. Retinoids can help unclog pores, while antibiotics can limit the growth of bacteria.

Dermatology 52

Dermatology Drugs Hormones FDA Approval 52

The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. .

Drugs 52

Drugs Research FDA Approval Manufacturing 52

XTalks

JUNE 8, 2022

Novartis’ biosimilars and generics drug division Sandoz has announced a new global campaign called ‘Act4Biosimilars’ to help raise awareness about biosimilars and increase their adoption by at least 30 percent in over 30 countries by the year 2030. Related: Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar.

Generic Pharmaceutical 69

Generic Pharmaceutical Branding Production Medicine 69

XTalks

FEBRUARY 5, 2024

Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. Nevertheless, Opdivo continues to hold strong and Bristol Myers Squibb filed an application with the FDA in December for Opdivo in combination with cisplatin chemotherapy as a first-line treatment in advanced urothelial carcinoma.

FDA Approval 52

FDA Approval Drugs Sales Development 52

The Pharma Data

MARCH 7, 2022

“The launch of our first generic version of Revlimid® in the U.S. This product adds to our broad generic portfolio of oncology treatments, which accounts for 73% of the essential medicines in this category, as defined by the World Health Organization.”. Currently, 1 in 12 generic prescriptions dispensed in the U.S.

Medicine 52

Medicine Production Generic Drugs FDA Approval 52

The Pharma Data

MAY 7, 2021

Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ). WHO approves emergency use of China’s Sinopharm Covid vaccine ( FT ). US move to loosen vaccine patents will draw drug companies to bargain ( Reuters ). Generic Drug Cos. .

Vaccination 52

Vaccination Vaccine Drugs Regulation 52

FDA Law Blog

AUGUST 16, 2021

Nonetheless, FDA has been calling them ANDAs and listing them in the Orange Book as ANDAs for years, but recent changes to the Orange Book have spurred some confusion. Thus, FDA divided them into their own category and is now seeking Comments on whether the 505(b) or the 505(j) regulatory scheme should apply.

Production 52

Production Drugs Generic Drugs Cosmetics 52

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

pharmaphorum

MARCH 3, 2022

” The average wholesale prices of the originator insulin are around $329 per vial and $510 for five pens, according to Civica, which says it will start clinical trials of the biosimilars this year with a view to filing for approval in 2023. Cheaper options are meanwhile becoming available.

Insulin 52

Insulin Production Generic Drugs FDA Approval 52

Pharmacy Checkers

DECEMBER 12, 2019

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” For an excellent overview of the EU’s regulatory system, see: Excellent overview of the European Union’s drug regulatory system.

Drugs 71

Drugs Manufacturing Medicine Compliance 71

The Pharma Data

MAY 4, 2021

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

Vaccination 40

Vaccination Vaccine Production Sales 40