pharmaphorum

AUGUST 6, 2020

Blenrep (belantamab mafodotin) has been approved in patients who have received at least four therapies including an anti-CD38 such as Darzalex, a proteasome inhibitor and an immunomodulatory agent. The post FDA approves GSK’s Blenrep for advanced multiple myeloma appeared first on. of patients in the cohort.

FDA Approval 87

FDA Approval Antibody Packaging Packaging 87

The Pharma Data

JANUARY 6, 2021

” AstraZeneca has already submitted a substantial data package to support a conditional marketing authorisation for its COVID-19 vaccine to the European Medicines Agency (EMA), as part of an ongoing rolling review process and will continue to work closely with the EMA to seek approval in the coming weeks. Source link.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

XTalks

MAY 18, 2023

The wireless charger — the transmitter — contains a metallic coil that converts electrical energy into a magnetic field, which is then collected and reverted into electricity by the receiver inside the implanted device. Zulauf expects human trials and the first FDA approval as early as 2024. billion in 2022. billion by 2032.

Development 96

Development Packaging Packaging Manufacturing 96

The Pharma Data

JANUARY 21, 2021

ViiV Healthcare is the marketing authorization holder for CABENUVA. CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression. Click to Tweet : #BREAKING: The #FDA has approved another treatment option for people living with #HIV. .

FDA Approval 52

FDA Approval RNA Drugs Containment 52

Pharmaceutical Technology

JULY 4, 2022

Russia is an already insular country and its worldview has tended to be self-contained, but this has hardened in the face of recent sanctions and counter-sanctions imposed during the war with Ukraine. Russian sites supply home market. There are no US FDA-approved pharma manufacturing facilities in Russia.

Pharma Production 305

Pharma Production Production Clinical Trials Clinical Trials 305

The Pharma Data

OCTOBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Production 52

Production Antibody Manufacturing Trials 52

XTalks

MARCH 29, 2023

Although salt substitutes have been on the market for years, the FDA is now not only permitting them, but recommending their use. Related: FDA Issues Draft Guidance for Plant-Based Milk Labels What are Salt Substitutes? Up until now, the FDA did not permit the use of salt substitutes in standardized foods.

Manufacturing 97

Manufacturing Packaging Packaging Production 97

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. It contains the antiviral medications nirmatrelvir and ritonavir.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

DECEMBER 17, 2020

Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

JANUARY 12, 2021

Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

The Pharma Data

DECEMBER 5, 2020

Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Antibody 40

Antibody Production Trials Medicine 40

The Pharma Data

JANUARY 9, 2021

We are proud to be a leader in the growing public health threat market, enabled by our development and manufacturing expertise, successful public-private partnerships, and broad portfolio of products and CDMO services. “Operationally, we rapidly responded to our customers’ needs, and financially, we delivered record revenue and earnings.

Production 52

Production Manufacturing Vaccination Vaccine 52

The Pharma Data

OCTOBER 28, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

DECEMBER 29, 2020

AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use.

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

AUGUST 6, 2020

See “Worldwide Pro Forma Revenue” in Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the revenue of the company and Celgene on a stand-alone basis for the prior-year period. billion, or $1.63 billion, or $1.18 Regulatory.

Production 52

Production Branding Marketing Licensing 52

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). REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Business Highlights.

Sales 52

Sales Production Manufacturing Antibody 52

The Pharma Data

NOVEMBER 20, 2020

Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. REGN-COV2 (casirivimab and imdevimab) FDA Approval History. Source: Regeneron. Source link.

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 30, 2020

We will file today for an Emergency Use Authorization from the FDA and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe.”. FDA and an application for Conditional Marketing Authorization (CMA) with the European Medicines Agency. W911QY-20-C-0100.

Vaccination 52

Vaccination Vaccine Medicine Clinical Trials 52

The Pharma Data

NOVEMBER 21, 2020

Casirivimab and imdevimab injection (REGEN-COV2) is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

Antibody 40

Antibody Production Clinical Trials Clinical Trials 40

The Pharma Data

MAY 13, 2021

Low Level Light therapy (LLLT), is FDA approved for treating conditions such as chronic joint pain and slow to heal wounds. (3). It contains something called boswellic acids that gives it these amazing properties. Tea tree contains a high concentration of Terpinin-4-ol, an anti-inflammatory compound.

Pharmacy 52

Pharmacy Production Doctors Doctor 52

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. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S.

FDA Approval 52

FDA Approval Antibody Production Trials 52