The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, Pa. and CHICAGO , Oct.

FDA Approval 52

FDA Approval FDA Treatment Pharmaceutical Companies 52

The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic.

Licensing 40

Licensing Licensing Therapies Laboratories 40

FDA Law Blog: Biosimilars

MARCH 13, 2024

4,631,286, where the PTO considered “whether Hoechst-Roussel is eligible to file an application for [PTE] based on a regulatory review conducted by its competitor, the marketing applicant Warner-Lambert, wherein Hoechst-Roussel was not associated with the regulatory review that led to FDA approval for commercial marketing of the approved product.”

FDA 59

FDA FDA Approval Production Marketing 59

The Pharma Data

OCTOBER 30, 2020

Regeneron Pharmaceuticals, Inc. 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. TARRYTOWN, N.Y. ,

Hospitals 52

Hospitals Virus Production Clinical Trials 52

The Pharma Data

MARCH 2, 2021

Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. government will manage allocation and distribution of the vaccine in the U.S.

Vaccine 52

Vaccine Clinical Trials FDA Hospitals 52

The Pharma Data

MAY 4, 2021

Direct Relief will allocate donations of baricitinib to low- and lower-middle-income countries (based on World Bank classification) for the treatment of hospitalized COVID-19 patients requiring supplemental oxygen, based on requests from these governments to Direct Relief. It is approved in the U.S. It is approved in the U.S.

Therapies 52

Therapies Hospitals FDA Approval Long-Term Care Facilities 52

The Pharma Data

DECEMBER 29, 2020

Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. government, Regeneron is producing approximately 300,000 doses (2,400 mg) for outpatient use under the EUA. government regarding additional doses. . In the U.S.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

NOVEMBER 5, 2020

05, 2020 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today reported its financial results for the quarter ended September 30, 2020 and provided a corporate update. FDA approval, and customary exceptions).

Pharmaceuticals 52

Pharmaceuticals Production Marketing Pharmaceutical Companies 52

The Pharma Data

JANUARY 9, 2021

This growth primarily reflects increased sales of contract development and manufacturing (CDMO) services to pharmaceutical and biotechnology innovators and government/non-government organization (NGO) customers, as well as higher product sales. Other 2021 Assumptions. FOOTNOTES. (1) FOOTNOTES. (1)

Government 52

Government Vaccine Production Licensing 52

The Pharma Data

DECEMBER 11, 2020

FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. Government to supply doses in 2020 & 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. immediately.

Vaccine 52

Vaccine Clinical Trials Licensing 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). Regeneron Pharmaceuticals, Inc. government. R&D: Up-front payments related to license and collaboration agreements. (85).

Production 52

Production FDA FDA Approval Trials 52

The Pharma Data

DECEMBER 17, 2020

17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. 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. TARRYTOWN, N.Y. ,

Hospitals 52

Hospitals Production Clinical Trials Virus 52

Agency IQ

NOVEMBER 3, 2023

So what about all of the “biotic” terms that pop up in the news, on products labels and even in FDA warning letters? Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community.

Therapies 40

Therapies Science FDA Production 40

The Pharma Data

DECEMBER 5, 2020

Regeneron Pharmaceuticals, Inc. About Regeneron Pharmaceuticals, Inc. 6 months of follow-up, 83% have ongoing responses for up to 13 months at the time of analysis. Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients.

Production 40

Production Trials Treatment Pharmaceuticals 40

The Pharma Data

OCTOBER 28, 2020

FDA, which is reviewing an Emergency Use Authorization submission for the REGN-COV2 low dose in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes. Regeneron Pharmaceuticals, Inc.

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

MAY 6, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years. Pfizer Inc. Source link: [link].

Licensing 52

Licensing Licensing FDA Approval FDA 52

Agency IQ

JANUARY 12, 2024

After lengthy review, FDA approves Florida’s drug importation plan After a years-long review process, the FDA today announced its approval of Florida’s proposal to import certain prescription drug products from Canada. Any such litigation may potentially further delay the implementation of Florida’s importation plan.

FDA Approval 40

FDA Approval FDA Science Drugs 40

The Pharma Data

NOVEMBER 20, 2020

In some cases, governments may have regulatory pathways similar to an EUA. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. Posted: November 2020.

Vaccine 52

Vaccine FDA Clinical Trials Trials 52

Drug Discovery World

SEPTEMBER 16, 2022

Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. . Neelam Patel, CEO of London cluster organisation, MedCity. .

Therapies 130

Therapies Clinical Trials Production Trials 130

The Pharma Data

DECEMBER 10, 2020

Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History.

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52

The Pharma Data

JANUARY 13, 2021

“Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: [link]. Source link.

Clinical Trials 52

Clinical Trials Trials FDA Pharmaceuticals 52

The Pharma Data

NOVEMBER 9, 2020

Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History.

Vaccine 40

Vaccine Clinical Trials Trials FDA 40

The Pharma Data

NOVEMBER 9, 2021

Biohaven Pharmaceutical Holding CompanyLtd. With this alliance, Biohaven Pharmaceutical and Pfizer believe there’s an occasion to change the paradigm in migraine treatment and potentially establish a new standard of care.” Rimegepant, commercialized as Nurtec® ODT in the U.S., Rimegepant is capitalized as Nurtec ® ODT in theU.S.,

Licensing 52

Licensing Licensing Treatment FDA Approval 52

The Pharma Data

NOVEMBER 20, 2020

November 21, 2020 – Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA). “The government and Regeneron signed an agreement for this initial supply of the casirivimab and imdevimab antibody cocktail. Casirivimab and imdevimab injection is not FDA approved for any use. TARRYTOWN, N.Y.,

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). government fiscal year runs from October 1 – September 30.

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

NOVEMBER 21, 2020

government allocation program. Regeneron Pharmaceuticals, Inc. Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need.

FDA 40

FDA Clinical Trials Hospitals Government 40

The Pharma Data

AUGUST 6, 2020

FDA) approval of Opdivo (nivolumab) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. This approval was based on the Phase 3 CheckMate -9LA study. Oncology and Hematology. Regulatory.

Production 52

Production International Licensing Licensing 52

Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

Science 40

Science FDA Packaging Production 40

The Pharma Data

NOVEMBER 4, 2020

As with much of the pharmaceutical industry, VASCEPA revenue and prescription growth have been adversely impacted by the COVID-19 pandemic. In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 This compares with licensing and royalty revenue of $0.2 million and $8.9 million and $5.7 million and $1.1

Production 40

Production FDA Trials Licensing 40

The Pharma Data

OCTOBER 29, 2020

29, 2020– Alexion Pharmaceuticals, Inc. ULTOMIRIS – Atypical Hemolytic Uremic Syndrome (aHUS): In September 2020 , Japan’s MHLW approved ULTOMIRIS for adults and children with aHUS. FDA approved the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS. BOSTON –(BUSINESS WIRE)–Oct.

Clinical Trials 40

Clinical Trials Production Trials Licensing 40

Agency IQ

SEPTEMBER 29, 2023

What we expect to be talking about in October: Government shutdown: The odds of a government shutdown happening in October are, we think, rather high absent a last-minute breakthrough in Congressional negotiations. That means that thousands of FDA staff are likely to be furloughed in early October, and potentially for weeks.

FDA 40

FDA Science Regulations Production 40

Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.”

FDA 40

FDA Pharmacy Production Drugs 40

Agency IQ

OCTOBER 27, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Government shutdown: At present, the U.S. federal government has appropriated funding through November 17. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Government shutdown: At present, the FDA has appropriated funding through January 19. Expect nearly every company to be closely reading this document when it’s eventually published.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

Regulations 40

Regulations FDA Science Production 40

The Pharma Data

APRIL 27, 2021

Pharmaceuticals. First-quarter 2021 Pharmaceutical sales increased 3.8% In Japan, sales were €59 million (up 53.7%), where strong demand was moderated by the government price decrease implemented in April 2020. Pharmaceuticals business operating income. First-quarter business operating income (BOI) increased 4.0%

Vaccine 52

Vaccine Production FDA FDA Approval 52

The Pharma Data

APRIL 26, 2021

Pharmaceuticals BU in line with prior year (0% cc, +4% USD) with continued strong growth from Entresto (+34% cc), Zolgensma (+81% cc), and Cosentyx (+11% cc). billion declined, mainly due to the USD 650 million upfront payment to in-license tislelizumab from BeiGene. New approvals. Kesimpta sales reached USD 50 million.

Production 40

Production Licensing Licensing Vaccine 40