The Pharma Data

MAY 7, 2021

Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process. “We Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We For more than 170 years, we have worked to make a difference for all who rely on us.

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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.

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The Pharma Data

MAY 4, 2021

Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ). The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. FDA approves expanded use for Chiesi’s sickle cell drug Ferriprox ( PMLive ).

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

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The Pharma Data

NOVEMBER 16, 2020

16, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. DJSI World is a leading global index comprised of organizations that are corporate leaders in environmental, social and governance (ESG) practices, representing the top 10 percent of most sustainable companies in each industry. SOURCE Regeneron Pharmaceuticals, Inc.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

5,196,404 covering ANGIOMAX (bivalirudin) after the company’s patent counsel untimely filed for a PTE 62 days after the ANGIOMAX NDA 020873 approval at 5:18 PM on Friday, December 15, 2000 (see our summary and “coda” posts here and here ). Taiho Pharmaceutical Co., which brings us to the topic of this post. 9,108,973 under 35 U.S.C.

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The Pharma Data

NOVEMBER 16, 2020

The partnership brings NIH together with other HHS agencies and government partners and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. Source: NIH.

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The Pharma Data

NOVEMBER 16, 2020

“We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “We

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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. ,

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FDA Law Blog: Biosimilars

JULY 24, 2023

Koblitz — Neither Jazz Pharmaceuticals nor Avadel CNS Pharmaceuticals has taken the battle of sodium oxybate—a drug approved to treat narcolepsy—lying down. After suing each other in patent litigation and Avadel’s suit against FDA challenging the Agency’s authority to compel patent certifications, it’s Jazz’s turn to sue FDA.

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The Pharma Data

FEBRUARY 24, 2022

The booster schedule is based on the labeling information of the vaccine used for the primary series COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. For more than 170 years, we have worked to make a difference for all who rely on us. Source link: [link].

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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).

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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. ,

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The Pharma Data

SEPTEMBER 7, 2020

Novartis will present 48 abstracts from its leading MS portfolio, including new data on recently FDA-approved Kesimpta ® (ofatumumab) — the first and only self-administered, targeted B-cell therapy for relapsing forms of MS (RMS )— Mayzent ® (siponimod) and Gilenya ® (fingolimod) . 4. Kesimpta Prescribing Information.

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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.

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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.

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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.

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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. Source link.

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Agency IQ

JUNE 7, 2024

However, this means that substances that were already available as dietary ingredients prior to their sponsors submitting an IND or obtaining FDA approval may still be marketed as such. L-glutamine offers an example of a more recently approved drug product. FDA’s problems with supplement oversight go well beyond just NDIs.

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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. ALEXION PHARMACEUTICALS, INC. Tables Follow). .

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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.”

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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.

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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. Regeneron Pharmaceuticals, Inc. government to supply our antibody cocktail as an important weapon in this fight.”

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The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. 24, 2020– Alnylam Pharmaceuticals, Inc. The FDA approval of Oxlumo represents a new path forward for many, providing an effective treatment option and a sense of hope.”. CAMBRIDGE, Mass.–(BUSINESS

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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.

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The Pharma Data

APRIL 27, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that that the U.S. About Takeda Pharmaceutical Company Limited. Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations. Ryoko Matsumoto .

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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.,

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The Pharma Data

NOVEMBER 9, 2021

Johnson & Johnson and its Janssen Pharmaceutical Companies moment blazoned they will appeal the$ 572 million civil judgment entered in Cleveland County District Court in the State of Oklahoma’s action against opioid manufacturers. The FDA-approved markers of these drugs give clear information about their pitfalls and benefits.

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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. About Regeneron Pharmaceuticals, Inc.

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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.”

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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 ). AZ’ Tagrisso first to win MHRA approval under Project Orbis ( PharmaTimes ) ( Pink Sheet ) ( MHRA ).

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The Pharma Data

AUGUST 25, 2020

In August 2017, Bristol Myers Squibb received full approval in the U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is the first and only FDA-approved therapy for patients with R/R AML and positive for an IDH2 mutation, which represents up to 19 percent of AML patients. About IDHIFA.

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The Pharma Data

JULY 29, 2021

HCV product sales increased 23% to $549 million for the second quarter 2021 compared to the same period in 2020, driven primarily by improved market starts in the United States and Europe as well as an unfavorable change in estimate of government rebates in the second quarter 2020. Trodelvy sales for the second quarter 2021 were $89 million.

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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.

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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.

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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.,

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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.

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