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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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.

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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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Agency IQ

JANUARY 4, 2024

To help control impurities, the FDA requires all starting materials used in drug manufacturing and final pharmaceutical products to be evaluated for “identity, strength, quality and purity.” The company submitted four separate citizen petitions to the FDA from March 2021 through October 2022 regarding benzene impurities.

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The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Toronto, Ontario–(Newsfile Corp. – January 25, 2021) – PharmaDrug Inc. About PharmaDrug Inc. PharmaDrug Inc.

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The Pharma Data

NOVEMBER 20, 2020

November 21, 2020 – Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA). 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.

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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

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. Casirivimab and imdevimab injection is not FDA approved for any use.

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The Pharma Data

DECEMBER 5, 2020

Regeneron Pharmaceuticals, Inc. About Regeneron Pharmaceuticals, Inc. SOURCE 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. Source link.

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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. About Regeneron Pharmaceuticals, Inc. Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn).

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The Pharma Data

DECEMBER 29, 2020

Regeneron Pharmaceuticals, Inc. 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.

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Agency IQ

SEPTEMBER 29, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

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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. SOURCE Regeneron Pharmaceuticals, Inc. Investor Relations Mark Hudson Tel: +1 (914) 847-3482 mark.hudson@regeneron.com .

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Agency IQ

OCTOBER 27, 2023

Date What’s Happening Explanation Source October 31 FDA deadline on Florida drug importation plan The FDA has said in court filings that it plans to make a ruling on Florida’s prescription drug importation plan by October 31. The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

NOVEMBER 21, 2020

Regeneron Pharmaceuticals, Inc. 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. government allocation program.

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Agency IQ

JUNE 16, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

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The Pharma Data

MAY 13, 2021

Before I show you what this breakthrough pain solution is, I want to let you in on the “dirty little secret” of the pharmaceutical industry. I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! And then got my Doctor of Pharmacy (Pharm. Please don’t blame yourself.

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FDA Law Blog: Biosimilars

OCTOBER 29, 2023

With this guidance, the Departments decided to reference the 2019 HRSA Guideline rather than the FDA Birth Control Guide for the range of identified categories of contraception (FAQ Part 54, Q2), stating that plans and issuers must cover without cost sharing at least one form of contraception in each category.

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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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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3210 Accelerated Approval : FDA’s Accelerated Approval Council must publish a report within one year of the passage of the FDORA legislation regarding its annual activities. The rule, will also, if finalized, address communication with State boards of pharmacy.

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. 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.

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Policy Prescription

OCTOBER 3, 2023

Salant’s paper supports personal drug importation and legalizing the importation of prescription drugs for commercial use so that wholesale pharmacies, including companies like Amazon and Costco, could tap into the parallel importation markets of other countries. pharmacies and personal imports from India can be safe as well.

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Drug & Device Law

MAY 26, 2023

A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications. For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use.

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Drug & Device Law

JULY 24, 2023

We’ve discussed recently how a federal statute intended to allow suits against international terrorists has been misapplied as allowing suits against pharmaceutical companies. Takeda Pharmaceuticals Co. , Takeda Pharmaceutical Co. , the relationship between [plaintiff] and its pharmacy benefit manager. . . 555, 565 (E.D.

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Drug & Device Law

JUNE 2, 2022

Even with some attempt to “stay in our lane,” we can see significant impacts on the legal framework in which a number of medical product manufacturers, to say nothing of distributors, pharmacies, and healthcare providers, operate. This is not a matter of us injecting our personal and political views into areas we do not belong. 472 (2013).

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Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. Forest Pharmaceuticals, Inc. Pacira Pharmaceuticals, Inc. 4th 851 (6th Cir. Preemption.

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

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Drug & Device Law

JUNE 29, 2022

We are always delighted to find a case that bars a claim based on FDA preemption, but Nexus Pharms., Rather, a pharmaceutical company sued a compounder for fraudulently stealing business from it. The FDA approved the plaintiff’s 5 mg solution, and the only other FDA approved ephedrine solutions came in the 50 mg concentration.

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Drug & Device Law

OCTOBER 10, 2023

2013), the court held that plaintiff could not “bring a claim that rests solely on the non-disclosure to patients of facts tied to the scope of [FDA] approval.” Finding non-disclosure different than, for example, a claim premised on false assertions of FDA approval. Similarly, the court in Nexus Pharmaceuticals, Inc.

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