XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity.

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Pfizer

SEPTEMBER 27, 2022

Biosimilars are FDA approved, and often offer a lower-cost alternative to biologic therapies that treat challenging diseases like cancer, diabetes, and rheumatoid arthritis. Americans deserve healthcare solutions that: Increase affordable access to breakthrough treatments. 08.22.2022. See more Updates and Statements.

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XTalks

SEPTEMBER 21, 2023

The company said it cannot “validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product.” Mounjaro, a dual GLP-1/GIP agonist was approved in May 2022 for type 2 diabetes. Lilly is seeking undisclosed damages in the lawsuits.

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pharmaphorum

JANUARY 28, 2021

If approved as a biosimilar, Semglee will be established as the first direct competitor of Lantus, giving providers an alternative treatment option that they can feel confident in prescribing. This milestone is also significant because insulin is covered under the Part D pharmacy benefit, and now, insulin biosimilars will be, too.

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XTalks

APRIL 24, 2023

The Recent Increase in Cellular and Gene Therapy Product Approvals for Rare Diseases As of December 2022, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cellular and gene therapy products. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.

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FDA Law Blog

FEBRUARY 27, 2023

Palmer — The 2008 Ryan Haight Online Pharmacy Consumer Protection Act placed strict limits on online prescribing or the use of telemedicine encounters to prescribe controlled substances. 829(e); and 2) the modified registration requirement for online pharmacies. By Karla L. 21 U.S.C. § 21 U.S.C. § 21 U.S.C. § 802(54)(D)(i).

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FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle. 21 U.S.C. §

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Pharmaceutical Technology

MAY 24, 2023

The FDA approval adds a further treatment avenue to tackle the opioid crisis in the US. Whilst the pharma industry has been relatively slow in developing new treatments – an array of legal challenges posed to pharma companies and pharmacies implicated in the crisis still trundles on.

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The Pharma Data

NOVEMBER 16, 2020

The stability at refrigerated conditions allows for storage at most pharmacies, hospitals, or physicians’ offices. No Dilution Required at Vaccination Site: The vaccine will not require onsite dilution or special handling, which facilitates vaccination across a range of settings including pharmacies and physicians’ offices.

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FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle. 21 U.S.C. §

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The Pharma Data

JANUARY 24, 2021

The Company owns 80% of Pharmadrug GmbH, a German medical cannabis distributor, with a Schedule I European Union narcotics license and German EuGMP certification allowing for the importation and distribution of medical cannabis to pharmacies in Germany and throughout the EU.

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Pharmaceutical Technology

MAY 5, 2023

In an alert issued last week , the FDA said apetamin is being promoted over social media as a weight-gain solution and highlighted that young adults are reporting cardiac and nervous system disorders, and liver injury after taking the drug.

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pharmaphorum

SEPTEMBER 29, 2021

Amazon is advancing into healthcare on multiple fronts, launching its own pharmacy business for medicines delivery in the US last year, whilst also entering the health wearables market with its own Halo device, and bolstering the health-related capabilities of its Alexa virtual assistant.

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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.

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XTalks

APRIL 10, 2023

As the first OTC naloxone product approved by the FDA, Narcan is expected to be sold directly to consumers without a prescription as an emergency life-saving medication to reverse opioid overdose. Narcan nasal spray contains a single 4 mg dose of naloxone hydrochloride, which is administered intranasally.

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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.

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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.

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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.

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Pharmacy Checkers

NOVEMBER 21, 2019

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

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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.

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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.

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

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The Pharma Data

MAY 13, 2021

I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! Which is how I got into pharmacy — after all, what better way to spend your life than by removing illness from the world. . … And then got my Doctor of Pharmacy (Pharm.

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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.

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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.

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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.

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Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Biosimilars with this designation are beneficial to payers as they eliminate the need for another prescription, she explains An interchangeable biosimilar can be automatically substituted for Humira at a pharmacy, Bhat adds.

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Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Throughout 2022, Novartis was at the opposing ends of legal cases.

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Pharmacy Checkers

DECEMBER 20, 2019

The FDA has done something that prescription drug importation advocates had possibly given up on. The agency drafted a new proposed rule to allow importation from Canada of lower-cost drugs and industry guidance for drug manufacturers to import their FDA-approved foreign drug versions, for which they can charge lower prices.

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