The Pharma Data

MAY 13, 2021

‘More Amazon and less pharmacy’: one exec on the company’s strategy for prescription drugs ( STAT ). Biogen licenses a stroke drug from Japanese drugmaker TMS ( BioPharmaDive ). ICER, Accelerated Approval And The Payer Voice At The US FDA ( Pink Sheet ). Pharma & Biotech.

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FDA Law Blog

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. See 21 U.S.C. 353b(a). Section II at 2. Draft Guidance III.B.2(e)

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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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XTalks

NOVEMBER 28, 2023

Samsung Bioepis was the first company to receive FDA approval for both high-concentration and low-concentration formulations of adalimumab biosimilar. However, it is important for all stakeholders to realize that the FDA interchangeability designation is a legal distinction, not a clinical one.

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The Pharma Data

NOVEMBER 8, 2020

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. About Sesquient.

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Pharmaceutical Technology

JUNE 9, 2023

Although AdCom verdicts are considered by the FDA when it comes to approvals, they are not binding. The FDA accepted nirsevimab’s biologics license application (BLA) in January, with a PDUFA date penned for Q3 2023. On 31 May, the FDA also approved Pfizer’s vaccine Abrysvo in the same patient population.

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The Pharma Data

JULY 29, 2021

Under the EUA, inpatient pharmacies in the U.S. Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. See Warnings and Precautions in the FDA-approved full Prescribing Information and Medication Guide for additional information on risks associated with longer-term treatment with baricitinib.

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Pharmacy Checkers

OCTOBER 2, 2020

Under these programs, the individual will obtain the imported prescription drugs from an authorized State licensed pharmacy through an authorized IWIP [Individual Waiver Importation Plans].”. They do so by buying directly from pharmacies in other countries. Personal importation is directly importing from a pharmacy in Canada.

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The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials.

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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

JUNE 12, 2023

Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals. This system is the first and only FDA-approved heart failure monitoring system that enables physicians to track changes in pulmonary artery pressure. The CardioMEMs HF system was another crucial launch for Abbott.

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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

DECEMBER 29, 2020

Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational.

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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). R&D: Up-front payments related to license and collaboration agreements. (85). Regeneron Pharmaceuticals, Inc. Oncology Program.

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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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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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Pharmacy Checkers

DECEMBER 12, 2019

Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. drug regulatory system, see: How FDA Approves Drugs and Regulates Their Safety and Effectiveness. For the reasons stated above: an American who is able to safely import a drug from a licensed pharmacy in the European Union or the UK (!),

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XTalks

MARCH 22, 2023

To celebrate this milestone, we’re taking a look back over the last 20 years in the pharmaceutical industry by highlighting some of the most talked-about mergers, blockbuster drugs, trends in FDA approvals and what’s next. Just last year, the FDA approved a one-time gene therapy treatment for hemophilia B priced at $3.5

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The Pharma Data

NOVEMBER 20, 2020

The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process.

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The Pharma Data

NOVEMBER 21, 2020

The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process.

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Pharmacy Checkers

SEPTEMBER 4, 2019

Stephen Salant, PhD, professor emeritus of economics at the University of Michigan and research professor at the University of Maryland has written a paper that I believe gives voice and pays respect to the millions of Americans who import or are on the verge of importing lower-cost medication using online pharmacies. drug prices.

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Pharmacy Checkers

OCTOBER 11, 2019

It doesn’t relate – at least not directly – to personal drug importation, but it frees the hands of drug companies to sell their own foreign versions of FDA-approved drugs at lower prices in the U.S. FDA-approved” drugs must be made in manufacturing plants that are registered with the FDA. are made outside the U.S.,

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Pharmacy Checkers

JANUARY 4, 2020

J(2) stipulates that the FDA can permit personal imports with specific waivers or by general regulation. J(3) is specific to Canada and basically tells the FDA to permit personal importation from licensed pharmacies that require a valid prescription. Rogue online pharmacies could be viewed as a public health threat.

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Pharmacy Checkers

NOVEMBER 8, 2019

But, since I accuse Big Pharma types and the FDA of ignoring reality about the safety of personal drug imports from licensed pharmacies in Canada and other countries, I won’t ignore reality! There are few people more supportive than I am of prescription drug importation as one policy to help Americans access lower drug prices.

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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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FDA Approval Antibody Production Trials 52

Pharmaceutical Technology

JANUARY 6, 2023

In the case of Novartis’ antihypertensive drug Exforge (amlodipine and valsartan), retail pharmacies including CVS, Walgreens, and two other plaintiff groups accused Novartis and Endo International’s Par Pharmaceutical unit of forming an illegal “reverse payment” agreement to delay the launch of less expensive generic versions of the drug.

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Pharmacy Checkers

AUGUST 2, 2019

The reality is that Americans have already been importing medications from foreign pharmacies because of substantially lower prices for many years, and the law is currently flexible to allow them to do so. But for “foreign versions” of FDA-approved drugs, this is not the case. See: Trump Safe Importation Action Plan.

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Pharmacy Checkers

MARCH 11, 2020

Founded in 2002, and launching its website in 2003, PharmacyChecker provides consumers with online pharmacy verification and comparative drug price information to help them make the best decisions for themselves and their families on how to afford prescription drugs. counterparts. Part J is written in three sections.

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