The Pharma Data

NOVEMBER 9, 2020

“This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic,” said David A. government’s allocation program.

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The Pharma Data

JANUARY 15, 2021

Achieving hematologic complete response is an important treatment goal, and today’s approval based on this clinical endpoint will provide doctors and the larger medical community with a new option to treat newly diagnosed patients.”. Davis Myeloma and Amyloid Program, Tufts Medical Center, and ANDROMEDA study investigator.

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The Pharma Data

JANUARY 4, 2021

We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. relevant government policies and regulations relating to our industry. Amorette Barber of Longwood University will be heading up our chPD1 program. “We believe Prof. Link to her profile: [link].

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Codon

JULY 27, 2023

There’s a TV show where a bunch of doctors are walking through a hospital corridor. government funded a massive effort: To sterilize millions of screwworms , initially with hospital x-ray machines, and air drop them over Florida, Texas, and elsewhere. All the colors had the same brightness. From McKyton et al. in Current Biology.

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Codon

JULY 27, 2023

There’s a TV show where a bunch of doctors are walking through a hospital corridor. government funded a massive effort: To sterilize millions of screwworms , initially with hospital x-ray machines, and air drop them over Florida, Texas, and elsewhere. All the colors had the same brightness. From McKyton et al. in Current Biology.

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The Pharma Data

MAY 13, 2021

Description: How A Handsome Doctor From Texas Saved My Life. I could hear doctors and nurses speaking in hushed tones…. I gave up carbs, fats, alcohol, meat – just as the doctor ordered…. That took me through the dark underbelly of the multi-billion dollar weight loss industry controlled by government and elite societies….

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The Pharma Data

NOVEMBER 4, 2020

“The third quarter was a productive but challenging quarter for Amarin as total net revenue grew to record levels reflecting increased prescription levels for VASCEPA, despite many patients not yet returning to their doctors’ offices for preventative healthcare due to the global pandemic,” stated John F. million and $8.9 million and $5.7

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Agency IQ

MAY 10, 2024

Most of the 80-page guidance lists specific “actions” in tables to address these different risks, recommending granular action items related to governance, oversight, scientific integrity, mitigating bias, and ensuring “operator and practitioner proficiency.” Notably, NIST is requesting comment on the list itself.

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The Pharma Data

MAY 15, 2021

Military and any and all government institutions do not in any way, shape or form endorse the PentagonFit Tracker or any products we create. Dr. Anne Peterson is a pen name for the doctor that endorses this product, to protect their privacy as they are actively practicing medicine. Please also note that The Pentagon, U.S.

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The Pharma Data

MAY 4, 2021

down 21%, driven by a negative impact from the COVID-19 pandemic resulting in a decline in patient visits to doctors for preventative health purposes, as well as the loss of patent protection in the U.S. government to 300 million. government will pay $1.95 7) BNT162b2 has not been approved or licensed by the U.S.

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The Pharma Data

MARCH 26, 2021

It marks an important milestone in the vaccine roll-out, as it could allow storage in pharmacies to support vaccinations at local practices/doctors’ offices. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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Agency IQ

MAY 28, 2024

Companies are paying for performance here, and it’s reasonable for them to expect performance” remarked Burgess, “And then we hear other discussions that the FDA wants to vastly expand its authority into licensing laboratory developed tests. If you don’t have the staff to do this, how are you going to have the staff to do that?”

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The Pharma Data

NOVEMBER 12, 2020

The restrictions will take effect Friday, and Cuomo said that local governments will be responsible for enforcing them. The curfew will apply only to bars and restaurants licensed by the state liquor authority, and restaurants can continue to provide takeout and delivery after 10 p.m., government. the Times reported.

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The Pharma Data

MAY 4, 2021

Big three drug distributors blame doctors, regulators in trial over opioid epidemic ( Reuters ). Gilead sues Russia over a compulsory license issued to a company making remdesivir ( STAT ). Gilead sues Russia over a compulsory license issued to a company making remdesivir ( STAT ).

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

The regulated cannabis marketplace brings in billions of dollars in revenue into state and federal governments, with predictions that cannabis sales will exceed $53 billion by 2027. Studies have found that marijuana access has public health benefits by reducing the rates of opioid use and opioid deaths.

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Codon

FEBRUARY 23, 2025

government issued a limited waiver that let PEPFAR resume HIV treatments abroad, pending further guidance. At a time when government HIV initiatives look uncertain, lenacapavir could prove a much-needed failsafe. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. By February, the U.S.

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Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. The case was governed by North Carolina substantive law, and NC rejects strict liability altogether. Polansky v. UnitedHealthcare, Inc. ,

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Drug & Device Law

SEPTEMBER 29, 2023

The defendant was a “naturopathic doctor” (which is new to us, but apparently is a licensed professional who treats patients using mainly natural remedies) who had a prior misdemeanor conviction for selling misbranded drugs. The latter is where the government got the defendant in Marschall. 21 U.S.C. § Marschall , at *7.

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Drug & Device Law

MAY 26, 2023

Both talk a fair amount about “commerce” and the respective roles of the states and federal government. You never need an authorization from a licensed professional to buy pork or fireworks. They look a lot like they are analyzing preemption, the DCC, or the plain old CC. Prescription drugs are not.

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Drug & Device Law

MAY 19, 2023

at *1, by threatening to revoke the license, and jail for at least three years, any West Virginia physician so bold as to prescribe the plaintiff’s FDA-approved drug for its FDA-approved use. That argument contravened the standing holdings of just about every other abortion case in history. See also GenBioPro, Inc. Sorsaia , C.A.

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Drug & Device Law

AUGUST 8, 2022

Apparently, a fraudulent foreign-trained “doctor” treated the plaintiffs, none of whom claimed malpractice or any physical injury whatsoever. Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. 23 in its current form. at *3) Rule 23(c)(4) partial class.

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Drug & Device Law

JUNE 13, 2022

That requirement comes with an exception: Provided, however , That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Bard, Inc. , 3d 1272 (11th Cir.

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