The Pharma Data

OCTOBER 1, 2021

Sotatercept is a Potentially First-In-Class Therapy in Phase 3 Development for the Treatment of Pulmonary Arterial Hypertension. Acquisition Complements and Strengthens Merck’s Cardiovascular Pipeline. The transaction is predicted to shut within the fourth quarter of 2021. About Merck.

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The Pharma Data

FEBRUARY 8, 2021

In addition, health-related quality of life (HRQoL), per total Functional Assessment of Cancer Therapy–Prostate (FACT-P), continued to be maintained with ERLEADA ®. Based on these data, ADT alone should no longer be considered sufficient for patients with advanced, castration-sensitive disease.”. About ERLEADA ® (apalutamide). 10 months. [5]

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Drug Discovery World

FEBRUARY 14, 2023

DDW Editor Reece Armstrong speaks to Peter Walters, Director Advanced Therapies, CRB, and Grace Linton , Director Process Architecture, CRB about automation within laboratory settings and its effect on the pharmaceutical industry. PW: At the moment, the cell and gene therapy sector is understaffed.

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Codon

JULY 14, 2024

While blood doesn’t fit neatly into the various definitions of an organ , it still comprises a discrete system with specific functions. From Early Transfusion to Component Therapy The earliest documented attempts at blood transfusions involved the transfer of blood from animals to humans in the 17 th century. Always free.

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The Pharma Data

AUGUST 19, 2020

August 19, 2020 – Johnson & Johnson (NYSE:JNJ) today announced it has entered into a definitive agreement to acquire Momenta Pharmaceuticals, Inc. Momenta), a company that discovers and develops novel therapies for immune-mediated diseases, in an all cash transaction for approximately $6.5 NEW BRUNSWICK, N.J.,

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Drug Discovery World

AUGUST 1, 2023

As per a definition provided by AstraZeneca: “Once inside, ASOs bind with high specificity to target mRNA or pre-mRNA, inducing its degradation – effectively silencing it – to prevent its translation into a detrimental protein product. Harwell, a science and innovation campus in Oxfordshire, was selected for the location.

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The Pharma Data

AUGUST 19, 2020

19, 2020 /PRNewswire/ — Johnson & Johnson (NYSE:JNJ) today announced it has entered into a definitive agreement to acquire Momenta Pharmaceuticals, Inc. Momenta), a company that discovers and develops novel therapies for immune-mediated diseases, in an all cash transaction for approximately $6.5 NEW BRUNSWICK, N.J. ,

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Agency IQ

JANUARY 19, 2024

Though some biological products may be developed using PCCs, such as viral vaccines, these cultures are also commonly used for in vitro experiments that seek to mimic in vivo conditions as closely as possible (e.g., for renal function studies ). Secondly, their use minimizes both the risk and the impact of viral contamination.

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Agency IQ

JUNE 21, 2024

Modeled on the Operation Warp Speed vaccine development communications approach, the pilot aims to test out a rapid communications approach for accelerating rare disease drug development. What the program means for sponsors: As explained by the FDA, the program seems akin to a more intensive version of Breakthrough Therapy Designation.

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The Pharma Data

OCTOBER 9, 2021

years of exposure 3 Design of a new open-label study assessing immune response to SARS-CoV-2 mRNA vaccines in MS-patients treated with Kesimpta 4 , and new findings from open-label study assessing immune response to SARS-CoV-2 mRNA vaccines in secondary progressive MS (SPMS) patients treated with Mayzent will be presented 5.

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Agency IQ

JUNE 9, 2023

Though some of the concepts can be applied to more complex products such as biologics and cell and gene therapies, these products are more difficult to assess as many animal species that can be used for in vivo testing of small molecule products are not suitable, as their immune systems are not comparable to humans.

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Agency IQ

MAY 31, 2024

The intended benefit for sponsors of this approach is that products making use of designated platforms would be eligible to receive expedited development benefits from the FDA, including access to early-stage development meetings with regulators. preliminary evidence” and “significant efficiencies”) in actually securing a designation.

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The Pharma Data

JUNE 2, 2022

In addition to an individual’s genetic predisposition, estrogens are well known to play an important role in the regulation of fibroid growth. suffer from symptoms of uterine fibroids, i and an estimated three million women are inadequately treated by current medical therapy. An estimated five million women in the U.S.

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The Pharma Data

JUNE 18, 2021

“Combining our novel therapies to deliver a new potential treatment is an example of AbbVie’s innovative approach to identify options for difficult-to-treat blood cancers, like CLL,” said Mohamed Zaki , M.D., IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. have kidney or liver problems.

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The Pharma Data

MAY 13, 2021

That’s right, if you’re suffering from pain, then “Red Light Therapy” is about to become your new best friend. But what actually is “Red Light Therapy”? Low Level Light therapy (LLLT), is FDA approved for treating conditions such as chronic joint pain and slow to heal wounds. (3). You see, Red Light Therapy is expensive.

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Agency IQ

SEPTEMBER 22, 2023

In 1972, when regulatory authority for biologic products was transferred from the National Institutes of Health (NIH) to the FDA, the agency extended the two-study framework to biologic regulation as well. The Heckler case helped to refine the definition of “substantial evidence” in two important ways.

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The Pharma Data

MAY 13, 2021

I’d always assumed that Jen just did estrogen replacement therapy or something like that…. Estrogen therapy is expensive and scary as heck. It’s for this reason that so many women are being pushed towards hormone therapies once they enter their 40s and 50s…. Or risky estrogen therapies…. Jenn told me.

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The Pharma Data

AUGUST 24, 2020

The announcement came a day after President Donald Trump accused the FDA of impeding the rollout of vaccines and therapeutics for political reasons, and on the eve of the Republican National Convention, where Mr Trump will launch his campaign to win a second term in the White House. . Balance of risks.

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