The Pharma Data

OCTOBER 9, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Application utilizes extrapolation-based strategy across existing breadth of STELARA data in patients living with this chronic inflammatory disease.

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The Pharma Data

APRIL 8, 2021

“Since the beginning of the pandemic, we have worked to expand the science behind COVID-19 therapies,” said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. Baricitinib, an oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. See the full Prescribing Information here.

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for PREVNAR 20 for the prevention of invasive disease and pneumonia in adults age 18 years or older. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Clin Infect Dis.

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The Pharma Data

MAY 4, 2021

ViiV Healthcare was granted Breakthrough Therapy Designation (BTD) for long-acting cabotegravir in November 2020 based on efficacy and safety results from HPTN 083. [1] ViiV Healthcare was granted Breakthrough Therapy Designation (BTD) for long-acting cabotegravir in November 2020 based on efficacy and safety results from HPTN 083. [1]

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Agency IQ

JULY 28, 2023

September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic.

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. It is approved in the U.S.

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The Pharma Data

OCTOBER 29, 2020

“Patients with alopecia areata deal with unpredictable and long-lasting episodes of hair loss and many don’t find relief from the therapies that are currently used,” said Lotus Mallbris, M.D., Baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed by Lilly under license from Incyte.

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The Pharma Data

MARCH 4, 2021

Baricitinib has received Breakthrough Therapy designation from the U.S. ” Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. Test patients for latent TB before initiating Olumiant and during therapy. Food and Drug Administration (FDA) for the treatment of AA.

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The Pharma Data

APRIL 6, 2021

Ongoing research for baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, in adult and pediatric AD, alopecia areata (AA), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), COVID-19 and for its approved indication for rheumatoid arthritis (RA) continues.

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The Pharma Data

AUGUST 3, 2021

Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. The most frequently used therapies were corticosteroids (79% of patients, mostly dexamethasone) and remdesivir (19% of patients). BC HCP EUA ISI 28JUL2021.

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LifeSciVC

OCTOBER 28, 2024

In-licensing molecules from other players, due to a partner’s strategic shifts, budget challenges, or geographic access, can be a great way to jumpstart early stage companies around more advanced assets. From 2009-2012, spec pharma and later stage asset plays were back in vogue, and platforms were really tough to gain market traction.

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The Pharma Data

JULY 29, 2021

The most frequently used therapies were corticosteroids (79% of patients, mostly dexamethasone) and remdesivir (19% of patients). Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. BC HCP EUA ISI 28JUL2021.

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The Pharma Data

FEBRUARY 25, 2021

Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac , its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. Tick-borne encephalitis virus in wild rodents in winter, Finland, 2008-2009.

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Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. Nature Reviews Molecular Cell Biology (2009). Nature Biotechnology (2009). Nature Methods (2009). Nature Reviews Molecular Cell Biology (2009).

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Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Last edit: 13 September 2023 Progress in biology is arguably moving faster today than at any point in the course of human history. Nature Reviews Molecular Cell Biology (2009). Nature Biotechnology (2009). Nature Methods (2009). & Weiss R. & Ellis T.

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Codon

FEBRUARY 23, 2025

After decades of research into therapies and preventive measures, though, global AIDS deaths have now fallen to about 600,000 annually. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. They’ve created voluntary licensing agreements with six other pharmaceutical manufacturers (Dr.

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. The plaintiffs’ causation allegations foundered in Himes because the treating physician did not believe that the claimed risks of electroconvulsive therapy were all that big of a deal, and thus did not warn about it. Wyeth , 2009 WL 3244890, at *?? (Pa. 3d 572 (Pa.

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