2009, FDA Approval and Licensing - Drug Discovery Digest

FDA Knows Its Own Strength—and It Includes Concentration

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Karst — While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. mL) in addition to Original Concentration Humira.”

FDA

FDA Biosimilars Production Regulations

Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis

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. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).

FDA Approval

FDA Approval FDA Treatment Pharmaceutical Companies

Advanced Bionics Receives FDA Approval for Marvel Cochlear Implant Platform and World’s First Sound Processor for Children

The Pharma Data

DECEMBER 9, 2020

.–( BUSINESS WIRE )– Advanced Bionics (AB) , a global leader in cochlear implant technology, in collaboration with Phonak, a leading provider of life-changing hearing solutions, receives FDA approval and announces it is bringing Marvel hearing technology to Advanced Bionics cochlear implant wearers. Life is on. Gifford, R.

FDA Approval

FDA Approval FDA Production Licensing

Lilly accelerating baricitinib’s availability in India following receipt of permission for restricted emergency use as a COVID-19 therapy via donations and licensing agreements | Eli Lilly and Company

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. It is approved in the U.S.

Licensing

Licensing Licensing Therapies Laboratories

Nearly 40% of Adults with Alopecia Areata Taking OLUMIANT® 4-mg Saw at Least 80% Scalp Hair Coverage at 52 Weeks in Lilly’s Pivotal Phase 3 Studies

The Pharma Data

MARCH 27, 2022

. “We’re excited OLUMIANT may be a potential first-in-disease medicine approved this year for adults with severe alopecia areata.” OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. It is approved in the U.S. ” About OLUMIANT®.

Licensing

Licensing Licensing FDA Approval Disease

OLUMIANT® Long-Term Safety Profile Established Up to 9.3 Years in Integrated Analysis of More Than 3,700 Patients with Rheumatoid Arthritis

The Pharma Data

NOVEMBER 9, 2021

FDA-approved labeling for OLUMIANT includes a Boxed Warning for Serious Infections, Malice, and Thrombosis. Marketing authorization for the treatment of rehabilitated cases with COVID-19 has been granted for OLUMIANT in multiple countries. See the full Prescribing Information then.

Treatment

Treatment FDA Approval Licensing Licensing

Lilly and Incyte’s baricitinib reduced deaths among patients with COVID-19 receiving invasive mechanical ventilation

The Pharma Data

AUGUST 3, 2021

For more information about the authorized use of baricitinib in COVID-19 and mandatory requirements of the EUA, please see the FDA Letter of Authorization , Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers ( English ) ( Spanish ). It is approved in the U.S. Serious Side Effects.

Hospitals

Hospitals Licensing Licensing FDA Approval

FDA broadens existing emergency use of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19 requiring oxygen

The Pharma Data

JULY 29, 2021

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. It is approved in the U.S. Serious Side Effects.

Hospitals

Hospitals FDA Laboratories Licensing

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. It is approved in the U.S.

Therapies

Therapies Hospitals FDA Approval Long-Term Care Facilities

New Drug Application for baricitinib for the treatment of moderate to severe atopic dermatitis

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.

Treatment

Treatment Clinical Trials Therapies Drugs

Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata

The Pharma Data

OCTOBER 29, 2020

“Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients,” said Brett King , MD, PhD associate professor of Dermatology at Yale School of Medicine.

Therapies

Therapies Treatment Disease Clinical Trials

U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

Vaccine

Vaccine FDA Approval FDA Disease

Phase 3 COV-BARRIER study of baricitinib in hospitalized COVID-19 patients

The Pharma Data

APRIL 8, 2021

Baricitinib, an oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. It is approved and commercially available as OLUMIANT in the U.S. in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. Warnings and Precautions ?in

Hospitals

Hospitals FDA Approval Laboratories FDA

DARPA Neurotechnology: The Deep Dive

Codon

MARCH 28, 2023

In 2009, the USC professor received millions from the Defense Advanced Research Projects Agency, or DARPA, to build a device that plugs into the brain and enhances memory recall. The first project, REMIND, began in 2009. View our database of DARPA neurotechnology projects online. “I am a brain, Watson.

Engineering

Engineering Research Science FDA Approval

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 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.

Regulations

Regulations FDA Science Production

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

In 2007, the FDA held a public workshop to hear from the public about the Medication Guides system; per the agency , “the public testified that the Medication Guides distribution processes needed improvement” and that it should be “shorter and easier to read.” After all, companies already have FDA-approved labels.

FDA

FDA FDA Approval Regulations Production

Baricitinib is First JAK-Inhibitor to Demonstrate Hair Regrowth in Phase 3 Alopecia Areata (AA) Trial

The Pharma Data

MARCH 4, 2021

There are currently no FDA-approved treatments for AA. ” Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is approved and commercially available as OLUMIANT in the U.S. OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S.

Trials

Trials Therapies Treatment Clinical Trials

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. In Bruesewitz v. Wyeth LLC , 562 U.S. at 237-38. Wyeth Laboratories, Inc. , 2d 397 (6th Cir. 2d at 401.

FDA

FDA FDA Approval Testimonials Vaccine

Drug Discovery Digest

FDA Knows Its Own Strength—and It Includes Concentration

Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis

Trending Sources

Advanced Bionics Receives FDA Approval for Marvel Cochlear Implant Platform and World’s First Sound Processor for Children

Lilly accelerating baricitinib’s availability in India following receipt of permission for restricted emergency use as a COVID-19 therapy via donations and licensing agreements | Eli Lilly and Company

Nearly 40% of Adults with Alopecia Areata Taking OLUMIANT® 4-mg Saw at Least 80% Scalp Hair Coverage at 52 Weeks in Lilly’s Pivotal Phase 3 Studies

OLUMIANT® Long-Term Safety Profile Established Up to 9.3 Years in Integrated Analysis of More Than 3,700 Patients with Rheumatoid Arthritis

Lilly and Incyte’s baricitinib reduced deaths among patients with COVID-19 receiving invasive mechanical ventilation

FDA broadens existing emergency use of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19 requiring oxygen

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

New Drug Application for baricitinib for the treatment of moderate to severe atopic dermatitis

Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata

U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

Phase 3 COV-BARRIER study of baricitinib in hospitalized COVID-19 patients

DARPA Neurotechnology: The Deep Dive

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Baricitinib is First JAK-Inhibitor to Demonstrate Hair Regrowth in Phase 3 Alopecia Areata (AA) Trial

The FDA and Feasible Alternative Designs

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