The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

FDA Approval 40

FDA Approval FDA Treatment Clinical Trials 40

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.

Licensing 40

Licensing Licensing Therapies Laboratories 40

The Pharma Data

OCTOBER 26, 2020

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). News information is not all-inclusive and updates are published once a week on Tuesdays. . . Please read more here. .

Vaccine 52

Vaccine FDA Approval Clinical Trials FDA 52

Codon

JULY 14, 2024

This means presenting the growth factors, cytokines, and hormones in the right sequence in an environment that’s low in oxygen. Despite the initial promise of PFCs and FDA approval of a product called Fluosol-DA in 1989, PFCs have many drawbacks. 5 There is a caveat in the linked studies, however.

Production 140

Production Clinical Trials Trials Therapies 140

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. Pfizer Inc.

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding.

FDA 40

FDA Pharmacy Drugs Production 40

The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer. [vii]

FDA 52

FDA FDA Approval Treatment DNA 52

The Pharma Data

DECEMBER 20, 2020

On May 14, the company presented data from the vibegron EMPOWUR 52-week extension study and data by age groups from the 12-week placebo-controlled EMPOUR study at the 2020 American Urological Association Annual Meeting. and Europe, including Russia. Actinic Keratosis is a common skin condition caused by UV light damage. Most Read Today.

FDA 52

FDA FDA Approval Licensing Licensing 52

The Pharma Data

JANUARY 21, 2021

Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. Global Head, Janssen Research & Development, Johnson & Johnson.

FDA Approval 52

FDA Approval Treatment RNA FDA 52

The Pharma Data

NOVEMBER 9, 2021

An operation for the blessing of rimegepant is presently under review by the European Medicines Agency and several fresh nonsupervisory authorities outside of theU.S. “ An operation for the blessing of rimegepant is presently under review by the European Medicines Agency and several fresh nonsupervisory authorities outside of theU.S. “

Licensing 52

Licensing Licensing Treatment FDA Approval 52

The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 4] , [5] , [6].

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

OCTOBER 27, 2021

The FDA has also granted precedence review to the company’s sBLA for Kymriah in adult cases with r/ r FL. Data from the trial was presented before this time as an oral donation during the 2021 Annual American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting.

FDA 52

FDA Treatment Trials FDA Approval 52

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

As FDA explains, Boehringer’s request would allow its “Cyltezo (adalimumab-adbm) injection, which contains the same total content of drug substance and same concentration as Original Concentration Humira (e.g., FDA’s licensure of IMLANDI (adalimumab-ryvk), and in a 40 mg/0.4 mL) in addition to Original Concentration Humira.”

FDA 59

FDA Biosimilars Production Regulations 59

The Pharma Data

AUGUST 19, 2021

The application will be reviewed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) under the centralized licensing procedure for all 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein. Additional data from the CAPELLA study will be presented at a future scientific conference.

Marketing 52

Marketing Treatment FDA FDA Approval 52

New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] “FDA Approves New Drug for Ulcerative Colitis” Medscape.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

FDA Law Blog: Biosimilars

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)

FDA 52

FDA FDA Approval Licensing Licensing 52

The Pharma Data

APRIL 26, 2022

These data were presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022). Veklury was approved by the FDA in October 2020, for adults and pediatric patients 12 years of age and older and weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization. Gilead Sciences, Inc.

Treatment 52

Treatment Hospitals Science Licensing 52

The Pharma Data

MARCH 4, 2021

There are currently no FDA-approved treatments for AA. Detailed results from the BRAVE program will be presented at an upcoming medical conference and published in a peer-reviewed journal later this year. ” Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly.

Trials 52

Trials Treatment Therapies Clinical Trials 52

The Pharma Data

AUGUST 3, 2021

” Lilly intends to publish detailed results from this additional sub-study in a peer-reviewed journal and present the findings at a medical meeting in the coming months. Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is approved in the U.S. European Union and other geographies.

Hospitals 52

Hospitals FDA FDA Approval Licensing 52

The Pharma Data

AUGUST 3, 2021

today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1?

Treatment 52

Treatment FDA FDA Approval Therapies 52

The Pharma Data

JUNE 28, 2021

The Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval.

Therapies 40

Therapies Disease Treatment FDA Approval 40

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 52

Treatment Drugs Clinical Trials Therapies 52

The Pharma Data

JANUARY 13, 2021

Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019, who have recently initiated a Phase 1 study with their formulation.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

The Pharma Data

OCTOBER 29, 2020

30, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT ® ) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. INDIANAPOLIS , Oct.

Therapies 52

Therapies Treatment Disease Clinical Trials 52

Agency IQ

APRIL 26, 2024

For these types of materials, FDA’s Office of Prescription Drug Promotion (OPDP) is primarily concerned with ensuring that advertisements are not “false or misleading,” that they include important information about a product’s benefits and risks, and present information in a way that is comprehensible to its intended audience.

Biosimilars 40

Biosimilars Science FDA Licensing 40

The Pharma Data

NOVEMBER 9, 2021

Eli Lilly and Company (NYSE LLY) and Incyte (NASDAQ INCY) will present these results, along with real- world safety results from cases with RA in Japan, at ACR Convergence 2021, the American College of Rheumatology’s virtual periodic meeting taking place November 3-9, 2021. It’s approved in theU.S.

Treatment 52

Treatment FDA Approval Licensing Licensing 52

The Pharma Data

JANUARY 5, 2021

based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C. A live webcast presentation can also be accessed via the Investors section of the Radius’ corporate web site at: [link].

Disease 52

Disease FDA Approval Clinical Trials Trials 52

The Pharma Data

JUNE 7, 2022

. “We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval.” With these data, Lilly plans to submit a Biologics License Application (BLA) to the U.S. Almirall S.A.’s

Trials 40

Trials Clinical Trials Licensing Licensing 40

The Pharma Data

MARCH 27, 2022

These 52-week pooled analyses demonstrate continued improvement in scalp, eyebrows and eyelash hair regrowth from 36-week results published today in the New England Journal of Medicine and presented at the 2021 European Academy of Dermatology and Venereology (EADV) Congress. It is approved in the U.S. ” About OLUMIANT®.

Licensing 40

Licensing Licensing Disease FDA Approval 40

Codon

APRIL 2, 2023

This paper presents a massive CRISPR screen, in Arabidopsis, that identifies many genes with previously "hidden functions." Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms. Nature Plants. Read The first step in plant gene-editing is to figure out which genes to edit.

DNA 52

DNA RNA Engineering Licensing 52

The Pharma Data

JULY 15, 2021

The study’s main findings, which had been previously presented at the 62 nd American Society of Hematology (ASH) Annual Meeting, were published along with new subgroup analyses showing favorable overall response rate (ORR) at week 24 for Jakavi across all major subgroups, including baseline individual organ involvement 1. Jakavi vs. 16.5%

Treatment 52

Treatment Disease Therapies FDA Approval 52

The Pharma Data

OCTOBER 27, 2020

Food and Drug Administration (FDA) has granted Orphan Drug and Rare Pediatric Disease (RPD) designations to PBKR03 for the treatment of Krabbe disease (Globoid Cell Leukodystrophy). Passage Bio expects to initiate a Phase 1/2 trial for PBKR03 in the first half of 2021. president and chief executive officer of Passage Bio.

Disease 40

Disease FDA Treatment Clinical Trials 40

The Pharma Data

FEBRUARY 4, 2021

“We successfully completed the transformative Allergan acquisition and delivered another year of strong results in 2020, despite the challenges presented by the global pandemic,” said Richard A. NORTH CHICAGO, Ill., Gonzalez , chairman and chief executive officer, AbbVie. ” Fourth-Quarter Results.

Production 52

Production Clinical Trials International Small Molecule 52

The Pharma Data

NOVEMBER 5, 2020

resolving patent litigation brought in response to Teva’s Abbreviated New Drug Application, seeking approval to market a generic version of Xtampza ER prior to the expiration of Collegium’s applicable patents. FDA approval, and customary exceptions). Reached a settlement with Teva Pharmaceutical USA, Inc.

Pharmaceuticals 52

Pharmaceuticals Production Marketing Pharmaceutical Companies 52

The Pharma Data

AUGUST 3, 2021

References in this release to “non-GAAP” measures, measures presented “on a non-GAAP basis” and to “free cash flow” (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. In May, the U.S. Tezepelumab. Non-GAAP Financial Measures.

Biosimilars 52

Biosimilars Production Treatment FDA 52

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). REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Oncology Program.

Production 40

Production Trials FDA FDA Approval 40

Agency IQ

JUNE 16, 2023

This proposed revision to 21 CFR 807 is for consistency with FDA’s current regulations under 21 CFR part 1271, subpart A. Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement.

Regulations 40

Regulations FDA Science Production 40