The Pharma Data

DECEMBER 16, 2020

NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. VICTORIA, British Columbia & ROCKVILLE, Md.–(

Licensing 52

Licensing Licensing Pharmaceuticals Disease 52

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 52

Vaccine FDA Approval FDA Disease 52

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

AUGUST 17, 2021

and in several global markets, including Japan and the European Union, where it is also approved for use in insulin pumps. Lyumjev ® and Humalog ® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Lyumjev is available in the U.S.

FDA Approval 52

FDA Approval FDA Doctors Production 52

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

The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec.

Small Molecule 40

Small Molecule Licensing Licensing Treatment 40

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Rescheduling Analyses, 2016 DEA noted in 2016 that a drug had a currently accepted medical use for purposes of the CSA if it was the subject of an approved new drug application (“NDA”) under the Federal Food, Drug and Cosmetic Act. FDA, Basis for the Recommendation to Reschedule Marijuana Into Schedule III of the Controlled Substances Act, 3.

FDA 69

FDA FDA Approval Treatment Drugs 69

Codon

JULY 14, 2024

Despite the initial promise of PFCs and FDA approval of a product called Fluosol-DA in 1989, PFCs have many drawbacks. The chemicals also have a short shelf life and are toxic, which led to their eventual withdrawal from the market. Patients transfused with Fluosol-DA, for example, must breathe enriched oxygen during therapy.

Production 131

Production Clinical Trials Trials Therapies 131

The Pharma Data

NOVEMBER 9, 2021

TERMS OF THE ARRANGEMENT Biohaven and Pfizer are entering into a collaboration and license agreement and affiliated sublicense agreement pursuant to which Pfizer will acquire rights to manipulate rimegepant and zavegepant outside of theU.S. In addition to the tiered double- number royalties owed to Biohaven on net deals outside of theU.S.,

Licensing 52

Licensing Licensing Treatment FDA Approval 52

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

New Drug Approvals

SEPTEMBER 8, 2024

1] Palopegteriparatide was approved for medical use in the European Union in November 2023, [2] and in the United States in August 2024. [1] 5] The FDA granted the application for palopegteriparatide orphan drug and priority review designations. [5] Food and Drug Administration (FDA) (Press release). 14 August 2024.

FDA 62

FDA International Trials FDA Approval 62

The Pharma Data

NOVEMBER 29, 2020

Y-mAbs Therapeutics has a target action date of November 30 for its Biologics License Application (BLA) for Danyelza (naxitamab) for patients with relapsed/refractory high-risk neuroblastoma. The drug was developed by researchers at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs.

FDA 52

FDA Licensing Licensing Pharmaceuticals 52

The Pharma Data

NOVEMBER 22, 2020

The FDA approved it under the brand name Gavreto on September 4. The FDA granted Breakthrough Therapy Designation to the drug for RET fusion-positive NSCLC that has progressed after platinum-based chemotherapy, and RET mutation-positive MTC that requires systemic treatment and for which there are no alternative treatments.

FDA 52

FDA Licensing Licensing Treatment 52

The Pharma Data

JANUARY 13, 2021

Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

The Pharma Data

NOVEMBER 9, 2021

Apost-marketing surveillance study of cases with RA in Japan estimated the safety of OLUMIANT 4-mg and OLUMIANT 2-mg in clinical practice and no new safety signals were linked. It’s approved in theU.S. FDA-approved labeling for OLUMIANT includes a Boxed Warning for Serious Infections, Malice, and Thrombosis.

Treatment 52

Treatment FDA Approval Licensing Licensing 52

The Pharma Data

AUGUST 6, 2020

Marketing, selling and administrative expenses increased 51% to $1.6 Cash, cash equivalents and marketable debt securities were $22.2 This approval was based on the Phase 3 CheckMate -9LA study. This approval was based on data from Part 1a of the Phase 3 Checkmate -227 study. billion, or $1.63 billion, or $1.18

Production 52

Production International Licensing Licensing 52

The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. Protalix has licensed to Pfizer Inc.

Disease 52

Disease Treatment Clinical Trials FDA 52

The Pharma Data

FEBRUARY 24, 2022

The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future.

Vaccine 52

Vaccine FDA Small Molecule Immune Response 52

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

FDA 59

FDA Production FDA Approval Licensing 59

The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 months (95 percent CI, 6.9 – NE). [7].

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Novel drug products are defined as products that have never been approved for any indication. Amanda Conti, AgencyIQ What kind of biologic products entered the market?

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

DECEMBER 8, 2020

The fully integrated pharmaceutical company creates value through China’s specialty pharmaceutical markets with focus on iron deficiency, pain management and respiratory. Cornering the untapped Chinese CNS market, SciNeuro launched with $100 million in their pocket. SciNeuro Pharmaceuticals .

RNA 52

RNA Therapies Disease Protein Expression 52

The Pharma Data

NOVEMBER 2, 2020

With newly inspired technology, and diabetic test strips already in the final stages of development, DECN products compete on a worldwide scale with legacy manufacturers currently selling to 71+ percent of a $15+ billion at-home testing market. The company’s new GenViro! Two of the company’s.

FDA 40

FDA Engineering FDA Approval Production 40

The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. billion during 2019-2023 (Technavio 2019).

FDA 52

FDA Drugs Clinical Development Disease 52

The Pharma Data

MARCH 2, 2021

The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021. The Janssen COVID-19 vaccine has not been approved or licensed by the U.S. There is no FDA-approved vaccine to prevent COVID-19. The terms of the EUA allow use of the vaccine while more data are gathered.

Vaccine 52

Vaccine Clinical Trials FDA Trials 52

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 40

Licensing Licensing Disease FDA Approval 40

The Pharma Data

DECEMBER 31, 2020

–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced that the Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies remains under review by the U.S. 1, 2021 11:59 UTC.

FDA 40

FDA FDA Approval Licensing Licensing 40

Agency IQ

APRIL 26, 2024

Sponsors should submit a completed copy of Form FDA 2253, plus any “specimens of mailing pieces and any other labeling or advertising devised for promotion of the reference product or biosimilar product” at the time of its initial publication or dissemination. Yes, the guidance confirms.

Biosimilars 40

Biosimilars Science FDA Licensing 40

The Pharma Data

DECEMBER 29, 2020

“We anticipate that the BRIDGE study results will be used to support the filing of a Marketing Authorization Application (MAA) with the European Medicines Agency, and having completed the analysis, we have taken an important step in the preparations for the application.” Protalix has licensed to Pfizer Inc.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

NOVEMBER 20, 2020

The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process.

Therapies 52

Therapies FDA Clinical Trials Hospitals 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

OCTOBER 29, 2020

Data support baricitinib’s ongoing Phase 3 program and potential to be the first approved medicine for people living with alopecia areata (AA). . Baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed by Lilly under license from Incyte. INDIANAPOLIS , Oct.

Therapies 52

Therapies Treatment Disease Clinical Trials 52

The Pharma Data

OCTOBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

The Pharma Data

OCTOBER 27, 2020

The FDA grants Orphan Drug designation to drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States.

Disease 40

Disease FDA Treatment Clinical Trials 40

Agency IQ

NOVEMBER 3, 2023

Keep in mind that this is the definition developed by ISAPP – there is no regulatory body confirming that any product on the market referred to as a “probiotic” has actually demonstrated benefits in clinical research. Most of the strains that are found on the market were developed in a lab and are marketed as proprietary ingredients.

Therapies 40

Therapies Science FDA Production 40

The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. When Lucentis ® (Ranibizumab) received FDA approval in late June 2006, the new macular degeneration drug was celebrated as a major medical breakthrough.

Science 40

Science Virus Treatment Disease 40

The Pharma Data

DECEMBER 15, 2020

In November , the European Medicines Agency agreed to review the Marketing Authorization Application for avacopan for the treatment of patients with ANCA-associated vasculitis. Patients treated with avacopan achieved both primary endpoints of clinical remission at 26 and 52 weeks. Oral, Small Molecules.

Disease 52

Disease Clinical Trials Small Molecule Trials 52