The Pharma Data

DECEMBER 16, 2020

CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. These statements relate to future events, future expectations, plans and prospects. Any forward-looking statements contained in this press release speak only as of its date.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 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. Biohaven Forward-looking statements.

Small Molecule 40

Small Molecule Licensing Licensing 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

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119

Therapies FDA FDA Approval Treatment 119

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

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 52

FDA Approval FDA Treatment Pharmaceutical Companies 52

The Pharma Data

JULY 29, 2021

It is not currently approved for use in COPD anywhere in the world. The following information is based on the US Prescribing Information for Nucala in licensed indications only. Discontinue Nucala in the event of a hypersensitivity reaction. Important safety information. CONTRAINDICATIONS. Hypersensitivity reactions (e.g.,

FDA Approval 52

FDA Approval FDA Clinical Trials Treatment 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

The Pharma Data

NOVEMBER 9, 2021

Among those treated with OLUMIANT, the overall prevalence rate of adverse events per 100 patient times of exposure was22.6, and the prevalence rate of serious adverse events was7.4. Priority check events included herpes zoster (3, n = 100), liver dysfunction (3, n = 100), serious infection (1.5, It’s approved in theU.S.

Treatment 52

Treatment FDA Approval Licensing Licensing 52

The Pharma Data

AUGUST 3, 2021

By Day 28, the frequency of adverse events, serious adverse events and serious infections were similar in the baricitinib group (88%, 50% and 44%, respectively) compared to placebo (95.9%, 71.4% Venous thromboembolic events were reported in 6 percent of patients treated with baricitinib and 6.1 It is approved in the U.S.

Hospitals 52

Hospitals Licensing Licensing FDA 52

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. The most common adverse events observed were injection site reactions.

Marketing 52

Marketing Treatment FDA FDA Approval 52

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 52

Therapies Hospitals FDA Approval Long-Term Care Facilities 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

AUGUST 19, 2021

The majority of treatment-related adverse events (AEs) were Grade 1-2. RYBREVANT TM (amivantamab-vmjw) received accelerated approval by the U.S. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. All events were Grade 1-2. as the primary endpoint.

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

MAY 31, 2022

if approved Acceptance marks another important step in advancing Dupixent for a broad range of diseases with underlying type 2 inflammation. The target action date for the FDA decision is September 30, 2022. The adverse event more commonly observed with Dupixent was conjunctivitis.

FDA 52

FDA Disease Trials FDA Approval 52

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. WARNINGS AND PRECAUTIONS.

Treatment 52

Treatment Clinical Trials Drugs Therapies 52

The Pharma Data

NOVEMBER 2, 2020

Currently, Amazon only offers special license for point of care and professional use medical products, which would preclude the individual use GenViro kit from being available on Amazon, even after FDA approval is secured. Two of the company’s. CONTACT INFORMATION: Decision Diagnostics Corp.

FDA 52

FDA Engineering FDA Approval International 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 FDA Approval Disease 40

The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. The safety results of these trials were generally consistent with the known safety profile of Dupixent in its approved indications. The most common adverse event observed with Dupixent, in Part A and Part B, was injection site reactions.

FDA 52

FDA Treatment FDA Approval Disease 52

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. versus placebo). WARNINGS AND PRECAUTIONS.

Therapies 52

Therapies Treatment Disease Clinical Trials 52

The Pharma Data

MAY 2, 2022

Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances.

Pharmaceuticals 52

Pharmaceuticals Production Biosimilars Treatment 52

The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Detailed results from this Phase 3 trial will be published later this year.

FDA 52

FDA Disease FDA Approval Treatment 52

The Pharma Data

DECEMBER 17, 2020

In the initial 275 patients, rates of adverse events (AEs) were similar among groups. Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

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 FDA Approval Treatment 40

The Pharma Data

FEBRUARY 13, 2022

If approved, Dupixent will be the first biologic medicine available in the U.S. The most common adverse events that were more commonly observed with Dupixent included conjunctivitis and herpes viral infections. to treat uncontrolled moderate-to-severe atopic dermatitis for these young children.

FDA 40

FDA Disease Treatment FDA Approval 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. PharmaDrug Inc.

FDA 52

FDA Drugs Clinical Development Pharmaceutical Companies 52

The Pharma Data

DECEMBER 29, 2020

It is important to remember that while the virology results from this analysis of hospitalized patients were robust, the clinical efficacy data are based on a small data set of events and cannot be viewed as conclusive at this stage. Casirivimab and imdevimab injection is not FDA approved for any use. high dose, 0.9%

Hospitals 52

Hospitals Trials Clinical Trials Production 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

DECEMBER 8, 2020

Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. Source: Moderna, Inc. . Source link.

Vaccine 40

Vaccine RNA Government Clinical Trials 40

NIH Director's Blog: Drug Development

JUNE 14, 2016

Scott and colleagues focused on six genes that encode potential drug targets licensed or in development by GlaxoSmithKline for the treatment of obesity or diabetes. That’s critical considering that just 1 in 10 drug candidates entering human clinical trials successfully goes on to receive FDA approval [5]. Novo Nordisk.

Drugs 52

Drugs Disease Drug Development Clinical Trials 52

The Pharma Data

JANUARY 12, 2021

Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

Government 52

Government Hospitals Virus Production 52

The Pharma Data

OCTOBER 27, 2020

RPD designation is granted by the FDA to encourage treatments for serious or life-threatening diseases primarily affecting children 18 years of age and younger and fewer than 200,000 people in the United States.

Disease 40

Disease FDA Treatment Clinical Trials 40

The Pharma Data

MAY 6, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years. Pfizer Inc.

FDA Approval 52

FDA Approval Licensing Licensing FDA 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

DECEMBER 5, 2020

The most common adverse events (AEs) were cytokine release syndrome (CRS; 39%; n=19), anemia (37%; n=18), fatigue (35%; n=17), nausea (31%; n=15), pyrexia (31%; n=15) and back pain (27%; n=13). 6 months of follow-up, 83% (10 of 12 patients) have ongoing responses for up to 13 months at the time of analysis.

Production 40

Production Trials Treatment Pharmaceuticals 40

The Pharma Data

DECEMBER 10, 2020

The most common adverse events of BNT162b2 were transient, mild to moderate pain at the injection site, fatigue and headache, and these generally resolved within two days. Rates of serious adverse events were similar between vaccine and placebo groups (0.6% BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History.

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52