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 Draft Guidance III.B.2(e)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

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

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. Source link.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

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

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

New Drug Approvals

DECEMBER 16, 2023

2 This is of particular importance to PNH, where one of the disease hallmarks is the mutation of the PIGA gene. [1] Research In a clinical study with twelve participants, iptacopan as a single drug led to the normalization of hemolytic markers in most patients, and no serious adverse events occurred during the 12-week study. [5]

FDA 62

FDA Small Molecule FDA Approval Treatment 62

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 Treatment FDA Approval 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 40

FDA Engineering FDA Approval Production 40

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. We look forward to supporting Radius through our U.S. Davis, executive chairman of Benuvia. Disease Highlights.

Disease 52

Disease FDA Approval Clinical Trials Trials 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 Trials Licensing 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 Treatment Disease 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

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

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

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

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 29, 2020

PRX-102 was well-tolerated in the study, with all adverse events being transient in nature without sequelae. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea. Protalix has licensed to Pfizer Inc. mL/min/ 1.73m 2 in males, and 86.14 nM and 13.81

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

JANUARY 12, 2021

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 52

Vaccine RNA Clinical Trials Science 52

The Pharma Data

JANUARY 6, 2021

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 52

Vaccine RNA FDA Clinical Trials 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 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 Clinical Trials Government 40

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 Disease 40

The Pharma Data

OCTOBER 28, 2020

Serious adverse events were numerically more frequent with placebo than REGN-COV2 treatment (0.8% Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

FEBRUARY 4, 2021

Recent Events. AbbVie announced that the European Commission (EC) has approved Rinvoq (upadacitinib, 15 mg, once daily) for the treatment of adults with active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS). and by AbbVie outside of the U.S. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc.

Production 52

Production Clinical Trials International Small Molecule 52

The Pharma Data

NOVEMBER 20, 2020

Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. The information contained in this release is as of November 20, 2020. Source: Pfizer Inc. . Posted: November 2020.

Vaccine 52

Vaccine FDA Clinical Trials Trials 52

The Pharma Data

NOVEMBER 9, 2020

Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. The information contained in this release is as of November 9, 2020. Source: Pfizer, inc. Posted: November 2020.

Vaccine 40

Vaccine Clinical Trials Trials FDA 40

Codon

MARCH 28, 2023

The recipient rat was able to perform a task, which normally took eight weeks to learn, in seconds, according to comments made by program manager, Geoff Ling, at a 2015 DARPA event. Researchers used an off-the-shelf, FDA-approved machine, developed by Blackrock Neurotech ; the algorithms were the main advancement.)

Engineering 52

Engineering Research Science FDA Approval 52

The Pharma Data

OCTOBER 29, 2020

ULTOMIRIS – Atypical Hemolytic Uremic Syndrome (aHUS): In September 2020 , Japan’s MHLW approved ULTOMIRIS for adults and children with aHUS. FDA approved the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS. The 2020 GAAP and non-GAAP tax rates do not benefit from one-time events that benefited the tax rates in 2019.

Clinical Trials 40

Clinical Trials Trials Production Licensing 40

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S. in 1-15 year olds and 98.7-100%

FDA Approval 52

FDA Approval Vaccine FDA Virus 52

The Pharma Data

JANUARY 21, 2021

Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. These events may have been associated with inadvertent (partial) intravenous administration and began to resolve within a few minutes after the injection. Hepatotoxicity: Hepatic adverse events were reported. REFERENCES.

FDA Approval 52

FDA Approval Treatment RNA FDA 52

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada. Related Articles: Zokinvy (lonafarnib) FDA Approval History.

FDA Approval 52

FDA Approval FDA Clinical Trials Disease 52

The Pharma Data

JANUARY 24, 2021

The patents cover the inhibition of soluble P-selectin that helps to prevent and/or reduce thrombotic events. Quercis’ lead drug candidate acts as an antithrombotic with significantly lower risk of adverse events than existing therapies. ZUG, Switzerland , Jan. Terms of the agreement have not been disclosed.

Licensing 40

Licensing Licensing Clinical Trials Medical Schools 40

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 40

FDA Approval FDA Treatment Clinical Trials 40

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 Clinical Trials FDA Treatment 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