The Pharma Data

MARCH 16, 2021

Aligning with a circuitry-based approach to precision psychiatry, the collaboration will leverage Boehringer Ingelheim’s deep experience in central nervous system (CNS) drug discovery and development alongside Lieber’s expertise in centrally acting COMT inhibitors. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros.

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The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Zai Lab is leading clinical development in its territory. “We Read on for this week’s.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. 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.

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The Pharma Data

OCTOBER 26, 2020

AR-711 exhibits high affinity for SARS-CoV-2 spike protein, approximately 10-fold or higher than mAb candidates currently in late stage clinical testing. AR-711 was previously shown to be effective in prophylactic as well as therapeutic treatment modes in a SARS-CoV-2 viral challenge study. About Aridis Pharmaceuticals, Inc.

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The Pharma Data

JANUARY 12, 2021

Marianne De Backer, Head of Business Development & Licensing in Bayer’s Pharmaceuticals Division, pictured above. Also in December, the company partnered with Atara Biotherapeutics to develop off-the-shelf T-cell immunotherapies for high mesothelin-expressing tumors. Photo courtesy of Bayer. We have set the bar high.

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The Pharma Data

NOVEMBER 8, 2020

Supernus Pharmaceuticals has a target action date of November 8, 2020 for SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD). The resubmission came after a meeting with the FDA in February 2020 and addresses issues raised by the agency’s Complete Response Letter (CRL) in November 2019. “We

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The Pharma Data

AUGUST 1, 2021

AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. 7,8,9,10,11. 7,8,9,10,11. Today’s approval of anifrolumab represents a big step forward for the entire lupus community.

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The Pharma Data

NOVEMBER 18, 2020

In pre-clinical dyslipidemia models, SEFA-1024 exhibited broad and marked beneficial effects, significantly reducing both non-HDL cholesterol and triglycerides in conjunction with an increase in HDL cholesterol. NST’s lead program, icosabutate, is currently in a phase 2b ‘ICONA’ study for the treatment of NASH. Notes to Editors.

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The Pharma Data

JANUARY 7, 2021

The ICONA study ( ICO sabutate in NA SH) aims to randomise 264 patients to one of three different treatment groups: placebo, icosabutate 300 mg once daily, or icosabutate 600 mg once daily, with a treatment period of 52 weeks. *Treatment difference (95% CI). 1) Loomba R, et al. NorthSea Therapeutics B.V.(NST)

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. billion during 2019-2023 (Technavio 2019). PharmaDrug Inc.

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The Pharma Data

JANUARY 25, 2021

. “ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019. but with a healthcare system that is still developing. 1 Globocan. American Cancer Society.

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The Pharma Data

JANUARY 13, 2021

We are developing the manufacturing processes for TNX-1500 and expect Good Manufacturing Practice (GMP) TNX-1500 to be available in the third quarter of 2021. include: infliximab (Remicade®), adalimumab (Humira®), certolizumab pegol (Cimzia®), and golimumab (Simponi®) for the treatment of certain autoimmune conditions. 1 Lederman, S.

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The Pharma Data

OCTOBER 26, 2020

2019. billion related to certain license and collaboration agreements, and certain other items. . $ in millions, except EPS amounts. . Third Quarter. . . . 2020. .

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The Pharma Data

DECEMBER 14, 2020

The Company anticipates using net proceeds from the offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes. Morgan Securities LLC, Goldman Sachs & Co.

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The Pharma Data

NOVEMBER 11, 2020

Submitted CTA for INZ-701 for the treatment of ENPP1 deficiency to United Kingdom regulatory agency. Received Rare Pediatric Disease and Fast Track Designations for INZ-701 for the treatment of ENPP1 deficiency. BOSTON, Nov. 12, 2020 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. . BOSTON, Nov.

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The Pharma Data

NOVEMBER 4, 2020

“Both of our clinical candidates represent important opportunities for new medicines that we hope will have a meaningful impact on the lives of patients.”. CTP-543: An Investigational Treatment for Moderate to Severe Alopecia Areata. CTP-692: An Investigational Adjunctive Treatment for Schizophrenia.

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Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group. What are the risks?

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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. Lucentis ® and Avastin ® collectively achieved over $9 billion in sales in 2019. LONDON and BOSTON, Jan.

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The Pharma Data

NOVEMBER 5, 2020

billion versus third quarter 2019 (4). billion versus third quarter 2019. billion versus third quarter 2019. Lastly, we are proud that our novel antibody cocktail REGN-EB3 recently became the first FDA-approved treatment for Ebola, underscoring the potential of antibody therapies to address deadly infectious diseases.”

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The Pharma Data

JANUARY 18, 2021

for the treatment of post-herpetic neuralgia. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. ZTlido ® was approved by the FDA on February 28, 2018.

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The Pharma Data

APRIL 27, 2021

the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorisation by the European Medicines Agency to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. AUTHORIZED USE IN THE EU: COMIRNATY® ? IMPORTANT SAFETY INFORMATION: Events of anaphylaxis have been reported.

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The Pharma Data

NOVEMBER 5, 2020

has been appointed to the additional role of president and will oversee the growth of the company’s technology portfolio for the treatment of ischemic and hemorrhagic stroke. Prior to joining Imperative Care in 2019, Davis served as chief commercial officer and president of North America at Penumbra, Inc.,

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The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. AUTHORIZED USE IN THE U.S.:

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The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine. AUTHORIZED USE IN THE U.S.:

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. SARSCoV2) in individuals 16 years of age and older.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. Ascentage Pharma (6855.HK)

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The Pharma Data

OCTOBER 30, 2020

NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.

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The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” and Roche will develop, manufacture and distribute it outside of the U.S.

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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The Pharma Data

NOVEMBER 29, 2020

HOOKIPA’s non-replicating prophylactic cytomegalovirus (CMV) vaccine candidate is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. 2019; 102: 900-931.

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The Pharma Data

DECEMBER 5, 2020

Among all patients responding to treatment, 95% experienced a very good partial response or better; among responding patients with ?6 “As these data continue to mature, we look forward to assessing whether responses will further deepen and remain durable with ongoing REGN5458 treatment.” TARRYTOWN, N.Y. ,

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The Pharma Data

DECEMBER 29, 2020

The benefit was driven by results starting one week post-treatment, when the risk of death or receiving mechanical ventilation was reduced by approximately half with antibody cocktail treatment, based on a post-hoc analysis. Evaluation of its safety and efficacy is ongoing in multiple clinical trials.

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The Pharma Data

OCTOBER 28, 2020

Food and Drug Administration as part of its review of our Emergency Use Authorization submission, and we continue to focus on completing our ongoing trials evaluating REGN-COV2 for the treatment and prevention of COVID-19.” Serious adverse events were numerically more frequent with placebo than REGN-COV2 treatment (0.8%

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The Pharma Data

DECEMBER 12, 2020

The medicine is approved in many countries for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uremic syndrome, generalized myasthenia gravis and neuromyelitis optica spectrum disorder. 5% have US Food and Drug Administration -approved treatments.

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The Pharma Data

SEPTEMBER 9, 2020

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

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The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Innovation Pharma (Formerly known as Cellceutix) (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. WAKEFIELD, Mass.,

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