The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. These findings were presented today at the 2020 Infectious Diseases Society of America (IDSA) IDWeek.

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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.

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The Pharma Data

MAY 7, 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.

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The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. ROCKVILLE, Md. and CHESTERBROOK, Pa., 07, 2021 (GLOBE NEWSWIRE) — Cerecor Inc.

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The Pharma Data

NOVEMBER 12, 2020

The CALAVI trials were launched based on preclinical and early clinical evidence that Calquence could decrease the hyperinflammatory immune response and improve clinical outcomes in patients hospitalised with respiratory symptoms of COVID-19.1 Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019. Wu J, Zhang M & Liu D.

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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. Food and Drug Administration (“FDA”) approval.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Balazs et al., Hammami et al.,

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Balazs et al., Hammami et al.,

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The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. About NVX-CoV2373. Source: Novavax, Inc. .

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The Pharma Data

AUGUST 25, 2020

senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. AML is one of the most difficult-to-treat blood cancers, and we’re committed to furthering our research and improving on the standards of care for patients living with this aggressive disease.”. Food and Drug Administration (FDA)-approved test.

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The Pharma Data

SEPTEMBER 9, 2020

Basel, 10 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new ENSPRYNG® (satralizumab) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system. Roche’s Chief Medical Officer and Head of Global Product Development. “The

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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. OKYO is focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and chronic pain.

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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. 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).

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The Pharma Data

NOVEMBER 30, 2020

We are now committed to pursuing other CGRP-mediated diseases through advancing novel investigational agents such as HTL0022562 into human studies.” We look forward to working on this new collaboration with Biohaven, a world leader in the clinical development of CGRP-targeted therapies.”

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The Pharma Data

SEPTEMBER 1, 2020

“Alongside our industry-leading collaborators, we are investigating novel endpoints, brain volume and cognition, which may help to further our understanding of the safety and efficacy profile of Zeposia and can advance transformational science for multiple sclerosis patients experiencing this unpredictable, debilitating disease.”.

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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.” Casirivimab and imdevimab injection is not FDA approved for any use. Have diabetes.

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The Pharma Data

OCTOBER 30, 2020

About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended June 30, 2020.

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The Pharma Data

JANUARY 15, 2021

“Patients with metastatic HER2 positive gastric cancer with progression following first-line treatment have historically faced poor outcomes, including low response to treatment and rapid disease progression,” said Ronan Kelly, MD, MBA, Director of the Charles A. mg/kg, interstitial lung disease occurred in 10% of patients. Caruth, Jr.

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The Pharma Data

APRIL 11, 2021

FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ?50 50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity. i Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

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Drug Target Review

JUNE 21, 2023

Most rare diseases are caused by a single gene defect, but severity can vary considerably among patients. Modifier genes can help explain that variability and can alter or even prevent disease onset and progression, making them appealing therapeutic targets. However, the identification of these genes is challenging.

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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.

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The Pharma Data

DECEMBER 29, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. cardiovascular disease, OR.

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The Pharma Data

DECEMBER 5, 2020

57% of evaluable patients (4 of 7 patients) were minimal residual disease (MRD) negative. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. 42% (n=8) had a CR or sCR. and the world, respectively, in 2020.

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The Pharma Data

DECEMBER 27, 2020

This year has been difficult, but it has reinforced the importance of our mission: to treat and potentially even reverse the effects of serious diseases and conditions by advancing our novel cell therapy product candidates through clinical trials and into the hands of physicians. Forward-Looking Statements.

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Drug Discovery World

JANUARY 17, 2024

With oncology accounting for a third of pharma’s product pipeline, significant challenges include fierce competition, high research and development costs over, 10-15 years for clinical development, and pressures to rapidly meet the demand for new treatments 2-4.

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The Pharma Data

OCTOBER 28, 2020

Treatment with REGN-COV2 reduced COVID-19 related medical visits by 72% in patients with one or more risk factor (including being over 50 years of age; body mass index greater than 30; cardiovascular, metabolic, lung, liver or kidney disease; or immunocompromised status) (combined dose groups; nominal p = 0.0065).

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The Pharma Data

DECEMBER 11, 2020

Centers for Disease Control and Prevention (CDC), will manage allocation and distribution of the vaccine in the U.S. We founded BioNTech to develop new technologies and medicines that utilize the full potential of the immune system to fight serious diseases,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. About BioNTech.

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The Pharma Data

DECEMBER 10, 2020

These pivotal data demonstrate that our COVID-19 vaccine candidate is highly effective in preventing COVID-19 disease and is generally well-tolerated. 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

NOVEMBER 9, 2020

The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. About BioNTech.

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The Pharma Data

NOVEMBER 20, 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. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. About BioNTech.

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Alta Sciences

APRIL 17, 2024

Ketamine is a dissociative anesthetic approved in 2019 by the U.S. Food and Drug Administration (FDA) as a nasal spray called esketamine, for treatment-resistant depression. Gene Therapy Gene therapy is currently considered for diseases, often rare, that have no other cures.

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Drug Discovery World

DECEMBER 13, 2023

Indeed, therapeutics based on single-domain antibodies are already making their way through the clinical development pipeline for the treatment of cancer, autoimmune diseases, infectious diseases and rare diseases. Caplacizumab, for the treatment of a rare blood clotting disease, achieved FDA approval in 2019 2.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The meeting’s outcome did not receive a rave review from former FDA Commissioner Scott Gottlieb, who led the agency between 2017 and 2019.

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The Connected Lab

APRIL 8, 2020

For patients suffering from an illness with no approved treatment, the wait can be unnerving. To this day, more than 400 million people suffer from rare diseases and 95% of rare diseases lack an FDA approved treatment 3. Billion; Approval Rate for Drugs Entering Clinical Development Is Less Than 12%.”

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The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase III clinical trial programme for fenebrutinib, an investigational medicine designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, which may offer novel approach to suppress disease activity and slow disease progression in MS.

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The Pharma Data

APRIL 8, 2021

OCREVUS data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs). Following U.S.

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The Pharma Data

OCTOBER 25, 2020

Real-world effectiveness data on Oxbryta ® (voxelotor) in the treatment of sickle cell disease featured as oral presentation. Two abstracts have been accepted for presentation, including real-world effectiveness data of Oxbryta ® (voxelotor) tablets in the treatment of sickle cell disease (SCD). FDA approval. 26-31, 2020.

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