Drug Discovery World

MAY 6, 2024

Amsterdam: The centre of European life sciences As a result of the UK withdrawing from the EU, in 2019 the EMA headquarters was moved from London to Amsterdam. Even before this, however, Amsterdam was established as an important centre for drug development. This article takes a closer look at several key clusters in the region.

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The Pharma Data

NOVEMBER 23, 2020

At Ultimovacs, he will lead all business and corporate development efforts and continue to maintain and foster connections with leading biotechnology and pharmaceutical companies. “In Ton Berkien joins Ultimovacs with over 15 years of experience in strategic business development and corporate finance in the biopharmaceutical industry.

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The Pharma Data

AUGUST 6, 2020

AstraZeneca reached a licensing deal with Chinese firm BioKangtai to help provide its adenovirus vector-based COVID-19 vaccine candidate, created by the University of Oxford, to China, AstraZeneca said (Chinese) in a social media post on Thursday. China has several home-grown COVID-19 vaccines in clinical development.

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Drug Discovery World

MARCH 29, 2023

Peter O’Donnell, Applied Clinical Trials’ Brussels Correspondent, summarises this as the EMA being tasked with creating a European network of patient representatives, academics, drug developers, investigators, and centres with expertise in the performance of studies in the paediatric population.

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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

MARCH 16, 2021

The potential of centrally acting COMT inhibitors has not yet been evaluated in the clinic due to the unavailability of such compounds. In partnering with the Lieber Institute, Boehringer Ingelheim has in-licensed preclinical pipeline candidates, representing a first-in-class approach for targets in neuropsychiatric disorders.

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The Pharma Data

MARCH 2, 2021

Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. Boehringer Ingelheim will advance the programs further and bring promising candidates into non-clinical and clinical development.

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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

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

OCTOBER 26, 2020

AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive Staphylococcus aureus ( S. AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa ( P. AR-301 (VAP). aureus) alpha-toxin in VAP patients. AR-101 (HAP).

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The Pharma Data

NOVEMBER 8, 2020

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 The NDA was resubmitted on May 2020. We have been encouraged by our interactions with the FDA following our CRL and are pleased to resubmit our Zimhi NDA,” said Dennis J.

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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 18, 2020

(NST) is a Dutch biotech company focused on developing structurally engineered fatty acids (‘SEFAs’) for the treatment of inflammatory, metabolic, and liver diseases. A Phase 2b study was initiated in July 2019 (ICONA) to study the efficacy of icosabutate in NASH.

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The Pharma Data

JANUARY 13, 2021

Structure 3:1031-1039 (1995) 3 Waters J, Biocentury ; October 26, (2018) 4 NCT02273960; ClinicalTrials.gov ; “Study to Evaluate Safety and Efficacy in Adult Subjects With ITP (ITP)”; results posted April 1, 2019, updated July 29, 2019 and accessed Jan 11, 2021 5 Ferrant JL et al., International Immunol. (11):1583

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The Pharma Data

OCTOBER 26, 2020

2019. billion related to certain license and collaboration agreements, and certain other items. Companies enter into exclusive license and co-development agreement to accelerate global reach of Tukysa (tucatinib), a small molecule tyrosine kinase inhibitor for the treatment of HER-2 positive cancers.

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The Pharma Data

JANUARY 7, 2021

(NST) is a Dutch biotech company focused on developing structurally engineered fatty acids (‘SEFAs’) for the treatment of inflammatory, metabolic, and liver diseases. A Phase 2b study was initiated in July 2019 (ICONA) to study the efficacy of icosabutate in NASH.

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The Pharma Data

AUGUST 1, 2021

The approval by the Food and Drug Administration (FDA) was based on efficacy and safety data from the Saphnelo clinical development programme, including two TULIP Phase III trials and the MUSE Phase II trial. 7,8,9,10,11. Saphnelo is under regulatory review for SLE in the EU and Japan.

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The Pharma Data

NOVEMBER 4, 2020

million as of December 31, 2019. Research and development expenses were $16.3 million for the same period in 2019. The increase in research and development expenses relates primarily to the ongoing Phase 2 clinical trial of CTP-692. million for the same period in 2019. 2019.

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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. Key Pipeline Progress Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. TARRYTOWN, N.Y. ,

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The Pharma Data

NOVEMBER 11, 2020

Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives approval of a biologics license application (BLA) for a rare pediatric disease product application may be eligible for a voucher which can be redeemed to obtain priority review for a subsequent marketing application for a different product.

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The Pharma Data

JANUARY 18, 2021

Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

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The Pharma Data

NOVEMBER 5, 2020

Prior to joining Imperative Care in 2019, Davis served as chief commercial officer and president of North America at Penumbra, Inc., Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies. Before GSK, Rosén was senior vice president, U.S.

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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

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® ?

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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

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

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. AUTHORIZED USE IN THE U.S.: IMPORTANT SAFETY INFORMATION FROM U.S.

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The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Pneumococcal Disease.

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The Pharma Data

OCTOBER 14, 2020

WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019. After a complete response letter (CRL) for the cataplexy indication was issued by the FDA in August 2019 , Harmony met with the Agency in December 2019 to discuss the deficiencies cited in the CRL.

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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 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. ” About Ascentage Pharma.

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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

OCTOBER 30, 2020

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. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S.

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The Pharma Data

DECEMBER 12, 2020

AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. During 2019, Alexion generated a total revenue of $5bn and profit before tax of $2.2bn.

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