The Pharma Data

AUGUST 6, 2020

Under the pact, AZ will transfer the vaccine’s technology to BioKangtai, which will in return reserve enough capacity to make at least 100 million doses of the shot by the end of 2020 and expand to 200 million doses per year by the end of 2021. China has several home-grown COVID-19 vaccines in clinical development.

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The Pharma Data

AUGUST 3, 2021

In the first half of 2021, Boehringer Ingelheim has supplied more humans and animals worldwide with innovative medicines than ever before. Our strong R&D pipeline has made further, decisive progress in the first half of 2021. In the first half of 2021, Boehringer Ingelheim generated strong net sales of around 2.3

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The Pharma Data

MARCH 9, 2021

New data from 10 studies will be presented by Eli Lilly and Company (NYSE: LLY) at the upcoming virtual International Conference on Alzheimer’s & Parkinson Diseases 2021 (AD/PD 2021), March 9-14, 2021.

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The Pharma Data

JANUARY 19, 2021

With this kind of a start, 2021 may be scorching. The company hopes to raise $140 million of common stock, which will be used to advance its clinical and earlier stage programs and for R&D, working capital and general corporate purposes. Last year was a record number of IPOs in the biotech industry, with 81 raising $13.5

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The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Late Breaking Oral Presentation OALC01LB03. Abstract 804. Paudel et al.

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The Pharma Data

MARCH 8, 2021

We are delighted to share our early data at CROI 2021 supporting the potential for a once-yearly dosing regimen for islatravir using a subdermal implant,” said Dr. Joan Butterton, vice president, global clinical development, infectious diseases, Merck Research Laboratories. “We

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The Pharma Data

SEPTEMBER 8, 2021

today announced that data reinforcing the potential of immunotherapies to impact clinical outcomes for patients will be featured at the European Society for Medical Oncology (ESMO) 2021 Virtual Congress from September 16-21. To date, the Opdivo clinical development program has treated more than 35,000 patients.

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The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Accessed April 2021].

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Cytel

OCTOBER 27, 2023

Since its launch in 2021, Project Optimus has been reforming the dose optimization and dose selection paradigm in oncology drug development. Most of these post-approval changes have been overall decreases in dose. To address this challenge, the FDA Oncology Center of Excellence initiated Project Optimus.

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The Pharma Data

JULY 23, 2021

(Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinical development portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021.

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Drug Target Review

AUGUST 24, 2023

She joined the company in November 2018 with more than 10 years of experience in drug discovery and non-clinical development of immunomodulatory drugs in the immuno-oncology space. 2021 Jul 6;120(13):2644-56. 2021 Dec 1;9(12):1425-38. 2021 Jun 17;12:685370. 2021 Nov 1;41. Biophysical Journal.

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The Pharma Data

APRIL 6, 2021

Bayer will present new research across its oncology portfolio at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 , taking place over two weeks on April 10-15 and May 17-21, 2021. o Abstract CT001; April 10, 11:30am EDT.

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The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. was approved by the European Commission in February 2021. The Phase 1/2 LIBRETTO-001 trial is the largest clinical trial of patients with RET -driven cancers treated with a RET inhibitor.

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The Pharma Data

JULY 21, 2021

These data were shared as a late-breaking oral presentation during the virtual 11 th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021).

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The Pharma Data

MARCH 17, 2021

Gallen International Breast Cancer Conference Poster Awards 2021. Gallen will be published in a supplement issue of The Breast, available on March 17, 2021. Available on-demand on March 10, 2021. Gallen International Breast Cancer Conference Poster Awards 2021. Available on-demand on March 10, 2021.

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The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan. SHANGHAI , Jan.

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The Pharma Data

DECEMBER 9, 2020

Initial results for the open-label study are expected in 2021. It has shown remarkably high safety and tolerability measure during non-clinical development. . The total transaction value for the acquisition also includes contingent clinical and regulatory milestones and is set to close in early 2021. .

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The Pharma Data

JANUARY 4, 2021

05, 2021 (GLOBE NEWSWIRE) — Polyphor AG (SIX: POLN) announced today that Gökhan Batur, Chief Executive Officer, will take part in a panel discussion at the LifeSci Partners 10th Annual Healthcare Corporate Access Event on Thursday, January 7 from 8:00AM Eastern Standard Time. ALLSCHWIL, Switzerland, Jan.

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The Pharma Data

JANUARY 12, 2021

13, 2021 /PRNewswire/ — EVOQ Therapeutics today announced a license and collaboration agreement with Amgen for the discovery and development of novel drugs for autoimmune disorders. ANN ARBOR, Mich. ,

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FDA Law Blog: Biosimilars

AUGUST 8, 2023

The Guidance, which provides details about nitrosamines and FDA’s experience regulating them, explicitly applies to all finished drug products (including Rx, OTC, and unauthorized drugs), to “prescription and OTC drug products in clinical development,” and to both API and drug manufacturers. An earlier FDA guidance, revised in 2021.

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The Pharma Data

SEPTEMBER 2, 2020

If successful, the companies intend to request regulatory approval in the first half of 2021. Sanofi and GSK are currently scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021.

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The Pharma Data

JANUARY 21, 2021

22, 2021 12:00 UTC. –( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial.

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Drug Target Review

DECEMBER 27, 2023

Aside from CD24, there are several other ‘don’t eat me’ signals that have been characterised, and there are multiple programmes currently in clinical development that target these signals. About the author Dr Roy Maute Cofounder & Chief Scientific Officer, Pheast Therapeutics Dr Maute joined Pheast Therapeutics in 2021.

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The Pharma Data

MARCH 27, 2021

Dr. Martin will assume responsibility for Gilead’s research organization effective April 12, 2021. (Nasdaq: GILD) today announced that Flavius Martin, MD will join the company as Executive Vice President, Research, and will become a member of the company’s senior leadership team, reporting to Chairman and Chief Executive Officer Daniel O’Day.

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The Pharma Data

JANUARY 27, 2021

– Second Product Candidate Expected to Enter Clinic in First Half of 2021. 28, 2021 (GLOBE NEWSWIRE) — Passage Bio , Inc. Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system (CNS) disorders, today announced that the U.S.

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The Pharma Data

JANUARY 13, 2021

13, 2021 (GLOBE NEWSWIRE) — Harpoon Therapeutics, Inc. NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today announced that the U.S. A presentation of interim data is anticipated in 2021, with initiation of a dose expansion cohort in the second half of 2021.

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The Pharma Data

JANUARY 7, 2021

Pivotal Data Anticipated in 2021 to Support Potential Registration, Addressing an Estimated Market Opportunity of Greater than $500 Million. a privately-held, clinical-stage biotechnology company developing imipridones, a novel class of compounds. The final confirmatory data analysis is expected in 2021.

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The Pharma Data

FEBRUARY 22, 2021

(Nasdaq: RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. vice president of immunology at Lilly. About Rigel.

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The Pharma Data

JANUARY 26, 2021

27, 2021 07:00 UTC. LEIDEN, The Netherlands–( BUSINESS WIRE )– VarmX , a biotech company focusing on the development of innovative approaches for the reversal of anticoagulation, today announces the appointment of Dr. Gerard Short, MBBS, as Chief Medical Officer (CMO).

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The Pharma Data

NOVEMBER 18, 2021

Gilead has been encouraged by early clinical data generated for each of the three programs. By concluding in early to all three programs now, Gilead and Arcus are suitable to accelerate the clinical development and advancement of these clinical- stage motes and grease the disquisition of treatment combinations across the portfolios.

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Broad Institute

OCTOBER 11, 2023

By early 2021, Calico and AbbVie had launched two early-stage clinical trials testing two PTPN2 inhibitors, either as a single therapy or in combination with existing PD-1 immunotherapies. The team found that deleting the gene Ptpn2 made tumors sensitive to PD-1 therapy, and they published their findings in Nature in 2017.

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The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. HELLERUP, Denmark , Jan. About orismilast.

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The Pharma Data

MARCH 8, 2021

These preliminary findings were presented today during Science Spotlights TM at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021). Findings from the primary efficacy and safety endpoints and additional secondary objectives will be presented at an upcoming medical meeting. “We About Molnupiravir.

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The Pharma Data

NOVEMBER 2, 2020

The sNDA has been assigned an action date by the FDA of March 19, 2021. The company will submit a New Drug Application in the first half of 2021. SEAL study patients who had been on placebo with objective progression were allowed to crossover to the Xpovio arm. Source link.

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The Pharma Data

APRIL 7, 2022

Sisunatovir significantly reduced viral load in a phase 2 RSV human challenge study in healthy adults and is currently in phase 2 clinical development in infants. The development program for sisunatovir is expected to continue in both adult and pediatric populations. Food and Drug Administration (FDA).

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The Pharma Data

JANUARY 7, 2021

07, 2021 (GLOBE NEWSWIRE) — Cerecor Inc. The offering is expected to close on or about January 12, 2021, subject to customary closing conditions. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007. ROCKVILLE, Md. and CHESTERBROOK, Pa., per share (the “Public Offering Price”).

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PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. 2021 [cited 16 December 2021]. Sci Rep 9, 18911 (2019).

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