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

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

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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The Pharma Data

JANUARY 20, 2021

20, 2021 (GLOBE NEWSWIRE) — CytomX Therapeutics, Inc. The offering is expected to close on or about January 25, 2021, subject to satisfaction of customary closing conditions. SOUTH SAN FRANCISCO, Calif., Morgan Securities LLC, Cowen and Company, LLC and Piper Sandler are acting as joint bookrunning managers for the offering.

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The Pharma Data

JANUARY 19, 2021

19, 2021 (GLOBE NEWSWIRE) — Fulcrum Therapeutics, Inc. The offering is expected to close on January 22, 2021, subject to customary closing conditions. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and Phase 3 for the treatment of COVID-19.

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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

JANUARY 14, 2021

15, 2021 /PRNewswire/ — Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX) (NASDAQ – CALT) today announced the program for the upcoming virtual R&D Day for investors, analysts and journalists on January 20, 2021 , which will take place between 1pm and 5pm CET. STOCKHOLM , Jan.

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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

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

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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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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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

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 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

JANUARY 10, 2021

10, 2021 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, will provide an update on Vision 3×3 and the company’s 2021 key milestones at the 39 th Annual J.P. Pipeline Updates.

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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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The Pharma Data

JANUARY 5, 2021

COVID-19 have caused delays to submission and processing of the regulatory application to initiate clinical development in China. Due to the unforeseen delays, Targovax has extended the term of IOvaxis’s license option by 3 months, otherwise the agreement remains unchanged. OSLO, Norway , Jan.

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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

JANUARY 12, 2021

13, 2021 (GLOBE NEWSWIRE) — Leading Biosciences , Inc. (“LBS”), The FDA Fast Track program is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. CARLSBAD, Calif., Nasdaq: SNCA) to form Palisade Bio, Inc., announced that the U.S. Tom Hallam, Ph.D.,

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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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The Pharma Data

JANUARY 10, 2021

PLANEGG / MUNICH, GERMANY / ACCESSWIRE / January 11, 2021 / MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that Jean-Paul Kress, M.D.,

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The Pharma Data

DECEMBER 9, 2020

SCYNEXIS has been granted approvals from the health authority and ethics committee, with dosing anticipated to start in the first quarter of 2021. (2) 2) New interim analysis of Phase 3 FURI and CARES open-label studies expected in the first quarter of 2021 , doubl ing the existing dataset of patient cases. Forward Looking Statement.

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The Pharma Data

JANUARY 17, 2021

“Having received RMAT designation from FDA during 2020, we now hope to work closely with regulatory agencies in both the United States and Europe to expedite clinical development and the registration path for this therapy.” These results were published in Journal of Clinical Oncology ( Ramos et al., BEDMINSTER, N.J.

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The Pharma Data

JANUARY 19, 2021

20, 2021 /PRNewswire/ — BioLineRx Ltd. The closing of the offering is expected to occur on or about January 22, 2021 , subject to satisfaction of customary closing conditions. TEL AVIV, Israel , Jan. per ADS, less underwriting discounts and commissions. per ADS, less underwriting discounts and commissions. Wainwright & Co.

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Cytel

OCTOBER 11, 2023

Moving beyond static evidence development to ensure local market access success; responding to recent changes in governmental drug regulations and the role of automation Written by Grammati Sarri and Radek Wasiak The worldwide drug regulation landscape is rapidly changing.

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