The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Pfizer and BioNTech completed the rolling submission of the BLA in May 2021.

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The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. With this clarity, we look forward to proceeding towards a full BLA submission in the second half of 2021. chief executive officer of Gamida Cell. About Omidubicel.

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The Pharma Data

APRIL 9, 2021

Biogen enters into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a proposed biosimilar referencing ACTEMRA ® (tocilizumab). The transaction is expected to close in the second quarter of 2021. Biogen Inc. Nasdaq: BIIB) and Bio-Thera Solutions, Ltd. Source link:[link].

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The Pharma Data

JULY 29, 2021

today reports results for the second quarter of 2021, which reflect robust product sales, continued advancement of the pipeline and strong clinical and operational performance across the company. “We Reports Second Quarter Revenues of $11.7 and Non-GAAP EPS of $1.93 board chair and chief executive officer, Bristol Myers Squibb.

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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. That has changed. Financial terms were not disclosed.

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The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — The members of the Nomination Committee for BioInvent International AB :s (publ) (“BioInvent) Annual General Meeting in 2021 have now been appointed. The Annual General Meeting will be held on April 29, 2021 in Lund, Sweden. LUND, Sweden , Dec. Chairman of the Nomination Committee.

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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. The information contained in this release is as of May 7, 2021. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

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The Pharma Data

DECEMBER 20, 2020

Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties.

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The Pharma Data

JANUARY 5, 2021

Due to the unforeseen delays, Targovax has extended the term of IOvaxis’s license option by 3 months, otherwise the agreement remains unchanged. To accommodate the delay caused by these unforeseen circumstances, Targovax has granted to IOVaxis an extension to the license option period by 3 months.

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The Pharma Data

MAY 18, 2021

Leverkusen, May 12, 2021 – The Bayer Group had a successful start to 2021. We’re seeing a good operational performance overall, but we were impacted by negative currency effects as expected,” said CEO Werner Baumann when the quarterly statement for the first quarter of 2021 was published on Wednesday. to 12.328 billion euros.

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The Pharma Data

APRIL 30, 2021

April 30, 2021 /PRNewswire/ — AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2021. “We are off to an excellent start to 2021, with strong performance across our core therapeutic areas and first quarter revenue and earnings results ahead of our expectations,” said Richard A. .

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The Pharma Data

MARCH 30, 2021

Basel, March 30, 2021 — Novartis has obtained exclusive worldwide rights to develop and commercialize therapeutic applications for a library of Fibroblast Activation Protein (FAP) targeting agents including FAPI-46 and FAPI-74, through an assignment agreement with iTheranostics, Inc., an affiliate of SOFIE Biosciences, Inc.

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The Pharma Data

JANUARY 18, 2021

In total, there were 31 mostly virtual expert panel meetings in 2020, but more than a dozen of those did not involve votes on New Drug Applications (NDAs), Biologics License Applications (BLAs) or new indications, but instead focused on devices, tobacco or other topics.

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The Pharma Data

JANUARY 18, 2021

18, 2021 — As more states legalize marijuana and more shops begin to sell it, more young adults are using pot and developing drug-use disorders, a new study finds. People with a higher number of licensed marijuana outlets within four miles of home were more likely to have used pot in the past month, the survey showed.

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The Pharma Data

JANUARY 19, 2021

– January 20, 2021) – BioHarvest Sciences Inc. CSE: BHSC) (the “Company” or “BioHarvest”) invites its shareholders and the general public to join a Live Video Conference (“Webinar”) on Thursday, January 21st, 2021 at 2:00 PM Eastern Standard Time (11:00 AM Pacific Standard Time).

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The Pharma Data

NOVEMBER 3, 2020

The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to fund development of a potential COVID-19 vaccine from China’s Clover Biopharmaceuticals with a global phase 2/3 study and through licensing and distribution. million investment announced in July. Earlier this year, CEPI provided $3.5

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The Pharma Data

NOVEMBER 9, 2021

The Bayer Group registered a significant increase in deals and earnings in the third quarter of 2021. “ Bayer has also streamlined the upgraded outlook for 2021 that it had issued in August. Group deals in the third quarter of 2021 rose by14.3 Net fiscal debt as of September 30, 2021, dropped to33.981 billion euros, down1.1

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The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec.

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The Pharma Data

JANUARY 10, 2021

11, 2021 06:35 UTC. Morgan Healthcare’ annual conference, taking place from 11 to 14 January 2021, in virtual format. WAINWRIGHT BioConnect 2021 conference. Its products are intended to be licensed to players in the health sector. At the same time, VALBIOTIS is also participating in the H.C.

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The Pharma Data

JANUARY 21, 2021

22, 2021 12:00 UTC. These presentations will take place as part of the IASLC 2020 World Conference on Lung Cancer (#WCLC20) hosted by the International Association for the Study of Lung Cancer (IASLC) taking place virtually January 28-31, 2021. HENDERSON, Nev.–( PT) Presentation Number: MA11.04.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. For example, FDA’s regulations have exempted from certain regulatory requirements (e.g.,

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. In June 2021, uniQure provided another regulatory update , announcing that FDA was requiring a demonstration of “durability of effect” based on data from patients followed for at least 52 weeks after FIX levels achieve steady state, which occurs by 26 weeks.

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The Pharma Data

OCTOBER 27, 2020

Top-line results with 12 months follow up data anticipated during the second half of 2021. The study design includes two stages of data analysis – upon 12-month data collection, anticipated in the second half of 2021, and upon 24-month data collection, anticipated in the second half of 2022.

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The Pharma Data

SEPTEMBER 2, 2021

Novartis will present 12 abstracts at the European Respiratory Society (ERS) International Congress 2021 for Enerzair ® Breezhaler ® (IND/GLY/MF*) and Atectura ® Breezhaler ® (IND/MF**) — for patients whose asthma is uncontrolled with LABA/ICS^ and ICS, respectively 1,2. g) and medium-dose (150/50/80?g) g) formulations.

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The Pharma Data

OCTOBER 15, 2020

That trial is continuing to enroll and dose patients, and results are expected in the first half of 2021. Takeda Pharmaceutical announced this month that it has linked up with Arrowhead Pharmaceuticals to develop and license ARO-AAT, a phase 2 investigational therapy for treating liver disease associated with AATD. James Miessler.

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The Pharma Data

SEPTEMBER 4, 2020

Slaoui also says that they will have enough vaccine doses to vaccinate the entire population by the middle of 2021. . Vaccines usually are in trial for years, so getting an effective treatment out by mid-2021 will break most norms of vaccine development.

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The Pharma Data

MARCH 11, 2021

Expected to enroll 415 participants; interim results expected in Q3 2021. The Companies expect interim results from this trial in the third quarter of 2021. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio. About the Phase 1/2 clinical trial. About Translate Bio.

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The Pharma Data

MAY 27, 2022

ViiV Healthcare and MPP are actively negotiating voluntary licensing terms to help widen access to innovative HIV prevention measure .

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The Pharma Data

NOVEMBER 8, 2020

10% of its Net Sales in R&D and also invests significantly in business development and in-licensing. Regulatory filings for Tirbanibulin have been completed and the product is under registration in the EU and the US, with a launch forecasted for the beginning of 2021. Almirall expects to make an option exercise decision in Q1 2021.

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The Pharma Data

NOVEMBER 23, 2020

This date has now been extended to May 25, 2021. On February 7, 2020 the NYSE American notified the Company that it accepted the Company’s plan to regain compliance before November 25, 2020 , the end of the compliance plan period. The Company will remain subject to periodic review by NYSE American staff during the extension period.

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The Pharma Data

NOVEMBER 17, 2021

Under a sub-license agreement with AstraZeneca, the vaccine is manufactured and supplied by the Serum Institute of India under the name COVISHIELD. AstraZeneca news release: AstraZeneca’s COVID-19 vaccine authorised for emergency supply in the UK [link] [Last accessed: November 2021] 2. Available at: [link] [Accessed August 2021] 6.

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Vaccine Clinical Trials Virus Licensing 52

The Pharma Data

JANUARY 4, 2021

5, 2021 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it is to regain the worldwide rights to its muscarinic agonist programs. The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. ” About the License Agreement.

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The Pharma Data

JANUARY 20, 2021

21, 2021 /PRNewswire/ — OrthogenRx, Inc., With additional focus on training, a focused commercial strategy, continued innovation, and a rich product portfolio, we are poised for continued success in 2021.” ” 2021 Outlook. . DOYLESTOWN, Pa. , OrthogenRx Inc.

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The Pharma Data

JANUARY 3, 2021

04, 2021 (GLOBE NEWSWIRE) — Passage Bio , Inc. The company expects to dose the first patient for the global PBGM01 clinical trial program in the first quarter of 2021. Imagine-1 study to commence in 1Q 2021. Passage Bio plans to report initial 30-day safety and biomarker data mid-year 2021 for Imagine-1.

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The Pharma Data

JANUARY 14, 2021

14, 2021 /PRNewswire/ — The American College of Emergency Physicians (ACEP) applauds the U.S. As a result, some clinicians are hesitant to pursue this DEA license or even engage in treatment of patients with OUD. WASHINGTON , Jan.

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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). Since licensed by Ridgeback all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and Merck.

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New Drug Approvals

SEPTEMBER 6, 2024

2 , 3 Lazertinib was first approved in South Korea on January 18, 2021, for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) with EGFR mutations. 2] Lazertinib was approved for medical use in South Korea in January 2021, [4] [5] and in the United States in August 2024. [2] 20 August 2024. 20 August 2024.

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