The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — ImaginAb Inc. , a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. ImaginAb will receive license fees and payments for manufacturing and other support. LOS ANGELES , Jan. No other terms were disclosed.

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The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Few details of the deal were disclosed in the announcement. A second liver biopsy will be performed after 18 months.

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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

JANUARY 11, 2021

11, 2021 23:59 UTC. a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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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 3, 2021

today announced financial results for the second quarter of 2021. 2021 total revenues guidance reaffirmed at $25.8-$26.6 COVID-19 update : Compared to the first quarter of 2021, we have seen gradual recovery from the impacts of the COVID-19 pandemic. As a result, we expect a 50-60% year-over-year Parsabiv sales decline in 2021.

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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

APRIL 27, 2021

Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% Q1 2021 business EPS ( 1) growth at CER driven by efficiency and sales performance, supported by a one-time payment. Sanofi has become a member of the top five companies of the 2021 Access to Medicine index.

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The Pharma Data

DECEMBER 9, 2020

With the expected Emergency Use Authorization (EUA) of Pfizer – BioNTech and Moderna ’s COVID-19 vaccines providing hope that the COVID-19 pandemic will soon be resolved, 2021 is going to need a new primary healthcare campaign. Atlas cofounded, seeded and incubated Vigil, with pre-clinical stage assets in-licensed from Amgen Inc.,

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The Pharma Data

MAY 6, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) authorized on May 10 , 2021. Pfizer Inc. This is the only COVID-19 vaccine authorized for this age group in the U.S.

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The Pharma Data

MARCH 25, 2022

Food and Drug Administration (FDA) has extended the review of the supplemental biologics license application (sBLA) for Reblozyl® (luspatercept-aamt) for the treatment of anemia in adults with non-transfusion-dependent (NTD) beta thalassemia to June 27, 2022. in November 2021. in November 2021. in November 2021.

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The Pharma Data

DECEMBER 16, 2020

NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., Food and Drug Administration (FDA) with an assigned Prescription Drug User Fee Act (PDUFA) target action date of January 22, 2021. VICTORIA, British Columbia & ROCKVILLE, Md.–(

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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 12, 2021

12, 2021 — Ebola vaccines are being stockpiled by the World Health Organization and other groups to combat future outbreaks of the deadly disease. Before it was licensed, the Merck Ebola vaccine was used under a “compassionate use” protocol to control outbreaks in Guinea and Congo, the AP reported. © 2021 HealthDay.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Each phase-in program requires the manufacturer to have had a Coverage Gap Discount Program agreement in effect in 2021, and only covers applicable drugs that have been in the market as of August 16, 2022 (i.e., of the total expenditures for all Part D drugs in 2021. had Part D expenditures on or before August 16, 2022).

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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

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

JANUARY 27, 2021

27, 2021 — Retired doctors and nurses are being called to the front lines of the U.S. The rules, drafted under the Public Readiness and Emergency Preparedness Act, will also be adapted to allow licensed doctors, nurses, and health practitioners to administer shots across state lines, Zients said. © 2021 HealthDay.

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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

JANUARY 17, 2021

18 , 2021 /PRNewswire/ — Hanmi Pharmaceutical Co., What will be Hanmi’s 2021 R&D strategy on new drugs. What will be Hanmi’s 2021 R&D strategy on new drugs. and “Oraxol,” which was licensed out to Athenex, Inc.

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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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New Drug Approvals

SEPTEMBER 29, 2024

In February 2021, the FDA placed a partial clinical hold on GAIN because of liver abnormalities in some participants ( press release ). In October 2021, Cortexyme announced top-line results indicating the trial had missed its co-primary endpoints of ADAS-Cog11 and ADCS-ADL ( press release ). 2017 ; Ilievski et al., 2018 ; Ding et al.,

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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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The Pharma Data

JUNE 24, 2021

This new agreement is in addition to the 600 million doses that have already been committed to the EU through 2021. The additional 900 million agreed doses are expected to be delivered on a monthly schedule beginning December 2021 and continuing into 2023. View the full release here: [link].

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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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