The Pharma Data

JUNE 28, 2021

Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. Bayer today announced that it has entered into an agreement to acquire Noria Therapeutics Inc. Noria) and PSMA Therapeutics Inc.

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DrugBank

AUGUST 15, 2024

Additionally, industry partners bring a wealth of experience in drug development and commercialization strategies, essential for translating scientific discoveries into marketable products that can reach patients worldwide. This highlighted the importance of defining patent scope and licensing terms in such collaborations.

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Drug Target Review

NOVEMBER 22, 2023

We are also developing our own TGF-β pathway inhibitor, IOA-359, which was licensed into iOnctura earlier this year. Our lead programme is an allosteric PI3K-Delta inhibitor, which we are developing as a small molecule immunotherapy. Pancreatic cancer is a very difficult cancer to treat.

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The Pharma Data

NOVEMBER 23, 2020

His most recent position was at Amgen as Director Global Business Development – Transactions, a position he assumed in August 2019 following the acquisition of Nuevolution, a Danish small molecule development company, at which he led the commercial and business activities as Chief Business Officer.

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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). Pfizer Inc. NYSE: PFE) today announced that the U.S.

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The Pharma Data

JANUARY 26, 2021

Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. billion by 2027. About Q BioMed Inc.

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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. COMIRNATY® will be produced in BioNTech’s and Pfizer’s manufacturing sites in Europe. AUTHORIZED USE IN THE EU: COMIRNATY® ?

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The Pharma Data

OCTOBER 26, 2020

The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. AR-711 is an in-licensed mAb that is directed against the receptor binding domain of the SARS-Cov 2 virus. AR-711 (COVID-19). AR-201 (RSV infection).

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The Pharma Data

MAY 6, 2021

BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

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The Pharma Data

NOVEMBER 22, 2020

The company will be conducting market research to gain additional feedback from physicians and payors to inform the potential path forward. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.

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The Pharma Data

JULY 21, 2021

Government at a not-for-profit price, that the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries, as well as a direct supply agreement with the COVAX facility for 40 million doses. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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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. The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally. NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc.

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The Pharma Data

NOVEMBER 5, 2020

Trading under “OCUP” on the Nasdaq Capital Market to begin November 6, 2020. Ocuphire has built a pipeline of multiple product candidates with demonstrated clinical activity that targets high value markets. Concurrent $21.15 FARMINGTON HILLS, Mich., FARMINGTON HILLS, Mich., NasdaqCM: REXN).

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The Pharma Data

MARCH 4, 2021

“Ovid may benefit significantly, but without the obligation to commit the substantial capital needed over the coming years as soticlestat completes pivotal trials and, if successful, enters the global market. Importantly, with the resources this agreement delivers, Ovid is strategically and financially positioned well into the future.

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The Pharma Data

SEPTEMBER 12, 2020

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

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Agency IQ

NOVEMBER 3, 2023

Keep in mind that this is the definition developed by ISAPP – there is no regulatory body confirming that any product on the market referred to as a “probiotic” has actually demonstrated benefits in clinical research. Most of the strains that are found on the market were developed in a lab and are marketed as proprietary ingredients.

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The Pharma Data

SEPTEMBER 9, 2020

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. About the BNT162 Vaccine Candidate Program.

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LifeSciVC

APRIL 24, 2024

and whether a molecule’s pharmacology can help to mitigate safety risk. Especially for oligo or small molecule discovery and development, it’s important to understand whether there are highly homologous sequences or proteins that may be impacted by a given therapeutic approach. in liver, in CNS)? Consider Fig.

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The Pharma Data

APRIL 23, 2021

Dostarlimab was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. Solid organ transplant rejection has been reported in the post-marketing setting in patients treated with PD-1 inhibitors.

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The Pharma Data

DECEMBER 1, 2020

Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world. The first doses are expected to arrive in the U.K. Manufacturing and Delivery Capabilities.

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world. Bahrain, and Canada. About the Phase 2/3 Study.

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The Pharma Data

NOVEMBER 20, 2020

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

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The Pharma Data

NOVEMBER 4, 2020

License and research and development revenue. Unrealized gain (loss) on marketable equity securities. Unrealized gain (loss) on marketable equity securities. . 2019. Revenue: .

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The Pharma Data

AUGUST 3, 2021

. – Second-quarter 2021 operating expenses increased 18 percent, driven primarily by higher research and development investments for late-stage assets, as well as higher relative marketing and selling expenses due to pandemic-related spending reductions in 2020. – Second-quarter 2021 earnings per share (EPS) decreased to $1.53

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The Pharma Data

NOVEMBER 9, 2020

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

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The Pharma Data

AUGUST 20, 2020

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

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The Pharma Data

OCTOBER 26, 2020

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. Canada and Europe.

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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. The vaccine is also currently available for individuals 12 through 15 years of age in the European Union under a Conditional Marketing Authorization. . Pfizer Inc.

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The Pharma Data

DECEMBER 12, 2020

AstraZeneca has developed a broad range of technologies, initially focused on small molecules and biologics and with a growing focus in precision medicine, genomics, oligonucleotides and epigenetics. 1 The global rare disease market is forecasted to grow by a low double digit percentage in the future.

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Agency IQ

JULY 26, 2024

BY LAURA DIANGELO, MPH , RACHEL COE, MSC | JUL 23, 2024 9:54 PM CDT Biosimilarity and interchangeability: A quick recap The Biologics Price Competition and Innovation (BPCI) Act of 2009 intended to increase the number of biologic products on the market by creating two types of approvals for biosimilar products. Any CMC changes (e.g.,

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The Pharma Data

SEPTEMBER 8, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

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Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. Read the AgencyIQ analysis here.

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The Pharma Data

NOVEMBER 11, 2020

As an orally bioavailable small molecule with broad antiviral activity, SLV213 could be a valuable treatment to meet today’s urgent need to fight COVID-19 as well other life-threatening infectious diseases, such as Chagas disease, Ebola virus disease, and Nipah virus infection.”. About SLV213. About Selva Therapeutics.

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The Pharma Data

SEPTEMBER 8, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Every day, Pfizer. the United States.

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The Pharma Data

DECEMBER 2, 2020

The drug is a small-molecule inhibitor of the S. ERS Genomics – Ireland’s ERS Genomics Limited, and Germany’s Vivlion GmbH, announced a non-exclusive license agreement granting Vivlion access to ERS Genomics’ CRISPR/Cas9 patent portfolio, to enhance Vivlion’s gene editing reagents and screening services. in Mainland China.

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The Pharma Data

NOVEMBER 8, 2020

Additionally, our pipeline and our recent transactions have significant mid-term value still to be unlocked that reinforces our potential in the market. Although the area of dermatology has been severely disrupted since the COVID-19 pandemic began, the EU market shows resilience and the US market is starting to show signs of recovery in Q3.

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The Pharma Data

AUGUST 3, 2021

Selling, General & Administrative (SG&A) expenses increased 7% driven by marketed product support due to increased customer engagement in response to the pandemic recovery and investment in new product launches. HLE BiTE ® molecules AMG 199 and AMG 910, targeting mucin 17 (MUC17) and claudin 18.2 percentage points to 13.5%.

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