LifeSciVC

JANUARY 16, 2024

Rise of the best-in-class biologics plays: Are you looking to in-license or invest in “de-risked” biology that is already in the clinic? Small molecule GLP1s? Whether it’s small molecules to target the incretins (GLP1R ± GIPR), targeting well-validated signaling nodes in I&I (e.g., Join the club.

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Small Molecule Trials Therapies Disease 140

The Pharma Data

DECEMBER 9, 2020

Atlas cofounded, seeded and incubated Vigil, with pre-clinical stage assets in-licensed from Amgen Inc., Libra will use this approach, along with the $29 million infusion, to develop novel small molecule drug candidates for the treatment of neurodegenerative diseases. which will remain a key shareholder. Tranquis Therapeutics.

Marketing 52

Marketing Small Molecule Disease Pharmaceuticals 52

The Pharma Data

MAY 7, 2021

BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (together 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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Licensing Licensing Vaccine FDA Approval 52

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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Small Molecule Licensing Licensing Therapies 52

Drug Discovery World

SEPTEMBER 26, 2022

A report by the medical charity LifeArc 1 puts the timeframe for a therapy brought to market through repurposing methods at anywhere from one to three years. This is a stark contrast to the often decade-long projects that pharmaceutical companies undertake to bring a drug to market. Volume 23 – Issue 4, Fall 2022. References .

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Pharmaceutical Companies Drugs Pharmaceuticals Clinical Trials 130

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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Licensing Licensing Small Molecule Therapies 52

Drug Discovery World

OCTOBER 16, 2023

A company within this ecosystem is STORM Therapeutics, a clinical stage biotechnology company creating novel small molecule therapies that inhibit RNA modifying enzymes (RME) for use in oncology and other diseases. The UK is additionally able to serve the US market with excellent international cultural and linguistic links.

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Drugs Science Therapies Targeted Protein Degradation 189

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.

Clinical Trials 52

Clinical Trials Small Molecule Pharmaceutical Companies Licensing 52

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.

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

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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FDA Treatment Small Molecule Government 40

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® ?

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

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).

Pharmaceuticals 52

Pharmaceuticals Virus Hospitals Clinical Trials 52

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.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

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.

Clinical Trials 52

Clinical Trials Licensing Licensing Trials 52

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.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

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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Vaccine Clinical Trials Licensing Licensing 52

Drug Discovery World

SEPTEMBER 6, 2022

Indeed, the growth of the cell and gene therapy market, coupled with the demand that the pandemic placed on manufacturing capacity, means the industry faces shortages of these crucial materials. The challenge for the market then, according to Boissel, is how much can a payor afford to pay upfront? . Workforce .

Therapies 130

Therapies Clinical Trials Vaccine Disease 130

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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Clinical Trials Trials Production Small Molecule 40

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.

Treatment 52

Treatment Pharmaceutical Companies Clinical Trials Licensing 52

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.

Vaccine 52

Vaccine Trials Clinical Trials Small Molecule 52

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.

Therapies 40

Therapies Science FDA Production 40

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

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.

Vaccine 52

Vaccine Clinical Trials Trials Government 52

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.

Therapies 52

Therapies Treatment Licensing Licensing 52

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.

Vaccine 40

Vaccine Clinical Trials Trials Production 40

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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Vaccine Trials Clinical Trials Therapies 52

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.

Vaccine 52

Vaccine FDA Clinical Trials Trials 52

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.,

Biosimilars 40

Biosimilars Science FDA Licensing 40

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: .

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Small Molecule 52

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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Production Marketing Research Government 52

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.

Vaccine 40

Vaccine Clinical Trials Trials FDA 40

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.

Vaccine 52

Vaccine Clinical Trials Trials Immune Response 52

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.

Vaccine 40

Vaccine Trials Licensing Licensing 40

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.

Licensing 52

Licensing Licensing FDA Approval FDA 52

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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Regulations International Disease Small Molecule 75

Drug Discovery World

AUGUST 5, 2022

Everyone can benefit from sharing experiences and learning from experts and specialists outside of their workplace or laboratory, and recruiting expert knowledge from outside of the organisation not only adds to a business’ knowledge bank but can also help to accelerate development and the speed of bringing new therapies to market.

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Drug Development Drugs Pharma Companies International 130

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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FDA Biosimilars Science Production 52