BMG Labtech

DECEMBER 20, 2024

Knowledge of metabolic control in bacteria is not only important for practical applications in biotechnology , medicine, and the environmental sciences but is also a foundation for fundamental research in laboratories across the globe. Measurement of bacterial growth based on optical density (OD 600 ) is frequently used in many laboratories.

Regulations 52

Regulations Laboratories Research Production 52

The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic.

Licensing 40

Licensing Licensing Therapies Laboratories 40

The Pharma Data

DECEMBER 15, 2020

16, 2020 /PRNewswire/ — Lipidor AB (Nasdaq First North: LIPI) announced today that the Company has signed a new cooperation agreement with Aurena Laboratories AB. Under the agreement, Aurena Laboratories will establish a production unit to meet the regulatory requirements for the manufacture of Lipidor’s pharmaceutical products.

Production 52

Production Laboratories Licensing Licensing 52

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 3] FDA further assumes that these laboratories collectively perform roughly 80,000 LDTs.

FDA 69

FDA Laboratories Regulations Production 69

The Pharma Data

SEPTEMBER 1, 2021

Study Now Enrolling Participants Who Live in the Same Household as Someone With Symptomatic, Laboratory-Confirmed COVID-19. The global study is enrolling individuals who are at least 18 years of age and reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms. MOVe-AHEAD Study.

Laboratories 52

Laboratories Clinical Trials Virus Trials 52

The Pharma Data

NOVEMBER 5, 2021

Li, administrative vice chairman and chairman, Merck Research Laboratories. “ Voluntary licenses As part of its commitment to wide global access, Merck preliminarily blazoned that it has entered into a licensing agreement with the Medicines Patent Pool to increase broad access for molnupiravir in low-and middle- income countries.

Licensing 52

Licensing Licensing Vaccine Laboratories 52

FDA Law Blog: Biosimilars

JULY 18, 2023

Those include biological products licensed under Biologics License Applications (BLAs), approved drugs under New Drug Applications (NDAs), and generic products under approved Abbreviated New Drug Applications (ANDAs). That leaves 60% that manufacture at least one application product.

FDA 52

FDA Licensing Licensing Laboratories 52

Codon

JUNE 30, 2024

Stanley Cohen’s laboratory bench from 1973. And like many other stories of invention, it began with a scientist working after hours in an unassuming laboratory tucked away inside an industrial research center. General Electric Research Laboratory in Schenectady, New York. Prometheus Laboratories, Inc., Chakrabarty.

DNA 105

DNA Engineering Laboratories Production 105

The Pharma Data

JULY 12, 2021

The Phase 3 portion of the global MOVe-OUT trial studying molnupiravir in non-hospitalized adult patients with laboratory-confirmed COVID-19 and at least one risk factor associated with poor disease outcomes is underway. If successful, molnupiravir could help address the continued urgent need for therapeutics.”.

Clinical Trials 52

Clinical Trials Laboratories Research Laboratories RNA 52

The Pharma Data

DECEMBER 2, 2020

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. Horizon Discovery Group – U.K.-based for its cGMP-compliant CHOSOURCE platform.

Licensing 52

Licensing Licensing DNA Vaccine 52

The Pharma Data

JANUARY 13, 2021

Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. Brilacidin antiviral research to date has been limited to laboratory-based experiments. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

The Pharma Data

JANUARY 25, 2021

Ambulero holds an exclusive license from the University of Miami to develop and commercialize research from the laboratories of Drs. As part of the investment, Ambulero and Orphinic formed a Polish subsidiary (Ambulero Sp. that will lead clinical testing of a novel gene therapy for a serious vascular disease in Europe.

Therapies 52

Therapies Disease Licensing Licensing 52

The Pharma Data

MARCH 14, 2021

This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. During the production of the vaccine more than 60 quality tests are conducted by AstraZeneca, its partners and by more than 20 independent testing laboratories.

Vaccine 52

Vaccine Virus Licensing Licensing 52

Drug Target Review

APRIL 9, 2024

These compounds were later licensed to the pharmaceutical industry for clinical development. Today, several companies have ATR inhibitors at various stages of clinical development, which to a significant extent was influenced by early works from the laboratory.

RNA 64

RNA Cell Biology Clinical Development Disease 64

The Pharma Data

NOVEMBER 5, 2020

Drawing upon 50 years of expertise in clinical research, biopharmaceuticals, biotechnology and drug discovery, Dr. Van Kampen excels as the chief executive officer of The Van Kampen Group, which assists other companies in research and liaisons with government and industry regarding licensing products for commercial use.

Research 52

Research Vaccine Doctors Pharmaceuticals 52

The Pharma Data

MARCH 16, 2021

In partnering with the Lieber Institute, Boehringer Ingelheim has in-licensed preclinical pipeline candidates, representing a first-in-class approach for targets in neuropsychiatric disorders. The potential of centrally acting COMT inhibitors has not yet been evaluated in the clinic due to the unavailability of such compounds.

Licensing 52

Licensing Licensing Research Laboratories Treatment 52

The Pharma Data

JULY 29, 2021

Essential safety information on the authorized emergency use of baricitinib includes warnings related to serious infections, thrombosis, abnormal laboratory values, vaccinations and hypersensitivity. Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. Additional safety information can be viewed below.

Hospitals 52

Hospitals FDA Laboratories Treatment 52

The Pharma Data

AUGUST 3, 2021

Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values. OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. Manage patients according to routine clinical guidelines.

Hospitals 52

Hospitals FDA FDA Approval Licensing 52

Molecule Blog

JANUARY 9, 2023

IP-NFTs upgrade our legacy intellectual system by unifying IP (patents, legal), underlying data (through decentralized storage and access control), and economics (royalties, license fees, sales) into one programmable, transactable, digital unit. ‍ Licensing fees and revenue generated flow back to the smart contract (eg.

Research 52

Research Licensing Licensing Science 52

The Pharma Data

OCTOBER 26, 2020

Enzo Biochem launched GoTestMeNow, an online platform that allows consumers to directly order physician-authorized laboratory testing, including for COVID-19 molecular and antibody testing, which will be the initial launch. Histogen and Amerimmune signed a deal to develop and commercialize emricasan for the treatment of COVID-19.

Vaccine 52

Vaccine FDA Approval Clinical Trials FDA 52

Broad Institute

JULY 25, 2024

Researchers identify cheap and effective biomarkers for DCIS tumor stage By Tom Ulrich July 25, 2024 Breadcrumb Home Researchers identify cheap and effective biomarkers for DCIS tumor stage New study shows how leveraging unsupervised learning can decode DCIS progression from chromatin images.

Research 69

Research Disease Treatment Clinical Trials 69

The Pharma Data

MARCH 8, 2021

“We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Molnupiravir.

Trials 69

Trials Virus RNA Research Laboratories 69

Molecule Blog

AUGUST 19, 2021

A DAO now owns this IP, the rights to future data, and is funding pioneering longevity research at the Scheibye-Knudsen Laboratory & University of Copenhagen. A researcher’s ability to do so dictates the success of their laboratory and further, the path of their career. Transacts the real-world legal rights/licenses of the IP (req.

Research 52

Research Licensing Licensing Drug Development 52

Codon

JULY 14, 2024

Karl Landsteiner in his New York laboratory. In each case, megakaryocyte cells in the laboratory only produced on the order of tens of platelets, far short of the 1,000 platelets generated per megakaryocyte in the human body. His laboratory develops technologies for the diagnosis and treatment of blood disorders.

Production 141

Production Clinical Trials Trials Therapies 141

The Pharma Data

NOVEMBER 22, 2020

The company has an exclusive collaboration and license deal with CStone Pharmaceuticals for development and commercialization of pralsetinib and specific other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. It holds the rights for the drug in the rest of the world. Revance Therapeutics’ DAXI to Treat Frown Lines.

FDA 52

FDA Licensing Licensing Treatment 52

Conversations in Drug Development Trends

NOVEMBER 27, 2023

Casgevy, the commercial product formerly known as exa-cel, is administered by taking stem cells out of a patient’s bone marrow and editing a gene in the cells in a laboratory, with the modified cells then infused back into the patient after conditioning treatment to prepare the bone marrow. In June 2023, the U.S.

Treatment 75

Treatment FDA Clinical Trials Therapies 75

DrugBank

FEBRUARY 9, 2023

Check out previous Trends & Insights Spotlights Academic User Spotlight Subhajit Dutta 1,2 & Ted Natoli 3 Laboratory of Cellular Differentiation & Metabolic Disorder, Department of Biotechnology, National Institute of Technology Durgapur, India. 2 Cancer Program, Broad Institute of MIT and Harvard, USA.

Clinical Pharmacology 52

Clinical Pharmacology Molecular Biology DNA Licensing 52

The Pharma Data

NOVEMBER 19, 2021

Still, PAXLOVID, which began in Pfizer’s laboratories, If approved or authorized. Pfizer moment blazoned an agreement with theU.S. government to supply 10 million treatment courses of its investigational COVID-19 oral antiviral seeker, PAXLOVID ™ (PF-07321332; ritonavir), subject to nonsupervisory authorization from theU.S.

Government 52

Government Treatment Clinical Trials Laboratories 52

The Pharma Data

APRIL 26, 2022

In vitro laboratory testing in multiple independent studies show that Veklury continues to demonstrate durable activity against SARS-CoV-2 as it evolves, including the Omicron variant and its subvariants BA.1 These licenses currently remain royalty-free, reflecting Gilead’s existing commitment to enabling broad patient access to remdesivir.

Treatment 52

Treatment Hospitals Science Licensing 52

The Pharma Data

APRIL 8, 2021

Baricitinib, an oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. Abnormal Laboratory Values: ?Evaluate Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values. Please see below for important warnings and information about the authorized use of baricitinib in the U.S.

Hospitals 52

Hospitals FDA Approval Laboratories Treatment 52

Codon

APRIL 2, 2023

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms. Nature Neuroscience. Read You love to see it! Will Bedingfield.

DNA 52

DNA RNA Engineering Licensing 52

The Pharma Data

AUGUST 17, 2021

This new indication follows an FDA priority review of the Biologics License Application and is based on the collective results from the dMMR endometrial cancer cohort A1 and the dMMR solid-tumour (non-endometrial cancer) cohort F of the ongoing GARNET trial. Grade 3 or 4 laboratory abnormalities (?2%) Common Adverse Reactions.

FDA 52

FDA FDA Approval Treatment DNA 52

The Pharma Data

MARCH 16, 2021

Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020 , the human monoclonal antibodies were optimised by AstraZeneca with half-life extension and reduced Fc receptor binding. The extended agreement is not anticipated to impact the Company’s financial guidance for 2021.

Treatment 52

Treatment Virus Trials Government 52

The Pharma Data

MAY 4, 2021

Abnormal Laboratory Values: Evaluate at baseline and thereafter according to local patient management practice. Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values. About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly.

Therapies 52

Therapies Hospitals Treatment FDA Approval 52

Advarra

JUNE 14, 2024

Laboratory certifications and normal ranges Institutional review board (IRB) membership lists CVs CTEP 1572s Essential Documents of a Regulatory Binder These documents demonstrate the investigator’s, sponsor’s, and monitor’s compliance with GCP and regulatory requirements.

Clinical Trials 40

Clinical Trials Trials Compliance FDA 40

The Pharma Data

JANUARY 17, 2021

Taconic Biosciences is a fully-licensed, global leader in genetically engineered rodent models and services. To learn more about Jh mice, please contact Taconic at 1-888-TACONIC (888-822-6642) in the US, +45 70 23 04 05 in Europe, or email info@taconic.com. About Taconic Biosciences, Inc.

Immune Response 40

Immune Response Pharmacokinetics Engineering Licensing 40

FDA Law Blog: Biosimilars

JULY 5, 2023

Under section 503B, drugs compounded by an FDA-registered outsourcing facility under the supervision of a licensed pharmacist can qualify for exemptions from FDA approval, labeling with adequate directions for use, and certain drug supply chain security requirements, subject to specific conditions. Draft Guidance III.B.2(e)

FDA 52

FDA FDA Approval Licensing Licensing 52