Delveinsight

AUGUST 4, 2020

MorphoSys in-licensed Monjuvi, which is a humanized Fc-engineered monoclonal antibody against CD19 – the same protein which CAR-T cell therapies target and is in abundance in cancerous B cells, from Xencor in 2010 and is under evaluation in B-cell malignancies in several ongoing combination trials.

Cardiology 55

Cardiology Antibody FDA Approval Trials 55

pharmaphorum

DECEMBER 21, 2020

A first-in-class treatment discovered by Alnylam and then licensed to The Medicines Company, the drug is being developed for treatment for hyperlipidaemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy. billion late last year.

Drugs 52

Drugs RNA Manufacturing Licensing 52

pharmaphorum

APRIL 23, 2021

Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . Amarin said that Vazkepa is one of the first drugs filed and licensed through the MHRA’s new “Reliance” route following the end of the Brexit transition period.

Cardiology 98

Cardiology Regulation Drugs Licensing 98

The Pharma Data

DECEMBER 12, 2020

It plays a crucial role in many inflammatory and autoimmune diseases across multiple therapy areas, including haematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. The complement cascade is pivotal to the innate immune system.

Development 75

Development Regulation Medicine Containment 75

The Pharma Data

OCTOBER 29, 2020

ALXN2060 (AG10) – Eidos: Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan. Enrollment is underway in two parallel Phase 3 studies – one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease. Eidos is currently evaluating AG10 in a Phase 3 study in the U.S.

Sales 40

Sales Clinical Trials Clinical Trials Production 40

Cloudbyz

AUGUST 16, 2024

The cost of implementing an eCRF system can vary depending on several factors, including: Licensing Fees: Ongoing costs for using the software, which may be subscription-based or one-time fees. Regulatory Compliance: Adhering to international standards, such as CDISC, for data collection and reporting.

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

pharmaphorum

JUNE 25, 2021

But Dr Craig Granowitz, chief scientific officer of cardiology drug developer Amarin, says that this is only the tip of the iceberg when it comes to the devastating impact of CVD on global populations. “In

Cardiology 101

Cardiology Drugs Development Clinical Trials 101

The Pharma Data

AUGUST 29, 2020

Presented at the ESC Congress 2020, the annual meeting of the European Society of Cardiology, the analysis evaluated the efficacy and tolerability of inclisiran on top of a maximally tolerated dose of statins, in two studies of more than 2,300 patients (of which 1,164 were on inclisiran) from the Phase III trials.

Medicine 52

Medicine Containment Trials Production 52

The Pharma Data

AUGUST 30, 2021

Results were presented at the ESC Congress 2021, organized by the European Society of Cardiology (ESC). Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals, a leader in RNAi therapeutics.

RNA 52

RNA Trials Production Containment 52

The Pharma Data

NOVEMBER 4, 2020

Expanded m edical society recommendations in support of the efficacy and safety of VASCEPA : The European Society of Cardiology expanded their guidelines to recommend use of VASCEPA in treating acute coronary syndrome patients. In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 million and $8.9

Sales 40

Sales Production Marketing Cardiology 40

The Pharma Data

SEPTEMBER 15, 2020

The results demonstrated that Penta immune responses were robust and noninferior to licensed meningococcal vaccines (MenB and MenACWY) in individuals 10-25 years of age, regardless of prior MenACWY exposure. A Phase 2 proof-of-concept study of Pfizer’s potential first-in-class pentavalent meningococcal vaccine candidate (Penta; MenABCWY).

Gene Therapy 52

Gene Therapy Vaccination Vaccine Trials 52

The Pharma Data

APRIL 1, 2021

. “When our specialties collaborate, we give our patients the best chance of success – which is highlighted in our professional society guidelines, including those from the American Diabetes Association and the American College of Cardiology.” This survey was conducted online within the U.S. The survey included 1,000 U.S.

Nurses 52

Nurses Cardiology Medicine Insulin 52

The Pharma Data

APRIL 26, 2021

billion declined, mainly due to the USD 650 million upfront payment to in-license tislelizumab from BeiGene. This decline was mainly due to the USD 650 million upfront payment to in-license tislelizumab from BeiGene and lower operating income adjusted for non-cash items, partly offset by favorable changes in working capital.

Sales 40

Sales Medicine Production Manufacturing 40

XTalks

AUGUST 2, 2023

Late in 2022, AbbVie partnered with HotSpot Therapeutics and announced an exclusive worldwide collaboration and option to license agreement for their interferon regulatory factor 5 (IRF5) inhibitor program for autoimmune disease treatment. In 2022, the FDA proceeded to grant official licensing for Moderna’s Spikevax COVID-19 vaccine.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

XTalks

DECEMBER 19, 2024

The agency issued a complete response letter (CRL) for the biologics license application (BLA) for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration. percent, including impacts from its 2023 acquisition of cardiology medtech company Laminar.

Sales 97

Sales FDA Approval Licensing Licensing 97