pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

Antibody 98

Antibody Trials Licensing Licensing 98

Pharmaceutical Technology

MAY 26, 2023

These figures are only expected to grow in the coming years, with sales forecasted to reach over $150 billion by 2028. At the moment, there are roughly 241 immuno-oncology agents that are studied across solid tumours, noted Chalk, adding that this is largely due to a large number of Phase I trials that are not cancer specific.

Marketing 264

Marketing Vaccination Vaccine Development 264

XTalks

MARCH 17, 2025

The partnership also outlines development milestones of $1.2 billion, primarily linked to initiating Phase III trials for petrelintide as a stand-alone therapy, with sales-based milestones that could push the total value to $5.3 Under the deal, Zealand Pharma will receive an upfront cash payment of $1.65 billion $1.4

Hormones 59

Hormones Drugs Sales Insulin 59

pharmaphorum

MARCH 15, 2022

Sanofi has agreed a deal with life sciences investor Blackstone to help fund clinical trials of a new formulation of Sarclisa for blood cancer multiple myeloma, accelerating its development. In return, it will get a royalty on sales if the new version gets approved.

Trials 97

Trials Sales Drug Delivery Antibody 97

pharmaphorum

JANUARY 14, 2022

In the latest episode of the pharmaphorum podcast, Dr Paul Tunnah speaks to head of Patient Engagement at Syneos Health, Marie Emms, and Elligo executive vice president and general manager of Worldwide Clinical Trials Early Phase Services, Keith Fern. Keith Fern joins Elligo with a decade of proven leadership in the CRO industry.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Development 98

XTalks

DECEMBER 10, 2021

Biohaven Pharmaceuticals revealed positive top line results from a late-stage trial which show that its migraine medication Zavegepant provides “ultra-rapid” pain relief in just 15 minutes. The trial has enrolled over 1,400 adult participants with a history of migraines.

FDA Approval 98

FDA Approval Trials Drugs Sales 98

Pharmaceutical Technology

FEBRUARY 14, 2023

upfront payment and eligible for royalties on net sales. It will also receive potential development and regulatory milestone payments of up to $130m along with potential commercial milestone payments of $555m. We look forward to working with CSPC to advance clinical development of this asset and realise its full potential.”

Antibody 130

Antibody Drugs Clinical Development Licensing 130

pharmaphorum

NOVEMBER 16, 2021

MK-0616 has been shown to reduce LDL cholesterol by a similar margin to injectables sold by Amgen and Sanofi/Regeneron – as well as Novartis’ longer-lasting RNAi therapy Leqvio – in two clinical trials reported at the American Heart Association (AHA) meeting.

Trials 98

Trials Drugs Sales Clinical Trials 98

Pharmaceutical Technology

APRIL 25, 2023

3BP receives an initial payment of $40m, and $425m as development, regulatory and commercial milestone payments. Tiered royalties on net sales are also included in the deal. 3BP continues to hold specific rights to develop its FAP-targeting imaging technology for diagnostic applications.

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Licensing Licensing Clinical Development Clinical Trials 130

Pharmaceutical Technology

OCTOBER 18, 2022

Additionally, Gilead will make tiered royalty payments on global net MGD024 sales and a flat royalty on international net product sales under the two research programmes to MacroGenics.

Antibody 130

Antibody Development Sales Clinical Trials 130

pharmaphorum

JANUARY 6, 2022

PureTech is developing a modified version of the active ingredient in Esbriet (pirfenidone) that has just been shown to be less likely to cause gastrointestinal side effects than Roche’s drug in a proof-of-concept trial. The first clinical data on the drug in healthy older adults seems to back up that hypothesis.

Trials 105

Trials Marketing FDA Approval Development 105

Pharmaceutical Technology

AUGUST 4, 2022

P-BCMA-ALLO1 is currently being analysed in a Phase I clinical trial while an investigational new drug (IND) application for P-CD19CD20-ALLO1 is anticipated next year. Roche and Poseida will also partner in a research programme for creating and developing next-generation features and enhancements for allogeneic CAR-T therapies.

Development 147

Development Clinical Trials Clinical Trials Gene Therapy 147

Pharmaceutical Technology

MARCH 23, 2023

Adcetris is currently active in multiple clinical trials, including the ECHELON-3 Phase lll study for patients with relapsed or refractory diffuse large B-cell lymphoma. Tivdak, a tissue-factor targeting ADC that was developed in collaboration with Genmab, was approved in 2021.

Licensing 147

Licensing Licensing Sales Trials 147

XTalks

JANUARY 29, 2025

The FDAs decision was based on data from the FLOW Phase IIIb kidney outcomes trial, which investigated the effects of once-weekly Ozempic 1 mg injections on major kidney and cardiovascular outcomes in adults with type 2 diabetes and CKD. With this new indication, Ozempic stands out uniquely as the most broadly indicated GLP-1 RA in its class.

FDA Approval 66

FDA Approval Trials Clinical Trials Clinical Trials 66

Pharmaceutical Technology

AUGUST 30, 2022

Under the deal, Zerion will handle the development of Dispersome formulations of marketed drugs. The finished product dosage form, clinical development and the final products’ marketing and sales across the globe will be handled by Insud. . All the clinical and other development expenses will be handled by Insud.

Development 130

Development Drugs Bioavailability Production 130

World of DTC Marketing

NOVEMBER 19, 2021

government has provided Moderna with nearly $10 billion in taxpayer money for research and development and the purchase of 500 million doses of this mRNA COVID-19 vaccine. This includes almost the entire cost of clinical development. billion for the development of its vaccine and to pay for doses once approved.

Vaccination 44

Vaccination Vaccine Allergies Production 44

Pharmaceutical Technology

FEBRUARY 17, 2023

Capricor will handle the clinical development of CAP-1002 and sell commercial products to Nippon Shinyaku. Additionally, Capricor will receive up to $89m in further development and sales-based milestones, along with a double-digit share of revenue based on product sales.

Gene Therapy 130

Gene Therapy Clinical Development Sales Gene 130

Pharmaceutical Technology

JUNE 2, 2023

Furthermore, Amarin will receive tiered double-digit percentage royalties on the net sales of Vascepa in the territory.

Clinical Trials 130

Clinical Trials Clinical Trials Clinical Development Sales 130

Pharmaceutical Technology

JULY 26, 2022

This sales growth will be in line with a steadily increasing disease prevalence and the entrance of novel agents into the market. The three major markets (3MM: the US, Germany and the UK) will increase in market size from $128.35m last year to $188.35m in 2031, at a compound annual growth rate (CAGR) of 3.9%.

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Marketing Gene Branding Clinical Development 306

pharmaphorum

JANUARY 5, 2022

GlaxoSmithKline places shingles vaccine Shingrix is among its top prospects, with peak sales potential of almost $6 billion. There’s also regulatory annd sales milestones totaling up to $200 million at the back end of the deal, and BioNTech will also get a share of gross profits from any future sales.

Vaccination 105

Vaccination Vaccine Sales Clinical Development 105

pharmaphorum

DECEMBER 4, 2020

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. Pfizer will pay up to $45 million in development related milestone payments and up to $143 million if the vaccine hits early sales targets.

Vaccination 119

Vaccination Vaccine Bacterium Protein 119

Pharmaceutical Technology

DECEMBER 14, 2022

Additionally, for WVE-006, GSK will make development and launch milestone payments of up to $225m to Wave, which is also eligible to get up to $300m in milestone payments based on sales. On completion of the first-in-patient clinical trial by Wave, GSK will be in charge of the development and marketing works.

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Life Science Development Gene Therapy Genetics 162

XTalks

JANUARY 7, 2025

billion Announced : April 2021 Closed : December 2021 Thermo Fisher Scientific, a worldwide supplier of analytical instruments, clinical development solutions, specialty diagnostics, lab, pharmaceutical and biotech services, acquired PPD , a leading global provider of clinical research services to the biopharma and biotech industry, for $17.4

Life Science 105

Life Science Manufacturing Production Clinical Development 105

Pharmaceutical Technology

DECEMBER 7, 2022

According to the deal, Pfizer and Clear Creek Bio will collaborate to detect a PLpro candidate, which would be advanced into clinical trials. On entering the clinic, Pfizer will solely handle the development and marketing works of the candidate.

Development 130

Development Clinical Trials Clinical Trials Clinical Development 130

Delveinsight

JULY 27, 2021

Remarkable drop was observed in altered filamin A plasma levels after treatment with simufilam in Phase 2b trials. a biotechnology (clinical stage immuno-oncology) company from California publicized the design of its new XPro therapy in Phase 2 clinical trials. P-tau 181 plasma levels were also reduced in a good amount.

Vaccination 96

Vaccination Vaccine Trials Manufacturing 96

Pharmaceutical Technology

MAY 31, 2023

Setanaxib is under clinical development by Calliditas Therapeutics and currently in Phase III for Primary Biliary Cholangitis (Primary Biliary Cirrhosis). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Clinical Trials 100

Clinical Trials Clinical Trials Production Drugs 100

The Pharma Data

SEPTEMBER 22, 2020

Trial design and other details are being evaluated and a comprehensive update on the overall Novartis SMA clinical development program will be provided at a future time following further discussions with health authorities. This guidance provides clarity on the path to registration for AVXS-101 IT.

Clinical Development 52

Clinical Development Gene Therapy Development Gene 52

pharmaphorum

MAY 14, 2021

China’s Kintor Pharmaceutical has begun late-stage US clinical development of its potential COVID drug proxalutamide – but there is scepticism over the company’s claims about its research. But Reuters reported that the doctor identified as its principal clinical trial investigator has said he is not in charge of the trial.

Drug Trials 52

Drug Trials Trials Drugs Dermatology 52

Pharmaceutical Technology

FEBRUARY 24, 2023

According to Globaldata, it is involved in 10 clinical trials, of which 4 were completed, 5 are ongoing, and 1 is planned. Applying the drug’s phase transition success rate to remaining R&D costs and likelihood of approval (LoA) to sales related costs provides a risk-adjusted NPV model (rNPV).

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Sales Production Medicine Clinical Trials 113

pharmaphorum

APRIL 19, 2022

Just days after dosing its first patient in a Duchenne muscular dystrophy trial, US biotech PepGen has pushed the button on an initial public offering (IPO). The Boston-based company has filed with the US Securities and Exchange Commission to raise up to $115 million from the IPO, according to a Renaissance Capital report.

Protein 105

Protein RNA Clinical Development Production 105

pharmaphorum

FEBRUARY 21, 2022

The approval is based on the phase 3 FIDELIO-DKD trial, in which Kerendia (finerenone) reduced the risk of kidney disease progression or renal death by 18% when added to the highest tolerated dose of standard therapy. The company reckons Kerendia has the potential to reach peak annual sales of around €1 billion.

Drugs 122

Drugs Trials Insulin FDA Approval 122

Pharmaceutical Technology

JUNE 5, 2023

Rezvilutamide is under clinical development by Jiangsu Hengrui Medicine and currently in Phase I for Liver Failure (Hepatic Insufficiency). GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Medicine 100

Medicine Hormones Production Clinical Trials 100

Pharmaceutical Technology

JUNE 5, 2023

Rezvilutamide is under clinical development by Jiangsu Hengrui Medicine and currently in Phase III for Prostate Cancer. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Medicine 100

Medicine Hormones Production Clinical Trials 100

Worldwide Clinical Trials

FEBRUARY 22, 2023

Panelists will answer questions such as: What are the greatest challenges holding patients back from enrolling in trials? Richie Kahn: I’m a public health and advocacy guy by training, a clinical researcher by trade, and a patient advocate by necessity. I have participated in many trials and studies. So, I decided to pivot.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Delveinsight

JULY 28, 2020

Daiichi’s DS-1062 , a trophoblast cell-surface antigen 2 (TROP2) directed DXd antibody-drug conjugate (ADC) is currently in Phase I clinical trial for multiple cancer types including the majority of non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). Daiichi holds exclusive rights to the drug in Japan.

Gene Therapy 52

Gene Therapy Trials Gene Vaccination 52

pharmaphorum

AUGUST 4, 2020

Redx will receive up to $17m in early payments between signing the deal and the successful start of the first clinical trial. The biotech based at AZ’s former UK R&D site in Alderley Park, Cheshire, could receive a further $360 million in development and commercial milestones plus tiered royalties.

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Drugs Clinical Trials Clinical Trials Pharma Companies 109

XTalks

SEPTEMBER 12, 2024

Ryan Brown Regional Vice President Sales-Trial Landscape H1 Diversity in clinical trials is not just a regulatory box to check — it’s an ethical imperative and a scientific necessity. Incorporating SDOH data into trial planning ensures that studies are more inclusive and accessible to diverse populations.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52