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Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

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The Case for Early Regulatory Consideration for Clinical Development of Chimeric Antigen Receptor T cell (CART)

CATO Research

Hence, the next clinical milestone will very likely be the development of allogeneic CART therapies that could offer off-the-shelf products with immediate availability as an on-demand therapeutic option for patients with high unmet medical needs. Meeting Clinical Objectives.

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Novartis Provides Update on AVXS-101 Intrathecal Clinical Development Program

The Pharma Data

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.

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Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine

The Pharma Data

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1.

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Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine | Novartis

The Pharma Data

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept.

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Are you ready for the new European clinical trial regulation?

CATO Research

The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive , the directive that currently describes how clinical trials should be conducted in Europe. The regulation will have a major impact on the conduct of clinical trials.

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Syncromune and Eucure enter antibody licence deal

Pharmaceutical Technology

According to the deal, the worldwide rights for developing and marketing intratumoral combination treatment containing Eucure’s YH002 and two additional active ingredients of the Syncrovax therapy will be acquired by Syncromune.

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Lifileucel, what is the likelihood that the drug will be approved?

Pharmaceutical Technology

Lifileucel is under clinical development by Iovance Biotherapeutics and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next. It develops products based on its tumor-infiltrating lymphocyte (TIL) technology.

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Astellas, Seagen and Merck Announce FDA Acceptance of Supplemental Biologics License Applications for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

The Pharma Data

Food and Drug Administration (FDA) has accepted for priority review supplemental Biologics License Applications (sBLAs) for PADCEV® (enfortumab vedotin-ejfv) and KEYTRUDA® (pembrolizumab) for use of these two agents in combination for the treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC) who are not eligible to receive cisplatin-containing chemotherapy. senior vice president and head of development therapeutic areas, Astellas.

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FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

The Pharma Data

In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy.

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As Vudalimab moves closer to clinical approval, what is the likelihood that the drug will be approved?

Pharmaceutical Technology

Vudalimab is under clinical development by Xencor and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next. It is developed based on XmAb bi-specific/ Xtend Fc domains antibody engineering technology.

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Rising demand for pediatric dosage forms requires reformulation, expertise, and to-scale manufacturing capabilities

Pharmaceutical Technology

But the challenges for drug producers developing PDFs are numerous and varied. Formulation decisions made in the development of PDFs can have important implications for drug stability, patient compliance, and accurate dosing.

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Gilead’s Long-Term Real-World Data Show HIV Drug Biktarvy Has High, Sustained Efficacy

XTalks

The US Food and Drug Administration (FDA) approved a label change for Biktarvy on October 14, 2022, updating the prescribing information to include clinical trial efficacy data from 144 weeks and safety data from 240 weeks in adults with HIV who began the treatment in Study 1489 and Study 1490.

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Synlogic Announces Third Quarter 2020 Conference Call & Webcast

The Pharma Data

Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced the Company will release its third quarter 2020 financial results before the market opens on Thursday, November 5, 2020. CAMBRIDGE, Mass. ,

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PT027 recommended by FDA Advisory Committee as new deliverance treatment for asthma

The Pharma Data

PT027 is a implicit first- in- class, pressurised metered- cure inhaler( pMDI), fixed- cure combination deliverance drug in the US containing albuterol, a short- acting beta2- agonist( SABA), and budesonide, ananti-inflammatory gobbled corticosteroid( ICS).

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European Commission Expands Merck’s VAXNEUVANCE ™( Pneumococcal 15- valent Conjugate Vaccine) suggestion to Include babies, Children and Adolescents

The Pharma Data

VAXNEUVANCE was developed to maintain a strong vulnerable response to serotypes included in presently available pneumococcal conjugate vaccines, or PCVs, while expanding content to complaint- causing serotypes that can pose substantial threat to babies and children, ” saidDr.

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MindMed aims for Nasdaq listing after Compass’ magic mushroom-fuelled IPO

Pharma Phorum

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression.

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Dyno attracts $1.6bn gene therapy deal with Astellas

Pharma Phorum

In September, it reported a fourth patient death in a clinical trial of its AT132 (resamirigene bilparvovec) gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), possibly linked to liver side effects.

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MorphoSys To Present At the 39th Annual J.P. Morgan Healthcare Conference

The Pharma Data

About MorphoSys MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases.

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Lexicon Pharmaceuticals Receives Fast Track Designation From the FDA for LX9211 for Diabetic Peripheral Neuropathic Pain

The Pharma Data

Food and Drug Administration (FDA) for the development of LX9211 in diabetic peripheral neuropathic pain. executive vice president of research and development. “We THE WOODLANDS, Texas, Dec. 11, 2020 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc.

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GSK and Wave Life Sciences announce collaboration to drive discovery and development of oligonucleotide therapeutics focusing on novel genetic targets

The Pharma Data

GSK and Wave Life Sciences announce collaboration to drive discovery and development of oligonucleotide therapeutics focusing on novel genetic targets. Nasdaq: WVE), a clinical-stage genetic medicines company committed to delivering life-changing treatments for people battling devastating diseases, today announced a strategic collaboration to advance oligonucleotide therapeutics, including Wave’s preclinical RNA editing programme targeting alpha-1 antitrypsin deficiency (AATD), WVE-006.

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Harpoon Therapeutics Granted Orphan Drug Designation from FDA for HPN217 for Treatment of Multiple Myeloma

The Pharma Data

NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today announced that the U.S. HPN217 is covered by a global development and option agreement with AbbVie Inc. Clinical TrailsSOUTH SAN FRANCISCO, Calif.,

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Takeda Enters Collaboration and Licensing Agreement with Zedira and Dr. Falk Pharma to Develop First-in-Class Celiac Disease Therapy

The Pharma Data

Collaboration Provides Takeda an Exclusive License to Develop and Commercialize ZED1227/TAK-227 in the United States and Other Countries Outside of Europe, Canada, Australia and China Agreement Adds Third Investigational Therapy to Takeda’s Pipeline for the Potential Treatment of Celiac Disease. Falk Pharma GmbH moment blazoned a collaboration and licensing agreement to develop ZED1227/ TAK- 227, a Phase 2b investigational remedy for the treatment of celiac complaint.

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Commencement of AAIC; GSK’s Shingles Vaccine Expanded Approval; Pfizer/ BioNtech Agreement with Biovac; Another Failure in Ulcerative Colitis Trial

Delveinsight

Various Active Pharmaceuticals & Biotechnological Companies including Cassava Sciences, INmune Bio, Cognito Therapeutics, Cortexyme among others presented their new and upcoming drugs, therapies, shared their research studies and clinical data.

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Strategizing for NDA/BLA Series Part 2: Planning Ahead for Your NDA or BLA

CATO Research

They can contain tens to hundreds of thousands of pages of documents. Often planning for the application is postponed until the pivotal Phase 3 clinical trials are nearing completion or are finished. Photo by Scott Graham on Unsplash.

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Moderna Announces Supply Agreement with the Ministry of Public Health to Supply Qatar with mRNA Vaccine Against COVID-19 (mRNA-1273)

The Pharma Data

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. 26, 2020 11:00 UTC. CAMBRIDGE, Mass.–(

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How patient-on-a-chip tech could be the future of drug discovery

Pharma Phorum

In testing new treatments, what is promising in animal models may not transfer particularly well to humans, which helps to explain why there is a 90% failure rate during clinical development. Quris has taken its technology and used it to develop its own drug candidate pipeline.

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Gilead Presents Real- World substantiation buttressing the Use of Biktarvy ® for the Treatment of People Living With HIV With a Range of Comorbidities

The Pharma Data

Gilead Presents Real- World substantiation buttressing the Use of Biktarvy ® for the Treatment of People Living With HIV With a Range of Comorbidities New Clinical issues from BICSTaR Study Show Sustained Impact of Biktarvy for People with HIV –. The rearmost five- time data from two Phase 3 studies( Study 1489 and Study 1490) give substantiation of the long- term safety and efficacity profile of Biktarvy in those who switch from a dolutegravir- containing authority.

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Mirena ® approved in Europe for extended duration of use in contraception

The Pharma Data

About the Contraceptive Efficacy & Mirena Extension Trial The contraceptive efficacity of Mirena for over to five times has been studied in five large clinical trials involving,330 women. About Mirena ® Mirena is a T- shaped device containing 52 mg of synthetic levonorgestrel. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

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Patient centricity and the changing pharmaceutical vista

Pharma Phorum

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. We talk a lot in clinical trials and drug development about benefit,” Dr Mullen said.

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Cyxone has filed an IND in the US with Rabeximod following positive feed-back from pre-IND meeting with the FDA

The Pharma Data

a clinical stage biotech company developing first-in-class drugs for diseases of the immune system, announced today that the company has filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) pertaining to its drug candidate Rabeximod.

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BioInvent and Transgene receive CTA approval for Phase l/lla trial of oncolytic virus BT-001 in solid tumors

The Pharma Data

BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene. “This clinical trial approval sets the stage to further broaden BioInvent’s promising clinical pipeline. BT-001 is our fourth program in clinical development.

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Merck Receives Positive CHMP Opinion for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in Infants and Children

The Pharma Data

Eliav Barr, elderly vice chairman, head of global clinical development and principal medical officer, Merck Research Laboratories. “ pneumoniae serotypes contained in the vaccine. Merck’s ongoing pneumococcal vaccine development program is designed to give customized options to address the specific requirements of different populations, including babies and children, healthy grown-ups and at- threat groups.

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Polyphor to Take Part in Panel Discussion on Novel Oncology Targets at the LifeSci Partners 10th Annual Healthcare Corporate Access Event

The Pharma Data

The panel is entitled “Separating the Wheat from the Chaff: Most Promising Novel Oncology Targets in Development”. In addition, it has discovered and is developing the Outer Membrane Protein Targeting Antibiotics (OMPTA). ALLSCHWIL, Switzerland, Jan.

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PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer

The Pharma Data

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Research and development efforts will be led by Dr. Paul Van Slyke.

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Moderna Partners with Takeda and the Government of Japan to Supply 50 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) to Japan

The Pharma Data

Moderna is responsible for the manufacture and supply of Moderna’s vaccine candidate, and Takeda, with the support of the MHLW, the Japan Agency for Medical Research and Development (AMED) and Moderna, is responsible for all import, local regulatory, development and distribution activities in Japan to ensure timely access starting during the first half of 2021. “We 29, 2020 06:00 UTC. CAMBRIDGE, Mass.–( –( BUSINESS WIRE )– Moderna, Inc.

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Game-based therapies and the attraction of engaging patients

Pharma Phorum

The ‘ gamification ’ of website design, app development, investment platforms, or just about any activity that exists on the internet, will contain examples of how this strategy maintains user engagement. Adding a unique clinical tool. Clinical development is no game.

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Oncology treatment decisions aren’t just based on clinical data

Pharma Phorum

Once widely acknowledged as so special that only scientists and clinical specialists need to apply, oncology has become exponentially more clinically targeted and sophisticated over the last decade.

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ASLAN Pharmaceuticals to Develop ASLAN003 as Next Generation DHODH Inhibitor in Autoimmune Conditions

The Pharma Data

ASLAN believes ASLAN003 has the potential to bethe most potent oral inhibitor of DHODH currently in development for autoimmune disease, more than 30 times more potent at inhibiting the DHODH enzyme than teriflunomide. ASLAN appoints neurologist Professor Gavin Giovannoni as a scientific advisorto establish clinical development strategy in multiple sclerosis. This release contains forward-looking statements.

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Five Prime Announces Pricing of Upsized Public Offering of Common Stock – Nov 13, 2020

The Pharma Data

Five Prime plans to use the net proceeds of the offering, together with other available funds, to fund ongoing clinical development of bemarituzumab and FPT155, to advance FPA157 through preclinical and into clinical development, to advance its late-stage research programs and for working capital and general corporate purposes. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

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Passage Bio Receives FDA Clearance of IND Application for PBFT02 Gene Therapy Candidate for Treatment of Patients with Frontotemporal Dementia with Granulin Mutations

The Pharma Data

– Second Product Candidate Expected to Enter Clinic in First Half of 2021. Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system (CNS) disorders, today announced that the U.S.

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Cerecor Inc. Announces Pricing of $36.4 Million Public Offering of Common Stock and Pre-Funded Warrants

The Pharma Data

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. ROCKVILLE, Md. and CHESTERBROOK, Pa.,

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MorphoSys’ Licensee Janssen Receives CHMP Positive Opinion for Tremfya(R) (guselkumab) for Treatment of Adults with Active Psoriatic Arthritis (PsA) in the European Union (EU)

The Pharma Data

PLANEGG / MUNICH, GERMANY / ACCESSWIRE / October 19, 2020 / MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) announced today that its licensee Janssen Research & Development, LLC. 2 There is no known cure, and it is estimated that up to a third of the 14 million people who are living with psoriasis in Europe will also go on to develop PsA.