The Pharma Data

SEPTEMBER 29, 2020

. Sosei Heptares has received a $5m milestone payment from its strategic alliance partner Pfizer after the first subject in a clinical trial was dosed with a new drug candidate from the collaboration between the two companies.

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New Drug Approvals

SEPTEMBER 29, 2024

link] 01 Aug 2022 Cortexyme is now called Quince Therapeutics You need to be a logged in or subscribed to view this content This small molecule is an orally available protease inhibitor targeting the lysine proteases of the periodontal pathogen Porphyromonas gingivalis. This trial involves 93 sites in the U.S. and Europe.

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The Pharma Data

DECEMBER 5, 2020

.–(BUSINESS WIRE) December 5, 2020 — Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today announced new clinical data from its Phase 2 trial evaluating SY-1425, its first-in-class selective retinoic acid receptor alpha (RAR?)

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The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

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Drug Target Review

MARCH 28, 2024

Between 2000 and 2020, approximately 30 percent of the newly introduced small molecule drugs were derived from natural products. 1 Researchers have also observed a correlation between greater translatability of natural products and increased progression through clinical trials. References Newman DJ, Cragg GM. 2020;83(3):770–803.

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The Pharma Data

SEPTEMBER 8, 2020

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS).

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The Pharma Data

NOVEMBER 15, 2020

Urovant’s lead drug candidate, vibegron, is an oral, once-daily small molecule beta-3 agonist being evaluated for the treatment of OAB, abdominal pain associated with irritable bowel syndrome (IBS) in men with OAB, and for men suffering from OAB with benign prostatic hyperplasia (BPH). The condition is most prevalent in men. .

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The Pharma Data

NOVEMBER 23, 2020

“In the last months, Ultimovacs has strengthened its corporate and clinical development position having launched multiple mid-stage clinical trials and established a solid financial runway. Ton Berkien joins Ultimovacs with over 15 years of experience in strategic business development and corporate finance in the biopharmaceutical industry.

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Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). set specific standards and expectations for discrete components of clinical trials (e.g.,

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The Pharma Data

NOVEMBER 4, 2020

. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 700 adult patients with moderate to severe alopecia areata.

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The Pharma Data

JANUARY 13, 2021

we determined the crystal structure of CD40-ligand 2 , developed a humanized version of our antibody (hu5c8, ruplizumab, or Antova®) and tested it in human trials for preventing organ transplant rejection and autoimmunity. Collaborating with a team at Biogen Inc., 175:1091-1101 (1992) 2 Karpusas, M et al., International Immunol. (11):1583

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The Pharma Data

DECEMBER 10, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. Chief Medical Officer and Co-founder of BioNTech. There were no COVID-19 related deaths.

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The Pharma Data

JANUARY 11, 2021

MediciNova intends to use the proceeds received from the private placement primarily for the following three programs: 1) To initiate a new clinical trial of MN-166 (ibudilast) for glioblastoma, which could be a pivotal trial. 3) To initiate a Phase 2 clinical trial of MN-001 (tipelukast) in nonalcoholic steatohepatitis (NASH).

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The Pharma Data

JULY 18, 2021

The application includes clinical data from the pivotal Phase 3 clinical trial of the vaccine, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.

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New Drug Approvals

DECEMBER 3, 2022

852808-04-9 ABT-737 is a small molecule drug that inhibits Bcl-2 and Bcl-xL , two members of the Bcl-2 family of evolutionarily-conserved proteins that share B cl-2 H omology (BH) domains. “Bcl-2 inhibitors: small molecules with a big impact on cancer therapy.” ABT-737 Molecular Weight 813.43 nM, and 197.8

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New Drug Approvals

DECEMBER 16, 2023

PMID 35561315. ^ “Novartis Phase III APPOINT-PNH trial shows investigational oral monotherapy iptacopan improves hemoglobin to near-normal levels, leading to transfusion independence in all treatment-naïve PNH patients” Novartis (Press release). . April 2019). 6 (15): 4450–4460. doi : 10.1182/bloodadvances.2022006960.

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The Pharma Data

DECEMBER 10, 2020

Lexicon is currently enrolling patients with diabetic peripheral neuropathic pain in a Phase 2 proof-of-concept study of LX9211 and is preparing to initiate a second Phase 2 clinical trial of LX9211 in post-herpetic neuralgia. LX9211 is a potent, orally delivered, selective small molecule inhibitor of adapter-associated kinase 1 (AAK1).

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The Pharma Data

NOVEMBER 29, 2020

” “The emergence of the PROTAC technology represents another breakthrough in the identification of small molecule drugs. Small-molecule inhibitors of the MDM2-p53 protein-protein interaction (MDM2 inhibitors) in clinical trials for cancer treatment. 2019, 62 , 445?447. Aguilar, A.; Bernard, D.;

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The Pharma Data

MAY 6, 2022

The sBLA includes updated longer-term follow-up data from the companies pivotal Phase 3 clinical trial of 2,228 participants 12 through 15 years of age. In the trial, a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per dose) was 100% effective (95% confidence interval [CI, 87.5,

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The Pharma Data

JANUARY 17, 2021

As Crooke explained, “With small molecules, if you make any chemical change, you have a new ballgame. Safety is critical in all clinical trials, but with ultra-rare diseases, even greater care is taken. We’ve created safety databases that begin with non-human primates and extend to controlled clinical trials.”

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The Pharma Data

OCTOBER 14, 2020

VBL has developed three platform technologies: a gene-therapy based technology for targeting newly formed blood vessels with focus on cancer, an antibody-based technology targeting MOSPD2 for anti-inflammatory and immuno-oncology applications, and the Lecinoxoids, a family of small-molecules for immune-related indications.

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The Pharma Data

NOVEMBER 8, 2021

“HER-MES is the first study that directly compared the therapeutic effects of an antibody and a small molecule in migraine prevention,” said Uwe Reuter, M.D., MBA, trial investigator and managing medical director at Charité Universitätsmedizin in Berlin. versus 38.9%).

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The Pharma Data

JANUARY 18, 2021

RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. for the treatment of post-herpetic neuralgia. for the treatment of post-herpetic neuralgia.

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The Pharma Data

JANUARY 18, 2021

Sarconeos (BIO101), our leading drug candidate, is a small molecule, administered orally, being developed as a treatment for sarcopenia in a Phase 2 clinical trial in the United States and Europe (SARA-INT).

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Drug Target Review

JULY 12, 2023

Once a new drug target is identified, a proprietary deep learning artificial intelligence (AI) platform we call Fluency can rapidly identify small molecules that selectively bind to a target of interest. We have so far observed extraordinary PK C max levels and a mean half-life of approximately two hours in our Phase I trial to date.

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The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase IIIb OCREVUS higher dose clinical trial programme and Phase IV study evaluating OCREVUS in minority populations. Roche is also deeply committed to addressing barriers to clinical trial participation and advancing inclusive research. Many people with NMOSD remain misdiagnosed and untreated.

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The Pharma Data

APRIL 7, 2023

” These sNDAs are supported by results from the PHAROS trial (NCT03915951), an open-label, multicenter, non-randomized, Phase 2 study (n=98) to determine the safety, tolerability, and efficacy of BRAFTOVI given in combination with MEKTOVI in patients with BRAF V600E-mutant metastatic NSCLC. Updated October 1, 2019.

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The Pharma Data

OCTOBER 14, 2020

The designation of lanifibranor as a Breakthrough Therapy for the treatment of NASH follows the publication in June 2020 of positive topline results from Inventiva’s NATIVE Phase IIb clinical trial with lanifibranor in NASH patients. The trial plans to evaluate safety, tolerability, cytokine profile and efficacy parameters.

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The Premier Consulting Blog

AUGUST 8, 2024

Since dedicated efficacy and safety trials are avoided and only a comparative BA study is required for approval, the 505(b)(2) NDA would qualify for the reduced PDUFA application fee, saving ~$2.1M. October 2019. [iv] For example, pharmacokinetic (PK) data from a comparative BA study and PK modeling approaches (e.g., July 28, 2023.

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The Pharma Data

JANUARY 19, 2021

Syros is redefining the power of small molecules to control the expression of genes. About Syros Pharmaceuticals. Based on its unique ability to elucidate regulatory regions of the genome, Syros aims to develop medicines that provide a profound benefit for patients with diseases that have eluded other genomics-based approaches.

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The Pharma Data

FEBRUARY 24, 2022

The positive opinion adopted by the CHMP is based on an evaluation of interim safety and efficacy data from a clinical trial of a booster dose of the vaccine in those aged 16 and over, together with published literature and post authorisation data plus real-world evidence from the use of booster doses in young patients in Israel.

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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. The Company’s pipeline is highlighted below: Aridis’ Pipeline.

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LifeSciVC

APRIL 27, 2023

Fourteen years on, this corporate experiment has gone far beyond the initial idea, and has established an R&D engine more effective than most big pharma R&D groups at producing best-in-class small molecules against targets that matter in human disease biology. The initial interactions with BMS were pragmatic and sensible.

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The Pharma Data

SEPTEMBER 9, 2020

“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As About the Phase 2/3 Study. billion doses by the end of 2021. billion doses by the end of 2021.

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Alta Sciences

APRIL 17, 2024

Ketamine is a dissociative anesthetic approved in 2019 by the U.S. Fifteen oligonucleotides have so far received market authorization in different countries, and several others are being test in clinical Phase I to III trials. Several small molecule GLP-1R agonists, such as oral orforglipron, are in late-stage clinical development.

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The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. “We are pleased to work with U.S.

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The Pharma Data

SEPTEMBER 9, 2020

The study is an event-driven trial. Pfizer and BioNTech are committed to decreasing health disparities in underrepresented populations through the clinical trial process. The companies are also working together with investigator sites and advocacy partners to raise awareness about the importance of participation in this trial.

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