The Pharma Data

MARCH 25, 2021

With more than six years of patient experience, a positive benefit-risk profile, strong clinical data and robust real-world data, the totality of evidence solidifies the role of IBRANCE plus endocrine therapy as a treatment for patients with HR+, HER2- metastatic breast cancer.”. The analysis also showed the two-year OS rate was 78.3%

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Conversations in Drug Development Trends

DECEMBER 20, 2023

Single-Arm Trial Design Single-arm trials have also become an increasingly common development strategy to support regulatory approval and allow patients expedited access to novel therapies, particularly in the accelerated access setting.

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The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. The study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the two concentrations.

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Alta Sciences

APRIL 17, 2024

Psychedelics Psychedelic therapy (or psychedelic-assisted therapy) refers to the use of psychedelic drugs, such as psilocybin, MDMA, LSD, ketamine, and ayahuasca, to treat mental disorders, especially those that have no effective treatments available or are treatment resistant.

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The Pharma Data

MARCH 9, 2022

Sanofi and Swedish Orphan Biovitrum AB (publ) (Sobi ® ) (STO:SOBI) today announced positive topline results from the pivotal XTEND-1 Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients ? 12 years of age with severe hemophilia A.

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The Pharma Data

MARCH 23, 2021

We have designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalized or in critical care. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

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The Pharma Data

MARCH 9, 2022

PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) is the first oral therapy specifically designed to combat COVID-19 to be evaluated in a pediatric clinical study PAXLOVID is currently authorized under U.S.

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The Pharma Data

APRIL 7, 2022

“At Pfizer, we have a strong heritage in, and commitment to, fighting infectious diseases, most recently evidenced by our delivery of the first authorized vaccine and oral therapy to combat COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. Sisunatovir has been granted Fast Track designation by the U.S.

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The Pharma Data

APRIL 11, 2023

Bayer is advancing its oncology R&D efforts in three scientific areas that have the potential to address unmet needs in cancer patients: next-generation Immuno-Oncology, Targeted Radionuclide Therapies and Precision Molecular Oncology. Data from all three areas of scientific focus will be showcased during this year’s meeting.

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The Pharma Data

APRIL 7, 2021

Nasdaq: BIIB) today announced that the European Commission (EC) has granted marketing authorization for a subcutaneous (SC) injection of TYSABRI® (natalizumab) to treat relapsing-remitting multiple sclerosis (MS). TYSABRI is a trusted high-efficacy therapy with a well characterized safety profile for patients living with MS.

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The Pharma Data

DECEMBER 13, 2020

About 15 to 20% of breast cancers cases are HER2+, and antibody-based therapies targeting HER2 have significantly improved outcomes of patients with HER2+ breast cancer. Zai is strongly positioned to take advantage of a growing pharmaceutical market in this region.”. We look forward to working with the FDA to bring ABP 798 to market.”.

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The Pharma Data

DECEMBER 27, 2020

phase I trial is a randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics (biomarkers – FGF19 and C4) of ASC42 in healthy subjects. Phase I Trial. This trial also investigates the food effect on ASC42 exposure.

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LifeSciVC

APRIL 24, 2024

with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g., Consider anticipated time to market (not just time to the clinic), competitiveness of the mechanism itself and broader competition for the indication at large, and potential impact on patient lives should discovery and development be successful.

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The Pharma Data

NOVEMBER 11, 2020

We now have compelling data showing SLV213 has potent antiviral activity against SARS-CoV-2 as well as data on the safety, tolerability, and pharmacokinetics and pharmacodynamics of SLV213 in several preclinical model systems, including nonhuman primates,” said Felix Frueh, Ph.D., Cofounder and Chief Scientific Officer of Selva Therapeutics.

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The Pharma Data

FEBRUARY 25, 2022

The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines. They have the ability to help increase patient access to essential medicines and provide value to the healthcare system by driving market competition that can lower the cost of care.

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Biosimilars FDA FDA Approval Small Molecule 52

The Pharma Data

NOVEMBER 8, 2020

The active ingredient is violaxazine hydrochloride, which has an extensive safety record in Europe, where it was previously marketed as an antidepressant. Celgene acquired it in 2018 from bluebird bio, who originally developed the therapy. SPN-812 is a serotonin norepinephrine modulating agent (SNMA).

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The Pharma Data

JANUARY 17, 2021

Syngeneic tumor animal models play a critical role because they use standard inbred mice that have a competent immune system, which is required to evaluate immune-modulating therapies. Because the Jh mouse cannot produce ADA, there is no neutralizing or pharmacokinetic impact on the therapeutic or anaphylaxis risk.

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The Pharma Data

JANUARY 26, 2021

Previous human pharmacokinetic (PK) study showed significantly better PK profile when compared to market leading product. US market for overdose rescue medications. Patent protection until 2039. UPPSALA, Sweden , Jan. Tel: +46 (0)18 780 88 00. About Orexo.

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The Pharma Data

AUGUST 9, 2021

Since 40% of people with DLBCL relapse after initial therapy, achieving meaningful treatment effects in the front-line setting has the potential to be transformative,” said Levi Garraway, M.D., Safety outcomes were consistent with those seen in previous trials. Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

APRIL 27, 2021

Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations. The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). and around the globe.”. About the Phase 1/2 Trial.

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The Pharma Data

AUGUST 19, 2021

3] While MET inhibitors have recently received accelerated approval in this setting in some regions, the vast majority of patients eventually acquire resistance to these therapies, thus underscoring the need for new treatment options. [4] METex14 mutations are found in approximately three percent of patients with NSCLC. [2] 4] , [5] , [6].

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The Pharma Data

DECEMBER 29, 2020

Of the 22 patients enrolled in the BRIDGE study, the majority of treatment emergent adverse events were mild or moderate in severity, with two patients (9.1%) withdrawing from the therapy due to hypersensitivity reaction that was resolved. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea.

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The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. The study will be conducted in South Africa. For more information, visit www.scynexis.com.

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

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The Pharma Data

MARCH 17, 2021

Verzenio (abemaciclib) : Abstract # P008 : Patients’ quality of life and side effect perceptions in monarchE, a study of abemaciclib plus endocrine therapy in adjuvant treatment of HR+, HER2-, node-positive, high risk, early breast cancer (Sara M. Accepted as ePoster – Adjuvant Systemic Therapy. Selected for one of the three St.

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The Pharma Data

OCTOBER 18, 2020

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML. About CG-806.

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The Pharma Data

SEPTEMBER 26, 2021

The CHMP’s positive opinion will now be mentioned the ecu Commission (EC), which grants marketing authorizations for medicines in Europe. “We Food and Drug Administration in October 2019 and is currently the amount one prescribed oral MS therapy within the country. Head of Research and Development at Biogen. for TECFIDERA.

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The Pharma Data

FEBRUARY 8, 2021

IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy. 2,3 In the U.S.,

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The Pharma Data

NOVEMBER 26, 2020

Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas.

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Agency IQ

OCTOBER 20, 2023

FDA’s newest draft guidance lays out considerations for developing treatments for diabetic foot infections In a new draft guidance document released within weeks of a related clinical practice guideline, the FDA provides considerations for developing therapies to treat diabetic foot infections, focusing on Phase 3 efficacy trials.

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The Pharma Data

APRIL 11, 2021

Retevmo (marketed as Retsevmo ® outside the U.S.) Initiate or adjust anti-hypertensive therapy as appropriate. Use of Retevmo for these indications is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 12 years and older.

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The Pharma Data

JULY 27, 2021

Each of these three investigational therapies uses a different approach to treat a highly prevalent disease for which new treatment options are very much needed. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

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The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days. ” About Hepion Pharmaceuticals.

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The Pharma Data

SEPTEMBER 15, 2020

Of note, The Phase 1b study is a double-blind, placebo-controlled clinical trial evaluating the safety, tolerability and pharmacokinetics of PF-07304814, a phosphate prodrug that when administered intravenously is metabolized to the active compound PF-00835321, shown to be a very potent inhibitor of the SARS-Cov2 3CL protease in preclinical studies.

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The Pharma Data

JULY 11, 2021

For more than a decade, we’ve listened to the HAE community to further understand the need for long-term, preventive targeted therapies and have committed our resources to developing treatment options,” said Neil Inhaber, M.D., percent of patients (n=116) and the most common being injection-site pain. TAKHZYRO Safety Information for Europe.

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The Pharma Data

DECEMBER 15, 2020

The clinical responses were sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor. The secondary outcome involves pharmacokinetic endpoints. 2 g/dl on three consecutive available visits during the 24-week treatment period, with the response not being attributed to rescue therapy.

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The Pharma Data

AUGUST 29, 2020

Oral, investigational complement factor B inhibitor LNP023 substantially improved hematological response as add-on therapy to eculizumab. To date, after at least six months of stable LNP023 add-on therapy, and at the investigators’ discretion, seven patients (70%) have discontinued eculizumab and remained on LNP023 as monotherapy.

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