Common Sense for Drug Policy Blog

JUNE 4, 2023

Opioid Substitution Treatment in the UK "Opioid substitution therapy (OST) is an evidence-based treatment for opioid dependency, with treatment engagement shown to be protective against drug related deaths ( Santo et al., 2019 ; Public Health England, 2018 ). 2019 ; Public Health England, 2018 ). Towl, G., & Harris, M.

Treatment 40

Treatment Pharmacy International Therapies 40

The Pharma Data

APRIL 9, 2021

today announced it will report first quarter 2021 financial results Thursday, April 22, 2021, before the financial markets open. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies.

Biosimilars 52

Biosimilars Disease Therapies Treatment 52

PLOS: DNA Science

OCTOBER 12, 2023

In the final chapter of my 2012 book The Forever Fix: Gene Therapy and the Boy Who Saved It , I predicted that the technology would soon expand well beyond the rare disease world. Gene therapy clearly hasn’t had a major impact on health care, offering extremely expensive treatments for a few individuals with rare diseases.

Therapies 69

Therapies Immune Response DNA Virus 69

The Pharma Data

MARCH 5, 2021

Biogen (Nasdaq: BIIB) today announced it will host webcasts of its pre-recorded presentations and live discussions related to its Alzheimer’s disease investigational therapy, aducanumab, at the upcoming AD/PDTM 2021 Virtual Conference. AD/PD Webcast Schedule Details: Wednesday, March 10, 2021, 6:45 a.m. About Biogen.

Licensing 52

Licensing Licensing Biosimilars Disease 52

The Pharma Data

JULY 29, 2021

econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We The series of promising pipeline updates included the data from the landmark ZUMA-7 study for the treatment of second-line large B-cell lymphoma.

Science 52

Science Production Treatment FDA 52

The Pharma Data

JANUARY 27, 2021

Pfizer’s and Myovant Sciences’ investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1 mg and norethindrone acetate 0.5 percent of participants given the combination treatment over one year experienced clinically meaningful reductions in menstrual pain, while 73.3 Data from the study found that 84.8

Science 52

Science Therapies Treatment Trials 52

FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.

Therapies 59

Therapies FDA Production Regulations 59

The Pharma Data

JANUARY 11, 2021

Pfizer has started dosing in a phase 3 study evaluating its investigational gene therapy, PF-06939926, in young male patients with Duchenne muscular dystrophy (DMD). The agency previously granted the gene therapy Orphan Drug and Rare Pediatric Disease designations in 2017. Source link.

Therapies 52

Therapies Trials FDA Treatment 52

The Pharma Data

JUNE 1, 2022

The United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to efanesoctocog alfa (BIVV001) for the treatment of people with hemophilia A, a rare and life-threatening bleeding disorder, based on data from the pivotal XTEND-1 P hase 3 stud y.

Therapies 52

Therapies FDA Science Treatment 52

The Pharma Data

JUNE 18, 2021

1 The full, long-term results from the Phase 3 SELECT-PsA 2 clinical trial will be presented at the EULAR 2021 Virtual Congress. 1 The full, long-term results from the Phase 3 SELECT-PsA 2 clinical trial will be presented at the EULAR 2021 Virtual Congress. Efficacy data reported based on randomized treatment. RINVOQ 15 mg. (n=211).

Treatment 40

Treatment Therapies Clinical Trials Disease 40

Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

Therapies 52

Therapies Clinical Trials FDA Production 52

The Pharma Data

JULY 6, 2021

Sanofi highlights scientific innovations in the field of rare blood disorders at I STH 2021. New research from first-in-class marketed and investigational therapies in hemophilia, immune thrombocytopenia and acquired thrombotic thrombocytopenic purpura will be presented. ePoster Abstract # OC48.2

Therapies 52

Therapies Pharmacokinetics RNA Treatment 52

The Pharma Data

AUGUST 3, 2021

Revenue in the second quarter of 2021 increased 23 percent, driven by volume growth of 22 percent. – Revenue from all key products grew in the quarter and 2021 year-to-date. . – Revenue from all key products grew in the quarter and 2021 year-to-date. – 2021 EPS guidance updated to be in the range of $6.73

Production 52

Production Marketing Research DNA 52

The Pharma Data

JANUARY 7, 2021

– January 8, 2021) – Notable Labs, which is redefining cancer treatment by taking a functional approach to precision oncology in hematological cancers, today announced that it is participating in Biotech Showcase 2021 and will be presenting the strategic plan for long-term growth.

Pharmaceutical Companies 52

Pharmaceutical Companies Therapies Science Pharmaceuticals 52

The Pharma Data

OCTOBER 14, 2021

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

Vaccine 52

Vaccine Therapies Immune Response Disease 52

The Pharma Data

JUNE 22, 2023

Kite Announces Completion of Marketing Authorization Transfer for Yescarta® CAR T-cell Therapy in Japan SANTA MONICA, Calif.–(BUSINESS We look forward to advancing new treatments in oncology with the potential to positively impact the lives of people with cancer in Japan. –(BUSINESS WIRE)– Kite Pharma, Inc.,

Therapies 40

Therapies Marketing Small Molecule Science 40

The Pharma Data

AUGUST 3, 2021

today announced financial results for the second quarter of 2021. 2021 total revenues guidance reaffirmed at $25.8-$26.6 COVID-19 update : Compared to the first quarter of 2021, we have seen gradual recovery from the impacts of the COVID-19 pandemic. Key results include: Total revenues increased 5% to $6.5 on a non-GAAP basis.

Biosimilars 52

Biosimilars Production Treatment FDA 52

The Pharma Data

JANUARY 31, 2021

1, 2021 /PRNewswire/ — Nevro Corp (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced that D. HF10 therapy has demonstrated the ability to reduce or eliminate opioids in ?65% . REDWOOD CITY, Calif. ,

Therapies 52

Therapies Treatment Production 52

The Pharma Data

AUGUST 5, 2020

Company expect to file regulatory submissions in 2021. Novartis has revealed positive results from a phase 2 study of its CAR-T therapy Kymriah (tisagenlecleucel) in patients with relapsed or refractory follicular lymphoma. Source link.

Therapies 52

Therapies Trials Treatment FDA 52

The Pharma Data

APRIL 7, 2021

today announced new data from its expansive neuroscience portfolio will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually from April 17-22. . Key AbbVie abstracts and presentation details for the 2021 AAN Annual Meeting program are outlined below. Abstract Title. Presentation Details.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

The Pharma Data

AUGUST 7, 2021

In June 2021, Wegovy , semaglutide 2.4 For the 2021 outlook, sales growth is now expected to be 10-13% at CER (previously 6-10%), and operating profit growth is now expected to be 9-12% at CER (previously 5-9%). ?? Lars Fruergaard Jørgensen, president and CEO: “We are pleased with the sales growth in the first half of 2021.

International 52

International Treatment FDA Therapies 52

KIF1A

OCTOBER 15, 2024

In February 2021, genetic testing revealed the name of my disease: KAND (KIF1A Associated Neurological Disorder), of which autism is one of the frequent symptoms. Symptoms and Therapies (Treatments while waiting for a cure) Today, I can walk short distances. Shortly after, I was diagnosed with autism. You can help.

RNA 52

RNA Therapies Treatment Regulations 52

The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company’s (NYSE: LLY) investigational antibody therapy for Alzheimer’s disease (AD).

Therapies 40

Therapies Disease Treatment FDA Approval 40

The Pharma Data

MARCH 9, 2021

New data from 10 studies will be presented by Eli Lilly and Company (NYSE: LLY) at the upcoming virtual International Conference on Alzheimer’s & Parkinson Diseases 2021 (AD/PD 2021), March 9-14, 2021. vice president of Alzheimer’s disease development unit, Eli Lilly and Company.

Disease 40

Disease International Research Therapies 40

Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. ADCs have the potential to redress the poor balance between safety and efficacy seen with traditional cancer treatment options.

Small Molecule 145

Small Molecule Drugs Clinical Pharmacology Trials 145

The Pharma Data

JANUARY 27, 2021

27 , 2021 /PRNewswire/ — Harbour BioMed (HBM) (HKEX: 02142.HK), HK), announced today that China Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), for the treatment of adult patients with Myasthenia Gravis (MG).

Therapies 52

Therapies Treatment International Licensing 52

The Pharma Data

AUGUST 3, 2021

Breakthrough results in the treatment of a type of heart failure, which is extremely difficult to manage Strong progress in mental health pipeline Good business performance in all areas, despite ongoing impact of COVID-19. Our strong R&D pipeline has made further, decisive progress in the first half of 2021.

Research 52

Research Treatment Clinical Trials Production 52

The Pharma Data

SEPTEMBER 10, 2020

The EMA has asked for full data from an ongoing Phase III study of the treatment in patients with severe haemophilia A. European regulators have requested more data to review the marketing application for BioMarin’s haemophilia A gene therapy Valrox (valoctocogene roxaparvove). Source link.

Therapies 52

Therapies Regulations Treatment Marketing 52

The Pharma Data

MARCH 11, 2021

Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. Session Title: Targeted Therapy and Ovarian Cancer Trials.

Research 52

Research Clinical Trials Trials FDA Approval 52

The Pharma Data

MAY 26, 2023

State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of investigational advanced therapy products by minimizing their time-out-of-environment.

Clinical Supply 52

Clinical Supply Therapies Clinical Trials Packaging 52

The Pharma Data

JANUARY 27, 2021

COVID-19 Antibody Treatments Exceed Expectations in Early Trials. 27, 2021 — Promising new data on two antibody cocktails suggest these therapies can keep COVID-19 patients out of the hospital and even prevent illness altogether in some people. © 2021 HealthDay. Posted: January 2021. Professional.

Treatment 52

Treatment Trials Hospitals Virus 52

The Pharma Data

DECEMBER 15, 2020

Food and Drug Administration (FDA) granted Novartis ’ experimental drug iptacopan Breakthrough Therapy designation in paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disorder. Iptacopan also demonstrated positive interim results as a monotherapy treatment in anti-C5 naïve PNH patients.

Therapies 52

Therapies FDA Treatment Disease 52

The Pharma Data

MARCH 24, 2021

of women who continued on relugolix combination therapy remained responders (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment at Week 52 (p < 0.0001). of women who continued relugolix combination therapy remained responders through Week 104. Eastern Time / 5:30 a.m.

Therapies 52

Therapies Treatment Science FDA Approval 52

The Pharma Data

FEBRUARY 8, 2021

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer. In addition, health-related quality of life (HRQoL), per total Functional Assessment of Cancer Therapy–Prostate (FACT-P), continued to be maintained with ERLEADA ®.

Treatment 52

Treatment Pharmaceutical Companies Therapies Pharmaceuticals 52

The Pharma Data

JANUARY 7, 2021

With eight drugs awaiting regulatory approval and 26 projects in Phase III studies, Sanofi is on the cusp of a transformative year during 2021. To meet that goal, Sanofi is investing in areas like synthetic biology and cell and gene therapy. ricochet64/Shutterstock. That was the message the company shared during a pre-J.P.

Disease 52

Disease Therapies Engineering Treatment 52

The Pharma Data

JUNE 26, 2021

Basel, June 23, 2021 — VISION data published today in The New England Journal of Medicine (NEJM) shows that 177 Lu-PSMA-617 plus standard of care (SOC) significantly improved both overall survival (HR = 0.62 [95% CI: 0.52? 3 treatment-emergent adverse effects was 52.7% months in the 177 Lu-PSMA-617 plus SOC arm versus 6.8

Therapies 52

Therapies Treatment International FDA 52

The Pharma Data

MARCH 9, 2022

The key secondary endpoint was also met, demonstrating once-weekly efanesoctocog alfa was superior to prior prophylactic factor VIII replacement therapy, showing a statistically significant reduction in ABR based on intra-patient comparison. The US FDA granted Fast Track Designation in February 2021.

Treatment 52

Treatment Pharmacokinetics Therapies FDA 52