The Pharma Data

JULY 8, 2021

Nasdaq:BIIB) today announced it will report second quarter 2021 financial results Thursday, July 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.

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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.

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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.

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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.

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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.

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Eye on FDA

JANUARY 12, 2022

During nearly all of 2021, FDA has been under the direction of an acting commissioner. COVID – 144 announcements were COVID-related in 2021, compared to 274 such announcements during 2020; Approvals – there were 77 announcements related to approvals this year, 22 of which were COVID-related announcements.

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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.

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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

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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 Second Quarter 2021 Financial Results. Total second quarter 2021 revenue of $6.2 As of June 30, 2021, Gilead had $7.4

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Drug Channels

MARCH 22, 2021

Click here to see the original post and comments from January 2021. I also highlight the expansion of exclusions into major specialty therapy classes. The 2021 formulary exclusion lists are available below for your downloading pleasure. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc.

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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 mg) helped reduce menstrual pain and nonmenstrual pelvic pain in women with endometriosis, according to findings from a phase 3 trial. Data from the study found that 84.8

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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.

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The Pharma Data

JANUARY 7, 2021

Mindfulness-Based Cognitive Therapy Aids Depressive Disorder. 7, 2021 — Mindfulness-based cognitive therapy (MBCT) can impact how individuals with recurrent depressive disorder relate to themselves, according to a study published online Jan. © 2021 HealthDay. Posted: January 2021. Professional.

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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.

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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.

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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.

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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. As a result, we expect a 50-60% year-over-year Parsabiv sales decline in 2021.

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The Pharma Data

MAY 15, 2021

Product Name: The Neuro-Balance Therapy. Click here to get The Neuro-Balance Therapy at discounted price while it’s still available… All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors. Q: How quickly can I notice results with Neuro-Balance Therapy?

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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.

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Drug Channels

JANUARY 12, 2021

I also highlight the expansion of exclusions into major specialty therapy classes. The 2021 formulary exclusion lists are available below for your downloading pleasure. Today, I update our annual tracking of the number of exclusions by each PBM.

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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. , .

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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

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The Pharma Data

JANUARY 19, 2021

19, 2021 — Noninvasive electrical stimulation of the brain, fine-tuned to specific “circuitry” gone awry, might help ease obsessive-compulsive behaviors, an early study hints. “Neuromodulation” is a broad term for therapies that use electrical pulses to alter the firing patterns of nerves. TUESDAY, Jan.

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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.

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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.

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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.

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Drug Channels

AUGUST 9, 2021

Informa Connect’s Medicaid Drug Rebate Program — MDRP 2021 Hybrid. In-Person: October 11-13, 2021 | New Brunswick, NJ Virtual: October 18-20, 2021 www.informaconnect.com/MDRP. Impactful Sessions Include: Policy Proposals from the Current Administration, House and Senate: What Can We Expect for 2021 and How Will It Impact You?

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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.

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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 –(BUSINESS WIRE)– Kite Pharma, Inc., to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, Inc. Kite’s manufacturing facility in El Segundo, California, U.S.

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Drug Target Review

SEPTEMBER 25, 2024

Most targeted cancer therapies used today operate by inhibiting targets along well-known oncogenic signalling cascades. The reactivation of oncogenic signalling upstream or downstream of the driving oncogene is a well-studied source of resistance to targeted cancer therapies.

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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.

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Drug Channels

MAY 10, 2021

Informa Connect’s Formulary, Reimbursement and Access Summit 2021. July 27-29, 2021 | Virtual Event www.informaconnect.com/formulary-access/. Copyright © 2006-2021 Pembroke Consulting, Inc. Choose between 3 Interactive Workshops on Day 2! Offer not valid academic/non-profit registrations. Drug Channels, or any of its employees.

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The Pharma Data

JANUARY 4, 2021

Collaboration with Biogen to develop gene therapy for an undisclosed target to treat inherited eye disease, plus option for additional target. 05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc.

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The Pharma Data

JANUARY 25, 2021

25, 2021 (GLOBE NEWSWIRE) — Ambulero, Inc. , a biotechnology company developing cell and gene therapy treatments for patients suffering from vascular disease, today announced that it raised up to $5.5M that will lead clinical testing of a novel gene therapy for a serious vascular disease in Europe. MIAMI, Jan.

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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.

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The Pharma Data

SEPTEMBER 10, 2020

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

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The Pharma Data

AUGUST 3, 2021

In the first half of 2021, Boehringer Ingelheim has supplied more humans and animals worldwide with innovative medicines than ever before. Our strong R&D pipeline has made further, decisive progress in the first half of 2021. These medical successes have the potential to improve the lives of millions of patients worldwide.”.

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