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 Government 52

The Pharma Data

JANUARY 12, 2021

13, 2021 /PRNewswire/ — EVOQ Therapeutics today announced a license and collaboration agreement with Amgen for the discovery and development of novel drugs for autoimmune disorders. ANN ARBOR, Mich. , EVOQ Therapeutics today announced a license and collaboration agreement with Amgen.

Licensing 52

Licensing Licensing Biosimilars Clinical Development 52

The Pharma Data

APRIL 30, 2021

April 30, 2021 /PRNewswire/ — AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2021. “We are off to an excellent start to 2021, with strong performance across our core therapeutic areas and first quarter revenue and earnings results ahead of our expectations,” said Richard A. .

FDA 40

FDA Production Treatment International 40

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

Science 40

Science Biosimilars FDA Production 40

Drug Channels

NOVEMBER 24, 2020

My recent tweets have highlighted: doctors against step therapy, distribution of COVID-19 therapies, biosimilar savings, copay accumulator data, prospects for smaller PBMs, the new transparency rule, specialty pharmacy profit metrics, the future of oncology practices, and an update on Diplomat founder Phil Hagerman.

Pharmacy 52

Pharmacy Specialty Pharmacies Biosimilars Doctors 52

Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Only one product was an advanced therapy medicinal product (ATMP), three products held PRIME designation, and three products were evaluated under accelerated assessments. for the years 2020 to 2022. for the years 2020 to 2022.

Biosimilars 40

Biosimilars FDA Production Treatment 40

Drug Discovery World

AUGUST 22, 2023

This will continue to be the case going forward, but the nature of the off-patent landscape will evolve in line with ongoing changes in the segment’s ‘pipeline’: the originator products of today, which will become the generic and biosimilar medicines of tomorrow. In all, around 130 clinical trials are ongoing for oligonucleotides.

Production 130

Production Pharma Companies Clinical Trials FDA 130

The Pharma Data

OCTOBER 26, 2021

Commencing a strategic review of Sandoz to maximize shareholder value , options range from retaining the business to separation 2021 Group guidance² unchanged. Sandoz is a global leader in generic pharmaceuticals and biosimilars. billion) and Entresto (at least USD 5.0 billion) and Entresto (at least USD 5.0 billion (+8%, +7% cc).

Biosimilars 52

Biosimilars Clinical Trials Treatment Marketing 52

Drug Discovery World

OCTOBER 20, 2022

Similarly, biosimilars are expected to grow. This is unsurprising – our drug discovery industry does, after all, centre itself around creating initiatives that leave no one behind, from cancer therapies to malaria vaccines. . Overview . Investment and collaboration .

International 130

International Drugs Science Government 130

The Pharma Data

MARCH 5, 2021

Following final agreement, Novartis plans to start production in the second quarter of 2021. First deliveries of the bulk drug product to CureVac are expected in the summer 2021. Novartis has also announced a collaboration with Molecular Partners to develop two DARPin® therapies designed for potential use against COVID-19.

Vaccine 52

Vaccine Production Biosimilars Hospitals 52

The Pharma Data

DECEMBER 27, 2020

NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. .–( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

Therapies 52

Therapies Clinical Trials Production Treatment 52

Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. By 2021, the number of PPD employees exceeded 30,000 globally, and Thermo Fisher Scientific Inc.

Clinical Trials 52

Clinical Trials Clinical Research Laboratories Trials 52

The Pharma Data

MARCH 16, 2022

In June 2021, the U.S. About Biogen As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. Please click here for full Prescribing Information , including Medication Guide , for ADUHELM.

Disease 52

Disease Clinical Trials Trials Biosimilars 52

The Pharma Data

FEBRUARY 1, 2021

01, 2021 (GLOBE NEWSWIRE) — Biogen Inc. Plegridy is a proven, effective therapy for relapsing MS, and this approval gives new and current MS patients a different delivery method that has the potential to significantly reduce injection site reactions.”. Available at: [link] Accessed: January 2021. Posted: February 2021.

FDA Approval 40

FDA Approval FDA Clinical Trials Biosimilars 40

The Pharma Data

MAY 6, 2021

ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU.”. . © 2021 Regulatory Affairs Professionals Society. Press Release. Source link.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Biosimilars 52

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

You see, Oncopeptides has has pending at the PTO since March 2021 a PTE application for U.S. We note all of this FDA law in the context of a patent-related PTE post because FDA’s withdrawal decision has ramifications beyond the FDA world. 6,992,207 covering PEPAXTO (Docket No. FDA-2022-E-3124 ).

FDA 59

FDA Production FDA Approval Compliance 59

The Pharma Data

AUGUST 1, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.

FDA 52

FDA Treatment Biosimilars International 52

The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. SHANGHAI, China, Jan.

FDA 52

FDA Clinical Trials Trials Treatment 52

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.,

Clinical Trials 52

Clinical Trials Treatment Therapies Production 52

The Pharma Data

JANUARY 26, 2021

27, 2021 10:02 UTC. The full data analysis on 353 subjects would be available by the end of February 2021. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives.

Hospitals 40

Hospitals Laboratories Biosimilars Pharmaceuticals 40

Drug Channels

DECEMBER 1, 2020

If all goes well, 2021 will begin our return to normalcy, as vaccines roll out across the country. Speaking of next year, Drug Channels Institute will host an exclusive live webinar, Drug Channels Outlook 2021 , on December 18, 2020, from 12:00 p.m. Pharmacy and healthcare provider markets experienced unprecedented volatility.

Pharmacy 52

Pharmacy Vaccine Drugs Pharmaceuticals 52

The Pharma Data

APRIL 27, 2021

Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% Q1 2021 business EPS ( 1) growth at CER driven by efficiency and sales performance, supported by a one-time payment. Sanofi has become a member of the top five companies of the 2021 Access to Medicine index.

Vaccine 52

Vaccine Production FDA FDA Approval 52

The Pharma Data

JUNE 7, 2022

New Indication for Amgen’s Fifth FDA-approved Biosimilar. “Our fully integrated portfolio of innovative and biosimilar medicines for inflammatory diseases reinforces our commitment to providing patients with high-quality and affordable treatment options that deliver substantial value to our healthcare system.”

Biosimilars 52

Biosimilars FDA Approval FDA Pharmacokinetics 52

The Pharma Data

JUNE 2, 2022

BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders BYOOVIZ will be commercially available through major distributors across the U.S. on July 1, 2022. Biogen Inc.

Biosimilars 52

Biosimilars FDA Approval Treatment Therapies 52

The Pharma Data

OCTOBER 29, 2020

If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and to meaningfully change the course of Alzheimer’s disease. If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease. CAMBRIDGE, Mass.

Marketing 40

Marketing Disease Clinical Trials Treatment 40

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. ” In June 2021, AbbVie Inc. “The Teneobio team is enthusiastic about joining forces with Amgen, a pioneer of biotherapeutics. anti-HBV/CD3).

Production 52

Production Clinical Trials Government Disease 52

The Pharma Data

JULY 8, 2021

Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies’ statement of June 23, 2021. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies.

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

The Pharma Data

DECEMBER 9, 2020

(Tokyo, Japan) announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer’s disease. In addition to the filing in Japan, aducanumab is under Priority Review with the U.S.

Clinical Trials 40

Clinical Trials Drugs Disease Licensing 40

Agency IQ

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. 6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., not discontinued) and are available for sale.

FDA 40

FDA Science Regulations Compliance 40

Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules. Read the AgencyIQ analysis here.

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . About Aducanumab. About Biogen. At Biogen, our mission is clear: we are pioneers in neuroscience.

Disease 40

Disease FDA Clinical Trials Licensing 40

Agency IQ

JUNE 9, 2023

High-priced cell and gene therapies are being increasingly developed for rare diseases. For example, a comparison of some gene therapy reimbursement shows that the single-treatment CAR-T cell therapy Kymriah (tisagenlecleucel) is reimbursed at 320,000 euros (based on outcome) in Italy, Germany, Spain and France.

Marketing 40

Marketing Biosimilars Regulations Drugs 40

The Pharma Data

MAY 5, 2022

Pioneering in digital therapeutics exemplifies Biogen’s commitment to advance novel therapies that we hope will improve outcomes for people living with MS.” “At MedRhythms is also eligible to receive tiered royalties in the high-single digits to low-teens on potential global sales. MedRhythms is headquartered in Portland, Maine.

Treatment 52

Treatment Biosimilars Licensing Licensing 52

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” If the pharmacist can resolve it, they must make a record of the resolution. Complaint ¶ 55. Complaint ¶ 58.

Pharmacy 139

Pharmacy Government Treatment Compliance 139

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

FDA 40

FDA Science Biosimilars Production 40

The Pharma Data

FEBRUARY 8, 2021

2021 financial outlook. Sanofi expects 2021 business EPS ( 1) to grow high single digit (3) at CER, barring unforeseen major adverse events. Applying average January 2021 exchange rates, the currency impact on 2021 business EPS is estimated to be between -4.5% In 2020, Dupixent ® sales reached €3,534 million, up 73.9%

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52

The Pharma Data

FEBRUARY 4, 2021

2021 financial outlook. Sanofi expects 2021 business EPS ( 1) to grow high single digit (3) at CER, barring unforeseen major adverse events. Applying average January 2021 exchange rates, the currency impact on 2021 business EPS is estimated to be between -4.5% In 2020, Dupixent ® sales reached €3,534 million, up 73.9%

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52