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

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.

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

JULY 29, 2021

100% Efficacy Observed in Phase 2b Trial of RSV Adult Vaccine Candidate; Provides New Data Updates on its COVID-19 Vaccine Booster and Oral COVID-19 Antiviral Programs As Part of a Broader Review of 8 Potentially First-in-Class Compounds NEW YORK, NY, Wednesday, July 28, 2021 – Pfizer Inc. Second-Quarter 2021 Revenues of $19.0

Vaccine 52

Vaccine Biosimilars Production International 52

The Pharma Data

MARCH 13, 2022

With a focus on immuno-inflammatory conditions in Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to small molecules, biologics and biosimilars.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Biosimilars Disease 52

The Pharma Data

NOVEMBER 17, 2021

Moment, we’ve an assiduity- leading portfolio of 24 approved innovative cancer drugs and biosimilars across further than 30 suggestions, including bone, genitourinary, colorectal, blood and lung cancers, as well as carcinoma. About Pfizer Improvements That Change Cases’Lives.

Biosimilars 52

Biosimilars Government Vaccine Treatment 52

Drug Channels

OCTOBER 10, 2023

Drug Distribution Industry Gaining from Anti-Obesity Drugs and Provider-Administered Biosimilars (press release) We’re offering special discounted pricing if you order before October 20, 2023! which examines the distribution of COVID-19 vaccines and therapeutics. pharmaceutical distribution industry. and Section 6.4.3.

Pharmaceuticals 40

Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars 40

The Pharma Data

APRIL 27, 2021

at CER driven by growth drivers Dupixent ® and Vaccines. Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere. Vaccines delivered growth in its core segments. Polio/Pertussis/Hib vaccines (incl. Influenza vaccines (incl. Meningitis/Pneumo vaccines (incl.

Vaccine 52

Vaccine Production FDA Disease 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 revenue, the largest CRO in the US was Thermo Fisher Scientific Inc., of total revenue).

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 52

Vial

APRIL 10, 2024

Therapeutic Area Coverage IQVIA: Oncology Central nervous system Infectious disease & vaccines Cardiovascular Dermatology Gastrointestinal & hepatology Endocrinology Allergy & respiratory Rheumatology Ophthalmology Nephrology Reproductive health Early clinical development Cell & gene therapy Rare diseases Pediatrics Biosimilars Vial: (..)

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

The Pharma Data

JULY 15, 2021

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

Disease 52

Disease Biosimilars Government Treatment 52

Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Reviews of orphan medicines and biosimilars have remained stable over the past three years. There were eight biosimilars reviewed in 2023, which is comparable to 2021 (seven) and 2022 (eight), but lower than 2020, which saw 12 biosimilars reviewed.

Biosimilars 40

Biosimilars FDA Production Treatment 40

The Pharma Data

MARCH 29, 2022

With a focus on immuno-inflammatory conditions in Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to small molecules, biologics and biosimilars.

Trials 52

Trials Small Molecule Disease Biosimilars 52

Drug Channels

DECEMBER 1, 2020

If all goes well, 2021 will begin our return to normalcy, as vaccines roll out across the country. They are now poised to play a vital role in distributing COVID-19 vaccines and therapeutics as they become available. This year has demonstrated the underlying resilience of U.S. distribution channels for prescription drugs.

Pharmacy 40

Pharmacy Drugs Vaccine Pharmaceuticals 40

PPD

JUNE 20, 2023

Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics.

Clinical Trials 52

Clinical Trials Drug Development Trials Clinical Research 52

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.”. . The rolling review idea is based on the experience of authorizing COVID-19 vaccines. .

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Production 52

FDA Law Blog: Biosimilars

JUNE 2, 2023

Vaccine”: Because vaccines are excluded from the MDRP, CMS proposes to define them solely for purposes of the MDRP. Vaccines would be defined as a product that is administered prophylactically to induce active, antigen-specific immunity for the prevention of one or more specific infectious diseases and that is licensed by FDA.

Drugs 59

Drugs Regulations Government Vaccine 59

FDA Law Blog: Biosimilars

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

Drugs 59

Drugs FDA Licensing Licensing 59

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

covered insulin product or vaccine). Applicable Discounts: The manufacturer discounts apply regardless of whether the enrollee is entitled to low-income subsidies (LIS) that pays their deductible, has an enhanced benefit plan with a reduced or no deductible, or uses a drug that is not subject to the deductible (e.g.,

Compliance 105

Compliance Drugs Pharmacy Licensing 105

The Pharma Data

JANUARY 26, 2021

Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Dr. Reddy’s operates in markets across the globe.

Hospitals 40

Hospitals Laboratories Pharmaceuticals Production 40

The Pharma Data

FEBRUARY 8, 2021

Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma. About Pfizer: Breakthroughs That Change Patients’ Lives.

Clinical Trials 52

Clinical Trials Treatment Therapies Production 52

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA 40

FDA Science Regulations Clinical Trials 40

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease.

Drugs 59

Drugs Regulations International Production 59

The Pharma Data

JULY 8, 2021

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

Disease 52

Disease Clinical Trials Government Research 52

The Pharma Data

MAY 15, 2023

Before joining Solvias Group, Karen held various senior leadership roles at Novartis, including global head investor relations from 2000 to 2006, head M&A and Executive Committee member, as well as site head for the Vaccines & Diagnostics division between 2006 and 2011.

Science 40

Science Doctors Government Pharmaceuticals 40

Agency IQ

JUNE 2, 2023

Given the number of approved drugs and biologics on the market that are dispensed on an outpatient basis – and their generic and biosimilar equivalents – the additional workload on FDA’s labeling review staff could be considerable. Some exemptions: Vaccine manufacturers are likely to benefit from the FDA’s proposed rule.

FDA 40

FDA FDA Approval Production Regulations 40

The Pharma Data

OCTOBER 27, 2020

As part of those efforts, it has become increasingly clear that to tackle the pandemic at a global level the development of medicines that can prevent and treat the virus, in addition to the development of vaccines, will be crucial. During the clinical development stage, Molecular Partners will provide clinical supply.

Therapies 40

Therapies Virus Treatment Clinical Trials 40

Agency IQ

JUNE 2, 2023

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., These inspections will be routine surveillance rather than inspections as part of an approval application.

FDA 40

FDA Science Regulations Production 40

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Liability is precisely why the vaccine market shrunk so significantly in the 1980s, going from 26 manufacturers to 4, after lawsuits claiming $3.5 Things got so bad that Congress acted to shield vaccine manufacturers from liability in order to ensure sufficient availability of vaccines.

FDA Approval 40

FDA Approval FDA Production Drugs 40

Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

FDA 40

FDA Science Regulations Production 40

The Pharma Data

SEPTEMBER 10, 2020

Today, we have an industry-leading portfolio of 23 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma. Pfizer Inc.: Breakthroughs that change patients’ lives.

Therapies 52

Therapies Clinical Trials Production Trials 52

The Pharma Data

FEBRUARY 1, 2021

The addition of the IM administration of Plegridy to Biogen’s MS portfolio offers another important option at a time when MS patients are being encouraged to discuss their MS treatment and considerations around COVID-19 vaccination with their physicians.1,2 MS, the coronavirus and vaccines – updated global advice. 3 Zhao Y, et al.

FDA Approval 40

FDA Approval FDA Clinical Trials Treatment 40

The Pharma Data

APRIL 7, 2023

Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma.

FDA 40

FDA FDA Approval Small Molecule Drugs 40

The Pharma Data

FEBRUARY 8, 2021

Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. to €36,041 million, driven by Dupixent ® (€3,534 million, up 73,9%) and Vaccines. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks.

Vaccine 52

Vaccine Production FDA Therapies 52

The Pharma Data

FEBRUARY 4, 2021

Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. to €36,041 million, driven by Dupixent ® (€3,534 million, up 73,9%) and Vaccines. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks.

Vaccine 52

Vaccine Production FDA Therapies 52

Agency IQ

JULY 8, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Positive August 2024 Enzalutamide Viatris (enzalutamide)** Viatris Limited Positive August 2024 Nilotinib Accord (nilotinib)** Accord Healthcare S.L.U.

Regulations 40

Regulations Pharmaceuticals Production Vaccine 40

Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

Regulations 40

Regulations Biosimilars Clinical Trials Production 40

The Pharma Data

MAY 4, 2021

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Adjusted Income (2).

Vaccine 40

Vaccine Production FDA Clinical Trials 40