The Pharma Data

JUNE 6, 2025

Drivers of Market Growth: From Precision Medicine to Cost Optimization The shift toward targeted therapies , rare diseases , and personalized medicine is fundamentally altering pharmaceutical commercialization strategies. Biosimilars and Generics : Where cost competition necessitates strategic brand differentiation and efficient coverage.

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Pharmaceutical Companies Compliance Pharmaceuticals International 40

Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

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PPD

FEBRUARY 22, 2023

In a survey of more than 150 global drug development leaders, more than a quarter (28%) cited lack of R&D funding as the top challenge facing their organization. With the imminent need for new therapies to offset the expected losses to generic formulas and biosimilars, the environment will be ripe for new partnerships to emerge.

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Clinical Research Biosimilars Marketing Trials 52

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

As a Principal Drug Regulatory Expert, Dr. Beitz joins HP&M’s Drug Development Team, which is comprised of attorneys and regulatory experts who assist companies on a range of drug and biological product legal, regulatory, and policy issues.

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Conversations in Drug Development Trends

JULY 9, 2024

The discussions at the conference shed light on innovative approaches to enhance long-term outcomes for patients, focusing on combination therapies that not only aid in weight loss but also help preserve muscle mass, an essential component of healthy body composition.

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Agency IQ

AUGUST 2, 2024

September 30, 2024 PDUFA Novel Approaches to Development of Cell and Gene Therapy Convene a public meeting to solicit input on methods and approaches (e.g., use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

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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.

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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.

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The Pharma Data

JULY 8, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. Please see full Prescribing Information including Medication Guide. About Biogen. At Biogen, our mission is clear: we are pioneers in neuroscience.

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Clinical Trials FDA Approval Trials FDA 52

Drug Target Review

MAY 5, 2025

They wait for the therapies that could significantly improve their quality of life or even save it knowing approval could be years or decades away. And yet, despite this learning, traditional clinical development processes have failed to evolve; they still have high asset failure rates, longer development timelines, and significant costs.

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Clinical Development Drug Development Therapies Science 52

DrugBank

AUGUST 9, 2024

This high attrition rate directly results from the scientific and regulatory hurdles that drug candidates must overcome. The Investment Landscape Despite these challenges, the potential rewards for successful drug development are substantial. The market for Alzheimer's disease therapeutics alone is projected to reach 7.16

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Pharmaceuticals Research Pharmaceutical Companies Clinical Trials 98

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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FDA Science Biosimilars Clinical Trials 40

The Pharma Data

OCTOBER 27, 2020

The collaboration aims to leverage Molecular Partners’ proprietary DARPin® technologies and Novartis’ broad expertise in global drug development, regulatory affairs, manufacturing and commercialization to rapidly advance the program in keeping with the unprecedented global urgency created by the pandemic.

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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. Vial adopts a fixed-fee pricing model devoid of change orders to streamline cost-effectiveness in drug development.

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Clinical Trials Trials Clinical Research Compliance 52

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.

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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.

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Agency IQ

JULY 28, 2023

September 2023 Legislative deadlines in Q3 Legislation Program Tag Requirement Due Date FDORA, Section 3202 Orphan Drug Program FDA shall publish final guidance related to the draft guidance titled, “Rare Diseases: Common Issues in Drug Development.” That would leave 19% of staff affected by furloughs.

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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. About Biogen At Biogen, our mission is clear: we are pioneers in neuroscience.

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Clinical Trials Drugs Disease Treatment 40

The Pharma Data

NOVEMBER 6, 2020

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. About Biogen. At Biogen, our mission is clear: we are pioneers in neuroscience.

Disease 40

Disease FDA Clinical Trials Licensing 40

Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

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FDA Science Regulations Production 40

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 (..)

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FDA Science Regulations Clinical Trials 40

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).

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Clinical Trials Clinical Research Trials Laboratories 52

Agency IQ

JULY 8, 2024

Negative *Biosimilar **Generic Notable public consultation periods and calls for evidence Below are various deadlines regarding European policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected to close into Q3 2024.

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DrugBank

DECEMBER 4, 2024

For instance,  in sub-Saharan Africa , where the burden of HIV/AIDS is disproportionately high, only 71% of people living with HIV have access to antiretroviral therapy, compared to over 90% in North America and Europe.  The high cost of drug development , estimated to be over $4.54

Drugs 52

Drugs Licensing Licensing Pharmaceutical Companies 52

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 (..)

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Agency IQ

DECEMBER 1, 2023

Title Type Comments Close Optimizing the Use of Postapproval Pregnancy Safety Studies; Public Workshop RFI November 30 Medical Devices; Laboratory Developed Tests Rule December 4 Stimulant Use Disorders: Developing Drugs for Treatment Guidance December 4 Modernizing the Food and Drug Administration’s Premarket Notification Program Notice December (..)

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FDA Science Regulations Production 40

Drug Target Review

APRIL 4, 2025

Co-founded and led by CEO Cameron Owen, rBio is a biotech company making a significant impact in the biosimilar insulin market. With a commitment to making insulin biosimilars more affordable and accessible, rBio is addressing a critical need for patients across the globe.

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FDA Law Blog: Biosimilars

JANUARY 16, 2025

Tobolowsky, who has been with the firm 3 years, focuses on assisting clients with legal and regulatory considerations for the development of new drug and biologic products as well as with post-marketing compliance.

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Compliance FDA Regulations Production 59