The Pharma Data

AUGUST 3, 2021

today announced financial results for the second quarter of 2021. Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). on a non-GAAP basis.

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Drug Discovery World

OCTOBER 20, 2022

Japan continues to be one of the largest pharmaceutical markets in the world, despite what the International Trade Administration described as ‘a challenging business landscape due to demographics’ 1. According to the International Trade Administration’s market overview, anti-tumour agents brought in the largest sales in 2020 in Japan.

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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. There is significant need for more cost-effective generic versions.

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Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Eight products received recommendations for conditional marketing authorization and one product was reviewed “under exceptional circumstances.” This most recent year saw 80 total opinions, compared to 92 in 2022 and 97 in 2021.

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The Pharma Data

MAY 6, 2021

Another set of proposals is intended to support “a competitive and innovative EU pharmaceutical industry.” Rasi, who stepped down as executive director of EMA late last year, told the agency of his plans to take up two positions at the start of 2021. © 2021 Regulatory Affairs Professionals Society. Press Release. Source link.

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Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). By geographical region, the global CRO services market in 2023 was dominated by North America. As a result, the global CRO market is estimated to grow at a compound annual growth rate (CAGR) of 9.6%

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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

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The Pharma Data

OCTOBER 29, 2020

Tokyo, Japan) today announced that the European Medicines Agency (EMA) has confirmed it has accepted for review, following a standard timetable, the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease. is a leading global pharmaceutical company headquartered in Japan.

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The Pharma Data

MAY 15, 2023

Huebscher , non-executive board member in companies, institutions and former CEO of Solvias Group, a Swiss contract research firm, which she led between 2014 and 2021. He also served on 2 Boards of Directors at Takeda Pharmaceuticals between 2013 and 2015 and Britannia Industries, India, between 2000 and 2008.

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The Pharma Data

MAY 18, 2021

Kundl, Austria further strengthens production for oral antibiotics while facility in Palafolls, Spain expands for sterile active pharmaceutical ingredients. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label.

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Drug Channels

DECEMBER 1, 2020

During 2020, the COVID-19 pandemic disrupted every aspect of the pharmaceutical channel—and our lives. Pharmacy and healthcare provider markets experienced unprecedented volatility. If all goes well, 2021 will begin our return to normalcy, as vaccines roll out across the country. distribution channels for prescription drugs.

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

of Miami, Florida, a contract manufacturer of over-the-counter (OTC) drug products, including oral cough and cold drug products marketed for both adults and children, was also advised in a Warning Letter to retain an independent expert on good manufacturing practices. Dextrum Laboratories Inc. Terragene S.A., Terragene S.A.,

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The Pharma Data

MARCH 17, 2021

If all conditions are met, the separation is on track for completion late in the second quarter of 2021. Robert Essner, Former chairman, CEO and president of Wyeth Pharmaceuticals, Inc. Shalini Sharp, Former CFO, Ultragenyx Pharmaceutical and Director Nominee. Cox, Former chairman and CEO of Humacyte, Inc., and Director Nominee.

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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. BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives.

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The Pharma Data

NOVEMBER 23, 2020

have partnered with Yangtze River Pharmaceutical Group, a leading Chinese pharmaceutical company, to form an exclusive strategic partnership for the commercialization of eight biosimilar medicines in China. Under this distribution and marketing agreement, Alvotech and Alvotech & CCHT Biopharmaceutical Co.,

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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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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. provides a 10-year market exclusivity period. Orphan designation in the E.U. countries examined between 2010 and 2017. member states.

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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.

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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. is a leading global pharmaceutical company headquartered in Japan. Please see the full Prescribing Information. INDICATION and IMPORTANT SAFETY INFORMATION. INDICATION.

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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.

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The Pharma Data

DECEMBER 9, 2020

Japan is the third market where we have applied for regulatory approval for aducanumab, and the filing represents continued progress on our commitment to bring this therapy to patients around the world,” said Michel Vounatsos, Chief Executive Officer at Biogen. is a leading global pharmaceutical company headquartered in Japan.

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Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Amanda Conti, AgencyIQ What kind of biologic products entered the market?

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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. . is a leading global pharmaceutical company headquartered in Japan. About Aducanumab.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

state pharmaceutical assistance programs). Each phase-in program requires the manufacturer to have had a Coverage Gap Discount Program agreement in effect in 2021, and only covers applicable drugs that have been in the market as of August 16, 2022 (i.e., of the total expenditures for all Part D drugs in 2021.

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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% Pharmaceuticals. percentage points to 27.1%.

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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% Pharmaceuticals. percentage points to 27.1%.

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The Pharma Data

OCTOBER 29, 2020

Established ULTOMIRIS as new standard of care in PNH ahead of set goal, with more than 70% patient conversion from SOLIRIS ® (eculizumab) in 3 largest markets – U.S. 29, 2020– Alexion Pharmaceuticals, Inc. Alexion plans to initiate a Phase 3 study of SOLIRIS in GBS in Japan in 2021, pending regulatory feedback.

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Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. Priority A List.

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Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. the drug and device) of the combination product.

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The Pharma Data

MAY 4, 2021

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS. Tue, 05/04/2021 – 06:45. Tuesday, May 04, 2021 – 06:45am. <!–*/. First-Quarter 2021 Revenues of $14.6 First-Quarter 2021 Reported Diluted EPS (1) of $0.86, Adjusted Diluted EPS (2) of $0.93. Anonymous (not verified). –*/. <!–*/.q4default.bwalignc

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FDA Law Blog: Biosimilars

APRIL 3, 2023

Vanda Pharmaceuticals, Inc. Vanda is also conducting clinical studies of a long-acting injectable form of its marketed drug Fanapt tablets, an anti-seizure drug. MJM-22-977 (Dist. See our memo summarizing CMS’s regulation here. In 2014 Vanda introduced Hetlioz (tasimelteon) capsules to treat a rare sleep disorder.

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Agency IQ

DECEMBER 1, 2023

Circuit vacated the final rule in 2021. The guidance will include FDORA, Section recommendations FDORA, Section on the inclusion of the “the longest feasible expiration date supported by such data” in a drug’s label. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025. the drug and device) of the combination product.

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The Premier Consulting Blog

APRIL 25, 2023

This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars. Synthroid® oral tablets) were marketed as unapproved drugs for the treatment of hypothyroidism in the US. ICH Harmonised Guideline S10: Photosafety evaluation of pharmaceuticals.

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Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. pharmaceutical law ceased to apply to the U.K. from the E.U.

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Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines.

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