The Pharma Data

MAY 6, 2021

Another set of proposals is intended to support “a competitive and innovative EU pharmaceutical industry.” MHRA created the role in response to the Cumberlege report , which called for a “substantial revision” of the agency to fix perceived failings in its handling of adverse events and engagement with the public.

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FDA Law Blog: Biosimilars

SEPTEMBER 25, 2024

Throughout his illustrious career, Al has been engaged with Hatch-Waxman, even authoring one of the earliest papers providing an account of the law: “ Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness? ” In his new book, “Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer,” which will be released (..)

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

The event is set to take place from March 4-6, 2024, in San Francisco, California. With over 26 years of dedicated service to the pharmaceutical and medical device industries, Ms. This annual gathering, renowned for its influential speakers and dynamic networking opportunities, will see Ms.

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FDA Law Blog: Biosimilars

JUNE 24, 2024

The event, titled “New and Improved – AMCP Format for Formulary Submissions v5.0,” aims to educate pharmaceutical manufacturers and other healthcare stakeholders on the latest updates and best practices in dossier development.

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Pharmaceuticals Drugs 52

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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Drug Discovery World

OCTOBER 3, 2022

Also on that day the Tech Theatre will run a presentation on How automation can push the discovery of biologics and biosimilars? The second day of the event will feature The Lab of the Future is Now: Using AI or Automation for the Drug Discovery Process , presented by Nicola Richmond, VP of AI, BenevolentAI.

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The Pharma Data

DECEMBER 28, 2020

29, 2020 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc. , (NASDAQ: AMPH) announced that the U.S. billion, three biosimilar products in development targeting products with a market size of approximately $13.0 Contact Information: Amphastar Pharmaceuticals, Inc. Source: Amphastar Pharmaceuticals, Inc.

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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. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. Upcoming E.U.

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Regulations Clinical Trials Production Biosimilars 40

Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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DrugBank

AUGUST 9, 2024

Investment Trends in Pharmaceutical Research and Development Investing in the pharmaceutical sector presents a unique set of challenges and opportunities; let’s examine them in more detail.  Pharmaceutical Market Analysis The global pharmaceutical market revenue in 2024 is projected to be 1.15

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Pharmaceuticals Research Pharmaceutical Companies Clinical Trials 76

FDA Law Blog: Biosimilars

JANUARY 4, 2024

Deb assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements. To obtain a copy of the conference brochure and to register for the event, please visit ACI’s website – here.

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Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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The Pharma Data

NOVEMBER 10, 2020

The event was held in one Chinese session and one English session, with more than 700 investors and analysts watched the webcast and communicated with management team about R&D and other business updates through Q&A.

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The Pharma Data

OCTOBER 27, 2020

Reddy’s”) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.

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Laboratories Biosimilars Government Pharmaceuticals 40

FDA Law Blog: Biosimilars

MARCH 4, 2024

This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. Hyman, Phelps & McNamara, P.C. (HP&M),

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The Pharma Data

MAY 2, 2022

Teva Branded Pharmaceutical Products R&D, Inc. and Auspex Pharmaceuticals, Inc., affiliates of Teva Pharmaceutical Industries Ltd. Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. About Teva.

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The Pharma Data

MARCH 17, 2021

Robert Essner, Former chairman, CEO and president of Wyeth Pharmaceuticals, Inc. Shalini Sharp, Former CFO, Ultragenyx Pharmaceutical and Director Nominee. Merck will host a virtual investor event on Monday, May 3 beginning at 10 a.m. Details will be provided at a date closer to the event merck.com/investor-relations.

Biosimilars 40

Biosimilars Pharmaceuticals Production International 40

Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Regulations Clinical Trials Production International 40

Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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Regulations Production Compliance Pharmaceuticals 40

FDA Law Blog: Biosimilars

JULY 18, 2023

Claud — The Office of Pharmaceutical Quality (OPQ), located within FDA’s Center for Drug Evaluation and Research (CDER), uses global inspection, surveillance, policy, and research activities to set quality standards for drugs. Consistent with that initiative, OPQ recently issued its 2022 Annual Report on the State of Pharmaceutical Quality.

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FDA Law Blog: Biosimilars

AUGUST 14, 2023

FDA also looked at how may of the Active Pharmaceutical Ingredients for those drugs were manufactured overseas. The GMP by the Sea conference, an annual conference sponsored by PharmaConference.com, is an annual event in Cambridge, Maryland, linked here.

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The Pharma Data

MARCH 28, 2022

(Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc. The adverse events (AEs) were mostly mild to moderate in severity and occurred at a similar rate across BIIB078 and placebo groups. About Ionis Pharmaceuticals, Inc. In this Phase 1 study, BIIB078 was generally well-tolerated.

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RNA Therapies Biosimilars Disease 52

FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

There have already been (with more coming) a slew of 40th anniversary celebration papers, analyses, and events in 2024, including: The Brookings Institution’s Hatch-Waxman at 40 The Association for Accessible Medicines’ Hatch-Waxman turns 40. And that name has stuck for many of us. Is it over the hill? (Or

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FDA Drugs International Pharmaceuticals 59

The Pharma Data

JANUARY 26, 2021

(BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.

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The Pharma Data

MARCH 5, 2021

At the Kundl site, Novartis is a pioneer and has decades of experience in pharmaceutical production of proteins and in more recent years of nucleic acids. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties.

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

MAY 15, 2023

Before joining Nestlé he served as CFO at Takeda Pharmaceuticals, one of the largest publicly listed companies in Japan, between 2013 and 2015, and CFO at Millicom, a NASDAQ listed global mobile phone operator based in Luxembourg, between 2008 and 2013. François-Xavier Roger, Chief Financial Officer of Nestlé S.A.,

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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. not discontinued) and are available for sale.

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FDA Law Blog: Biosimilars

JUNE 13, 2023

Wasserstein & Dara Katcher Levy — After about a year without any untitled letters from OPDP, Xeris Pharmaceuticals received an untitled letter for their promotion for Recorlev (levoketoconazole) for misleading safety and efficacy claims. By Jeffrey N. Would that it were so!

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The Pharma Data

AUGUST 3, 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). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

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The Pharma Data

AUGUST 31, 2020

As a global pharmaceutical leader, Novartis is a strategic partner for AMSP to unlock access to the latest and best-performing medicines for Africans in an affordable way.”. With AMSP, countries don’t have to search the market for supplies. The prices are negotiated and fixed to unlock the supply space.”.

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

of Seattle, Washington (selling products marketed as “energy enhancing supplements or food” that contained sildenafil, tadalafil, or other drug active pharmaceutical ingredients; Warning Letter. Shah, M.D., Legal Assistant

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FDA Law Blog: Biosimilars

JULY 24, 2023

Koblitz — Neither Jazz Pharmaceuticals nor Avadel CNS Pharmaceuticals has taken the battle of sodium oxybate—a drug approved to treat narcolepsy—lying down. After suing each other in patent litigation and Avadel’s suit against FDA challenging the Agency’s authority to compel patent certifications, it’s Jazz’s turn to sue FDA.

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