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.

Pharmaceuticals 52

Pharmaceuticals Production Biosimilars Treatment 52

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. While these were not the results we were hoping for, they are clear and will inform future research across our broad pipeline of investigational ALS therapies.

RNA 52

RNA Biosimilars Therapies Disease 52

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.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

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.

FDA 40

FDA Science Regulations Production 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.

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

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. Novartis has also announced a collaboration with Molecular Partners to develop two DARPin® therapies designed for potential use against COVID-19. Source link:[link].

Vaccine 52

Vaccine Production Biosimilars Hospitals 52

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.

FDA 40

FDA Science Regulations Clinical Trials 40

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.

Hospitals 40

Hospitals Laboratories Pharmaceuticals Biosimilars 40

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.

FDA 40

FDA Science Regulations Compliance 40

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.

Biosimilars 52

Biosimilars Production Treatment FDA 52

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.

FDA 52

FDA Regulations Clinical Trials Production 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 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. is a leading global pharmaceutical company headquartered in Japan. Please see full Prescribing Information including Medication Guide.

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. is a leading global pharmaceutical company headquartered in Japan. About Eisai Co., Eisai Co.,

Clinical Trials 40

Clinical Trials Drugs Disease Licensing 40

The Pharma Data

AUGUST 3, 2021

– Notable pipeline events included positive data readouts for tirzepatide for type 2 diabetes and Jardiance for adults, with or without diabetes, who live with heart failure with preserved ejection fraction (HFpEF). . Key Events Over the Last Three Months Regulatory. 23% Net Income – Reported 1,390.2 2)% EPS – Reported 1.53

Production 52

Production Marketing Research Government 52

Drug Discovery World

NOVEMBER 9, 2023

These include: Samantha Bailey-Bucktrout, PhD, Senior Vice President, Akamis Bio, on: ‘Tumour specific immunogene therapy to deliver protein therapeutics to solid tumour microenvironments’. Jonathan Fisher, PhD, Group Leader, University College London, on: ‘Local secretion of immune active proteins for direct and bystander tumour killing’.

Engineering 130

Engineering Therapies Protein Production Science 130

Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 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.

Regulations 40

Regulations Clinical Trials Production Biosimilars 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. is a leading global pharmaceutical company headquartered in Japan. 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

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. In the proposed revision to the European pharmaceutical legislation, both the regulation and directive introduce two very similar though distinct concepts: unmet medical need, and high unmet medical need.

Marketing 40

Marketing Biosimilars Regulations Drugs 40

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 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. Of note: A government shutdown would likely delay or cancel some of the events listed below.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

OCTOBER 27, 2020

The companies will work together to scale-up manufacturing capacity, in collaboration with Sandoz, the generics and biosimilar Novartis division, to provide worldwide supply. Molecular Partners has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics across multiple therapeutic areas.

Therapies 52

Therapies Virus Treatment Clinical Trials 52

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 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.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

OCTOBER 29, 2020

29, 2020– Alexion Pharmaceuticals, Inc. ALXN2040 (Danicopan) – PNH with Extravascular Hemolysis (EVH): Alexion plans to initiate a Phase 3 study of ALXN2040 as an add-on therapy for PNH patients with EVH by the end of 2020. Initiated Phase 3 program for CAEL-101 in AL amyloidosis in collaboration with Caelum Biosciences.

Clinical Trials 40

Clinical Trials Production Trials Licensing 40

The Pharma Data

FEBRUARY 8, 2021

Sanofi expects 2021 business EPS ( 1) to grow high single digit (3) at CER, barring unforeseen major adverse events. Pharmaceuticals. Fourth-quarter 2020 Pharmaceutical sales increased 2.4% Fourth-quarter 2020 Pharmaceutical sales increased 2.4% In 2020, Pharmaceuticals sales increased 3.1% Specialty Care.

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52

The Pharma Data

FEBRUARY 4, 2021

Sanofi expects 2021 business EPS ( 1) to grow high single digit (3) at CER, barring unforeseen major adverse events. Pharmaceuticals. Fourth-quarter 2020 Pharmaceutical sales increased 2.4% Fourth-quarter 2020 Pharmaceutical sales increased 2.4% In 2020, Pharmaceuticals sales increased 3.1% Specialty Care.

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 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.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

APRIL 27, 2021

Sanofi expects 2021 business EPS ( 1) to grow high single digit (2) at CER, barring unforeseen major adverse events. Pharmaceuticals. First-quarter 2021 Pharmaceutical sales increased 3.8% At the end of the first quarter, Dupixent ® was launched in 49 countries with approximately 260 000 patients on therapy. . Lemtrada ®.

Vaccine 52

Vaccine Production FDA FDA Approval 52

The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. The study was designed to assess the safety and efficacy of continued treatment with relugolix combination therapy for up to two years.

Vaccine 40

Vaccine Production FDA Biosimilars 40

Agency IQ

SEPTEMBER 1, 2023

pharmaceutical law ceased to apply to the U.K. The Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. from the E.U. on February 1, 2020 started a year-long transition period; The E.U.

International 40

International Regulations Production Marketing 40