Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? provides a 10-year market exclusivity period. The sponsor must show at the time of marketing authorization application (MAA) that the orphan designation criteria are still met. Orphan designation in the E.U. countries examined between 2010 and 2017.

Marketing 40

Marketing Biosimilars Regulations Drugs 40

Perficient: Drug Development

MAY 30, 2024

.” – Mike Porter Top Trend: Transformation, Modernization, and Mandates LinkedIn | Blogs The health insurance industry is constantly changing, driven by the pressures it faces from customers, regulators, and market forces.

Regulations 88

Regulations Science Marketing 88

Perficient: Drug Development

AUGUST 22, 2023

According to Gartner’s 2022 Industry Cloud Survey , about 40% of IT leaders say they have started to adopt industry cloud platforms, with another 15% in pilots; another 15% are considering deployment by 2026. We understand that the healthcare market is drastically changing.

Science 98

Science Marketing Production 98

Drug Discovery World

JULY 1, 2024

billion) in 2023, 51% higher than 2022, marking the company’s largest annual net profit going back to 1989, according to data from S&P Global Market Intelligence 1. According to the Washington Post 2 , Novo Nordisk turned an annual profit of 83.7 billion DKK ($11.97 million).

Disease 162

Disease International Research Science 162

Perficient: Drug Development

SEPTEMBER 27, 2023

The overall EV market is quickly gaining momentum as governments worldwide push for a future with net-zero emissions and automakers rev up production to meet growing demand. In the first quarter of 2023, the total EV market share increased to 7.2% And demand is indeed growing. of total sales, representing a 50% jump year over year.

Regulations 59

Regulations Marketing Government Production 59

The Pharma Data

SEPTEMBER 27, 2021

7.125% Notes due 2025 532457 AM0 3 0.750% due August 31, 2026 0.820% 15 bps $1,222.65 5.500% Notes due 2027 532457 AZ1 7 0.750% due August 31, 2026 0.820% 40 bps $1,226.23 3.100% Notes due 2027 532457 BP2 13 0.750% due August 31, 2026 0.820% 35 bps $1,100.66 and Citigroup Global Markets Inc. BNP Paribas Securities Corp.

Disease 52

Disease Marketing 52

Drug Discovery World

OCTOBER 13, 2022

At the end of 2019, the combined market capitalisation of the top five public companies listed and focused on mRNA platforms was $15 billion. Reflecting this, the global C&GT manufacturing services market is predicted to grow at a compound annual growth rate (CAGR) of 12.4% billion by 2026 9.

Vaccine 130

Vaccine Therapies Drugs RNA 130

FDA Law Blog: Biosimilars

JUNE 14, 2023

The striking phrase “valley of death,” is generally understood to refer to the tendency for innovative technologies to fail to reach market, whether due to reimbursement and/or physician or patient preference. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).

Production 45

Production FDA Clinical Trials Marketing 45

The Pharma Data

OCTOBER 31, 2020

.” According to Global Data, the global market for influenza antivirals reached 2.34 billion USD by 2026 at a CAGR of 11.5%. Currently the market is comprised primarily of the neuraminidase inhibitor oseltamivir and the newly developed endonuclease inhibitor baloxavir. billion USD in 2019 and is estimated to reach 5.03

FDA Approval 52

FDA Approval FDA Virus Clinical Development 52

Drug Discovery World

JANUARY 24, 2024

Wigerinck has taken four drugs (Prezista, Olysio, Jyseleca and Rekambys) to market. Fibrocor Therapeutics, a developer of novel therapeutics to treat fibrosis, recently appointed Piet Wigerinck as Chief Scientific Advisor.

Small Molecule 147

Small Molecule Research Pharma Companies Disease 147

Drug Target Review

JULY 4, 2023

The drivers behind the demand for ADCs Providing more targeted therapeutic options in the oncology space has underpinned the rapid growth of the ADC market; between 2016 to 2020, the US ADC market grew by 45 percent to a value of nearly $1.5 The oncology market for antibody–drug conjugates.

Small Molecule 145

Small Molecule Drugs Clinical Pharmacology Trials 145

The Pharma Data

MAY 2, 2023

Starting in 2026, this facility will develop manufacturing processes for active pharmaceutical ingredients and produce drugs for use in clinical trial phases. This step is crucial for Boehringer Ingelheim to rapidly advance new drug candidates from the company’s vast research pipeline to clinical trials and ultimately to market approval.

Small Molecule 40

Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 40

ACTO

DECEMBER 19, 2023

The payoff of, on average, 15+ years of R&D and $2 billion invested to bring a new therapy to market comes down to what is done in the 180 days following a product launch. There is no margin for error, but there is no blueprint for success.

Science 52

Science Marketing Production Therapies 52

The Pharma Data

JULY 6, 2021

Adjusted operating margins are expected to improve from the current mid-20s level to over 30% by 2026. Cash generated from operations is expected to exceed £10 billion by 2026. 2021-2026 outlook refers to the 5 years to 2026 with 2021 as the base year.

Government 52

Government Vaccine Production Science 52

Drug Discovery World

FEBRUARY 26, 2024

Challenges “There are some cell therapies on the market but the cost of those is maybe $500,000 a dose. Bit.bio plans to generate initial clinical data in 2026 but is basing its approach for bbHEP01 on preclinical and clinical data 2 that show the feasibility of this type of cell therapy.

Therapies 130

Therapies Treatment Engineering Disease 130

Drug Target Review

JANUARY 4, 2024

By this point, we have undertaken a thorough analysis of what the market will look like at the anticipated product launch, including potential reimbursement models. Then it’s on to dosing and administration studies in animals, pivotal toxicology studies, and, following a successful funding round, first-in-human studies in 2026.

Therapies 98

Therapies Small Molecule Production Disease 98

Drug Discovery World

FEBRUARY 22, 2024

But psychopharmacology developments petered out, and few new drugs reached the market during the last four decades. The report also highlights that the global neuroscience market (GNM) “was worth $612 billion in 2022 and could grow to $721 billion by 2026.

Drugs 147

Drugs Clinical Trials Disease Therapies 147

Perficient: Drug Development

AUGUST 29, 2023

Market Overall, the automotive industry is up 13%. Further, there are fresh signs of labor market strength that reinforce a picture of an economy with broad momentum despite high interest rates. Tighter than expected labor market. An Overview of the U.S. On the retail side, it is up 9% while the fleet side is up 35%.

Marketing 52

Marketing Production 52

The Pharma Data

MARCH 31, 2022

million patients, provided with essential medicines by the global health unit, for the treatment of non-communicable diseases in 40 of the world’s poorest countries, between 2022 and 2026. The coupon amounts are linked to the achievement of a sustainability performance target defined as the cumulative number of patients, being at least 1.5

Government 52

Government Treatment Vaccine Disease 52

Drug Discovery World

JANUARY 25, 2023

The market, worth an estimated $8.8 billion, by 2026 1. The logistics of DCTs The number of clinical trials being conducted via the DCT and hybrid model has increased significantly in recent years, and the pace of change shows no sign of slowing. billion in 2021 is expected to increase by 10% year on year, to $14.2

Trials 130

Trials Clinical Trials Laboratories Nurses 130

Drug Discovery World

OCTOBER 4, 2022

There’s no question that cell and gene therapies have emerged as some of the most promising and innovative medicines on the market. . The global lab automation market for drug discovery is expected to grow by a CAGR of 5% between 2021 – 2026, according to a report by Mordor Intelligence. . Cell and gene therapies.

Drugs 130

Drugs Therapies Clinical Trials Cell Based Assays 130

The Pharma Data

DECEMBER 8, 2020

The company’s commercial priorities are three-fold: (1) Initially focusing its commercial efforts on rare diseases within its prolific neurology and cardiology franchises (2) pioneer new markets where there are no available treatments (3) create new standards of care where there has been a lack of innovation to optimize patient care.

RNA 52

RNA Pharmaceuticals Production Disease 52

The Pharma Data

SEPTEMBER 7, 2021

0.750% due August 31, 2026. 0.750% due August 31, 2026. 0.750% due August 31, 2026. 0.750% due August 31, 2026. and Citigroup Global Markets Inc. toll-free at +1 (888) 292-0070 or collect at +1 (980) 387-3907 or to Citigroup Global Markets Inc. 3.950% Notes due 2049. 532457 BT4. 1,500,000,000. 532457 AM0.

Licensing 52

Licensing Licensing Marketing 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The Discount Program is similar to the CGDP with respect to several requirements and operational processes, and CMS will implement it in a similar manner.

Compliance 105

Compliance Pharmacy Drugs Licensing 105

The Pharma Data

APRIL 14, 2021

Sanofi’s decision to locate its first-in-Asia digitally-enabled vaccine production center in Singapore, to supply markets in the region and beyond, is an endorsement of Singapore’s position as a leading centre for advanced manufacturing” said Dr Beh Swan Gin, Chairman, EDB. “EDB

Vaccine 52

Vaccine Production Disease International 52

The Pharma Data

MAY 15, 2023

Sandoz is a pioneer and market leader in biosimilars and this partnership with Just – Evotec Biologics comes shortly after the company announced increased investments in its Holzkirchen site in Germany to create a core Biopharma Technical Development hub supporting future biosimilar growth.

Biosimilars 40

Biosimilars Production Government Clinical Trials 40

The Pharma Data

APRIL 6, 2022

“With our portfolio of in-market medicines and up to 20 major pipeline assets that could be approved by 2026, Novartis is in a strong position to deliver above-peer-median sales and margin growth in the mid- and long-term.” ” Integrating Pharmaceuticals and Oncology business units.

International 52

International Pharmaceuticals Drug Development Compliance 52

Agency IQ

MAY 17, 2024

At that time, the FDA would no longer be able to award new vouchers to companies, unless the product already had rare pediatric disease designation, and obtained approval before October 1, 2026. focuses on marketing exclusivity periods granted to orphan drugs. DORIS MATSUI (D-Calif.) and GUS BILIRAKIS (R-Fla.),

FDA 40

FDA Disease FDA Approval Production 40

The Pharma Data

NOVEMBER 11, 2020

market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfa pump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. In the U.S., and Canada.

Therapies 40

Therapies Marketing Disease Clinical Research 40

The Pharma Data

JANUARY 6, 2021

This new facility will offer large-scale cell culture manufacturing of bulk drug substance with 8 x 20,000L bioreactors (physical volume), with the potential to expand and add a further 24 x 20,000L bioreactors based on market demand. “ The United States is the world’s biggest market for biopharmaceuticals.

Packaging 52

Packaging Small Molecule Production FDA Approval 52

The Pharma Data

DECEMBER 16, 2020

market for the alfa pump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfa pump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. In the U.S., and Canada.

Therapies 40

Therapies Marketing Disease Clinical Research 40

Agency IQ

FEBRUARY 2, 2024

This means that the medical device frameworks – including the pre-market pathways and evidentiary requirements, as well as post-market quality system frameworks and reporting requirements – are applied to the vast majority of all (CDRH-regulated) IVD products. IVDs used in blood donation screening/processing). In the E.U.,

FDA 40

FDA Regulations Laboratories Production 40

The Pharma Data

JANUARY 18, 2021

Under this program, companies are eligible to receive a priority review voucher following approval of a product with rare pediatric disease designation if the marketing application submitted for the product satisfies certain conditions, including approval prior to September 30, 2026 unless changed by legislation.

Therapies 52

Therapies Disease Treatment FDA 52

The Pharma Data

JUNE 26, 2021

Those taking up this offer will be required to hold the Shares or the corresponding FCPE units for a period of approximately five years, i.e. until 31 May 2026, except upon the occurrence of an early release event provided for under Article R. 3324-22 of the French Labour Code and authorized in the subscriber’s country.

Regulations 52

Regulations Marketing 52

The Pharma Data

JANUARY 25, 2021

The Company may not redeem the notes prior to February 6, 2026. This activity could increase (or reduce the size of any decrease in) the market price of the Company’s common stock, the notes or the Company’s 2.50% Convertible Senior Notes due 2027 at that time. per share on the Nasdaq Global Select Market on January 25, 2021.

Marketing 52

Marketing Disease Clinical Trials Production 52

Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2026 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Patient-Focused Drug Development FDA must issue or update guidance regarding the Agency’s collection of information from medical device facilities prior to inspection. Priority A List.

FDA 40

FDA Science Biosimilars Production 40

Agency IQ

MAY 10, 2024

BY LAURA DIANGELO, MPH | MAY 9, 2024 9:20 PM CDT Background: Servicing and remanufacturing – and why the difference matters Medical device regulatory oversight does not end at the point of market access, nor do the manufacturing requirements after distribution. Remanufacturing versus servicing: What it is and why it matters.

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FDA Regulations Compliance Production 40