The Premier Consulting Blog

APRIL 27, 2023

Then, in 1997, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) formed the ICH M8 Expert Working Group/Implementation Working Group (EWG/IWG). Premier Consulting has been a trusted eCTD vendor for small to midsize pharmaceutical, biotech, and medical device companies since 1995.

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Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. A rise of clinical trial outsourcing due to cost management, globalization, and digitalization.

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The Pharma Data

JANUARY 26, 2021

. With very limited approved first-line pharmaceutical therapies for HCC available today, challenges include drug resistance, adverse side effects, and high costs. billion by 2027. An estimated 700,000 people are diagnosed with HCC each year, with the global market for liver cancer drugs expected to grow to $3.9

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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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FDA Law Blog: Biosimilars

JUNE 7, 2023

Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards). Complaint at 2.

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Agency IQ

OCTOBER 6, 2023

France In January, the French ecology ministry published a PFAS action plan enumerating six objectives for regulating forever chemicals more comprehensively by 2027. In other words, the European pharmaceuticals industry could find itself directly affected rather than indirectly impacted through the supply chain.

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FDA Law Blog: Biosimilars

MARCH 5, 2024

To the extent that AstraZeneca alleged that CMS would cause it this type of harm in 2027, the court found that allegation to be too speculative. Because the alleged harm arises from the Act, not from the Guidance, the court found that AstraZeneca did not meet the causation or redressability elements of standing under this argument.

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Vial

DECEMBER 7, 2023

billion by 2027 , at a compound annual growth rate (CAGR) of 45.7% Although this staggering growth rate is related to the rise in adoption of cloud-based digital technology, as well as the need for more efficient drug discovery approaches, traditional methods continue to hold significant value in the pharmaceutical world.

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Agency IQ

MARCH 15, 2024

California implements a variety of extended producer responsibility (EPR), programs, including programs to address paint, carpet, mattress, pharmaceutical and battery waste. Entities that become producers in the state after 2027 must join a PRO within six months or become an approved independent producer under state regulations.

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Agency IQ

MAY 17, 2024

GDUFA III), which reauthorized the program through 2027. The first hypothetical involved a topical gel product with two active pharmaceutical ingredients (APIs). The generic drug user fee program is currently on its third iteration (i.e.,

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Agency IQ

SEPTEMBER 6, 2023

This impact was apparently enough for the FDA and generic pharmaceuticals industry to include a new meeting type in the most recent iteration of the Generic Drug User Fee program (GDUFA), called a “Post-Warning Letter Meeting.” In FY2025, that will increase to a goal of 70%, and in FY2026-2027, it will increase to 80%.

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Agency IQ

FEBRUARY 2, 2024

Class A (lowest risk) devices needed to be IVDR-ready on the original date (May 26, 2022), but class D had until May 2025, class C until May 2026, and class B and sterile class A until May 2027. The proposal will be discussed at the Council of the EU Working Party on Pharmaceuticals and Medical Devices, taking place January 30.

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Agency IQ

FEBRUARY 21, 2024

As other health authorities started to require data standards, some, such as Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s National Medical Products Administration (NMPA) decided to opt for CDISC for regulatory submissions.

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BioPharma Drive: Drug Pricing

JULY 21, 2025

As more ustekinumab biosimilars come to market—such as Bio-Thera Solutions and Hikma Pharmaceuticals’ Starjemza, the eighth to be approved by the FDA—it remains to be seen if any one factor will set a biosimilar apart. Right now, all the available ustekinumab biosimilars are approved for each of Stelara’s indications.

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Drug Target Review

JUNE 5, 2023

How does Zymeworks plan to advance at least five novel medicines into clinical studies by 2027 under its ZYME 5×5 R&D objectives? We continue our in-house development strategy of accelerating our time from preclinical development candidate selection through IND filing.

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The Pharma Data

JUNE 16, 2025

BioMarin Boosts Enzyme Therapy Business with Inozyme Acquisition BioMarin Pharmaceutical and Inozyme Pharma today announced that BioMarin has entered into a definitive agreement to acquire Inozyme for $4.00 per share in an all-cash transaction valued at approximately $270 million in total consideration.

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Agency IQ

AUGUST 2, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V.

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Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2027 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Digital Health Technologies Publish draft guidance describing a process to evaluate a predetermined change control plan for digital health devices. primary and secondary). primary and secondary).

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Agency IQ

JULY 5, 2023

The Agency is now reconsidering that action. The EPA is changing the current absorption cross-section to the revised consensus-based value because it reflects an advancement in science and measurement technology that will improve the bias and reduce the uncertainty in this value.

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The Pharma Data

DECEMBER 14, 2020

Positive impetus came from the pharmaceuticals business in particular. Market researchers expect the global market for gene and cell therapy to grow at a CAGR of over 25% through 2027. The Leipzig-based company can look back on a successful 2020 and is planning for a stronger future. Over 85 % of sales now come from products.

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Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. But despite the law’s age, it is not yet fully operational.

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The Pharma Data

DECEMBER 30, 2020

The companies agreed to the steep price cuts in order to have their drugs made available to the world’s second-largest pharmaceutical market. billion by 2027. The average price cut is 10 percentage points less than last year, Bloomberg said. China’s national medical insurance fund covers more than 95% of the country’s 1.4

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Agency IQ

JUNE 16, 2023

The standards would begin with model year 2027 heavy-duty vehicles, with stringency levels through model year 2030 and beyond. The standards will begin with model year 2027 light-duty vehicles, with stringency levels set at least through model year 2030.

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The Pharma Data

APRIL 7, 2021

Yet as challenging as 2020 was, it also brought us –Sanofi and the pharmaceutical industry– closer to our purpose than at any other time in living memory ,” said Hudson. “The pandemic has forced us to question nearly every aspect of our lives: how we live and work, and how we connect with our communities and the planet.

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Agency IQ

DECEMBER 15, 2023

March 2024 February 2024 Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles—Phase 3 Final Rule Stage 2060-AV50 On April 12, 2023, EPA announced a proposal for more stringent standards to reduce greenhouse gas emissions from HD vehicles beginning in model year (MY) 2027. 7521(a), starting with model year 2027.

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BioPharma Drive: Drug Pricing

JUNE 30, 2025

as early as the 2026-2027 flu season. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes. FDA submission of the flu vaccine data could also pave the way for Moderna to also seek approval of a combination COVID-19 and influenza shot.

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The Pharma Data

MAY 4, 2021

RE47,739 for Ibrance by more than four years until March 2027. In March 2021, Pfizer and BioNTech announced that the European Medicines Agency (EMA) approved storage of BNT162b2 at -25°C to -15°C for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers.

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The Pharma Data

NOVEMBER 25, 2020

The most-favored-nation (MFN) model will be in place between January 1, 2021, and December 31, 2027, allowing time for CMS to evaluate its effect on access to therapeutics, their costs, and quality of care. This is an attempt to contain the growth in Medicare Part B spending without compromising healthcare quality. Another study found U.S.

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Drug Target Review

MARCH 20, 2025

These studies, anticipated to complete in 2027, could open doors for abelacimab’s approval in this indication. “We anticipate ASTER will complete in early 2027 and could form the basis for approval in the treatment and prevention of venous thrombotic events in patients with cancer,” Bloomfield said.

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