The Pharma Data

OCTOBER 27, 2020

NYSE: LCI) today announced that it will report financial results for its fiscal 2021 first quarter on Wednesday, November 4, 2020 , after the market closes. Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications.

Packaging

Cytel

MAY 24, 2023

As of March 2023, specifically for any study started on or after March 15, 2023, 1 the submission of SEND, SDTM, and ADaM packages to the FDA requires the use of Define-XML 2.1 while this is not yet the case for PMDA).

Packaging

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

In June 2021, uniQure provided another regulatory update , announcing that FDA was requiring a demonstration of “durability of effect” based on data from patients followed for at least 52 weeks after FIX levels achieve steady state, which occurs by 26 weeks. That brings us to the product’s approval.

Therapies

The Pharma Data

NOVEMBER 30, 2020

The Compact will bring together in one package all WHO materials for the prevention and management of diabetes, both existing and new. The Compact will be launched in April 2021. . The goals of the Compact, the development of which will be led by WHO, are: . Source link.

Packaging

The Pharma Data

JANUARY 6, 2021

6, 2021 — The American Red Cross is urging COVID-19 survivors to donate blood plasma for hospital patients who need it to recover. 1 and 20 will be automatically entered to win the “Big Game at Home” package for viewing at home, with a 65-inch television and a $500 gift card. © 2021 HealthDay. WEDNESDAY, Jan.

Hospitals

The Pharma Data

DECEMBER 14, 2020

The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. Given a positive outcome of the approved Phase 1 study, the company intends to initiate Phase 2 by the end of 2021.

Clinical Development

The Pharma Data

MAY 3, 2021

Posted 03 May 2021 | By Kari Oakes . Studies are also underway in younger school-aged children and preschoolers, with results expected over the summer and by fall 2021, respectively. . © 2021 Regulatory Affairs Professionals Society. The companies look forward to working closely with the U.S. EMA. . . . Source link.

Vaccine

Eye on FDA

APRIL 13, 2022

The agency stated that material facts about the risks were not properly conveyed with particular regard to advising women about the risks during pregnancy and noted that the package insert advises a pregnancy test within 2 weeks prior to therapy initiation and advises on the use of contraception during treatment.

FDA

FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. Once the device is required to bear a UDI, any NHRIC and NDC codes will no longer be permitted on the device label or device packaging.

Packaging

The Premier Consulting Blog

APRIL 27, 2023

Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5 Implementation Package v1.5 Module 1 Implementation Package FDA eCTD v4.0 The agency will begin accepting eCTD v4.0 How can you prepare? How can you prepare? FDA eCTD v4.0

Packaging

The Pharma Data

OCTOBER 27, 2020

Top-line results with 12 months follow up data anticipated during the second half of 2021. The study design includes two stages of data analysis – upon 12-month data collection, anticipated in the second half of 2021, and upon 24-month data collection, anticipated in the second half of 2022.

Clinical Trials

The Premier Consulting Blog

MAY 4, 2023

The new guidance provides detailed information to applicants and manufacturers regarding compliance with the requirements in 21 CFR Part 4 for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers. 2] On April 16, 2021, the U.S.

FDA

The Pharma Data

MAY 17, 2021

Posted 17 May 2021 | By Jeff Craven . © 2021 Regulatory Affairs Professionals Society. The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. . “Any

Research

Agency IQ

SEPTEMBER 15, 2023

On March 5, 2021, the division added perfluorobutane sulfonic acid (PFBS) notification levels of.5 In the same month, the California Department of Toxic Substances Control (DTSC) presented its chemical profile for carpets and rugs containing PFAS as well as a webinar for its findings on PFAS in food packaging. ppt for PFOS and 5.1

Regulations

FDA Law Blog: Biosimilars

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Whether a firm used the 10-day call and/or an SIR, it should include any prior feedback from those interactions with FDA in the AI response and describe how and where in the AI response package the prior feedback was addressed.

FDA

Agency IQ

MARCH 15, 2024

In 2021, California Senate Bill (SB) 343 set a new standard for what constitutes deceptive labeling surrounding recyclability. Background: SB 54 and its requirements On June 30, 2022, Governor Gavin Newsom signed into effect SB 54, the Plastic Pollution Prevention and Packaging Producer Responsibility Act.

Regulations

Perficient: Drug Development

OCTOBER 4, 2023

CLIENT An American multinational corporation that develops medical devices, pharmaceuticals, and consumer packaged goods. In early 2021, our Life Sciences experts presented a Clinical Data Review Platform (CDRP) that demonstrated our strong industry perspective and expertise.

Clinical Trials

The Pharma Data

MAY 26, 2023

The 6,000-square-meter Shiga site opened in October 2021 to support customers both locally and globally, providing flexible clinical supply solutions, including primary packaging, Catalent’s FastChain ® demand-led supply, white glove handling and logistics.

Clinical Supply

Perficient: Drug Development

MAY 9, 2024

Perficient’s Giving ERG was established in 2021 , as a way for employees to bond over philanthropy and inspire generosity. While we were putting together the care packages and organizing clothing, we even noticed a few unhoused people come in and grab shoes and clothes they needed.

Packaging

The Pharma Data

SEPTEMBER 10, 2021

Today, SVG Ventures | THRIVE and Bayer announced the winners of their 2021 Sustainability Challenge. Haystack will receive a prize package that includes investment from SVG Ventures and a place in THRIVE’s award winning Accelerator Program, in addition to access to Bayer’s investment and R&D teams.

Packaging

The Pharma Data

JUNE 17, 2022

As part of the comprehensive submission package to the EMA, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing Hyrimoz 50 mg/mL 2 and Hyrimoz HCF. Our broad portfolio of high-quality medicines, covering major therapeutic areas, accounted for 2021 sales of USD 9.6 Source link: [link].

Biosimilars

The Pharma Data

JANUARY 18, 2021

Further, combined with the early successes in improving cardiac performance, now when combined with MRI compatibility, CCM adds to the armamentarium of the cardiologist and electrophysiologist in further optimizing FDA-approved medical therapies in 2021.”

FDA Approval

The Pharma Data

DECEMBER 9, 2020

Full and complete packages resulting from this collaboration are expected to be made available in 2021 towards the end of the year. About SOLABS: SOLABS’ award winning EQMS (Enterprise Quality Management Software) allows mid-size Life Science organizations learn from experience, continuously improve and do more with less.

Science

Practical Cheminformatics

DECEMBER 4, 2022

In addition, the core code for extracting ring systems from molecules has been incorporated into the latest version of my pip installable useful_rdkit_utils package. A 2021 paper extended Peter's previous work and led to the development of a web tool for navigating scaffolds found in the ChEMBL and ZINC databases.

Packaging

Agency IQ

AUGUST 4, 2023

as of January 1, 2021. These came into effect on January 1, 2021. This reliance procedure was implemented on January 1, 2021, for a planned two-year span, but last September, MHRA extended the effective period for the procedure to the end of 2023. only” label can be affixed anywhere on the packaging. However, the “U.K.

Packaging

The Pharma Data

OCTOBER 30, 2020

In the first half of 2021, pending licensure of mRNA-1273 in Japan, Takeda has said it will aim to import and distribute 50 million doses to support supply preparedness in Japan. Sign up now to save your seat at the keynote sessions on design thinking in pharma, digital transformation and connected packaging to understand patient behavior.

FDA Approval

Agency IQ

FEBRUARY 12, 2024

FDA and EMA launched the Parallel Scientific Advice (PSA) Pilot Program for Complex Generic/Hybrid Products in September 2021. The program officially launched on September 15, 2021. Second, the submitters provide a full meeting package with detailed information on the development history and context, available data, and questions.

FDA

The Premier Consulting Blog

NOVEMBER 16, 2022

Involving nonclinical/toxicology experts early on is key to reducing the package of studies as much as possible. essential oils for topical drug product use) can be very difficult and require not only a full nonclinical qualification package but also a full characterization of each component of the complex mixture.

FDA

The Premier Consulting Blog

MAY 11, 2023

The guidance provides information to biopharma manufacturers regarding ophthalmic drugs packaged with eye cups, eye droppers, or other ophthalmic dispensers, where those articles meet the device definition. All regulated parties, including ophthalmic drug and device manufacturers, should take note.

FDA

The Pharma Data

NOVEMBER 18, 2021

In November 2021, Gilead and Arcus amended the collaboration in connection with Gilead’s option exercise for three of Arcus’s also-clinical stage programs. That stock purchase agreement was amended and paraphrased in February 2021 in connection with Gilead’s increased equity stake in Arcus from 13 to19.7,

Research

The Pharma Data

NOVEMBER 4, 2020

. “If we can win in New Jersey, Mississippi, South Dakota, Montana and Arizona, it’s going to send a really loud message to Congress that it’s time to fix this at the federal level in 2021.” The affected product is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01.

Packaging

Alta Sciences

NOVEMBER 5, 2024

Their advantages include ease of scalability and manufacturing, ease of packaging, and high product stability. This blog was originally posted 07/26/2021 and updated on 11/05/2024 Reference [link] Image Thumbnail_Blog-LFHSCs-alt.jpg Synopsis Liquid-filled capsules can be rapidly developed and tested, moving quickly from R&D to clinic.

Marketing

Agency IQ

FEBRUARY 23, 2024

In the same month, the California Department of Toxic Substances Control (DTSC) presented its chemical profile for carpets and rugs containing PFAS as well as a webinar for its findings on PFAS in food packaging.

Packaging

The Pharma Data

NOVEMBER 22, 2020

They believe they will have a capacity of up to 3 billion doses in 2021 on a rolling basis, pending regulatory approval. Pfizer has designed its own packaging using dry ice that can be stored for weeks without the specialized freezers. Trials are also being run in the U.S.,

Vaccine

Broad Institute

MAY 14, 2025

Compact tools NovaIscB is derived from a bacterial DNA cutter that belongs to a family of proteins called IscBs, which Zhangs lab discovered in 2021. Zhang and his team reported their work today in the journal Nature Biotechnology. Because they are bulkier, tools developed using Cas9 can require a more complicated delivery strategy.

Engineering

FDA Law Blog: Biosimilars

JANUARY 11, 2024

mL for subcutaneous injection was approved on October 15, 2021; the supplement for 10 mg/0.2 Boehringer’s interchangeable Cyltezo in 40 mg/0.8 mL and 20 mg/0.4 mL was approved on March 18, 2022. Thus, 18 months from approval would result in expiration of FIE on April 15, 2023, and on September 18, 2023 respectively.

Biosimilars

The Pharma Data

JANUARY 30, 2021

31, 2021 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) today announced new data from the COMMENCE clinical trial that demonstrate Edwards’ bioprosthetic surgical aortic valve with the company’s novel RESILIA tissue platform show favorable safety and hemodynamic performance through a median of five years follow-up. .”

Clinical Trials