Outsourcing Pharma

MARCH 3, 2021

The 2020 Pfizer/BioNTech COVID-19 vaccine trial recruited more than 44,000 participants and reached submission for emergency authorization in 248 days: showing unprecedented speed and agility in the context of a global pandemic.

Vaccines 137

Vaccines 137

Pharma in Brief

MAY 29, 2023

The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices. Health Canada has also updated its fee for CSP applications.

Documentation 59

Documentation 59

FDA Law Blog: Biosimilars

MAY 8, 2023

Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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Documentation Labelling 98

Big Molecule Watch

APRIL 9, 2024

regulatory submission for ENHERTU was reviewed under the Real-Time Oncology Review (“RTOR”) program and Project Orbis , two initiatives of the FDA which are designed to bring safe and effective cancer treatments to patients as early as possible.

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FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

If DHT is a medical device and… Then… is cleared or approved and used in a clinical investigation in accordance with its approved or cleared indications for use a submission of an IDE to the FDA is not required. c) a submission of an IDE to the FDA is not required. c) a submission of an IDE to the FDA is not required.

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Documentation 105

FDA Law Blog: Biosimilars

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Now, with explicit statutory authority, FDA’s push for cybersecurity has a firm legal footing. Note that FDA does not conduct an RTA acceptance review for submissions submitted via eSTAR.

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Documentation Labelling Communication 105

European Pharmaceutical Review

JANUARY 2, 2024

Over the past several years, the pharmaceutical industry has faced challenges regarding quality assurance in drug development, the author asserted. highlighted that “in the EU market, a relatively low number of approved pharmaceutical products adopted the QbD methodology or describe QbD elements in their regulatory submissions.”

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Drug Development Biosimilars Documentation 99

Express Pharma

AUGUST 28, 2023

Enoxaparin plays a role in addressing blood clot formation in patients suffering from deep-vein thrombosis, acute coronary syndrome, heart attacks and pulmonary embolism.

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FDA Law Blog: Biosimilars

JUNE 20, 2023

Mullen — On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. For example, FDA expressly notes that feedback on EUAs is outside the pre-submission process, and pre-submission meetings include videoconferences.

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Documentation Communication 45

Big Molecule Watch

JUNE 30, 2023

Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates. Formycon and Celltrion are the second and third biosimilar developers to announce submissions of aflibercept aBLAs, following Viatris Inc.’s s submission in October 2021. As we have previously reported , Biocon Biologics Ltd.

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Biosimilars Diabetes 62

Express Pharma

MAY 22, 2023

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercialising and co-promoting the product and Eisai having final decision-making authority.

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Syner-G

AUGUST 9, 2022

As a result of repeat business, IMPACT (now part of Syner-G BioPharma Group) was contracted by a large, global pharmaceutical company to author the CSRs and accompanying submission documents to support a simultaneous US and EU submission for a combination respiratory product. and 2.7.2), and the Clinical Overview (Module 2.5).

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Documentation Clinical Pharmacology Pharmaceutical Companies Pharmaceutical Companies 40

Pharmafile

MARCH 31, 2023

Published date: 31/03/2023 Summary: — NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China — — FRESCO-2 showed fruquintinib treatment reduced the risk of death by 34% in refractory metastatic colorectal cancer (0.66

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Pharma in Brief

JANUARY 19, 2023

We previously reported on the IO here. Feedback on the Regulatory Amendments and draft guidance documents can be submitted to Health Canada here.

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Documentation Labelling Vaccines 52

Express Pharma

AUGUST 31, 2023

Section 505-1 of the FD&C Act authorizes FDA to require the submission of a Risk Evaluation and Mitigation Strategy (REMS) for this product. The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India). Zydus’ proposed REMS has also been approved by FDA.

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FDA Law Blog: Biosimilars

JUNE 28, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

Documentation 52

Documentation 52

pharmaphorum

MARCH 2, 2021

For example protocol management, CRF design , metadata management, and the collection, analysis, and submission of compliant clinical study data to regulatory authorities. Our automated processes are streamlined for CRF design, data collection, tabulation, analysis, and submission. Automated processes and clinical MDRs.

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Pharma in Brief

APRIL 13, 2021

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Continued authorization for COVID-19 drugs. Intellectual property considerations.

Vaccines 52

Vaccines Biosimilars Documentation 52

Big Molecule Watch

JANUARY 8, 2024

District Court for the Northern District of West Virginia, alleging patent infringement under the Biologics Price Competition and Innovation Act (“BPCIA”) based on the Defendants’ submission of aBLAs for their proposed biosimilars of EYLEA (aflibercept).

Biosimilars 67

Biosimilars 67

LifeProNow

APRIL 6, 2023

April 3, 2023 : “Sandoz, a global leader in off-patent (generic and biosimilar) medicines announced that the European Commission (EC) granted marketing authorization in the European Union (EU) for a citrate-free high concentration formulation (HCF; 100 mg/mL) of its biosimilar Hyrimoz ® (adalimumab).

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Biosimilars Packaging 130

FDA Law Blog: Biosimilars

APRIL 2, 2024

Finally, FDA asks Congress to amend to FDCA § 505(j) to address the submission and review of drug-device combination product ANDAs, as well as drug products submitted in an ANDA that are used with devices. FDA also asks for recall authority over drugs—both human and animal—to remove violative drug products from market “more quickly”.

Labelling 104

Labelling Biosimilars Drug Pricing Dosage 104

Pharma in Brief

JANUARY 18, 2021

Canada has added the UK to the list of countries that must be considered for the “timely submission requirement” in an application for a Certificate of Supplementary Protection ( CSP ). The prescribed countries relevant to the “timely submission requirement” are set out in paragraph 6(1)(a) of the CSP Regulations.

Documentation 52

Documentation 52

European Pharmaceutical Review

MARCH 25, 2024

The Committee for Medicinal Products for Human Use (CHMP) has recommended granting of a marketing authorization for antibiotic combination Emblaveo® (aztreonam-avibactam) for treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of aerobic Gram-negative bacteria.

Hospitals 95

Hospitals 95

Pharmaceutical Technology

DECEMBER 18, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 1 (mRNA-1273.214) booster for usage in children aged six to 11 years.

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Vaccines Communication 121

Pharma Pathway

FEBRUARY 11, 2023

Note – Candidates with injectables -RnD or complex analytical characterization experience and willing to transition to RA are also welcome (NOT for routine analytical or validation folks) Kindly send your CV to rahul.roy1@viatris.com with the following nomenclature else your profile will not be shortlisted 1.

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Data Entry Documentation 40

PharmaShots

JANUARY 23, 2023

In collaboration with Eli Lilly, HUTCHMED focuses on late-stage clinical trials & commercialization of fruquintinib in mainland China, approved under the brand name Elunate The marketing authorization submissions in the US, EU & Japan are planned to complete in 2023 with rolling submission to the US FDA in H1’23.

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Pharma in Brief

AUGUST 9, 2021

The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market. The proposed amendments require applicants to provide the Minister with an RMP as part of their application for a drug authorization for human use. Background.

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Labelling Packaging Biosimilars 98

The Guardian - Pharmaceutical Industry

MARCH 23, 2023

On Thursday afternoon the Therapeutic Goods Administration (TGA) published the almost 4,000 public submissions made in response to the government’s proposed vaping reforms, aimed at tackling rising youth vaping rates and a burgeoning black market.

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European Pharmaceutical Review

APRIL 17, 2024

Roche multiple sclerosis subcutaneous injection: late-breaking data “Updated results from OCARINA II further underline the potential benefits of subcutaneous OCREVUS for patients with both relapsing and progressive forms of MS,” shared Scott Newsome , DO, lead author, Johns Hopkins University School of Medicine.

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PharmaShots

JUNE 26, 2023

Shots: The EMA’s CHMP has recommended Soliris for marketing authorization in the EU to treat refractory gMG in children & adolescents aged 6-17yrs. who are AChR Ab+. The efficacy & safety were consistent with the established profile of Soliris incl.

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Pharmaceutical Technology

SEPTEMBER 29, 2022

The European Medicines Agency (EMA) has accepted Moderna ’s submission seeking a variation to the Conditional Marketing Authorization (CMA) for assessing a 50µg dose of the Omicron-based bivalent Covid-19 booster candidate, mRNA-1273.222, for adults aged 12 years and above. 5 subvariants of Omicron. 1 subvariant, mRNA-1273.214.

Vaccines 59

Vaccines 59

PharmaShots

APRIL 3, 2023

Shots: The EMA’s CHMP has recommended Ultomiris for marketing authorization in the EU for adult patients with NMOSD who are anti-aquaporin-4 Ab+ The opinion was based on the P-III trial (CHAMPION-NMOSD) evaluating Ultomiris in 58 patients across North America, the EU, Asia-Pacific & Japan.

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Big Molecule Watch

FEBRUARY 1, 2024

Celltrion Submits BLA for Tocilizumab Biosimilar On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar. Aflibercept is used in the treatment of neovascular age-related macular degeneration and other retinal diseases.

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Biosimilars 62

PharmaShots

MAY 11, 2023

The regulatory submissions are under review with multiple health authorities, incl. in the US & Japan Ref: AstraZeneca | Image: AstraZeneca Related News:- AstraZeneca Receives EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Ultomiris (ravulizumab) for Neuromyelitis Optica Spectrum Disorder PharmaShots!

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Big Molecule Watch

JULY 21, 2023

On July 14, Dong-A ST announced that the European Medicines Agency accepted its Marketing Authorization Application (MAA) for DMB-3115, a biosimilar referencing STELARA (ustekinumab). STELARA is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Biosimilars 52

Biosimilars 52

PharmaShots

APRIL 27, 2023

Shots: The US FDA has granted Breakthrough Device Designation for Ultromics’ EchoGo Amyloidosis, an AI-enhanced platform that detects cardiac amyloidosis by using AI to analyze echocardiograms EchoGo Amyloidosis platform is intended to be included within the company’s EchoGo Platform (developed in conjunction with various clinical collaborators (..)

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pharmaphorum

DECEMBER 23, 2022

And technology like digital asset management (DAM), medical, legal, and regulatory review (MLR), and content authoring tools will help drive further acceleration.”. “As Dynamic digital content will drive MLR, health authority collaboration. For example, allowing one submission for 20 versions of an email to support personalisation.

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