European Pharmaceutical Review

OCTOBER 13, 2022

Scientists at MIT have demonstrated that a novel robotic capsule could potentially replace conventional biologic injection methods by tunnelling through the intestinal mucus barrier to deliver insulin. Traditionally, delivering protein drugs orally has been challenging. The capsule is also coated with small studs that brush mucus away.

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Pharmaceutical Technology

AUGUST 2, 2022

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Topic sponsors are not involved in the creation of editorial content. Last year, the companies entered a strategic collaboration.

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Vaccines 104

Safe Biologics

NOVEMBER 12, 2023

FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. Read the full letter here.

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Express Pharma

JULY 29, 2023

In this video: Manisha Chaudhari, Senior Technical Application Expert, Merck Lifescience, India Topic: Addressing pharmaceutical & biological product development challenges with innovative excipients Key Highlights: 1) Predictive formulation promises to increase speed, reduce cost and create better outcomes in drug development 2) In the first (..)

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Drug Development 52

Safe Biologics

NOVEMBER 12, 2023

On November 6, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer.

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Biosimilars 113

Quality Matters

NOVEMBER 27, 2023

FDA's Draft Guidance for Topical Ophthalmic Drug Products: USP Standards This year has seen a flurry of activity by the U.S. Food and Drug Administration surrounding ophthalmic products. Noncompendial ophthalmic drug products should also follow the above USP 65 General Chapter. Identification threshold: 10 ppm.

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European Pharmaceutical Review

MARCH 5, 2024

International participation and trending topics With over 900 exhibitors, analytica 2024 promises an impressive lineup. The analytica conference addresses this topic with a session on the applications of AI algorithms in laboratory medicine. Top topics at the trade fair include digitalisation, Laboratory 4.0,

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Labelling 86

Safe Biologics

DECEMBER 3, 2023

The most recen t of the webinars, hosted July 29th, examined the negative impact of the Inflation Reducation Act’s Medicare drug price setting provisions. medical community and patient advocacy organizations, a decade of state-level policymaking, and CMS’ recent assurances, according to the Alliance for Safe Biologic Medicines.

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Biosimilars Labelling Drug Pricing Packaging 130

Pharmaceutical Technology

MAY 26, 2023

Krystal Biotech has received approval from the US Food and Drug Administration for topical gene therapy VYJUVEK to treat dystrophic epidermolysis bullosa (DEB) in adults and in children aged six months and above. Topic sponsors are not involved in the creation of editorial content.

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Express Pharma

SEPTEMBER 14, 2023

With our innovative research tools, automated analytical instruments, bio-manufacturing and purification solutions, we aim to make your drug discovery and production simpler, faster, and more sustainable,” said Abhijit Ghosh, Head of Sales for LPS India and SAARC.

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Drug Development 52

Pharmaceutical Technology

FEBRUARY 8, 2023

Genenta Science and AGC Biologics have signed a development and manufacturing service agreement (MSA). Under the deal, AGC Biologics will be responsible for manufacturing the cell therapy lentivirus-based product for the ongoing clinical programmes of Genenta Science.

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Immunity Immunization 52

Safe Biologics

DECEMBER 8, 2022

ASBM Presents at Festival of Biologics 2022 Europe From November 2nd-4th, ASBM representatives participated in the Festival of Biologics 2022 Europe, held in Basel, Switzerland. Professor Schneider also presented a poster session on the topic featuring data from ASBM’s recent survey of 401 US physicians. 11% were unsure.

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Biosimilars Communication Drug Development 100

Pharmaceutical Technology

MAY 24, 2023

Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases. Topic sponsors are not involved in the creation of editorial content.

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LifeProNow

MAY 4, 2023

FDA is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites. May 02, 2023: “The U.S.

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Packaging 130

Pharmaceutical Technology

JANUARY 11, 2023

Anima’s mRNA Lightning platform uses automated high-scale phenotypic screening in live mRNA biology and MOAi technology to identify small molecule mRNA drugs and their mechanisms of action. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper. Optimise your cell therapy process: a guide to cell thawing.

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Communication 59

Safe Biologics

FEBRUARY 1, 2024

Any change to a patient’s medication, including the automatic substitution of a biosimilar for the originator biologic without physician involvement, can pose a significant risk to patient stability. The Proposed Rule was announced in November 2023.

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Biosimilars Documentation Drug Pricing 130

FDA Law Blog: Biosimilars

NOVEMBER 30, 2023

The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. (“HPM”), HPM”), as well as other experts from FDA, DOJ, and the private sector. The conference will also include its annual panel discussion with FDA’s Center Compliance Directors.

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Communication 59

Pharmaceutical Technology

JUNE 9, 2023

Rocket Pharmaceuticals has received fast track and orphan drug designations for RP-A601 from the US Food and Drug Administration (FDA) to treat plakophilin-2-related arrhythmogenic cardiomyopathy (PKP2-ACM). In April 2023, the FDA approved the investigational new drug (IND) application for RP-A601 to begin a Phase I clinical trial.

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Communication 59

Pharmaceutical Technology

APRIL 4, 2023

AGC Biologics has entered into a service agreement with the Jikei University in Japan for an idiopathic pulmonary fibrosis (IPF) project. The company will undertake a technology transfer and feasibility study for a drug product focused on the treatment of IPF at its centre of cell and gene expertise in Milan, Italy.

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Pharmaceutical Technology

SEPTEMBER 22, 2022

Avrobio has received rare pediatric disease designation from the US Food and Drug Administration (FDA) for its investigational gene therapy, AVR-RD-04, designed to treat cystinosis. Additionally, no adverse events (AEs) linked to the drug have been reported so far. . Cystinosis patients have a high deficiency of this protein.

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Pharmaceutical Technology

MAY 23, 2023

In 2022, Avrobio’s investigational gene therapy, AVR-RD-04, received a rare paediatric disease designation from the US Food and Drug Administration. Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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pharmaphorum

OCTOBER 22, 2021

Sanofi and Regeneron’s Dupixent has become the first biologic drug to show activity in prurigo nodularis (PN), raising the hope of a new treatment option for the rare and highly debilitating skin disease.

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Immunity Immunization 105

pharmaphorum

MAY 25, 2022

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder. The post Dermavant claims its first approval as FDA clears psoriasis drug appeared first on.

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Labelling Biosimilars 52

Express Pharma

APRIL 20, 2023

Continuous manufacturing The topic of continuous manufacturing is also discussed in frames of PHARMAP 2023. As I can see from one perspective more and more important starts to be biological products or biotechnology in general”, said Piotr Lipiński, Global Quality Auditor, Novartis.

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Packaging Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

MARCH 10, 2023

A review by researchers on ocular drug delivery discussed strategies that could enhance ocular bioavailability. Currently, effective topical administration is challenging as the industry aims to prolong drug residence time and guarantee appropriate ocular permeation.

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Pharmaceutical Technology

JUNE 1, 2023

A new intracellular drug delivery centre will be established in the UK to support potential ribonucleic acid (RNA) vaccines and therapeutics , as well as the development of innovative drug delivery technologies. Topic sponsors are not involved in the creation of editorial content.

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Vaccines Drug Development 97

Pharmaceutical Technology

FEBRUARY 9, 2023

ReviR combines computational and high throughput drug discovery technologies to deliver advanced medicines to patients. The company’s VoyageR AI platform integrates computational methods to drug traditionally undruggable RNA targets. Topic sponsors are not involved in the creation of editorial content.

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Communication 96

Pharmaceutical Technology

AUGUST 17, 2022

Biopharmaceutical contract development and manufacturing organisation (CDMO) AGC Biologics has entered a strategic collaboration with RoosterBio to expedite the manufacturing of cell and exosome therapies. Topic sponsors are not involved in the creation of editorial content.

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Vaccines Drug Development 52

FDA Law Blog: Biosimilars

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. HP&M is proud to have our professionals participating in these important events. On March 20-21, Counsel John W.M.

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Pharmaceutical Manufacturing Drug Development Pharmaceutical Companies Pharmaceutical Companies 59

Big Molecule Watch

AUGUST 24, 2023

In continuation of Goodwin’s previous webinar series concerning biosimilars, Big Molecule Watch is launching the 2023-2024 webinar series , which will dive deep into some of the key topics pertaining to this burgeoning industry and corresponding area of law.

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Biosimilars Labelling 52

Pharmaceutical Technology

APRIL 14, 2023

Twist CAR and TCR Libraries allow researchers and drug developers to fine-tune these receptors to address the challenges of cell therapies, including off-target toxicity, enabling rapid advancement toward the clinic.” Topic sponsors are not involved in the creation of editorial content.

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Drug Development 98

Pharmaceutical Technology

AUGUST 25, 2022

The recommendation of the European Medicines Agency (EMA) for Roctavian to maintain orphan drug designation permitting a ten-year market exclusivity window was endorsed by the EC. The company plans to resubmit a Biologics License Application (BLA) for Roctavian by the end of next month.

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European Pharmaceutical Review

MAY 2, 2023

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. Ultimately, the regulatory body hopes the approach will result in more treatment options and improved patient outcomes.

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Packaging 79

Pharmaceutical Technology

MAY 22, 2023

The US Food and Drug Administration (FDA) has granted approval for Krystal Biotech’s Vyjuvek (beremagene geperpavec-svdt) to treat dystrophic epidermolysis bullosa (DEB) in patients aged six months and above. Vyjuvek is a non-invasive, topical, re-dosable gene therapy that delivers functional human COL7A1 gene copies to offer wound healing.

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Pharmaceutical Technology

MAY 24, 2023

The therapy has also received orphan drug and fast-track designations. The RMAT designation programme is intended to accelerate the drug’s development and review processes for products, including gene therapies. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

APRIL 25, 2023

Forge Biologics has received a qualified person (QP) declaration to manufacture adeno-associated virus (AAV) gene therapies to support European clinical programmes. It received orphan drug, fast track and rare paediatric disease designations from the US Food and Drug Administration.

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pharmaphorum

JANUARY 13, 2022

AstraZeneca has expanded its efforts to develop new therapies targeting transcription factors – proteins that regulate processes in the cell that have become a hot topic for drug discovery in cancer and other diseases. It’s not the big pharma’s first foray into the transcription factor area.

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