Drug Discovery World

JUNE 23, 2023

FDA approves first gene therapy for Duchenne muscular dystrophy Sarepta Therapeutics’ Elevidys has become the first gene therapy for Duchenne muscular dystrophy (DMD) to gain marketing authorisation in the US. The post This week in drug discovery (19-23 June) appeared first on Drug Discovery World (DDW).

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pharmaphorum

JUNE 15, 2022

Manufacturing problems wreaked havoc with Mallinckrodt’s first attempt to secure FDA approval of its treatment candidate terlipressin for hepatorenal syndrome (HRS), but the drugmaker is having another attempt. There is no FDA-approved therapy available.

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XTalks

JULY 27, 2022

Yet over the past few weeks, she’s faced numerous questions about Pink Sauce’s ingredients, packaging and marketing, prompting a social media-based food scandal. Several other customers said they received leaking bottles of rotten-smelling sauce in the mail, with approximately 50 packages being impacted. FDA-Approved?

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pharmaphorum

SEPTEMBER 15, 2022

Mallinckrodt has finally claimed FDA approval for terlipressin as a treatment for hepatorenal syndrome (HRS), after manufacturing problems scuppered an earlier attempt. The drug is already approved for this indication in dozens of other countries around the world, including much of Europe, Australia and New Zealand.

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Pharmaceutical Technology

NOVEMBER 22, 2022

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

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pharmaphorum

JANUARY 24, 2023

Eli Lilly is leaving nothing to chance when it comes to making the most of its fast-growing diabetes therapy Mounjaro – it is investing another $450 million at a facility in North Carolina that will make the drug. It will boost the site’s its capacity for parenteral filling, device assembly and packaging even further.

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Pharmacy Checkers

FEBRUARY 14, 2020

Years ago, they took on the Food and Drug Administration in regards to Budeprion XL distributed by Teva Pharmaceuticals, the supposed generic equivalent to the popular antidepressant, Wellbutrin XL. Finally, I put it together that this was related to the drug because when I wouldn’t take it I would begin to feel better. Below are U.S.

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The Pharma Data

OCTOBER 30, 2020

To increase demand for products during the novel coronavirus pandemic, the US Food and Drug Administration (FDA) has already approved at-home testing and investigated the effectiveness of malaria pills and other antiviral drugs to treat Covid-19 9. FDA approves first treatment for Covid-19. Source link.

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The Pharma Data

MAY 17, 2021

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. . Posted 17 May 2021 | By Jeff Craven .

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Camargo

OCTOBER 14, 2021

The Center for Drug Evaluation and Research (CDER) has announced the rollout of the Novel Excipient Review Pilot Program in Federal Register Vol. The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation.

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FDA Law Blog

SEPTEMBER 6, 2023

Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S. Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

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Camargo

DECEMBER 9, 2020

If you are facing an FDA remote review, Camargo can help design a comprehensive approach in order to avoid such pitfalls. Approval of the Month: Alnylam to Use Value-Based Agreements for Ultra-rare Disease Treatment. Evergreening Orphan Drugs May Be Over. Without that showing, the FDA is directed to revoke the exclusivity.

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Camargo

NOVEMBER 15, 2021

FDA Guidance Addresses Real-World Evidence Data Standards. The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). FDA Publishes ICH Guidelines on Continuous Manufacturing.

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Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. John’s doctor was skeptical of drugs bought online from other countries. Is the drug safe?

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FDA Law Blog

MARCH 3, 2024

Effect on FDA approvals— In cases where a biological product or drug needs to change aspects of its manufacturing processes to avoid using a covered equipment or service, will it need to file supplements with FDA for the CMC update?

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FDA Law Blog

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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XTalks

MARCH 28, 2024

The US Food and Drug Administration (FDA) has given the nod to Winrevair (sotatercept-csrk injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO (World Health Organization) functional class (FC) and reduce the risk of clinical worsening events.

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Camargo

JUNE 4, 2021

Approval of the Month: Non-Opioid for Post-Surgical Pain Gets FDA Nod. Heron Therapeutic received FDA approval for its bupivacaine/meloxicam extended-release solution product to treat post-operative pain after total knee replacement, bunionectomy, and groin hernia repair. The Unapproved Drug Initiative is Back!

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pharmaphorum

SEPTEMBER 21, 2021

The company has earmarked $360 million for the new-build project at the 41-acre campus at College Park in Blanchardstown, Dublin, which will be used to manufacture active pharmaceutical ingredients (APIs) for small-molecule drugs. It is AZ’s first manufacturing facility in Ireland, where until now it has only run commercial operations.

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FDA Law Blog

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § patients in harm’s way.” FDA responded in late July, denying Vanda’s petitions.

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Advarra

JULY 19, 2022

Q: If an emergency use authorization (EUA) is granted, once there is an approved treatment, does that mean that the EUA is no longer valid? If the sponsor wants their drug approved, they need to complete all clinical studies and submit an application. Q: Can you ship a drug from another country to the U.S.

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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. Pfizer Inc.

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XTalks

JANUARY 13, 2023

Medical imaging tech company Polarean Imaging has recently announced that the US Food and Drug Administration (FDA) has approved their drug-device combination product Xenoview (xenon Xe 129 hyerpolarized). After hyperpolarization, it is packaged into a dosage delivery bag.

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The Pharma Data

APRIL 4, 2023

As part of the comprehensive submission package to the European Marketing Authorization, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50 mg/mL 2 with the 100 mg/mL (HCF). The adalimumab reference medicine (Humira ® *) was first approved with an adalimumab concentration of 50 mg/mL.

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Advarra

JULY 5, 2022

When returned directly to participants, aggregate results should be packaged and communicated in user-friendly formats, such as in newsletters or web pages constructed with readability and health literacy principles in mind. Conversely, a CGM not yet FDA-approved assessed in the study for reliability, would yield an investigational result.

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pharmaphorum

NOVEMBER 16, 2022

has announced that its platinum-resistant ovarian cancer drug ELAHERE (mirvetuximab soravtansine-gynx) has been granted FDA accelerated approval. RxDx Assay – Roche’s immunohistochemistry (IHC) companion diagnostic for identifying ovarian patients eligible for ELAHERE – has been contemporaneously approved by the FDA.

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The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration (FDA) advisory panel in regard to the COVID-19 vaccine from Moderna. To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval. Boumen Japet/Shutterstock.

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pharmaphorum

AUGUST 6, 2020

The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. This is an accelerated approval based on response data and GSK may need survival data from a larger trial to keep the drug on the market in the longer term.

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The Pharma Data

MAY 15, 2021

The product is made here, in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. After you fill in your information and confirm your package will be shipped for free right to your doorstep as soon as possible. Dentitox Pro is non-GMO and safe.

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Pharmaceutical Technology

JUNE 9, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of AstraZeneca’s and Sanofi’s respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) prophylactic nirsevimab for use in newborns and infants entering their first RSV season.

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The Pharma Data

DECEMBER 8, 2020

AbCellera’s AI-powered antibody discovery platform speeds the otherwise lengthy and grueling process by analyzing the database of natural immune systems to find antibodies that can be developed into drugs. Tackle the toughest problems in drug development.” The promise to partners is to “move quickly. Reduce cost. Remix Therapeutics .

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The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. TITUSVILLE, N.J. ,

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XTalks

MAY 18, 2023

” XTALKS WEBINAR: Drug Delivery — Addressing Global Regulatory Challenges in Co-Packaged, On-Body Systems Live and On-Demand: Thursday, June 15, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn about the differences and similarities between the US and EU regulatory frameworks for co-packaged combination products.

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The Pharma Data

MAY 16, 2021

Every capsule is made here, in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. If you order the 3 bottles or 6 bottles package (which we highly recommend as we estimate that we will run out of stocks soon as this has happened before) you’ll also take advantage of a huge discount.

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XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. Pfizer’s total global revenue in 2022 from Comirnaty was $37.81

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Pharmacy Checkers

DECEMBER 12, 2019

wholesale importation of lower-cost drugs. Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Food and Drug Administration exemplifies the “gold standard” in drug safety. is not the gold standard in drug safety, it would fatally weaken anti-importation arguments. If the U.S.

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XTalks

FEBRUARY 7, 2023

The FDA approval is an important step forward for both women and men living with metastatic breast cancer, especially for those individuals whose tumor is no longer responding to endocrine-based therapies and who are facing a poor prognosis,” said Laura Carfang, executive director, SurvivingBreastCancer.org, in the press release.

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