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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XTalks

AUGUST 3, 2023

Last month, the US Food and Drug Administration (FDA) stood by its decision, denying a petition asking it to reevaluate the use of eight ortho-phthalates in food-contacting packaging materials.

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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.”

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BioTech 365

SEPTEMBER 15, 2020

US FDA approves +PLUSPAK™ (polymer bottle) Pharmacy Bulk Package for the gadolinium-based contrast agent, Clariscan™ (gadoterate meglumine) As the only polymer bottle for an MRI contrast agent, Clariscan in +PLUSPAK offers the potential for increased workplace safety, efficiency, convenience and … Continue reading →

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Camargo

OCTOBER 14, 2021

Eligibility for the pilot program has been limited to excipients that 1) have not been previously used in FDA-approved drug products, and 2) do not have an established use in food. The sponsors of the accepted proposals will submit a full package consisting of required toxicology and quality data, as outlined in the Federal Register.

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Pharmacy Checkers

FEBRUARY 14, 2020

Of our most merciful health insurance companies, few are willing to cough up the cost of expensive brand meds when there’s an FDA-approved generic on the market. Retail Price from GoodRX | *As the Canadian-based pharmacies only offer quantities in 90 or 180 tablet packages, this price was calculated based on the 90-day supply price.

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XTalks

FEBRUARY 25, 2025

As the competitive landscape for skilled professionals intensifies, companies are re-evaluating their health benefits packages to include innovative treatments that go beyond traditional healthcare offerings. Many job seekers are thus factoring the availability of GLP-1 drug coverage into their decisions about where to work.

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pharmaphorum

JANUARY 24, 2023

It will boost the site’s its capacity for parenteral filling, device assembly and packaging even further. In its third-quarter results, Lilly said that the early take-up of Mounjaro had been “ viral in nature ,” with sales approaching $100 million even though it only got FDA approval for diabetes the previous May.

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Camargo

NOVEMBER 15, 2021

Batch steps include filter drying, milling, and packaging. Proposals for novel excipients that have not been previously used in an FDA-approved drug product, and do not have an established use in food, are being accepted through December 7, 2021, for the first stage of review.

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The Pharma Data

OCTOBER 30, 2020

Dive into this week’s update for more details on the actions taken by the FDA in the ongoing response to the Covid-19 pandemic. FDA approves first treatment for Covid-19. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.

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Pharmaceutical Technology

OCTOBER 25, 2022

Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 Cambrex has collaborated and partnered with pharmaceutical customers to develop and manufacture FDC drugs that are US FDA-approved and are currently in the various stages of clinical development.

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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. In November, the FDA ended its Unapproved Drug Initiative. Unapproved Drug Initiative Ends.

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XTalks

MAY 18, 2023

In addition, Resonant Link can charge implants that are as small as 3 mm in diameter and implanted up to 6 cm deep, all while meeting the US Food and Drug Administration (FDA)-mandated temperature limits for implants that prevent surrounding tissues from burning. Zulauf expects human trials and the first FDA approval as early as 2024.

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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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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. The exact same FDA-approved drugs are sold in America and other countries, but with different labels.

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Pharmaceutical Technology

JANUARY 15, 2023

While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. Vetter Pharma-Fertigung GmbH & Co KG is conducting the parenteral manufacture and packaging for Trulicity. Source: GlobalData Pharmaceutical Intelligence Center.

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The Pharma Data

MAY 17, 2021

These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

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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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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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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. The adalimumab reference medicine (Humira ®* ) was first approved with an adalimumab concentration of 50 mg/mL.

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XTalks

MAY 31, 2024

The EpiMonitor earned US Food and Drug Administration (FDA) clearance for use in adults and children aged six and above. This makes it the only FDA-approved wearable for seizure detection available for purchase in the US.

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Advarra

JULY 19, 2022

A: This is a complex topic and is best outlined in the FDA’s guidance document. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? A: The FDA’s guidance document indicates the briefing package is submitted four weeks before the meeting. Could you please confirm?

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XTalks

OCTOBER 2, 2024

The new Stelo TV commercial shows people going about their everyday lives, saying how they’re already tracking many things, from the distances they travel to weather forecasts to tracking packages and their sleep. The Stelo glucose biosensor received clearance from the US Food and Drug Administration (FDA) in March.

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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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FDA Law Blog

SEPTEMBER 6, 2023

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. Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S.

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Pharmacy Checkers

DECEMBER 12, 2019

drug regulatory system, see: How FDA Approves Drugs and Regulates Their Safety and Effectiveness. When it comes to a system of track and trace of approved prescription drugs through their respective supply chains, which help prevent fake meds, the EU is ahead of the U.S. For a longer report about the U.S

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FDA Law Blog

AUGUST 17, 2023

The difference at issue here is the fact that Vanda’s Hetlioz product includes braille writing on its packaging, with some accompanying language (“Do not cover Braille”), and the generic products’ labeling does not. Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling. . § 314.94(a)(8)(iv),

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The Pharma Data

DECEMBER 8, 2020

Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease. Already having been in clinical studies at Roche, all four candidates have strong clinical and preclinical safety packages. Series D funds will be used to accelerate reimbursement coverage for its three commercial products. .

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Clinical Trial Podcast

FEBRUARY 23, 2021

Say you’re in the midst of securing FDA approval to start a new clinical trial. You find out that the FDA has follow-up questions. Unfortunately, the FedEx package drop-off time is 4:00 pm and the pick-up truck has left for the day. A great project manager would drive to the airport and drop off that package.

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The Pharma Data

JUNE 28, 2021

Injectable semaglutide 1 mg is a GLP-1 receptor agonist and the highest dose of injectable semaglutide FDA-approved for the treatment of type 2 diabetes. Lilly intends to submit the full registration package to regulatory authorities by the end of 2021.

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The Pharma Data

OCTOBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

DECEMBER 17, 2020

Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

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Roots Analysis

AUGUST 27, 2024

The implantable neurostimulation systems usually contain sophisticated electronics, such as stimulating leads, internalized pulse generator, and electrode extenders to subcutaneously connect the leads to pulse generator which is packaged within a hermetically sealed titanium case.

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The Pharma Data

DECEMBER 5, 2020

Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

OCTOBER 28, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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Pharmaceutical Technology

NOVEMBER 30, 2022

These contracts involve the manufacturing of biological and small molecule active pharmaceutical ingredients (APIs), parenteral manufacturing and packaging, and other manufacturing-related tasks. Following similar decisions by the American and European regulators, Swissmedic approved Pfizer/BioNTech’s bivalent Comirnaty booster.

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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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