Fierce Pharma

SEPTEMBER 13, 2024

It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company's initia | The under-the-skin formulation trims administration time down to seven minutes compared to the 30 to 60 minutes needed for intravenous Tecentriq. (..)

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FDA Approval Manufacturing Drugs 120

Pharmaceutical Technology

JUNE 23, 2022

In the last year, well-known contract manufacturing organisations (CMOs) such as Agilent Technologies (Santa Clara, California) and Abzena (Cambridge, UK) have expanded their continuous manufacturing capabilities. US Congress is also making substantial investments to improve the continuous manufacturing of pharmaceuticals.

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Manufacturing Contract Manufacturing Production Drugs 162

BioPharma Reporter

AUGUST 22, 2024

The US regulator has confirmed a delay to the approval of linvoseltamab while a manufacturing issue is resolved with a third-party provider.

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Manufacturing FDA Approval Regulation Drugs 98

Drug Patent Watch

OCTOBER 24, 2019

CDMOs, equipment manufacturers, regulatory consultants, and…. The post Customer Success: How do we identify generic entrants before they get FDA approval? DrugPatentWatch can help identify generic entrants at the earliest stages Many clients come to DrugPatentWatch seeking to identify generic entrants well before they launch.

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FDA Approval Manufacturing 105

Bio Pharma Dive

DECEMBER 16, 2024

Elsewhere, drugs from Neurocrine Biosciences, Checkpoint and Galderma won new FDA approvals. Novo Nordisk is investing more than $1 billion in a new production facility in Denmark.

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FDA Approval Manufacturing Trials Production 130

Pharmaceutical Technology

FEBRUARY 21, 2024

WuXi ATU received FDA approval to commence the analytical examination and production of Iovance’s Amtagvi at its Philadelphia site.

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FDA Approval Manufacturing Production 130

XTalks

JUNE 12, 2023

Bristol Myers Squibb (BMS), a multinational pharmaceutical company based in New York City, has announced that its new state-of-the-art cell therapy manufacturing facility in Devens, Massachusetts, has received approval for commercial production from the US Food and Drug Administration (FDA).

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Manufacturing Gene Therapy FDA Approval Gene 95

Pharmaceutical Technology

JUNE 9, 2023

The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts. The site has been involved in the development, manufacture and testing of clinical and commercial medicines.

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FDA Approval Production Gene Therapy Manufacturing 130

Pharmaceutical Technology

JUNE 13, 2023

The company’s products are processed in advanced FDA-inspected, FDA-registered, cGMP (current good manufacturing process)-compliant cleanrooms in Gainesville, Florida, US. It developed perinatal tissue-derived therapeutics to transform a broad spectrum of diseases treatment of high unmet medical needs.

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FDA Approval Production Clinical Development Manufacturing 147

XTalks

NOVEMBER 28, 2023

This liquid formulation of metronidazole is the sole FDA-approved liquid option, offering a groundbreaking prescribing alternative for patients encountering difficulties in swallowing or facing taste-related obstacles. With a 24-month shelf life and no need for refrigeration, Likmez provides a convenient option for patients.

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FDA Approval Bacteria DNA Drugs 103

Outsourcing Pharma

JULY 23, 2024

Rusan Pharma Private Limited has announced that its active pharmaceutical ingredient (API) manufacturing facility in Ankleshwar, Gujarat, has been granted Good Manufacturing Practice (GMP) approval by the FDA.

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Manufacturing FDA Approval Drug Delivery Drugs 81

Pharmaceutical Technology

JANUARY 15, 2023

In order to get a therapy to the market, pharma companies often outsource the drug manufacturing to specialist contract manufacturing organizations (CMOs). 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. EMA and NICE news.

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Manufacturing Packaging Packaging Contract Manufacturing 130

Pharmaceutical Technology

OCTOBER 25, 2022

Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Pharmaceutical companies – and the FDA – are embracing FDCs.

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Manufacturing Production Packaging Packaging 130

XTalks

SEPTEMBER 6, 2022

On Friday, Azurity Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved their innovative oral liquid formulation Konvomep (omeprazole and sodium bicarbonate for oral suspension). Patients are our priority, and our purpose is to bring them new formulations that help them benefit from established medicines.

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FDA Approval Containment Pharmacy Medicine 98

Pharmaceutical Technology

APRIL 6, 2023

A recent wave of monoclonal antibodies, including the FDA-approved Eisai / Biogen ’s Leqembi (lecanemab), is expected to shake up the space. If proven and approved, the rapid introduction of AD04 into the U.K. The difficulty in finding a treatment for Alzheimer’s disease has plagued the drug industry for decades.

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FDA Approval Licensing Licensing Antibody 264

XTalks

OCTOBER 22, 2021

In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes. The FDA approved the supplemental Biologics License Application (sBLA) for Cyltezo as the first interchangeable biosimilar with Humira.

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FDA Approval Production Insulin Antibody 98

Fierce Pharma

AUGUST 30, 2023

Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases.

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FDA Approval Doctor Doctors Manufacturing 110

Fierce Pharma

OCTOBER 18, 2023

UCB has been “eagerly awaiting” an FDA approval for its psoriasis therapy Bimzelx (bimekizumab) after manufacturing problems resulted in a rejection last May. The FDA rejected the drug last May after conducting an inspection at UCB's Belgian manufacturing plant. Now, the wait is over. |

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Manufacturing FDA Approval Drugs 86

XTalks

NOVEMBER 6, 2024

Unlike its counterpart, wet AMD, which involves abnormal blood vessel growth, dry AMD lacks effective, FDA-approved treatment options, leaving patients at risk of significant vision loss. AMD is a leading cause of vision loss for people aged 65 and older. percent among individuals aged 45 to 49 to 27.2

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Manufacturing FDA Approval Packaging Packaging 104

XTalks

AUGUST 7, 2023

has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Formerly known as VP-102, Ycanth is the first cantharidin formulation approved for this purpose. Another noteworthy contender is Novan Inc.’s

FDA Approval 98

FDA Approval Dermatology Trials Clinical Trials 98

BioPharma Reporter

SEPTEMBER 17, 2024

The original concerns of the US regulatory agency over the manufacturing of Eli Lillyâs Ebglyss seem to have been resolved, as the FDA greenlit the antibody drug on Friday.

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FDA Approval Drugs Antibody Manufacturing 97

XTalks

OCTOBER 22, 2024

The FDA had rejected Vyloy in January due to “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility” for the drug. Approximately 38 percent of patients with advanced gastric or GEJ adenocarcinomas express the CLDN18.2

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FDA Approval Drugs Licensing Licensing 105

XTalks

AUGUST 19, 2022

While the two therapies are similar in design, they are manufactured differently. In a press release , bluebird said the approval of Zynteglo is “the culmination of nearly ten years of clinical research of gene therapy in patients with transfusion-dependent beta-thalassemia.”. “Any

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Gene Therapy FDA Approval Gene Clinical Trials 95

World of DTC Marketing

OCTOBER 21, 2021

More than $170 million of this spending was for products voluntarily withdrawn by their manufacturers after clinical trials showed that they did not improve overall survival in people with various types of cancer. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5

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Clinical Trials Clinical Trials FDA Approval Trials 234

pharmaphorum

AUGUST 6, 2020

GSK has not released information about its plans for pricing in the US, but antibody drugs tend to be less expensive than CAR-Ts, which are manufactured using a costly process that involves harvesting a patient’s cells and modifying them to fight cancer. Keratopathy leading to treatment discontinuation affected 2.1%

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FDA Approval Antibody Drugs Packaging 87

Pharmacy Checkers

NOVEMBER 12, 2020

The new federal rule on drug importation from Canada , drafted pursuant to Section 804 of the FDCA, does not allow for the importation of foreign versions of FDA-approved drugs. It only allows for the importation of FDA-approved drugs. Kesselheim called “ Reputation and Authority FDA and the Fight over U.S.

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FDA Approval Drugs Filler Manufacturing 62

XTalks

MARCH 29, 2022

Jazz Pharmaceuticals has broken ground on a new $100 million manufacturing plant for cannabis-based medicines in the UK. Sativex, which is administered as an oral spray, was approved in the UK in 2010 for the treatment of neuropathic pain, overactive bladder and other symptoms of multiple sclerosis (MS).

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Medicine Manufacturing Sales FDA Approval 111

XTalks

MARCH 30, 2022

The editorial team also talked about Jazz Pharmaceutical’s new $100 million manufacturing facility in the UK dedicated to the production of cannabis-based medicines. This includes the company’s bestselling epilepsy drug Epidiolex, which is the first FDA-approved cannabis-based medication.

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Life Science Manufacturing FDA Approval Drugs 93

Drug Patent Watch

APRIL 8, 2025

This means ensuring that generic manufacturers adhere to the same quality control standards as brand-name companies, and that patients have access to accurate and reliable information about the medications they're taking. As the demand for generic drugs continues to grow, it's essential that we prioritize patient safety above all else.

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Generic Drugs Drugs Branding FDA Approval 52

BioPharma Reporter

MARCH 19, 2024

Food and Drug Administration has cleared AGC Biologicsâ Milan site to begin manufacturing of Orchard Therapeuticsâ Lenmeldy (atidarsagene autotemcel), a gene therapy for early-onset metachromatic leukodystrophy (MLD).

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Gene Therapy Manufacturing Gene FDA Approval 59

Fierce Pharma

NOVEMBER 2, 2023

Ever since Novo Nordisk won FDA approval for its GLP-1 weight-loss med Wegovy more than 2 years ago, analysts and investors have been keeping a close eye on the blockbuster drug launch.

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FDA Approval Sales Manufacturing Drugs 86

Pharmaceutical Technology

JULY 21, 2022

Aprecia Pharmaceuticals’ Spritam, an anti-epileptic drug, is the first and only 3D-printed pharmaceutical, having received US Food and Drug Administration (FDA) approval in 2015. While large pharma companies have been slow in this area, Merck and GSK are now using 3D printing for clinical trials and manufacturing.

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FDA Approval Pharma Companies Drugs Clinical Trials 245

Fierce Pharma

NOVEMBER 15, 2023

CorMedix went through a lot to secure its FDA approval for DefenCath. CorMedix went through a lot to secure its FDA approval for DefenCath. There was a reorganization, a CEO change, an exit from Europe, two complete response letters and a switch of manufacturers and suppliers.

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FDA Approval Manufacturing Drugs 93

BioSpace

MARCH 6, 2024

Two CRLs from the FDA last week cited concerns with third-party manufacturers, while Indian CDMOs may make a bid for U.S. business if there is a decoupling from Chinese companies under the BIOSECURE Act.

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Manufacturing FDA Approval 52

XTalks

MARCH 21, 2025

Following Neffys FDA approval , ARS Pharma reported $2.3 At the same time, the company has plans to expand US manufacturing investments to meet rising demand across its growing pipeline, creating around 13,000 jobs. With a 30-month shelf life and rapid absorption, Neffy offers an on-the-go alternative to auto-injectors.

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Genome Genomics FDA Approval Trials 59

XTalks

AUGUST 22, 2022

To reach approval, Axosome had to address some concerns that the FDA had raised related to chemistry, manufacturing and controls (CMC), which were resolved early in the year, according to Axosome. Auvelity’s approval comes after Axosome’s migraine treatment AXS-07 was rejected by the FDA in May.

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FDA Approval Production Marketing Drugs 98

BioPharma Reporter

APRIL 6, 2022

The US Food and Drug Administration (FDA) has granted commercial licensure approval for Novartisâ Durham, N.C. site, a multi-product gene therapy manufacturing facility, which will start producing Zolgensma immediately.

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Gene Therapy Manufacturing Gene FDA Approval 52