Pharmaceutical Technology

JUNE 8, 2023

The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A).

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World of DTC Marketing

FEBRUARY 25, 2022

billion on Thursday for allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought in 2019. Food and Drug Administration approval for the non-Hodgkin lymphoma drug by a Dec. The post BMS: Delayed new drug to avoid paying billions?

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European Pharmaceutical Review

JUNE 21, 2023

The US Food and Drug Administration (FDA) has approved LODOCO ® , the “first drug to target cardiovascular inflammation,” reported Dr Paul Ridker, MPH, Professor of medicine at Harvard Medical School and Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital.

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World of DTC Marketing

JANUARY 10, 2022

Pharma companies are flush with cash and looking to make deals, but there are still a lot of small biotech companies that don’t have enough money to launch their products entirely. A study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average price was $1.3 million $1228.9

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Pharmaceutical Technology

AUGUST 18, 2023

Nuvectis Pharma has received US Food and Drug Administration (FDA) orphan drug designation for NXP800 to treat cholangiocarcinoma.

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European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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European Pharmaceutical Review

JANUARY 17, 2024

The small molecule heart failure drug acoramidis has potential in slowing or stopping the progression of transthyretin amyloid cardiomyopathy (ATTR-CM), according to study data published in the New England Journal of Medicine. The drug was also shown to lower cardiac congestion.

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European Pharmaceutical Review

NOVEMBER 25, 2022

The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). If successful, the drug is forecasted to reach sales of $63.5 GlobalData’s report showed LY03010 is expected to launch in the US in 2024. million in 2031, representing 0.6

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European Pharmaceutical Review

SEPTEMBER 12, 2023

Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months. Attending CPHI Barcelona 2023?

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European Pharmaceutical Review

NOVEMBER 16, 2022

The drug will support patients in the worsening opioid crisis in the US, driven by the increased prevalence of synthetic opioids, such as fentanyl. Other drugs in Opiant’s development pipeline include OPNT004, a CB-1 antagonist in preclinical development as a potential injectable treatment for acute cannabinoid overdose (ACO).

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Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 mg tablet) to treat cardiovascular disease.

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Pharmaceutical Technology

MAY 1, 2023

Astellas Pharma has entered into a definitive agreement to buy US-based biopharmaceutical company Iveric bio, in a deal valued at nearly $5.9bn. Under the deal terms, the company, through Astellas US Holding’s wholly owned subsidiary Berry Merger Sub, will acquire all the outstanding Iveric Bio shares for $40.00 in cash for each share.

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European Pharmaceutical Review

NOVEMBER 22, 2022

a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.

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Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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World of DTC Marketing

FEBRUARY 2, 2022

Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. Food and Drug Administration on Biogen Inc.’s

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European Pharmaceutical Review

FEBRUARY 22, 2023

The hurdles encountered in development and approval of a new drug can be overwhelming. 1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. billion, and rising.

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Pharmaceutical Technology

JUNE 12, 2023

The US Food and Drug Administration (FDA) has granted approval for Milla Pharmaceuticals’ generic version of Precedex, dexmedetomidine hydrochloride injection 4mcg/ml in 50mL and 100mL. Milla Pharmaceuticals stated that Precedex is now on the US FDA’s drug shortages list.

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World of DTC Marketing

DECEMBER 2, 2021

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Presenting quantitative information increased participants’ gist and verbatim recall of drug efficacy. ” Uh…no.

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Pharma Leaders

APRIL 20, 2023

The US Food and Drug Administration (FDA) has granted approval for Ajinomoto Bio-Pharma Services’ high potency vial line to manufacture a commercial product. It also noted that this multi-purpose fill line is designed to meet the commercial compliance of FDA and EMEA.

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pharmaphorum

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.

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World of DTC Marketing

FEBRUARY 4, 2021

Merck’s old drugs are under more scrutiny, and anti-vaxxers are causing problems by cherry-picking unreliable information. regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label.

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Pharma Leaders

MAY 1, 2023

The US Food & Drug Administration (FDA) has declined to approve Ascendis Pharma’s New Drug Application (NDA) for TransCon PTH (palopegteriparatide) to treat hypoparathyroidism in adult patients. If approved, Ascendis Pharma intends to launch TransCon PTH in Germany early next year.

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World of DTC Marketing

APRIL 12, 2021

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. We can’t continue to develop drugs the same way as we have done before.

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World of DTC Marketing

JUNE 22, 2022

PBMs, insurers, pharma companies, and hospitals don’t want to give up their profits even if it’s better for the general population. To help it along, it has enlisted Bakul Patel; a former official tasked with creating the regulatory classification of “software as a medical device” at the FDA.

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World of DTC Marketing

JULY 15, 2021

SUMMARY: The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug. Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.

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Pharma Leaders

APRIL 4, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to HuidaGene Therapeutics’ HG004 gene replacement therapy. HuidaGene co-founder and CEO Xuan Yao said, “We are pleased to have received this significant regulatory feedback from the US FDA.

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Pharma Leaders

MARCH 27, 2023

Iovance Biotherapeutics has completed submission of the Biologics License Application (BLA) for lifileucel to the US Food and Drug Administration (FDA). Iovance has submitted BLA based on positive clinical data from the C-144-01 clinical study in patients with advanced post-anti-PD1 melanoma.

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Pharmaceutical Technology

JUNE 5, 2023

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health.

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Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. They are available in 2mg, 5mg and 10 mg dosages and are the generic equivalent of Swedish Orphan Biovitrum’s Orfadin.

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Pharmaceutical Technology

NOVEMBER 2, 2022

Ascletis Pharma has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for its drug candidate for Covid-19. The international intellectual property rights for the drug are owned by the company.

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Pharmaceutical Technology

JANUARY 19, 2023

Sun Pharma stated that it will follow Concert’s plan to seek approval from the US Food and Drug Administration (FDA) for its new drug application in the first half of the year. The post Sun Pharma to buy Concert Pharmaceuticals for $576m appeared first on Pharmaceutical Technology.

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European Pharmaceutical Review

DECEMBER 1, 2023

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. What are the trends affecting drug development today?

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Pharma Leaders

JUNE 7, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson is seeking approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) from the US Food and Drug Administration (FDA) through submission of a supplemental Biologics License Application (sBLA).

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PM360

NOVEMBER 29, 2022

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

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Pharmaceutical Technology

MAY 17, 2023

The Inflation Reduction Act, which became US law in August 2022, has invited its fair share of critics and supporters over its drug pricing provisions. At the core of the debate was a new provision allowing the US Centers for Medicare & Medicaid Services (CMS) to negotiate prices with pharmaceutical companies for a select number of drugs.

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Pharmaceutical Technology

OCTOBER 31, 2022

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date.

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Pharmaceutical Technology

MAY 7, 2023

Formosa Pharmaceuticals along with AimMax Therapeutics has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for APP13007, a new formulation to treat inflammation and pain after ocular surgery. It was studied in two Phase III randomised, double-masked trials in over 60 US sites.

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