Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. Novartis and Incyte Corp’s Jakafi was the first FDA-approved drug for the treatment of myelofibrosis in November 2011.

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World of DTC Marketing

JANUARY 1, 2022

1ne: The value proposition of prescription drugs still outweighs potential side effects – Wegovy’s demand quickly exceeded supply after the FDA approved once-weekly semaglutide injections. People don’t want to lose weight through diet and exercise if they can lose it through a prescription drug.

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pharmaphorum

NOVEMBER 25, 2022

The FDA has issued a complete response letter (CRL) to Spectrum Pharma for poziotinib, its pan HER2 inhibitor for a form of lung cancer, according to South Korea’s Hanmi Pharma, which originally developed the drug. The post FDA rejects Spectrum’s lung cancer drug poziotinib appeared first on.

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Pharmaceutical Commerce

FEBRUARY 16, 2024

The Masimo product is expected to address a significant gap in the market for dependable home-use medical devices.

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Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. Shares in Futura Medical rose following the FDA nod – opening 28% higher than the previous day’s (June 9) close.

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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 The company expects to launch LODOCO for prescription use in the second half of 2023. mg tablet) to treat cardiovascular disease.

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World of DTC Marketing

DECEMBER 23, 2020

Among the 26% of respondents who talked to a health care provider about a specific prescription drug they saw advertised, 16% said they received a prescription for the advertised drug. Online research is used to evaluate new prescription drugs. The FDA can be myopic when researching how consumers view and react to DTC.

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European Pharmaceutical Review

DECEMBER 6, 2022

The European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for tofersen, to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). Clinical data included in the marketing authorisation application. Biogen licensed tofersen from Ionis Pharmaceuticals, Inc. Sign up now !

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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. Ad recall is essential for CPGs, but for prescription drugs, the question that’s missing is “what action did it lead to?

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Pharmaceutical Technology

MAY 2, 2023

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS).

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Pharmaceutical Technology

OCTOBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

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Legacy MEDSearch

MARCH 7, 2024

Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. Dexcom disclosed its plans to make Stelo available for purchase online without the need for a prescription, starting in summer 2024. On March 5, the U.S. Are you hiring?

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PM360

DECEMBER 20, 2023

Given China’s status as the world’s second most populous nation and an economic powerhouse, it represents both a monumental market opportunity and a dynamic arena of challenges for pharmaceutical products. From 2017 to 2022, the Chinese market witnessed a growth rate of 5.3%, compared to the average market growth of 6.6%

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PM360

MAY 25, 2023

The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption. The guidance document is short at 19 pages, and by design not prescriptive.

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World of DTC Marketing

FEBRUARY 25, 2021

SUMMARY: Per the Times, “what if consumers could calculate the benefits and risks of taking a prescription drug as easily as they can gauge the carbohydrates and calories in an Oreo cookie?” ” Drug facts boxes are needed, but the FDA disagrees. A Drug Facts Box? A sample drug facts box.

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World of DTC Marketing

APRIL 12, 2021

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. The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain.

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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Ironwood Pharmaceuticals’ LINZESS (linaclotide) as a once-a-day treatment for functional constipation in paediatric patients aged between six and 17 years.

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pharmaphorum

JANUARY 4, 2023

Retail pharmacies in the US will be able to dispense mifepristone-based therapies to end pregnancies after the FDA introduced changes to its regulatory framework for the products. The American College of Obstetricians and Gynaecologists (ACOG) said the FDA’s decision was a victory for women’s health.

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Pharmaceutical Technology

JUNE 15, 2023

The US Food and Drug Administration (FDA) has accepted Ipsen’s supplemental new drug application (sNDA) for the Onivyde regimen as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) patients. The regulator has set 13 February 2024 as a Prescription Drug User Fee Act goal date for the review of Ipsen’s sNDA.

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Pharmaceutical Technology

APRIL 14, 2023

Alvotech has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its biologics licence application (BLA) for AVT02, a biosimilar to Humira (adalimumab). The FDA performed an inspection of the Reykjavik site in March 2022 and found deficiencies there.

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Pharmaceutical Technology

MAY 25, 2023

Pushing back an initial deadline, the US Food and Drug Administration (FDA) has proposed a new regulatory action date of 22 June, by which time the agency will assess the logistics of a possible approval for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy.

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World of DTC Marketing

MARCH 10, 2022

market until next year, with the pharmaceutical company announcing Tuesday a settlement with the Iceland-based Alvotech. The cost of Humira, which is injected via syringe, was more than $72,000 a year on prescription drug websites this week and is not expected to come down until at least 2023. Sales of Humira earned AbbVie $20.7

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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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pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The post Relief for Amylyx as FDA clears controversial ALS drug Relyvrio appeared first on.

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pharmaphorum

SEPTEMBER 26, 2022

Digital health company Better Therapeutics has submitted its lead prescription digital therapeutic (DTx) BT-001 to the FDA, seeking approval for use by adults with type 2 diabetes (T2D). Still to come, of course, will be the challenges of ensuring access and reimbursement for the DTx, if approved by the FDA.

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Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). The therapy is being offered immediately through prescription for eligible ALGS patients.

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Legacy MEDSearch

JUNE 30, 2023

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). This marks Cresilon’s first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company’s global mission to transform wound care. CHG is for prescription use only.

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World of DTC Marketing

JANUARY 4, 2022

These cost estimates include cancer-attributable costs for medical services and oral prescription drugs. The FDA says it has used innovative research shortcuts to speed up the availability of medicines for desperately ill patients. National costs for cancer care were estimated to be $190.2 billion in 2015 and $208.9 population.

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Pharmaceutical Technology

APRIL 19, 2023

The US Food and Drug Administration (FDA) has accepted Arcutis Biotherapeutics ’ new drug application (NDA) for roflumilast foam 0.3% The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target action date for the decision on the application. in patients with seborrheic dermatitis.

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World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. oncology therapeutics market has reached $71 billion. ” The U.S.

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Pharmaceutical Technology

SEPTEMBER 30, 2022

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Verismo Therapeutics’ SynKIR-110 to treat mesothelin-expressing mesothelioma patients. The latest development comes after the US FDA granted clearance for Verismo’s Investigational New Drug (IND) application to begin the Phase I STAR-101 trial.

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Pharmaceutical Technology

JUNE 1, 2023

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug.

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Pharmaceutical Technology

JULY 25, 2022

AstraZeneca and Daiichi Sankyo have received Priority Review for their supplemental Biologics License Application (sBLA) from the US Food and Drug Administration (FDA) of antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), to treat unresectable or metastatic HER2-low breast cancer in adults.

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pharmaphorum

AUGUST 31, 2022

Futura Medical’s development of a topical treatment for erectile dysfunction (ED) is approaching the finish line in the US, as the UK biotech reports confirmatory phase 3 data ahead of an FDA filing later this month. ” The post Futura eyes FDA filing as topical ED drug passes phase 3 test appeared first on.

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World of DTC Marketing

MARCH 11, 2022

What does this mean for DTC and HCP marketing? However, the public is aware that they may need prescription drugs to manage chronic health conditions. Even patients will still line up if a prescription drug shows promise. Even patients will still line up if a prescription drug shows promise.

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Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. There are only two marketed treatments for ALS in the US. The FDA’s action plan.

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PM360

AUGUST 9, 2022

According to a 2021 study by Statista, 40% of prescriptions written in 2005 were for brand-name medications. 1 How is this possible, given that more than 20,000 prescription drugs are currently in circulation in the U.S. Of the 50 new drugs approved by the FDA in 2021, a majority treated conditions affecting small patient populations.

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