Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s new drug application (NDA) for repotrectinib for priority review. The Phase I/II study assessed the pharmacokinetics, tolerability, safety and anti-tumour activity of repotrectinib in patients with advanced NSCLC.

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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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Food and Drug Administration FDA Safety Prescription 52

Pharma Leaders

JUNE 21, 2023

The US Food and Drug Administration (FDA) has accepted bluebird bio’s Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) gene therapy and granted priority review for the product’s use in the treatment of sickle cell disease (SCD). It is claimed to be the longest follow-up of any gene therapy programme for SCD.

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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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Pharmaceutical Technology

FEBRUARY 8, 2023

The US Food and Drug Administration (FDA) has accepted Aldeyra Therapeutics’ new drug application (NDA) for topical ocular reproxalap to treat signs and symptoms of dry eye disease. The regulator has assigned 23 November 2023 as the Prescription Drug User Fee Act (PDUFAs) date for its decision.

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European Pharmaceutical Review

DECEMBER 6, 2022

“Through our clinical development programme, we have seen that tofersen has the potential to slow the progression of this relentless and ultimately fatal disease,” commented Priya Singhal, Head of Global Safety and Regulatory Sciences and Interim Head of R&D at Biogen. Biogen licensed tofersen from Ionis Pharmaceuticals, Inc.

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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. home health visits).

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World of DTC Marketing

APRIL 15, 2021

Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. And while there’s concern that the Covid-19 vaccines were rushed and that that means they haven’t been properly vetted or that their safety is otherwise in question, it’s simply not the case.

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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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Food and Drug Administration FDA Safety Prescription 52

World of DTC Marketing

FEBRUARY 4, 2021

prescriptions of finasteride, as the drug is known, for hair loss increased to over 2.4 The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data. Newly unsealed court documents show that Merck and U.S.

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Pharmaceutical Technology

JULY 14, 2022

Avrobio has received orphan drug designation for its gene therapy, AVR-RD-05, from the US Food and Drug Administration (FDA) to treat mucopolysaccharidosis type II (MPSII) or Hunter syndrome. Furthermore, this status provides some incentives that may include tax credits for clinical trial costs and prescription drug user fee waivers.

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Pharmaceutical Technology

AUGUST 22, 2022

When it comes to pharmaceutical, nutritional or cosmeceutical dosing, some of the most crucial parameters are safety, product effectiveness and patient adherence. Softgels have now achieved strong recognition in the prescription, consumer health and supplements markets. billion by 2028, at a CAGR of 12.6%. 200x260/0 (who.int).

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PM360

NOVEMBER 29, 2022

Drug labels hold value for life sciences companies because they are rich, extensive documents that can be used across labeling, regulatory, safety, and medical affairs. Typically, a drug label refers to any information provided with prescription drugs, as requested by regulators such as the U.S.

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pharmaphorum

AUGUST 11, 2022

Zantac was originated by GSK and launched by the company in the early 1908s, which sold it as a prescription and over-the-counter (OTC) product for indications like heartburn and acid indigestion over the years. Some voluntarily took their products off the market as soon as the NDMA finding was reported by the FDA.

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Legacy MEDSearch

JUNE 30, 2023

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). CHG is for prescription use only. For additional important safety information, please see the CHG Instructions For Use.

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European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. 1435 (“Affordable Prescriptions for Patients Act of 2021”), [link] gov/bill/117th-congress/senate-bill/1435/text; H.R. Citizen Petitions before the FDA. Actavis, 570 U.S.

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pharmaphorum

AUGUST 11, 2022

More than 60 percent of all American adults take prescription drugs , amounting to approximately 131 million individuals. These drugs have been rigorously tested by regulatory bodies around the world before they’re made available to ensure they work as labelled, but despite that, adverse events crop up. billion in the United States alone.

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pharmaphorum

OCTOBER 27, 2022

Additionally, SeresTx’s BLA has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) target date of 26 th April 2023. In July 2021, Swiss food giant Nestle paid $175 million upfront for North American co-marketing rights to SER-109.

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European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

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PM360

AUGUST 9, 2022

Furthermore, when providers rely on self-reporting, they may be receiving inaccurate data, such that providers may erroneously acknowledge a patient’s filled prescription as evidence of adherence. Measuring and monitoring adherence in clinical trials would add valuable information about the effectiveness and safety of drugs.

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pharmaphorum

JANUARY 25, 2023

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021.

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Clarivate

MARCH 17, 2022

How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information. Drug developers often face a Catch-22 regarding clinical trials and pregnancy.

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Pharmaceutical Technology

MAY 31, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a new drug application (NDA) for its investigational single-tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) to the US Food and Drug Administration (FDA), to treat pulmonary arterial hypertension (PAH).

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Food and Drug Administration FDA Medicine Prescription 98

European Pharmaceutical Review

JANUARY 5, 2023

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in all infants. The safety profile of nirsevimab was similar to placebo.

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Pharmaceutical Technology

JANUARY 6, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca ’s nirsevimab biologics licence application (BLA) for review to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in children aged up to 24 months. Nirsevimab showed a 74.5%

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Clarify Health

MAY 24, 2023

After the fact, they also have to navigate obtaining any follow-up referral appointments, filling prescriptions, and paying their bill. And the researchers found that older and sicker patients were twice as likely to find and report an error — which they said indicates even more severe safety and care quality implications.

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Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. The FDA has also cleared Akilii’s EndeavorRx , a prescription-only medical device for attention deficit hyperactivity disorder. Proteus’s profile grew considerably; it was soon valued at $1.5

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Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The agency describes the current system as “confusing, conflicting, incomplete, or repetitive”, based on study data.

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Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The role of primary packaging has extended beyond the primary objectives of sterility, physical and chemical protection, and security.

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Pharmaceutical Technology

MAY 1, 2023

After a US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) Advisory Committee (AdCom) meeting in March 2023 voted unanimously in support of GSK’s respiratory syncytial virus vaccine, the odds for an approval have increased. Even in LICs, they do yearly checks or catch up campaigns.

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World of DTC Marketing

SEPTEMBER 22, 2020

To do so would derail our drug safety and lead to patients and HCP’s to question all prescription drug data. To do so would mean an end to ANY trust in prescription drugs and their safety. We cannot allow an incompetent administration to put politics ahead of patient safety.

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World of DTC Marketing

MAY 6, 2021

Some commercially insured patients who pay only prescription drug copayments appear to be insulated from increases in drug prices. About 40 percent of drugs fail in preliminary Phase I studies, which assess a drug’s safety in humans and typically cost just $25 million a drug.

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