pharmaphorum

DECEMBER 24, 2020

But that was before the first reports emerged of a highly contagious coronavirus and 2020 will be forever associated with COVID-19 and the global devastation and disruption it has wrought. Nevertheless, the pandemic was clearly the biggest change-agent for digital health and digital pharma in 2020. billion acquisition of Livongo.

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Communication FDA 126

pharmaphorum

DECEMBER 21, 2020

2020’s M&A activity hasn’t quite reached the heights of last year’s, where two pharma mega-mergers – BMS’ buyout of Celegne and AbbVie’s acquisition of Allergan – accounted for almost 40% of total M&A deal values. Here we take a look at the biggest mergers and acquisitions of 2020 and what they might mean for the companies involved.

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Chemotherapy Immunization FDA 126

Fierce Pharma

JUNE 29, 2023

After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.

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FDA 139

Fierce Pharma

SEPTEMBER 20, 2024

Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated multiple myeloma. Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated multiple myeloma. That changed Friday.

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FDA 116

Drug Topics

JUNE 12, 2025

Updated October 23, 2020. ClinicalTrials.gov identification: NCT00160108. Updated March 20, 2018. Accessed June 12, 2025. Diet and Body Composition (CENTRAL). ClinicalTrials.gov identification: NCT01530724. Accessed June 12, 2025. Effects of Green-MED Diet Via the Gut-fat-brain Axis (DIRECT-PLUS). Updated July 15, 2019.

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Pharmacy Times

FEBRUARY 2, 2024

Daratumumab and hyaluronidase-fihj in combination with other therapies was previously approved by the FDA in May 2020 for 8 indications in multiple myeloma.

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FDA 122

pharmaphorum

MAY 18, 2022

FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted more than 13 years. Current FDA Commissioner Robert Califf spent some time as an advisor to Google parent Alphabet after his earlier stint at the head of the regulator. Bakul Patel.

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FDA 139

Fierce Pharma

APRIL 8, 2024

The FDA refused to accept Supernus' first approval bid after the company acquired the med in 2020. The third time is decidedly not the charm for Supernus and its Parkinson’s disease infusion pump. | The following year, the agency doled out a complete response letter, dashing Supernus' second try.

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FDA 119

Fierce Pharma

DECEMBER 8, 2023

Vertex Pharmaceuticals and CRISPR Therapeutics have won an historic FDA approval for their sickle cell disease gene therapy Casgevy. Groundbreaking? Game-changing? Transformational?

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FDA 130

STAT

DECEMBER 4, 2023

Meanwhile, FDA budgeting and staffing held steady, although resources allocated for each inspection surged and more plants were cited for serious violations. For foreign facilities, about 17% of all inspections conducted the past two years yielded citations compared with just 5% in 2020.

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FDA 128

The FDA Law Blog

OCTOBER 27, 2024

a homeopathic drug company, filed a complaint on behalf of the homeopathic drug industry against FDA in the District Court for the District of Columbia (“D.D.C.”). This lawsuit presents an interesting reading of the statute at issue, one that is diametrically opposed to that of FDA. It’s a dessert topping; no, it’s a floor wax.

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FDA 100

STAT

SEPTEMBER 20, 2024

  Segan was chief medical officer at Olympus from 2020 to 2023. Olympus is a leading distributor of endoscopes and the recipient of FDA warning letters claiming the company did not adequately address product defects — including instances where endoscope caps fell into patients’ bodies.

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FDA 135

Drug Topics

JUNE 24, 2025

With the goal of determining obesity-related mortality during the study period, researchers explored age-adjusted mortality rates (AAMRs) for 3 timeframes within the COVID-19 pandemic: pre-pandemic (2018-2019), COVID-19 (2020-2021), and post-pandemic (2022-2023).

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pharmaphorum

JUNE 20, 2025

The company said it will now share the results with the FDA as part of the Galleri premarket approval application (PMA), along with preliminary data from a screening study in 140,000 volunteers aged 50 to 77, conducted with the UK NHS, that is being run in 150 locations across England, with final results expected next year.

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FDA Pharmaceutical Companies Pharmaceutical Companies 71

pharmaphorum

JUNE 10, 2024

With actinic keratosis (AK) diagnoses on the rise, there is some good news for patients, with the FDA approval of expanded use of Almirall’s topical therapy Klisyri.

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FDA 102

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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FDA Documentation Packaging Labelling 105

The FDA Law Blog

DECEMBER 15, 2022

By Riëtte van Laack — On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products. This concludes FDA’s reevaluation of the regulation of homeopathic drugs which it started in 2015. FDA denied that petition in 2019.

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FDA Labelling 98

The FDA Law Blog

DECEMBER 22, 2022

Koblitz — Back in June, when Congress was negotiating the User Fee Acts, FDA asked Congress to add in some provisions reversing several lawsuits that it had just lost. Ultimately, FDA lost that fight, and a slimmed down version of the FDA Safety and Landmark Advancements (“FDASLA”) passed without those sections.

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FDA Labelling 114

Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth. Covis Pharma added the drug to its portfolio through the acquisition of AMAG Pharmaceuticals in November 2020.

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FDA 97

Fierce Pharma

NOVEMBER 20, 2024

Roche's spinal muscular atrophy (SMA) medicine Evrysdi only gained its FDA approval in 2020, but generics companies are already eying the blockbuster as a potential target. | The spinal muscular atrophy drug is a growth driver for the Swiss pharma giant, prompting the company to prioritize its defense against potential generics.

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FDA 128

Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth. Covis Pharma added the drug to its portfolio through the acquisition of AMAG Pharmaceuticals in November 2020.

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FDA 95

pharmaphorum

JULY 6, 2021

Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes the drug. billion in 2019, and will be hoping for a swift response from the FDA to get the programme back on track and recoup its investment.

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FDA 105

STAT

MAY 1, 2024

In March 2020, as Bauman was preparing to undergo the surgery at a Mount Sinai medical facility in midtown Manhattan, he said he was invited to participate in a research study — one only open to patients already committed to undergo DBS at Mount Sinai. The review, which lists consultations with 16 different FDA officials, was scathing.

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Documentation FDA Nursing Homes 145

pharmaphorum

DECEMBER 9, 2020

The FDA has started its review of Nucala (mepolizumab) for the inflammatory condition, which results in the growth of nasal polyps in the nose that can obstruct airflow and cause mucus discharge, sometimes requiring surgical intervention. The post Sanofi/Regeneron on notice as FDA reviews GSK’s Nucala for nasal polyps appeared first on.

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FDA 111

The Checkup by Singlecare

JANUARY 19, 2024

Food and Drug Administration (FDA) has granted the state of Florida the authority to import certain prescription drugs from Canada—an important measure to counteract soaring prescription costs. After delays that took a lawsuit to resolve, the FDA authorized the program on Jan. In a landmark decision, the U.S. an outlier?

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STAT

SEPTEMBER 19, 2023

This population represents less than 2% of all premature babies, but the problem is growing; the Centers for Disease Control and Prevention reported that the preterm birth rate rose by 4% between 2020 and 2021. Continue to STAT+ to read the full story…

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FDA 131

European Pharmaceutical Review

MAY 2, 2023

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. This draft guidance builds on recommendations published by the agency in 2020.

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pharmaphorum

NOVEMBER 26, 2020

Y-mAbs Therapeutics has claimed its first product approval, getting a green light from the FDA for Danyelza for the rare cancer neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved,” said Gad, who is chairman and president of Y-mAbs. “I

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FDA Chemotherapy Labelling 105

Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. The post US FDA approves GSK’s Jesduvroq to treat anaemia of CKD appeared first on Pharmaceutical Technology.

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FDA 105

Pharmaceutical Technology

APRIL 4, 2023

The FDA has seen a record surge in review designations being awarded over the last two years for Alzheimer’s indications, with 12 review designations being awarded to drugs between 2020 and 2022. Between 2020 and 2021, the number of designations increased by 600%, with seven designations being awarded by the FDA in 2021.

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FDA 98

pharmaphorum

AUGUST 17, 2022

The clock is now ticking on the FDA’s review of GSK’s momelotinib for myelofibrosis patients with anaemia – the centrepiece of its $1.9 The post GSK gets June 2023 FDA decision date for momelotinib appeared first on. billion acquisition of Sierra Oncology which completed last month.

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FDA 105

pharmaphorum

OCTOBER 27, 2022

The Swiss biotech is seeking a priority review for vamorolone, which was licensed from US biotech ReveraGen BioPharma in 2020 after Santhera its former DMD therapy candidate idebenone failed clinical testing and was abandoned. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

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FDA Immunization 98

Pharmacy Times

OCTOBER 24, 2022

The test has been available under emergency use authorization (EUA) since March of 2020 and was the first commercial molecular test to receive EUA status.

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FDA 107

pharmaphorum

DECEMBER 29, 2021

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. billion in 2020. The post Leo puts target on Dupixent in US as FDA clears tralokinumab appeared first on. billion in the same year.

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FDA Labelling 111

STAT

SEPTEMBER 29, 2023

In 2020, as biotech stocks surged amid the pandemic, a startup called Taysha Gene Therapies raised over $300 million off an audacious promise: It was going to license and develop gene therapies for at least 18 different rare and serious neurological diseases. Continue to STAT+ to read the full story…

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FDA 138

pharmaphorum

APRIL 27, 2021

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.

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FDA Chemotherapy Documentation 90

pharmaphorum

JUNE 24, 2021

The FDA has started a review of a new implant version of Roche’s ranibizumab therapy for wet age-related macular degeneration, that could offer patients with the sight-robbing disorder an alternative to monthly eye injections. . billion in 2020 revenues. Ranibizumab PDS is also under review by the EMA in Europe.

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FDA 95