pharmaphorum

AUGUST 21, 2020

It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis.

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FDA Hospitals 116

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

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

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. Spectrum licensed worldwide rights to poziotinib – excluding Korea and China – from Hanmi in back in 2015.

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FDA Documentation 98

STAT

AUGUST 22, 2024

In 2015, the FDA began reporting on the representation of individuals in clinical trials, with the hope that raising awareness would drive meaningful change. Lack of diversity occurs at all levels of the pharmaceutical ecosystem, from the makeup of C-suite and research staffs to participation in clinical trials.

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FDA 123

The Checkup by Singlecare

MARCH 31, 2023

Food and Drug Administration (FDA) approved a non-prescription version of Narcan (naloxone), a nasal spray used to rapidly reverse the effects of an opioid overdose. According to the FDA, drug overdose is a persistent public health problem in the United States. This week the U.S. chief medical officer of Toolbox Genomics.

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FDA Packaging Insurance 98

Pharmaceutical Technology

APRIL 17, 2023

On 14 April 2023, experts from the US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) voted largely in favour of the potential approval of Otsuka’ s and Lundbeck Pharmaceuticals’ Rexulti for the treatment of agitation associated with Alzheimer’s dementia (AAD). The FDA will consider the AdCom as it reviews the drug’s sNDA.

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FDA Medical Schools Labelling Communication 96

The FDA Law Blog

SEPTEMBER 30, 2022

Valentine — On September 29, 2022, FDA approved Amylyx’s NDA for its drug, Relyvrio (sodium phenylbutyrate/taurursodiol), for treatment of patients with amyotrophic lateral sclerosis (ALS) (see FDA announcement here ). We would like to acknowledge FDA for its efforts on this devastating condition, ALS. By Frank J.

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FDA 98

The FDA Law Blog

OCTOBER 16, 2022

James’s practice focuses on regulatory considerations for developing new drug and biologic products and FDA regulatory requirements for approval/licensure. Valentine will become the firm’s newest Director beginning on January 1, 2023.

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FDA 105

The FDA Law Blog

MARCH 18, 2025

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. FDA has already been there , of course, with respect to 180-day exclusivity.)

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Pharmaceutical Companies Pharmaceutical Companies FDA 59

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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Dosage FDA 111

STAT

SEPTEMBER 23, 2022

the first biosimilar was launched in September 2015. As I write this, there are 38 FDA-approved biosimilars ; 22 of them are commercially available. I believe there are other metrics, like cost savings or signs of greater patient access, that should also be used to define biosimilars’ successes or failures. In the U.S.,

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FDA 97

pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Praluent meanwhile – which also made its debut in 2015 – is faring less well, bringing in €59 million ($67 million) for Sanofi and $45 million for Regeneron in the same period.

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Labelling FDA 105

The FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. FDA further retained some definitions in the QSMR. Revised § 820.3

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FDA Labelling Packaging Documentation 59

pharmaphorum

AUGUST 19, 2020

The FDA has rejected Gilead and Galapagos’ rheumatoid arthritis (RA) pill filgotinib over concerns that it could damage male fertility, prompting speculation that the big US pharma could become disillusioned with the project. This is on top of $2 billion when it signed a partnership over filgotinib in 2015.

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FDA 63

Pharma Mirror

NOVEMBER 24, 2020

Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it had entered into a commercial supply agreement with Blueprint Medicines following FDA approval of GAVRETO™ (pralsetinib).

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FDA 52

pharmaphorum

MARCH 23, 2021

Safety has been an issue throughout development and in 2012 the FDA put tanezumab on clinical hold because of a class-related issue with joint destruction, which was finally lifted in 2015. Stopping the drug after progression to more serious disease does not appear to be effective in preventing further damage to joints, the FDA added.

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FDA Documentation 59

Pharmaceutical Technology

MAY 10, 2023

The CDC had applied for patents back in 2006, and was later granted four in 2015. The FDA approved Truvada as the first PrEP treatment in July 2012, with Descovy receiving a nod for this use in October 2019. Truvada has since gone generic, with Teva Pharmaceuticals launching the first FDA-approved Truvada generic in October 2020.

Pharmaceutical Companies 105

Pharmaceutical Companies Pharmaceutical Companies FDA 105

European Pharmaceutical Review

JANUARY 25, 2023

Collaboration between Vertex and CRISPR Therapeutics Vertex and CRISPR Therapeutics entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. Costs and profits worldwide are shared with CRISPR Therapeutics.

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Labelling FDA 111

pharmaphorum

NOVEMBER 27, 2020

The new EU approval comes after the FDA approved the expanded label last year, and provides the first treatment option that tackles the underlying cause of CF in patients aged six to 11 with these mutations. Together these drugs cover the CFTR mutations seen in around half of all CF patients.

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Labelling FDA 134

pharmaphorum

MAY 13, 2022

The FDA has delivered a blow to UCB’s late-stage pipeline, after saying it is unable to approve its latecomer IL-17 inhibitor bimekizumab for moderate-to-severe plaque psoriasis. “We are cooperating with the FDA and are working to address these observations as expeditiously as possible,” said UCB in a statement.

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FDA 52

pharmaphorum

JUNE 17, 2025

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Pharmaceutical Companies 89

Pharmaceutical Companies Pharmaceutical Companies FDA 89

pharmaphorum

SEPTEMBER 15, 2021

The two FDA-approved oral GnRH antagonists – AbbVie and Neurocrine Biosciences’ Oriahnn (elagolix) and Myovant’s Pfizer-partnered Myfembree (relugolix) – are both combined with hormonal drugs. It licensed linzagolix from Japanese drugmaker Kissei in 2015 and has worldwide commercial rights, for the product outside Asia.

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FDA Labelling 98

pharmaphorum

JUNE 26, 2025

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Pharmaceutical Companies 83

Pharmaceutical Companies Pharmaceutical Companies FDA 83

pharmaphorum

JUNE 12, 2025

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Health and Personal Care Stores 59

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Insurance Coverage 59

European Pharmaceutical Review

APRIL 29, 2024

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. Pfizer stated that the gene therapy enabled sustained bleed protection, “potentially avoiding years of treatment burden with prophylaxis for many patients”.

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FDA 96

The Checkup by Singlecare

OCTOBER 4, 2023

That’s why you may have seen people talk about a medication called Vyvanse, which is FDA approved to treat ADHD and binge eating disorder, as a good option for weight loss. In 2015, the FDA approved Vyvanse to be used in the treatment of binge eating disorder. Does Vyvanse cause weight loss?

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Labelling FDA Controlled Substances Hospitals 125

pharmaphorum

DECEMBER 21, 2020

AstraZeneca’s Tagrisso (osimertinib) has been approved by the FDA in a new lung cancer indication that extends its use to a group of patients with early-stage disease. The results also suggest further uses for the drug in early disease and more revenues to come from one of the company’s biggest success stories from the last decade.

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FDA 98

The FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Javitt & Michael D. Shumsky & Philip Won & Adrienne R. Gaulkin & Jeffrey N.

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FDA Hospitals Immunization 81

European Pharmaceutical Review

JANUARY 30, 2023

In 2015, the EMA and US Food and Drug Administration (FDA) approved Humira ® HCF, which contains adalimumab at a concentration of 100mg/ml. The proportion of patients who had at least a 75 percent reduction in symptoms after 16 weeks of treatment was 68 percent with Hyrimoz and 63 percent with Humira.

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Packaging FDA 98

pharmaphorum

AUGUST 13, 2020

The FDA has started a speedy review of Regeneron’s ANGPTL3-targeting antibody evinacumab for a rare, inherited disorder that dramatically raises the risk of heart disease. The post Regeneron’s cholesterol drug evinacumab claims February FDA date appeared first on.

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FDA 52

pharmaphorum

OCTOBER 30, 2022

Shares in US biotech Y-mAbs Therapeutics have lost almost a third of their value after FDA advisors unanimously rejected its brain cancer therapy 131I-omburtamab in 16 to 0 vote. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

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FDA Documentation Labelling Immunization 52

pharmaphorum

JULY 1, 2025

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Vaccines 66

Vaccines Pharmaceutical Companies Pharmaceutical Companies FDA 66

pharmaphorum

NOVEMBER 20, 2022

A Wall Street Journal investigation in 2015 discovered that most of the tests Theranos claimed to perform on its analyser were actually being performed by standard blood-testing machines. “Holmes understood that at best it could only perform a few basic tests and was slower than existing devices, said the US Department of Justice.

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FDA 122

pharmaphorum

FEBRUARY 1, 2021

But Novartis took control of ofatumumab in 2015 as part of a multi-billion-dollar asset swap with GSK and the big Swiss pharma has reworked the drug as a treatment for relapsing multiple sclerosis.

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FDA 98

European Pharmaceutical Review

OCTOBER 14, 2022

The report stated that 39 biosimilar products have been approved and 22 products have been launched since 2015, the year the first biosimilar was approved in the US. The autoimmune drug Humira ® (adalimumab) has had seven biosimilars approved by the US Food and Drug Administration (FDA) for its reference product since entering the market.

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FDA 97

pharmaphorum

JUNE 14, 2021

It’s not the first therapy in the oncolytic virus class to be approved around the world, as that accolade went to Amgen’s Imlygic (talimogene laherparepvec), which was cleared by the FDA for the skin cancer melanoma in 2015.

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Chemotherapy FDA 119