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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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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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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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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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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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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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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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

The Checkup by Singlecare

JANUARY 16, 2025

Some options include : Repatha (evolocumab) is a brand-name medication that is FDA approved to lower cholesterol and reduce the risk of heart attacks and strokes, by helping to restore blood flow to the heart in individuals with heart disease. It first gained FDA approval in 2015.

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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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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

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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pharmaphorum

OCTOBER 20, 2020

The FDA has granted a fast review for AstraZeneca’s Tagrisso oncology drug in certain patients with early-stage lung cancer. The FDA reserves these faster reviews, taking six months at the most instead of the standard ten-month timeframe, for medicines that demonstrate superior efficacy or safety for serious diseases.

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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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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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The FDA Law Blog

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. The purpose of this program is to reduce the volume of reports that a manufacturer needs to submit to FDA and to “make malfunction event trends more readily apparent.”. By McKenzie E.

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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.

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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

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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pharmaphorum

NOVEMBER 11, 2022

According to court documents, Cohen reached out in 2015 to Moshe Alafi, former general partner at Alafi Capital who he had known for decades – and his son Christopher Alafi, who is the firm’s capital director – to seek investment in Nuredis.

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Documentation FDA 113

Pharmaceutical Technology

MAY 5, 2023

The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and Drug Administration (FDA). In this case, the woman had taken apetamin in the form of cyproheptadine, lysine, and vitamin syrup.

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pharmaphorum

DECEMBER 16, 2020

An FDA advisory committee 12 to 1 in favour of approving Entresto (sacubitril/valsartan) for heart failure with preserved ejection fraction (HFpEF), which accounts for around half of all heart failure cases but proves highly resistant to drug treatment. The post Entresto set for big sales hike after FDA panel endorsement appeared first on.

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pharmaphorum

JUNE 14, 2022

Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinical trials, leading to the FDA rejecting certain treatments and clarifying what is required for approval. China’s ambition to become a leader in the biopharma industry has been clear in the last few years.

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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

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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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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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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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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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

Pharmaceutical Technology

NOVEMBER 22, 2022

The Chinese government announced its ten-year 'Made in China 2025' strategic plan in 2015, which aimed to make the country a global leader in several high-tech industries. Since 2015, the government has greatly increased its investment and support for biotech to stimulate innovation in the sector.

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pharmaphorum

AUGUST 28, 2020

Shares in dermatology specialist Cassiopea, which is listed on the SWX exchange in Switzerland, rose almost 17% after news of the FDA approval emerged. Cassiopea spun out of Ireland-domiciled Cosmo Pharma in 2015. The post FDA hands Cassiopea its first approval, for acne drug Winlevi appeared first on.

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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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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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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

The FDA Law Blog

AUGUST 7, 2024

Additionally, Novartis alleged that FDA unlawfully permitted the carve-out of critical safety information of a modified dosing regimen. While denying a Citizen Petition from Novartis asking FDA to refuse to approve any ANDA that omits the new dosing regimen or changes the indication, FDA approved MSN’s ANDA on July 24, 2024.

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Labelling FDA Hospitals 59

Pharmaceutical Technology

JULY 21, 2022

Aprecia Pharmaceuticals’ Spritam, an anti-epileptic drug, is the first and only 3D-printed pharmaceutical, having received US Food and Drug Administration (FDA) approval in 2015. For pharma and medical device companies, 3D printing can reduce costs, waste, and the environmental burden.

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Hospitals FDA 98

The Checkup by Singlecare

NOVEMBER 30, 2023

Food and Drug Administration (FDA) used to rely heavily on a letter-based rating system for drug safety during pregnancy , with category A drugs being the safest to take, category X drugs being contraindicated because the risks outweigh the benefits, and category B, C, and D drugs varying in safety and adverse effects.

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