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.

FDA 96

FDA Medical Schools Labelling Communication 96

pharmaphorum

NOVEMBER 23, 2022

The Japanese pharma said it has filed for approval of TAK-003 with the FDA for the prevention of dengue disease caused by any dengue virus serotype in individuals aged four through 60. The post FDA starts speedy review of Takeda’s dengue vaccine appeared first on. Takeda said last year that the vaccine could reach up to $1.6

Vaccines 119

Vaccines FDA 119

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.

FDA 91

FDA Documentation Packaging Labelling 91

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.

FDA 113

FDA Hospitals 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.

FDA 52

FDA Labelling 52

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.

FDA 98

FDA 98

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Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices.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.

FDA 59

FDA Documentation 59

Pharmaceutical Technology

MARCH 30, 2023

On March 29, the US Food and Drug Administration (FDA) granted approval for the first nonprescription, “over-the-counter” (OTC) naloxone nasal spray, Narcan. The FDA also has an Overdose Prevention Framework that aligns with this national strategy. The FDA first approved Narcan 4mg nasal spray as a prescription drug in 2015.

FDA 52

FDA Packaging 52

The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Interestingly, the Plaintiffs alleged that this duty existed when the mother was pregnant in 2015 even though the studies relied upon in the litigation are from 2021.

Labelling 40

Labelling FDA Vaccines Communication 40

PharmaShots

JUNE 21, 2023

Shots: The US FDA has approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children aged ≥10yrs. Jardiance & Synjardy was approved in the US in 2014 & 2015, respectively. with inadequately controlled T2D.

FDA 40

FDA 40

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.

FDA 52

FDA 52

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.

FDA 105

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).

FDA 52

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.

FDA 52

FDA Documentation Labelling Immunization 52

The FDA Law Blog

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. This means that there multiple same-day FDA NDA approvals for the same drug. FDA-2020-E-1840 (Mar.

FDA 59

FDA Controlled Substances Hospitals 59

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.

FDA 57

FDA Documentation 57

The FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

FDA 59

FDA Documentation 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”.

FDA 73

FDA 73

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.

FDA 52

FDA Labelling 52

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.

Dosage 103

Dosage FDA 103

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.

FDA 81

FDA Hospitals Immunization 81

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.,

FDA 74

FDA 74

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.

FDA 64

FDA Packaging Vaccines 64

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.

FDA 53

FDA Labelling 53

pharmaphorum

MARCH 21, 2022

Bristol-Myers Squibb has won FDA approval for the first LAG-3 inhibitor drug ahead of its rivals in cancer immunotherapy including Merck & Co. The post BMS gets FDA OK for first LAG-3 checkpoint inhibitor appeared first on. months, versus 4.6 months for Opdivo alone.

FDA 52

FDA Immunization 52

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.

FDA 52

FDA 52

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

The FDA Law Blog

OCTOBER 5, 2022

By Riëtte van Laack — On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.” The term healthy, as an implied nutrient claim, was first defined by FDA in 1994. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

FDA 52

FDA Labelling Packaging Documentation 52

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.

FDA 52

FDA Immunization 52

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.

FDA 44

FDA 44

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.

Labelling 97

Labelling FDA 97

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.

Labelling 102

Labelling FDA 102

ISPE

JULY 5, 2023

7 A critical feature of the ETP is representation from all relevant FDA quality assessment and inspection programs, from early engagement with stakeholders through application submission and assessment. 13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

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?

Labelling 125

Labelling FDA Controlled Substances Hospitals 125

The Checkup by Singlecare

MAY 24, 2024

Metformin hydrochloride is a generic drug approved by the Food and Drug Administration (FDA) to help manage blood sugar levels in people with type 2 diabetes mellitus. OTC substitutes for metformin There are no exact OTC substitutes for metformin, and there aren’t any FDA-approved OTC medications for diabetes.

FDA 52

FDA Labelling Dosage Compounding 52

The FDA Law Blog

NOVEMBER 8, 2023

When FDA released the final rule, it outlined its ambitious goals. The journey began in October 2015 when the President’s Council of Advisors on Science and Technology (PCAST) during the Obama Administration recommended the creation of a class of hearing aids for OTC sale. However, FDA missed that deadline. Access has expanded.

Health and Personal Care Stores 64

Health and Personal Care Stores FDA Customer Service 64

The FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. b)(1)(iii).

Packaging 59

Packaging FDA Communication 59