Drug Discovery World

NOVEMBER 21, 2022

Dr Eleanor Ramos, Chief Medical Officer at Provention Bio, added: “As described in the approved label, TZIELD binds to CD3 (a cell surface antigen present on T lymphocytes) and its mechanism is believed to involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T lymphocytes.

FDA Approval 130

FDA Approval FDA Therapies Disease 130

Drug Discovery World

OCTOBER 4, 2022

Following this, the Association held multiple meetings with FDA officials, including a public We Can’t Wait Action Meeting in May 2021. . The Association also provided scientific and regulatory guidance and in 2022, drove over 14,000 individual emails to the FDA urging approval. . Success of Ice Bucket Challenge .

FDA Approval 130

FDA Approval FDA Treatment Clinical Trials 130

The Pharma Data

JUNE 2, 2023

Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. In the U.S., For the U.S.

FDA Approval 52

FDA Approval FDA Therapies Treatment 52

Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. References [1] 2023 Novel Small Molecule FDA Drug Approvals. 2] Iversen et al., 131(5): 311- 324.

Small Molecule 52

Small Molecule FDA Approval FDA Pharmacokinetics 52

Drug Discovery World

FEBRUARY 22, 2024

trillion on 31 December 2022 to $3.67 Lilly’s growth was further fuelled by Mounjaro’s FDA approval for the treatment of obesity received in Q3, with Mounjaro forecasted to reach global forecast sales of $4.7 in 2023, fuelled by the FDA approval of its CRISPR-based ex vivo cell therapy Casgevy. billion for 2023.

Marketing 130

Marketing FDA Approval Biosimilars FDA 130

Drug Discovery World

JULY 3, 2023

BioMarin’s Roctavian (valoctocogene roxaparvovec-rvox) has been approved for the treatment of adults with severe haemophilia A (congenital factor VIII (FVIII) deficiency with FVIII activity < 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test. bleeds/year).

FDA 130

FDA Therapies FDA Approval Virus 130

The Pharma Data

MARCH 22, 2023

The adalimumab citrate-free HCF (100 mg/mL) is approved to treat seven indications covered by the reference medicine, Humira ® * (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis. Source link: [link]

Biosimilars 40

Biosimilars FDA Approval FDA Pharmacokinetics 40

Drug Discovery World

MAY 24, 2024

Atara Biotherapeutics has submitted a Biologics License Application (BLA) for Tabelecleucel (Tab-cel), a for treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) with the US Food and Drug Administration (FDA). There are currently no FDA approved therapies in this treatment setting.

Therapies 147

Therapies Licensing Licensing FDA 147

Drug Discovery World

NOVEMBER 14, 2023

billion by 2031, growing at a CAGR of 7% from 2022 to 2031 2 , but is also reflected in data by The Antibody Society, which shows that of the over 100 approved mAbs, around 40% are for cancer 3. On 6 January 2023, the FDA approved lecanemab-irmb via the Accelerated Approval pathway for the treatment of Alzheimer’s disease.

Disease 147

Disease FDA Approval Treatment FDA 147

Eye on FDA

JANUARY 16, 2023

By contrast in 2021 there were only 10 (see blue bars below in the chart tracking meetings from 2017 – 2022). Yet in the midst of that range, the number of new molecular entities approved by FDA actually increased. But conversely, in 2022 the number of NMEs plummeted. Pre-pandemic numbers were consistently higher.

FDA 52

FDA FDA Approval Production Therapies 52

The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. Commun Biol 5, 169, 2022. ” Other authors on the paper include Sydney A.

FDA Approval 52

FDA Approval FDA Molecular Biology Virus 52

Drug Discovery World

MARCH 1, 2024

This is the first time the FDA has used the amended procedures for withdrawal of accelerated approval that were enacted in 2023, as part of the Food and Drug Omnibus Report Act of 2022 (FDORA).

FDA 130

FDA Clinical Trials FDA Approval Trials 130

Fierce BioTech

OCTOBER 5, 2023

Discover Strategies for Combatting Disruptions in Gene Therapy Development Cell and gene therapy development has exploded, with Q4 2022 showing more FDA approvals than over the past five years combined.[1] 1] How can sponsors keep pace with this rapidly growing market and avoid costly delays that can threaten critical timelines?

Therapies 52

Therapies FDA Approval FDA Marketing 52

Drug Discovery World

APRIL 26, 2024

More than 35,000 new cases of multiple myeloma were diagnosed in the European Union in 2022. The EC also approved the conversion of the conditional marketing authorisation (MA) for cilta-cel to a standard MA, as the obligations of the conditional approval have now been met.

Therapies 130

Therapies FDA Approval Treatment Disease 130

Agency IQ

JANUARY 12, 2024

After lengthy review, FDA approves Florida’s drug importation plan After a years-long review process, the FDA today announced its approval of Florida’s proposal to import certain prescription drug products from Canada. Read our analysis of the lawsuit against the drug importation rule here. ]

FDA Approval 40

FDA Approval FDA Science Drugs 40

Drug Discovery World

SEPTEMBER 13, 2022

The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2022 by Professor Robin Jones, MD, Head of the Sarcoma Unit at The Royal Marsden Hospital, London. Desmoid tumours are rare, connective tissue tumours that can have aggressive infiltrative growth and a high risk of local recurrence.

Treatment 130

Treatment FDA Approval Clinical Trials Hospitals 130

The Pharma Data

APRIL 19, 2022

Food and Drug Administration (FDA) has approved commercial production at the company’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer. Our median cycle time is industry leading at 16 days in the U.S.,

FDA Approval 52

FDA Approval Therapies FDA Hospitals 52

Drug Discovery World

DECEMBER 21, 2023

A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years. DDW Multimedia Editor Megan Thomas explored three trends in the market.

FDA Approval 147

FDA Approval Therapies Small Molecule Clinical Trials 147

The Pharma Data

FEBRUARY 24, 2022

Allergan, an AbbVie (NYSE: ABBV) company, today announced new data to be presented from Allergan’s leading portfolio of eye care treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting being held in Nashville, TN and virtually from March 3-6. The DURYSTA data presentations coincide with the two-year anniversary of the U.S.

Treatment 52

Treatment FDA Approval FDA Production 52

Drug Discovery World

JUNE 1, 2023

A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2. DDW’s Megan Thomas explores three trends in the market.

Marketing 245

Marketing FDA Approval Licensing Licensing 245

The Pharma Data

MARCH 31, 2023

Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl. “The FDA remains committed to addressing the evolving complexities of the overdose crisis.

FDA Approval 40

FDA Approval FDA Production Treatment 40

New Drug Approvals

DECEMBER 19, 2022

FDA 12/1/2022, To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, Rezlidhia Olutasidenib , sold under the brand name Rezlidhia , is an anticancer medication used to treat relapsed or refractory acute myeloid leukemia. [1] 1 December 2022. J Med Chem.

FDA Approval 52

FDA Approval FDA Treatment International 52

Drug Discovery World

OCTOBER 18, 2023

Food & Drug Administration (2017) FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss. Food & Drug Administration (2019) FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality.

Therapies 162

Therapies Clinical Trials FDA Approval Virus 162

FDA Law Blog: Biosimilars

APRIL 21, 2024

But that’s the controversy here: Did FDA approve LYTGOBI NDA 214801 on September 30, 2022 when the Agency issued its initial approval letter , or on October 5, 2022 when FDA issued a corrected approval letter ? That’s important, because PTE applications for U.S. Patent Nos. Patent Nos.

FDA 59

FDA FDA Approval Production Marketing 59

Drug Discovery World

MARCH 7, 2023

In its ‘Women in Business 2022’ report, Grant Thornton reported that at 39%, the healthcare industry had the highest proportion of women in senior management out of the 15 industries surveyed. She has also been awarded the 2022 Liverpool Women In Business, Woman of the year Award.

International 246

International Science Pharmaceuticals DNA 246

EG Life Sciences

FEBRUARY 15, 2023

The year 2022 reflected a transformative path for the drug development industry. It is without a doubt that 2022 predicted change and opportunity in biopharma and biotech clinical trials in 2023. The US Food and Drug Administration (FDA) approved around 26 novel drugs in 2022.

Drug Development 52

Drug Development FDA Approval Virus Drugs 52

Drug Discovery World

AUGUST 21, 2023

Combination therapy with pembrolizumab In July 2021, the Food and Drug Administration (FDA) approved Merck’s pembrolizumab (Keytruda) for high-risk, early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

Treatment 130

Treatment Virus Therapies Clinical Trials 130

The Pharma Data

APRIL 7, 2022

This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class. About Biogen.

Treatment 52

Treatment Therapies Disease FDA Approval 52

FDA Law Blog: Biosimilars

OCTOBER 29, 2023

Since that blog post, an important step forward was the decoupling of the coverage requirement from the FDA Birth Control Guide in the guidance provided by the Department to plans and issuers.

FDA Approval 45

FDA Approval FDA Production Pharmacy 45

Drug Discovery World

MARCH 16, 2023

Around one third of patients with AML are diagnosed with FLT3-mutations, which are associated with a higher risk of relapse and poor clinical outcome.

Treatment 130

Treatment FDA FDA Approval Drug Development 130

The Pharma Data

FEBRUARY 12, 2022

This data will be presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022) taking place from February 12-16. Veklury was approved by the FDA on October 22, 2020 for grown-ups and pediatric cases 12 times of age and aged and importing at least 40 kg for the treatment of COVID-19 taking hospitalization.

Pharmacokinetics 52

Pharmacokinetics RNA Hospitals Laboratories 52

FDA Law Blog: Biosimilars

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. Two PTE applications were submitted to FDA ( See FDA Docket Nos. Patent Nos.

FDA Approval 59

FDA Approval FDA Production Therapies 59

Drug Discovery World

JANUARY 11, 2023

Supported by landmark clinical data from a Phase III trial, next-in-class anti-Aβ monoclonal antibody (MAb) lecanemab appears poised for full US FDA approval and ex-US launches. Lecanemab and Donanemab are poised to help treat early-stage Alzheimer’s disease. Donanemab, and others in the class (e.g.,

Drugs 130

Drugs Pharmaceuticals Trials Treatment 130

Drug Discovery World

JULY 13, 2023

The FDA says that it permits some unapproved drugs to be marketed if they are relied on by healthcare professionals to treat serious medical conditions when there is no FDA-approved drug to treat the condition or there is insufficient supply of FDA-approved drugs.

Drugs 237

Drugs Licensing Licensing Regulations 237

New Drug Approvals

JANUARY 3, 2023

Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]

FDA 52

FDA Clinical Trials FDA Approval Small Molecule 52

Drug Discovery World

JANUARY 17, 2024

2022) performed RNA-sequencing analysis on metastatic tumour biopsies and CTCs from breast cancer patients, to find that overall expression of clinically actionable genes was concordant between the two samples and that CTCs revealed a higher expression of immune oncology targets. 40 , 3077–3077 (2022). link] (2022). Michuda, J.

DNA 147

DNA Clinical Trials RNA Treatment 147

Drug Discovery World

SEPTEMBER 26, 2023

Key findings The following are some of the key findings in the report: Between 1 August 2022, and 31 July 2023, the FDA approved 14 new anticancer therapeutics, 12 previously approved therapeutics for treating new cancer types, and two new diagnostic imaging agents. million cancer deaths avoided.

Clinical Trials 130

Clinical Trials Science FDA FDA Approval 130