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.

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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.

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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]

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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.

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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.

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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.

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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).

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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?

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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.

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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.,

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Drug Discovery World

SEPTEMBER 7, 2023

5 The Research to Accelerate Cures and Equity (RACE) for Children Act of 2017 authorised the Food and Drug Administration (FDA) to require paediatric clinical trials for new oncology drugs with relevant molecular targets and has a had a positive impact on the number of drugs approved in paediatric indications.

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The Pharma Data

OCTOBER 9, 2021

FDA is anticipated in late 2022. “As With the limited availability of pediatric patients for clinical trial inclusion, researchers can extrapolate data from trials with adults to determine the potential efficacy and tolerability of a treatment for a pediatric population. A decision from the U.S.

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Eye on FDA

DECEMBER 6, 2023

For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. By contrast, in 2023, the number of recommendations for approval was over three times the number of negative outcomes.

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Drug Discovery World

AUGUST 30, 2022

TPOXX is an FDA-approved antiviral drug for the treatment of smallpox. The recent global outbreak of monkeypox has led to more than 45,500 cases as of August 22, 2022. It limits viral spread in the body by inhibiting the work of the protein involved in the release of the enveloped virus. Context and treatment.

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Drug Discovery World

JULY 2, 2024

Then, in 2013, Roche gained FDA approval with breakthrough therapy designation for its chronic lymphocytic leukaemia agent obinutuzumab (Gazyva/Gazyvaro) which was discovered at Roche Glycart, and as a result, the new drug generated CHF 730 ($821) million revenue in 2022.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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The Pharma Data

OCTOBER 22, 2021

With 25 request share in soybean pesticides in Brazil, Bayer plans to upgrade this product in 2022 with the launch of Fox Supra, further expanding its commanding position in this largely important request, with a peak deals eventuality of further than€ 500 million. is underway.

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Drug Discovery World

NOVEMBER 13, 2023

Valneva reported final pivotal Phase III data for the vaccine in March 2022 showing a 98.9% seroresponse rate at 28 days with a single vaccination and final lot-to-lot consistency results in May 2022. The post FDA approves world’s first chikungunya vaccine appeared first on Drug Discovery World (DDW).

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The Pharma Data

MARCH 28, 2022

The FDA approval is based on the results from the SUSTAIN FORTE trial. We are pleased with the FDA approval for a higher 2.0 The approval of the 2.0 mg in the United States in the second quarter of 2022. mg is now approved in the US, the EU, Canada and Switzerland. Compared to semaglutide 1.0

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FDA Law Blog: Biosimilars

MARCH 29, 2023

While many states have had standing orders that allow for the dispensing of naloxone without an individual prescription, “harm reduction programs” that provide products and services to at-risk individuals still faced logistical difficulties in acquiring naloxone due to its prescription-only status which I discussed in this October 2022 blog post.

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Drug Discovery World

APRIL 23, 2024

In a March 2022 report by the New York Times, Eve M. Tremendous strides have been made with other diseases, yet there are still no FDA-approved drug therapies for TBI. Historically, drug development efforts have focused on moderate to severe traumatic injuries.

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Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. With these exceptions, no other cannabis, cannabis-derived, or cannabidiol (CBD) products are FDA-approved and therefore on the market 1.  We are seeing producers of what we call “snake oil” entering the markets as legitimate brands.

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KIF1A

APRIL 25, 2024

September 2022 – We were contacted by n-Lorem to obtain blood from Sloane, my husband, and me. However, we needed to wait for Susannah to finish her trial before we could submit to the FDA for Sloane’s ASO use. February 2024 – n-Lorem submitted an IND (investigational new drug) to the FDA for Sloane.

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Drug Discovery World

MARCH 12, 2024

MJ : From the first known reference to medicinal use of plants on a Mesoptamian clay tablet written during the third millennium BC to the FDA approval of the blockbuster anticancer drug Taxol in the 1990s, natural products from plants have been at the forefront of efforts to overcome human diseases, such as cancers, hypertension, and pain.

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Drug Discovery World

OCTOBER 4, 2022

million in 2022 to 12.7 billion in 2013 to less than $3 billion in 2018) due to loss of patent protection for the five FDA approved pharmacologic treatments available for AD, none of which slow or stop the damage from the disease. . “We Volume 23 – Issue 4, Fall 2022. million by 2050.” . About the author .

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