Camargo

JANUARY 14, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Issues Advice on Combination Products. Approval of the Month: FDA Clears Orladeyo from Biocryst Pharmaceuticals. Bill Stoltman, JD.

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XTalks

JANUARY 2, 2024

Filsuvez topical gel is a sterile botanical drug product designed for topical use, containing birch triterpenes within an oil base. For instance, Vyjuvek , the first FDA-approved gene therapy for DEB, is priced at $24,250 per vial. Regarding the price of Filsuvez, it has not yet been publicly disclosed by the company.

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XTalks

DECEMBER 7, 2021

The approval is the first for Massachusetts-based VBI Vaccines, a biopharmaceutical company focused on leveraging immunology “in the pursuit of powerful prevention and treatment of disease,” according to the company’s mission statement. And in another first, VBI’s shot is the only approved three-antigen HBV vaccine for adults in the US.

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XTalks

AUGUST 7, 2023

Ycanth (cantharidin) topical solution, developed by Verrica Pharmaceuticals Inc., has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. What is Molluscum Contagiosum?

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Section 351(a) is the traditional pathway for approving biologics under the PHS Act. BLA process (CBER).

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XTalks

OCTOBER 18, 2022

Global medical device company Nevro Corp has received US Food and Drug Administration (FDA) approval for the Senza HFX iQ spinal cord stimulation (SCS) system for the treatment of long-term or chronic pain.

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Camargo

DECEMBER 9, 2020

If you are facing an FDA remote review, Camargo can help design a comprehensive approach in order to avoid such pitfalls. Approval of the Month: Alnylam to Use Value-Based Agreements for Ultra-rare Disease Treatment. Camargo can help you to develop the right pricing and access strategy for your product; contact us for more information.

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XTalks

JANUARY 28, 2022

Kimmtrak is part of a novel class of bispecific T cell immunotherapies being developed by Immunocore. Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Related: Cancer Blood Test Developed by University of Oxford Researchers Can Detect Metastasis.

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pharmaphorum

DECEMBER 4, 2020

That means it targets both the primary mutation in this form of NSCLC and the resistance mechanism at the same time, according to J&J, which has previously said it plans to expand use of the drug to “all EGFR-containing tumours”, challenging Tagrisso and other TKIs like AZ’s older Iressa (gefitinib) and Roche’s Tarceva (erlotinib).

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Camargo

JUNE 4, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Non-Opioid for Post-Surgical Pain Gets FDA Nod. In the News: May 2021 Regulatory and Development Updates.

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Pharmaceutical Technology

MAY 24, 2023

The FDA approval adds a further treatment avenue to tackle the opioid crisis in the US. Whilst the pharma industry has been relatively slow in developing new treatments – an array of legal challenges posed to pharma companies and pharmacies implicated in the crisis still trundles on.

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Pharmaceutical Technology

APRIL 28, 2023

It has also been approved by the FDA for otitis media prevention in infants and children aged between six weeks and five years caused by the original seven serotypes contained in PREVNAR. The latest approval is based on data obtained from the Phase II and Phase III trials of PREVNAR 20 for paediatric indication.

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Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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XTalks

AUGUST 18, 2020

SalivaDirect, a saliva-based COVID-19 test that was tested among players of the National Basketball Association (NBA), has been given emergency use authorization (EUA) by the US Food and Drug Administration (FDA). We are not developers of diagnostics. And now it’s getting approval. Grubaugh admitted that he was hesitant. “We

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XTalks

JULY 27, 2023

“We evaluated the reconsideration petition and concluded that it does not provide a basis for modifying the FDA’s response to the original citizen petition,” the FDA said in a constituent update. Research and subsequent petitions have concluded that ortho-phthalates should be excluded from an extensive range of products.

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Pfizer

AUGUST 3, 2022

Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy. Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. deliesschef.

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XTalks

APRIL 25, 2024

Now we recognize that over the last ten years or so there have been major developments in pharmacotherapy for the management of different etiologies of heart failure,” says Dr. Nicholas Alp, MD, PhD, FACC, FRCP, Vice President of the Medical Department at Medpace. Innovative approaches to chordal modifications have also shown promise.

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pharmaphorum

JANUARY 12, 2023

Airsupra (PT027), a new asthma rescue treatment developed by AstraZeneca (AZ) and development partner Avillion, has been approved by the US Food and Drug Administration (FDA). The new approval continues the company’s unmarred success rate in clinical co-development partnerships across multiple therapeutic areas.

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XTalks

JULY 26, 2024

The US Food and Drug Administration (FDA) has given the green light to Femlyv , a combination oral contraceptive containing norethindrone acetate and ethinyl estradiol. Norethindrone acetate and ethinyl estradiol are legacy drugs that have been approved since 1968 in a swallowable tablet form for the prevention of pregnancy.

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XTalks

NOVEMBER 5, 2024

per unit, included 958,903 units, each containing one ordinary share and three warrants to purchase additional shares at an exercise price of $4.38 Proceeds from the IPO will fund preclinical and clinical development for Polyrizon’s innovative hydrogel product candidates, supporting further research and development (R&D).

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XTalks

APRIL 6, 2021

The US Food and Drug Administration (FDA) has granted approval to the world’s first non-surgical pulmonary valve to treat severe pulmonary valve regurgitation, a condition often resulting from congenital heart disease. The condition causes blood to leak backward into the right lower chamber of the heart.

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pharmaphorum

SEPTEMBER 21, 2020

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

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XTalks

JANUARY 17, 2023

The US Food and Drug Administration (FDA) granted approval to AstraZeneca’s Airsupra (albuterol/budesonide), formerly known as PT027, for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in individuals aged 18 years and older who have asthma.

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Pharmaceutical Technology

OCTOBER 26, 2022

Early gene therapy methods were proposed in the 1970s, and the first approved gene therapy clinical research in the US began in 1990. New doors were opened in the 2000s with the development of genome editing, such as CRISPR-Cas9, which introduces molecular tools to change existing DNA. The future of cell and gene therapies.

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XTalks

NOVEMBER 10, 2023

The disorder usually develops in infancy or early childhood but can also appear in adulthood, including during pregnancy, in some cases. Adzynma is a an ERT containing purified recombinant form of the ADAMTS13 enzyme administered to boost levels of the deficient enzyme in patients with cTTP.

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The Pharma Data

AUGUST 31, 2021

In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy.

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Pharmaceutical Technology

FEBRUARY 26, 2023

The idea behind these treatments relies on altering the gut microbiome by designing therapeutics that contain bacteria derived from donated stool samples. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI.

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XTalks

JANUARY 18, 2023

Ayesha also talked about the FDA approval of AstraZeneca’s asthma inhaler Airsupra, the first-in-class drug that contains both a beta agonist and corticosteroid. The inhaler is approved as a rescue medication for adults with asthma to help treat bronchoconstriction and asthma attacks.

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pharmaphorum

SEPTEMBER 29, 2021

The 10 startups – all from the US – will now embark on a four-week programme of assessment, training and development to ensure their technologies are ready for widespread deployment in the Amazon Web Services (AWS) cloud. The finalists are: AIVA , a startup that has developed a voice operating system for patient care.

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pharmaphorum

DECEMBER 14, 2022

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. It contains 109% of the American Heart Association’s ideal daily allowance for sodium intake.

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Camargo

MAY 19, 2021

The HUD designation provides an incentive for sponsors developing medical devices to be used in the treatment or diagnosis of diseases affecting small populations. The FDA should respond to the request within 45 days. Note: An HUD designation and the subsequent submission of an HDE application do not guarantee FDA approval.

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XTalks

APRIL 29, 2022

Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. GLP-1 agonists were first developed as diabetes treatments.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S.

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Pharmaceutical Technology

MAY 5, 2023

In an alert issued last week , the FDA said apetamin is being promoted over social media as a weight-gain solution and highlighted that young adults are reporting cardiac and nervous system disorders, and liver injury after taking the drug.

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pharmaphorum

NOVEMBER 1, 2021

Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). The post Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia appeared first on.

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Pharmaceutical Technology

NOVEMBER 22, 2022

Vaccines are our number one weapon in the fight against infectious diseases, but their development has historically involved a long and complex process taking up to a decade. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. With the world watching, the biopharmaceutical community got to work.

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