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). Additionally, under its 2018 agreement, Avillion had regulatory responsibility, including filing the New Drug Application (NDA) through to FDA approval.

FDA Approval 52

FDA Approval Allergies Trials Life Science 52

XTalks

NOVEMBER 10, 2023

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. Today, we are proud to further support the rare disease community by delivering Adzynma as the first FDA-approved therapeutic option for people with cTTP.”

FDA Approval 59

FDA Approval Gene Therapy Gene Clinical Trials 59

XTalks

AUGUST 18, 2023

The FDA approval of Izervay is great news for the retina community and our patients suffering from geographic atrophy,” said Arshad M. Izervay contains avacincaptad pegol sodium, an effective complement C5 inhibitor. How Does Izervay Work?

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FDA Approval Drugs Clinical Trials Clinical Trials 52

XTalks

DECEMBER 2, 2022

As the first FDA-approved fecal microbiota product, (the) action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” said Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER). Rebyota is not indicated for the first occurrence of C.

FDA Approval 59

FDA Approval Bacteria Clinical Trials Clinical Trials 59

XTalks

MARCH 10, 2023

This US Food and Drug Administration (FDA)-approved drug was also awarded a rare pediatric disease priority review voucher. Omaveloxolone Clinical Trials Skyclarys is an oral medication that contains omaveloxolone, an activator of the nuclear factor-erythroid 2 related factor 2 (Nrf2) pathway.

FDA Approval 52

FDA Approval Engineer Clinical Trials Clinical Trials 52

XTalks

JANUARY 5, 2021

Even more interestingly, now there are drugs that have FDA approval that were conducted by decentralized clinical trials. AI is expected to make significant strides in the life science and healthcare sectors in 2021. Technology, eConsent and eCOA were deployed at a large scale,” says Dr. Oyegunwa.

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Life Science Clinical Trials Clinical Trials Trials 98

XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy has also become the first targeted therapy for the dMMR positive subset of endometrial cancers.

FDA Approval 105

FDA Approval Trials Antibody DNA 105

XTalks

JANUARY 28, 2022

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Kimmtrak is a bispecific protein that contains a soluble T cell receptor fused to an anti-CD3 immune-effector function. Uveal melanoma is a rare and aggressive type of melanoma of the eye.

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FDA Approval Development Licensing Licensing 98

XTalks

AUGUST 18, 2023

After Johnson & Johnson’s US Food and Drug Administration (FDA) approval last week for its second multiple myeloma bispecific, Talvey (talquetamab), Pfizer received an FDA nod for its B-cell maturation antigen (BCMA)-directed therapy Elrexfio (elranatamab) in the same indication.

FDA Approval 98

FDA Approval Drugs Antibody Trials 98

XTalks

SEPTEMBER 28, 2023

a Texas-based pharmaceutical firm specializing in psychotropic drug development, revealed that its groundbreaking antidepressant, Exxua (gepirone extended release) for treating major depressive disorder (MDD), received US Food and Drug Administration (FDA) approval on September 22, 2023. Fabre Kramer Pharmaceuticals, Inc.,

FDA Approval 105

FDA Approval Clinical Trials Clinical Trials Trials 105

XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Ozempic was approved for the management of type 2 diabetes mellitus in adults in addition to a reduced-calorie diet and exercise. The approved drugs contain the base form of semaglutide.

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FDA Approval Containment Drugs Pharmacy 98

XTalks

JUNE 29, 2022

The new FDA approval gives Breyanzi (lisocabtagene maraleucel) the broadest patient eligibility of any CAR T-cell therapy in relapsed or refractory LBCL. Product logo and product image courtesy of Bristol Myers Squibb. Lymphoma is one of the most aggressive types of cancer. The patients were randomized and grouped into Arm A or Arm B.

FDA Approval 52

FDA Approval Gene Therapy Antibody Gene 52

XTalks

AUGUST 18, 2020

Moreover, samples for the SalivaDirect test can be collected in any sterile container, and hence does not require any specific type of swab or collection vessel, making collection quick and easy. Last month, the FDA approved a pooled test for COVID-19 developed by Quest Diagnostics. And now it’s getting approval.

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FDA Approval Reagent RNA Genome 90

XTalks

JANUARY 25, 2021

GlaxoSmithKline’s (GSK) ViiV Healthcare — which focuses on HIV treatments and prevention — has received approval from the US Food and Drug Administration (FDA) for its highly anticipated injectable HIV treatment. The long-acting injection can help relieve HIV patients from having to take a daily cocktail of pills.

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical Trials 52

XTalks

FEBRUARY 27, 2023

Chiesi Global Rare Diseases recently announced in a press release that Lamzede (velmanase alfa-tycv) received US Food and Drug Administration (FDA) approval for the treatment of non-neurological manifestations of alpha-mannosidosis in both adult and pediatric patients.

FDA Approval 52

FDA Approval Life Science Containment Genetics 52

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.

FDA Approval 97

FDA Approval Containment Allergies Drugs 97

XTalks

DECEMBER 22, 2023

Glaukos Corporation, a leader in ophthalmic medical technology and pharmaceuticals with a focus on novel treatments for glaucoma, corneal disorders and retinal diseases, has secured US Food and Drug Administration (FDA) approval for iDose TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog intended for one-time use per eye.

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FDA Approval Clinical Trials Clinical Trials Trials 98

XTalks

FEBRUARY 8, 2024

Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, life sciences and pharmaceutical sectors. Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. mL subcutaneous solution (2 mg/1.5

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Sales Insulin FDA Approval Drugs 52

XTalks

AUGUST 9, 2023

Xdemvy, specifically formulated as an ectoparasiticide (anti-parasitic) for Demodex blepharitis treatment, contains the active ingredient lotilaner, a member of the isoxazoline compound family. How Does Xdemvy Work? Its significant efficacy is supported by a multitude of clinical assessments. “We

FDA Approval 98

FDA Approval In-Vitro Trials Bacteria 98

XTalks

JUNE 6, 2023

Posluma is now the first and only radiohybrid PSMA-targeted PET imaging agent to receive FDA approval. Posluma contains a radioactive imaging agent, fluorine-18 ( 18 F), that is designed to specifically bind to the PSMA over-expressed on prostate cancer cells. How Does Posluma Work?

FDA Approval 96

FDA Approval Clinical Trials Clinical Trials Marketing 96

Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. This is the first approval of a Section 804 Importation Program ( SIP ) by the FDA. Biologics, controlled substances, and certain other drugs are not eligible for importation.

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Drugs Regulation FDA Approval Manufacturing 52

XTalks

AUGUST 15, 2023

Akeega is approved for use with the corticosteroid prednisone in adults with BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. Lynparza received FDA approval in May 2020 for mCRPC in patients with homologous recombinational repair ( HRR ) gene mutations.

FDA Approval 52

FDA Approval Gene Hormones Licensing 52

Drug Discovery World

AUGUST 9, 2023

The life sciences sector has seen significant M&A activity over the last few weeks. The new acquisition gives Biogen rights to Reata’s portfolio of products for neurological diseases, including the FDA-approved Skyclarys (omaveloxolone), the only approved treatment for Friedreich’s ataxia (FA) in the United States.

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Drugs Drug Delivery Systems Drug Delivery Life Science 52

XTalks

JUNE 14, 2023

The solution of Vevye does not contain water, anti-microbial preservatives, oils or surfactants. More Drugs for Dry Eye Disease Are on the Way Several other drugs have recently gained FDA approval or are currently in advanced stages of clinical development for the treatment of dry eye disease.

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Gene Silencing Drug Delivery FDA Approval RNA 97

XTalks

JUNE 28, 2023

The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile. After the vote, the FDA extended the decision date by one month due to concerns it raised in briefing documents before the committee meeting.

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Gene Therapy Gene Protein FDA Approval 98

XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity.

FDA Approval 59

FDA Approval Manufacturing Drugs Pharmacy 59

pharmaphorum

APRIL 13, 2021

Dr Cindy Jacobs, chief medical officer of Achieve Life Sciences discusses the potential of cytisinicline therapy for smoking cessation. . Higher rates occur with FDA-approved treatment therapies developed for users of combustible cigarettes. Dr Cindy Jacobs is president and chief medical officer of Achieve Life Sciences.

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Life Science FDA Approval Trials Development 107

pharmaphorum

OCTOBER 2, 2020

It’s the same indication targeted by Janssen with another medicine that drew inspiration from an illegal recreational drug – Spravato is an FDA-approved nasal spray containing esketamine, an isomer of ketamine. New partnership tests low-dose psilocybin.

Medicine 119

Medicine Life Science FDA Approval Development 119

XTalks

JUNE 1, 2022

BONESUPPORT has recently received market authorization from the US Food and Drug Administration (FDA) for Cerament G, its bone graft with antibiotic elution. Xtalks learned more about BONESUPPORT and its first FDA-approved drug-device combination product Cerament G through an email interview with BONESUPPORT’s CEO Emil Billbäck.

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Filler FDA Approval Production Marketing 98

XTalks

AUGUST 6, 2020

The US Food and Drug Administration (FDA) has approved the use of an oral cannabidiol (CBD) solution called Epidiolex for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients aged one year and older. Epidiolex is the only FDA-approved formulation that contains CBD derived from the cannabis plant.

FDA Approval 64

FDA Approval Protein Containment Genetic Disease 64

XTalks

APRIL 25, 2024

The Barostim NEO System received FDA approval in 2019 for use in specific HFrEF patients who have exhausted other treatment options. This approval has since been expanded, broadening the eligibility to include more patients based on clinical criteria, including NYHA Class and NT-proBNP levels.

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Development Trials Clinical Trials Clinical Trials 111

XTalks

MARCH 12, 2024

“This approval is an important milestone for people living with obesity and cardiovascular disease, as the SELECT data demonstrated that Wegovy has the potential to prolong lives by addressing some of the leading causes of preventable deaths by reducing the risks of cardiovascular events.”

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Drugs Production Trials Clinical Trials 105

XTalks

MAY 24, 2022

In March, the FDA released a complete response letter (CRL) for lenacapavir, citing compatibility issues of the drug solution in borosilicate glass and it resulted in the clinical hold of the drug. Gilead’s journey to fight HIV took off with FDA approvals of its drugs between 2011 and 2018. Mechanism of Action of Lenacapavir.

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Drugs Clinical Trials Clinical Trials Trials 98

XTalks

MAY 1, 2023

Qalsody contains tofersen, an antisense oligonucleotide that specifically targets the mRNA made from mutated SODI genes to prevent the formation of toxic SOD1 proteins. Attendees will explore how Virtual Research Coordination (VRCC) can help with attracting a more diverse patient population, and more. How Does Qalsody Work?

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FDA Approval Gene Genetics Protein 89

XTalks

DECEMBER 5, 2022

The CBD prodrug will be going up against Jazz Pharma’s Epidiolex, the first FDA approved CBD drug formulation. Approved in 2018, Epidiolex is a CBD oral solution indicated for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, rare and severe forms of epilepsy, in patients two years of age and older.

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Bioavailability FDA Approval Trials Drugs 97

pharmaphorum

AUGUST 31, 2021

For the innovators and early adopters of the life sciences industry, engineering a regulatory-grade ECA can be daunting. Lastly, we look to our life science partners themselves, who have undoubtedly spearheaded ECAs for their own pipelines. It is true that RWD contains more potential bias as a result.

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Clinical Trials Clinical Trials Life Science Trials 75

XTalks

MARCH 3, 2021

Today’s action marks the first FDA approval for a therapy to treat this devastating disease,” said Hylton V. Joffe, MD, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research, in a press announcement from the FDA.

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FDA Approval Genotype Clinical Trials Clinical Trials 64