XTalks

JANUARY 3, 2024

Wainua is the only FDA-approved drug for the treatment of ATTRv-PN that can be self-administered via an auto-injector. Approval of Wainua represents a meaningful advancement in treatment, one that gives those who are living with transthyretin-mediated amyloid polyneuropathy help managing the disease,” said Michael J.

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XTalks

NOVEMBER 30, 2023

Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.

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XTalks

JANUARY 25, 2023

Massachusetts-based TheracosBio has received US Food and Drug Administration (FDA) approval for diabetes med Brenzavvy (bexagliflozin) to help improve glycemic control in adults with type 2 diabetes. It is the first FDA-approved SGLT2 inhibitor for any animal species. What is the Animal Drug Regulatory Process?

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XTalks

DECEMBER 29, 2022

The life sciences and healthcare are among the biggest industries globally, and their significance was particularly highlighted during the past couple of years by the COVID-19 pandemic. Given the hyperfocus on the life sciences thanks to COVID, consumers appear to be more autonomous and vocal about their medical demands and choices.

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XTalks

MAY 2, 2022

Mycovia Pharmaceuticals received approval from the US Food and Drug Administration (FDA) for Vivjoa (oteseconazole) for the treatment of recurrent vulvovaginal candidiasis (RVVC) or chronic yeast infection for permanently infertile or postmenopausal women. In the global VIOLET studies, 93.3 percent and 96.1 percent and 60.6

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XTalks

MAY 5, 2022

Supernus Pharmaceuticals’ Qelbree was approved by the FDA on Friday. Qelbree is the newest nonstimulant ADHD drug for adults after two decades. The US Food and Drug Administration (FDA) has approved two classes of drugs for the treatment of ADHD: stimulants and nonstimulants.

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XTalks

NOVEMBER 10, 2021

Pfizer released data from an interim analysis of a Phase III trial evaluating the drug, which shows that it can reduce the risk of hospitalizations by almost 90 percent. The results were so strong that an independent data monitoring committee and the FDA told Pfizer they could stop enrolling participants in the trial.

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XTalks

AUGUST 18, 2023

Iveric Bio, a company of Astellas, has secured recent approval from the US Food and Drug Administration (FDA) for its innovative drug, Izervay (avacincaptad pegol intravitreal solution). Another New Treatment for Geographic Atrophy There is one other FDA-approved drug for geographic atrophy on the market.

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XTalks

JANUARY 4, 2023

MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

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XTalks

APRIL 24, 2024

ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) along with the Bacillus Calmette-Guérin (BCG) vaccine has won US Food and Drug Administration (FDA) approval for the treatment of non-muscle invasive bladder cancer (NMIBC). Bladder cancer is the tenth most commonly diagnosed cancer worldwide.

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XTalks

OCTOBER 22, 2021

The US Food and Drug Administration (FDA) has approved Cyltezo (adalimumab-adbm) as the first interchangeable biosimilar for Humira (adalimumab) for the treatment of several inflammatory conditions. This means AbbVie, maker of the world’s top-selling drug Humira, could be in for some stiff competition.

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Pharmaceutical Technology

MARCH 14, 2023

Biopharmaceutical firm Cingulate and life sciences commercialisation firm Indegene have entered into a joint commercialisation deal for the former’s attention-deficit/hyperactivity disorder (ADHD) therapy CTx-1301 (dexmethylphenidate).

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XTalks

OCTOBER 4, 2022

The US Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ Rolvedon (eflapegrastim-xnst) injection. Myelosuppressive drugs kill cancer cells and normal cells in the bone marrow, which diminishes the amount of normal red blood cells, white blood cells and platelets in the bone marrow and blood.

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XTalks

JANUARY 26, 2023

The US Food and Drug Administration (FDA) recently granted approval for the Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) based on the results from two Phase III clinical trials. Brukinsa is now approved to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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XTalks

OCTOBER 17, 2023

The US Food and Drug Administration (FDA) has granted approval to Pfizer’s anti-inflammatory Velsipity (etrasimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC). This class of drug is typically used as immunomodulators to treat multiple sclerosis (MS).

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XTalks

JULY 28, 2021

Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. It has been one of Pfizer’s best-selling drugs. Both shots are indicated for adults aged 18 years and older.

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XTalks

DECEMBER 13, 2023

The US Food and Drug Administration (FDA) has approved the first gene therapies for the treatment of sickle cell disease, approving two on the same day. The landmark approvals were awarded to bluebird bio’s Lyfgenia (lovo-cel) and Vertex Pharmaceuticals and CRISPR Therapeutics’ jointly developed Casgevy (exa-cel).

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XTalks

FEBRUARY 29, 2024

Two years after its approval in 2021 , Biogen has decided to pull the plug on its Alzheimer’s drug Aduhelm (aducanumab). After its accelerated approval in January 2023, Leqembi received full US Food and Drug Administration (FDA) approval in July 2023. But Biogen couldn’t convince payers of its benefits.

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XTalks

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Takeda Pharmaceuticals’ Adzynma, the first recombinant protein product for prophylactic (preventive) or on‑demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare blood clotting disorder.

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

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XTalks

JULY 7, 2023

Pfizer’s alopecia JAK inhibitor Litfulo (ritlecitinib) has become its fourth US Food and Drug Administration (FDA) approved product in the past several weeks. Litfulo is entering the alopecia market to rival Eli Lilly’s Olumiant (baricitinib), which was approved as the first drug for alopecia areata a year ago.

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XTalks

APRIL 11, 2024

After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.

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XTalks

DECEMBER 10, 2021

Zavegepant is an antibody drug that prevents binding of the calcitonin gene-related peptide (CGRP) to the CGRP receptor. CGRP receptor antagonists are a new class of antibody drugs used for migraine treatment. Related: Nerivio: New Drug-Free Wearable Technology Used to Treat Migraines.

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XTalks

DECEMBER 2, 2022

Swiss company Ferring Pharmaceuticals has won a historic approval from the US Food and Drug Administration (FDA) for its fecal transplant-based therapy Rebyota (fecal microbiota, live-jslm) to reduce the recurrence of bacterial infection. The therapy is the first of its kind to be approved in the US. Difficile. “As

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Drug Discovery World

FEBRUARY 24, 2023

Abbey Vangeloff is the Director of Business Development, Life Sciences, at Yahara Software. DDW’s Megan Thomas catches up with Vangeloff to learn why AI and data science are so important for the future of the sector. This, Vangeloff says, is the part they get excited about when working with life science clients.

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World of DTC Marketing

JANUARY 24, 2022

Venture capitalists have poured $42 billion into drug development over the past three years. Most small biotech companies rely on venture capitalist funding to develop new drugs but is that a good way to go? billion, which was much lower than previous studies, which have placed the average cost of drug development as $2.8

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XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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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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XTalks

DECEMBER 17, 2021

Xtalks is taking a look at some of the major stories and innovations of the year in the life sciences, many of which were driven by new, emerging and improved technologies. The year 2021 was all about continuing innovations in the life sciences. Life Science Innovations: Malaria and Influenza Vaccines.

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XTalks

AUGUST 2, 2022

The US Food and Drug Administration (FDA) has granted approval to Azurity Pharmaceuticals’ liquid version of its epilepsy drug zonisamide (100 mg/5 mL; brand name Zonisade) as an adjunct therapy for the treatment of partial seizures in adults and pediatric patients 16 years of age and older with epilepsy.

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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.

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XTalks

APRIL 5, 2024

Amylyx Pharmaceuticals announced yesterday that it will be pulling its ALS (amyotrophic lateral sclerosis) drug Relyvrio from the market after failing in a confirmatory trial. Amylyx said patients currently taking Relyvrio in the US and Canada can be transitioned to a free drug program.

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XTalks

AUGUST 22, 2022

Axsome Therapeutics’ extended-release tablets of Auvelity (dextromethorphan HBr -bupropion HCl) has been approved by the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD). What sets Auvelity apart from other antidepressants on the market is its ability to act rapidly.

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XTalks

AUGUST 31, 2023

As Takeda’s blockbuster attention-deficit/hyperactivity (ADHD) drug Vyvanse (lisdexamfetamine dimesylate) reached its patent cliff this month after enjoying 16 years on the market, the US Food and Drug Administration (FDA) gave approval to a slew of generics to coincide with the end of its patent protections.

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XTalks

AUGUST 19, 2021

The US Food and Drug Administration (FDA) has approved a new indication for Jazz Pharmaceuticals’ (Nasdaq: JAZZ ) Xywav for idiopathic hypersomnia (IH) in adults. With the FDA green light, Xywav has become the first drug approved for IH. This, despite the drug having strict regulations and safety concerns.

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pharmaphorum

JULY 19, 2021

A new report published by Medicines Discovery Catapult and CPI details the huge medical and market potential for complex medicines in the UK. A complex medicine applies novel technologies that deliver or target drugs, by modification of a pharmaceutical ingredient, formulation or using a new delivery route.

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XTalks

MAY 24, 2023

Eyecare giant Bausch + Lomb received its first prescription drug approval from the US Food and Drug Administration (FDA) for its dry eye disease med Miebo (perfluorohexyloctane ophthalmic solution). The drug addresses a significant unmet need for patients, said Bausch + Lomb CEO Brent Saunders in a press release.

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