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

MARCH 28, 2024

Italy-based drugmaker Italfarmaco has won US Food and Drug Administration (FDA) approval for its oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. Duvyzat received Priority Review, Orphan Drug and Rare Pediatric Disease designations from the FDA.

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XTalks

JUNE 3, 2024

Biocon Biologics’ Yesafili (aflibercept-jbvf) and Biogen and Samsung Bioepis’ jointly developed Opuviz (aflibercept-yszy) have been given the green light by the US Food and Drug Administration (FDA) as the first interchangeable biosimilars to blockbuster eye drug Eylea. In the US, Biogen will market Yesafili.

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XTalks

JULY 26, 2024

Femlyv is the first FDA-approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication,” said Janet Maynard, MD, MHS, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research (CDER).

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XTalks

FEBRUARY 8, 2023

In this episode, Ayesha talked about the launch of Amgen’s Amjevita, the first Humira biosimilar to hit the market. Amjevita received FDA approval in 2016 and after a legal settlement with Humira maker AbbVie, has finally reached market launch. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

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XTalks

SEPTEMBER 16, 2024

Ocrevus Zunovo’s approval builds on the strong safety and efficacy data from the original Ocrevus IV formulation, which has been used to treat over 350,000 people worldwide. Currently, Ocrevus and Ocrevus Zunovo remain the only therapies approved for both RMS and PPMS. billion in 2024 to $38.94

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XTalks

SEPTEMBER 6, 2024

For the international market, Novartis will continue to partner with external isotope suppliers. Novartis said the new facilities represent the company’s continued investment in developing a robust infrastructure to support the expanding use of radioligand therapies to treat cancer. billion acquisition of RayzeBio.

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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 22, 2021

In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes. The FDA approved the supplemental Biologics License Application (sBLA) for Cyltezo as the first interchangeable biosimilar with Humira. Cyltezo and the Emerging Humira Biosimilars Market.

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XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. BTK plays an important role in the immune system by regulating B cell receptor signaling through its effects on the development and maturation of B cells.

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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

OCTOBER 4, 2022

Rolvedon is indicated to lower the chance of infection from febrile neutropenia (the development of fever, often with other signs of infection, in patients with a very low number of neutrophil granulocytes in the blood) in adult patients with non-myeloid malignancies on myelosuppressive anti-cancer drugs. How Does Rolvedon Work?

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XTalks

MAY 2, 2022

For Mycovia Pharmaceuticals , Vivjoa is the company’s first FDA-approved drug in its pipeline of novel treatments for fungal infections. North Carolina-based Mycovia is an emerging biopharmaceutical company devoted to recognizing and empowering people living with unmet medical needs through the development of novel therapies.

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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

AUGUST 30, 2024

This blog highlights the top 10 largest publicly traded pharma and biotech companies by market capitalization in 2024 , showcasing their influence and contributions to global health. Johnson & Johnson (JNJ) Market Capitalization: $402.1 Novo Nordisk (NVO) Market Capitalization: $377.2 MRK) Market Capitalization: $280.4

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XTalks

SEPTEMBER 10, 2024

Amneal Pharmaceuticals and Shilpa Medicare have announced US Food and Drug Administration (FDA) approval of Boruzu, a ready-to-use formulation of bortezomib for subcutaneous or intravenous (IV) administration. This will help healthcare providers seamlessly incorporate this ready-to-use solution into their clinical practice.

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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

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

NOVEMBER 10, 2023

The disorder usually develops in infancy or early childhood but can also appear in adulthood, including during pregnancy, in some cases. 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.”

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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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XTalks

MAY 5, 2022

There are four FDA-approved ADHD-specific nonstimulant drugs, namely Eli Lilly’s Strattera (atomoxetine), Shionogi’s Kapvay (clonidine), Takeda’s Intuniv (guanfacine) and now Supernus’ Qelbree (viloxazine). In 2002, Strattera became the first FDA-approved nonstimulant drug to treat ADHD in adults.

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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

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). The company is planning to launch Anktiva commercially in the US by mid-May.

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XTalks

OCTOBER 17, 2023

million people in the US and typically affects individuals between the ages of 15 and 30, but it can develop at any age. Pfizer says due to the chronic and unpredictable nature of symptoms, the impact of ulcerative colitis can go beyond the physical to other aspects of life. It affects an estimated 1.25

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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

AUGUST 2, 2022

The FDA finally inspected the site in January this year. According to Azurity, Zonisade is the first and only zonisamide formulation for oral liquid administration to be FDA approved as an adjunctive therapy for the treatment of partial seizures in adults and pediatric patients aged 16 years and older with epilepsy.

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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. Complex medicines offer the potential to combat elusive “undruggable” targets and the development of medicines for conditions that are currently untreatable.

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XTalks

AUGUST 22, 2022

What sets Auvelity apart from other antidepressants on the market is its ability to act rapidly. Additionally, Axsome says Auvelity is the first oral MDD medication with a new mechanism of action to hit the market in more than 60 years. Auvelity’s approval comes after Axosome’s migraine treatment AXS-07 was rejected by the FDA in May.

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XTalks

JUNE 29, 2021

Prescription digital medicine company Akili Interactive is set to launch a digital campaign for its FDA-approved video game for the treatment of attention deficit hyperactivity disorder (ADHD). The video game is called EndeavorRx and is the first and only FDA-backed therapy delivered through a video game experience.

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XTalks

JUNE 16, 2023

Foundation Medicine recently announced that the US Food and Drug Administration (FDA) approved FoundationOne Liquid CDx to serve as a companion diagnostic for identifying metastatic colorectal cancer patients with BRAF V600E alterations, suitable for treatment with Pfizer’s Braftovi (encorafenib) with cetuximab.

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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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Drug Discovery World

JULY 2, 2024

DDW’s Diana Spencer takes a closer look into why Switzerland is such a life sciences powerhouse and how Swiss researchers are advancing new technology and tackling modern health challenges. Switzerland, however, boasts three (or arguably, four) separate yet complimentary centres of life science innovation.

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XTalks

JUNE 12, 2023

Additionally, BMS is developing another manufacturing site in Leiden, Netherlands. Over the past decade, this site has been pivotal in the development, production and testing of both clinical and commercial medications. In recent years, several cell therapy manufacturing facilities in the US have garnered FDA approval.

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XTalks

JULY 11, 2024

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. Merck is also looking to tread into the eye disease market.

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XTalks

DECEMBER 27, 2022

Ferring Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved Adstiladrin (nadofaragene firadenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

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XTalks

JULY 7, 2021

In this episode, Ayesha talks about the launch of a digital marketing campaign for the first FDA-approved therapeutic video game to help treat ADHD. It was developed by digital medicine company Akili Interactive. Read the full articles here: Akili Launches Digital Ad Campaign for First FDA-Approved ADHD Video Game.

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XTalks

DECEMBER 10, 2021

Zavegepant has an advantage over the two as it’s the only CGRP receptor antagonist in both intranasal spray and oral pill formulations that is in clinical development for the treatment of acute or episodic migraines. In the third quarter of 2021, Nurtec sales totalled $136 million , a 46 percent jump from the previous quarter.

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