Search Results for “AbbVie” – Page 4 – media

AbbVie Files Patent Infringement Lawsuit Against BeiGene’s Brukinsa

By Alejandra Manjarrez www.biospace.com Pictured: Judicial gavel and scales of justice/iStock AbbVie has filed a lawsuit accusing China-based BeiGene’s new blood cancer drug Brukinsa (zanubrutinib) of infringing on its patent for Imbruvica (ibrutinib). Imbruvica was co-developed by J&J’s Janssen and AbbVie’s Pharmacyclics and approved in 2014 by the FDA as a treatment for chronic lymphocytic leukemia. Brukinsa, which gained its FDA approval in January 2023, had its patent issued on Tuesday. Through its complaint, filed that same day in federal court in Delaware, AbbVie is seeking a declaratory judgment of infringement plus damages, Bloomberg Law reported. BeiGene’s shares in Hong Kong and mainland China have fallen more than 10% since the announcement. Both Brukinsa and Imbruvica are BTK inhibitors designed as oral medications to treat the slow-growing blood cancers chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). They are different forms of the same disease and account for about ...
- Source: drugdu
- 112
- June 17, 2023
AbbVie and Genmab’s blood cancer therapy granted FDA accelerated approval

AbbVie and Genmab’s blood cancer therapy, Epkinly (epcoritamab-bysp), has been granted accelerated approval by the US Food and Drug Administration (FDA). The authorisation specifically applies to adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least two prior lines of treatment. DLBCL is the most common type of aggressive lymphoma, with approximately 150,000 cases of the disease diagnosed globally each year. For R/R patients, several targeted therapies including T-cell mediated treatments have recently emerged, the companies said. However, single agent and ready-available or off-the-shelf treatment options are limited. Epkinly, which is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration, is now the first and only T-cell engaging bispecific antibody for this indication. The FDA’s decision was supported by positive results from a phase 1/2 trial, in which Epkinly delivered an overall response rate of 61%, a complete response rate ...
- Source: drugdu
- 117
- May 24, 2023
AbbVie’s Rinvoq scores its 7th FDA nod, this one for Crohn’s disease

In developing immunology treatment Rinvoq, AbbVie is employing the same game plan it used to make predecessor Humira a megablockbuster. And the company seems to be getting better at it.Thursday, AbbVie scored its seventh FDA approval for Rinvoq in a span of less than four years, getting the JAK inhibitor across the finish line as a treatment for Crohn’s disease. A look at Humira’s approval history shows that AbbVie has become more efficient in adding indications to its immunology blockbusters. After Humira was initially blessed in 2002, it took AbbVie 10 years to get the TNF blocker endorsed for its seventh disease type. Coincidentally, Rinvoq’s new FDA approval came hours after the U.K.’s National Institute for Health and Care Excellence signed off on the drug for Crohn’s disease. This is the second gastroenterology indication for Rinvoq after it won approval for ulcerative colitis in March of last year. Rinvoq’s first ...
- Source: drugdu
- 125
- May 21, 2023
AbbVie nabs seventh FDA approval for Rinvoq, adds Crohn’s disease indication

Beth Snyder Bulik Senior Editor AbbVie picked up another indication for blockbuster Rinvoq on Thursday, this time for Crohn’s disease. The seventh FDA approval for the JAK inhibitor is specifically for use in moderate to severe Crohn’s patients who have had inadequate response or intolerance of at least one TNF blocker. While there are several other biologics already on the market to treat moderately to severely active Crohn’s including J&J’s Stelara, Takeda’s Entyvio and AbbVie’s own Skyrizi, the FDA noted that Rinvoq is the first oral drug. The approval was based on results from three studies, the U-EXCEED and U-EXCEL initial trial and the U-ENDURE maintenance trial, determining statistical significance in the co-primary endpoints of endoscopic response and clinical remission. AbbVie consultant and gastroenterologist Edward Loftus, who was a U-EXCEL investigator, said in a news release, “Based on the clinical trial results, treatment with RINVOQ shows both early and long-term ...
- Source: drugdu
- 122
- May 21, 2023
AbbVie weathers first months of biosimilar challenge to top-selling Humira

Ned PagliaruloLead Editor Dive Brief: AbbVie withstood the first months of U.S. copycat competition to its lucrative arthritis drug Humira about as Wall Street had expected, conceding on price to maintain insurance coverage in response to Amgen launching the country’s first biosimilar rival in January. U.S. Humira sales totaled nearly $3 billion, a decline of 26% from the same period one year ago and just over analysts’ consensus forecasts. AbbVie executives told investors on a Thursday conference call that most of that impact was driven by price changes. Amgen, which recorded $51 million in U.S. revenue for its biosimilar Amjevita, is selling its Humira rival at two different prices: a 5% discount to Humira’s nearly $90,000 annual list price, and a 55% discount. The approach is meant to address the unique demands of the U.S. healthcare system, in which insurers rely on manufacturers providing rebates off of a drug’s sticker ...
- Source: drugdu
- 164
- April 30, 2023
survey

The FDA approval of AbbVie’s oral CGRP inhibitor Qulipta in chronic migraine could unleash a fresh phase of growth for the drug. That is the conclusion of survey data gathered by Spherix Global Insights, which found most physicians are very willing to prescribe the drug to patients with chronic migraine. Prior to the FDA approval, Spherix spoke to 74 neurologists and 101 primary care physicians about the migraine market, including their interest in prescribing Qulipta for the treatment of patients who have headaches at least 15 days per month. The survey suggests that AbbVie’s work to drum up interest in Qulipta since winning approval in episodic migraine in 2021 has primed the product for growth. Almost two-thirds of the surveyed neurologists said they would be very willing to prescribe Qulipta to chronic migraine patients, up from half earlier in the launch. Similarly, more than 50% of primary ...
- Source: drugdu
- 129
- April 27, 2023
Nonprofit Report Discloses Worst Patent ‘Offenders’; AbbVie, Roche and Pfizer

A new report by nonprofit group Initiative for Medicines, Access & Knowledge (I-MAK) exposes the prime offenders of the U.S. patent system, the pharma giants who are taking advantage of its loopholes to amass huge profits.
- Source: FiercePharma
- 609
- August 8, 2018
Market Views pharmaceutical company pharmaceutical drugs
AbbVie Investors Need not Abandon Ship yet

After watching Scott Gottlieb, M.D. of the FDA comments regarding the rebate rule changes and a warning tweet on biosimilars, AbbVie investors are bailing out. But the industry watchers claim that they don’t need to be.
- Source: FiercePharma
- 1,088
- July 24, 2018
AbbVie biopharmaceutical FDA Market Views
Carisma Therapeutics Bags $53 Million in Series A Funding led by AbbVie

Philadelphia-based Carisma Therapeutics bagged $53 million in series A funding, led by AbbVie Ventures Co-led by HealthCap, new backers Wellington Partners, MRL Ventures Fund, TPG Biotech, and Agent Capital.
- Source: FierceBiotech
- 726
- June 28, 2018
biotech CAR-T therapies Company Insights funding
Amegen and Celgene to be Threatened by Pfizer and AbbVie

It is broadly estimated that JAKs are likely to dominate around 24% of the market which is not a good news for products like Enbrel manufactured by Amgen. It is likely that the drug is to cascade into fast decline as physicians increasingly prefer JAK as a second drug after Humira of AbbVie.
- Source: Ddu
- 617
- May 23, 2018
Market Views pharma

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.