AbbVie

664 articles with AbbVie

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  UPDATED: Shire Rejects Takeda’s $60 Billion Acquisition Bid and Allergan Repo...

  4/19/2018

  Takeda Pharmaceutical has made an official bid to acquire London’s Shire for about $60 billion. And in breaking news, Shire rejected the bid, saying it undervalued the company.
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  Eli Lilly and Incyte Shares Drop as FDA Raises Concerns about Arthritis Drug

  4/19/2018

  Ahead of next Monday’s U.S. Food and Drug Administration (FDA) committee review of Eli Lilly and Incyte’s baricitinib for rheumatoid arthritis, concerns over blood clots, may scuttle the drug’s chances.
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  FDA Pushes Back PDUFA Date for AbbVie’s Endometriosis Drug

  4/11/2018

  The U.S. Food and Drug Administration wants more time to review AbbVie’s elagolix, a treatment for endometriosis-associated pain.
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  Pipeline Concerns: Four Biotechs to Keep Your Eye On

  4/11/2018

  When a pipe in someone’s house breaks or leaks it can cause a lot of damage to the property if it is not addressed in a timely manner. The same can be said for the pipelines of biopharma companies.
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  Survey Says These Five Biotech Companies are Top Places to Work

  4/11/2018

  There are a lot of factors that must come together in order to make a “great” workplace. A new report suggests that two of the key features of a great workplace are a “strong sense of purpose and lived-out values.”
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  New Database Tracks Pharma Donations to Patient Advocacy Groups

  4/10/2018

  The relationship between pharmaceutical companies and patient advocacy groups is long and deep and involves millions of dollars in donations, a new report reveals.

• AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain

  4/10/2018

  FDA requires extended time for review of additional information in New Drug Application (NDA)

• Upadacitinib Meets All Primary and Ranked Secondary Endpoints Including Superiority Versus Adalimumab in Phase 3 Study in Rheumatoid Arthritis

  4/9/2018

  Upadacitinib significantly inhibited radiographic progression at week 26 compared to placebo

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  AbbVie’s Arthritis Drug Dazzles in Phase III Trial

  4/9/2018

  AbbVie announced positive top-line data from its Phase III SELECT-COMPARE clinical trial of upadacitinib in moderate to severe rheumatoid arthritis.
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  UPDATED: FDA Issues CLRs for Two Celltrion and Teva Biosimilars

  4/6/2018

  The FDA issued two Complete Response Letters (CRLs) to South Korean manufacturer Celltrion. Teva Pharmaceutical Industries signed a deal in 2016 with Celltrion to commercialize the two biosimilars.

• Biogen and Samsung Bioepis Agree to Settlement with AbbVie Allowing Commercialization of IMRALDI™ (Adalimumab Biosimilar) in Europe

  4/5/2018

  Biogen expects to launch IMRALDI in Europe on October 16, 2018

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  AbbVie Strikes Deal: Blockbuster Humira is Safe Until 2023

  4/5/2018

  U.S. sales of AbbVie’s blockbuster Humira is safe from a biosimilar challenge from Samsung Bioepis, a joint project between Samsung and Biogen, until 2023.

• Samsung Bioepis Settles Patent Disputes with AbbVie, Clearing the Way for the Commercialization of SB5 (Adalimumab) in All Approved Markets Worldwide

  4/5/2018

  Samsung Bioepis’ IMRALDI® expected to launch in Europe on October 16, 2018

• AbbVie Announces Global Resolution of HUMIRA® (adalimumab) Patent Disputes with Samsung Bioepis

  4/5/2018

  - Agreements Provide Non-Exclusive License to Samsung Bioepis for HUMIRA-Related Intellectual Property in the U.S. Effective June 30, 2023, and in Other Markets on Different Dates - Samsung Bioepis Acknowledges Validity of AbbVie's Intellectual Property for HUMIRA

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  The Big Tease: Takeda Considers Buying Shire

  3/28/2018

  Shire stock prices jumped up to 26 percent on rumors that Takeda Pharmaceuticals was considering a buyout.
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  After Rova-T Failure, A Look at AbbVie’s Pipeline

  3/27/2018

  Analysts look at what else AbbVie has in the pipeline after Rova-T Failure.
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  Ablynx Drug Fails Again in Mid-Stage Trial

  3/26/2018

  For the second time Ablynx’s anti-IL-6R Nanobody, vobarilizumab has failed to pass muster. This morning Belgium-based company said vobarilizumab did not meet primary endpoints in a Phase II dosing study for lupus patients.
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  Poor Mid-Stage Results Sink AbbVie’s Plans for Cancer Drug

  3/22/2018

  After disappointing mid-stage results and discussions with the FDA, AbbVie will not ask for accelerated approval for its lung cancer drug.

• AbbVie Announces Results from Phase 2 Study Evaluating Rovalpituzumab Tesirine (Rova-T) for Third-Line Treatment of Patients with DLL3-Expressing Relapsed/Refractory Small Cell Lung Cancer

  3/22/2018

  AbbVie will not seek accelerated approval for Rova-T in third-line relapsed/refractory small cell lung cancer (SCLC)

• AbbVie and the International Myeloma Foundation Announce Partnership to Study the Role of a Genetic Mutation in Outcomes of Patients with Multiple Myeloma

  3/21/2018

  - Study is among the largest and most comprehensive in multiple myeloma (MM), and will assess outcomes from 1,500 patients with MM and the t(11;14) translocation at participating International Myeloma Foundation sites globally - Study will provide insight into the relatively unknown role of genetic mutations in response to treatment and the corresponding outcomes in patients with MM