Top News from Annual J.P. Morgan Healthcare Conference 2018

Celgene to Acquire Impact Biomedicines, Adding Fedratinib to Its Pipeline of Novel Therapies for Hematologic Malignancies

January 8, 2018

Celgene Corporation and Impact Biomedicines have announced the signing of a definitive agreement in which Celgene will acquire Impact Biomedicines, which is developing fedratinib for myelofibrosis and polycythemia vera. Under the terms of the agreement, Celgene will pay approximately $1.1 billion upfront and up to $1.25 billion in contingent payments based on regulatory approval milestones for myelofibrosis. Additional future payments for regulatory approvals in additional indications and sales-based milestones are also possible.

AbbVie’s Upadacitinib Granted Breakthrough Therapy Designation from the U.S. FDA for Atopic Dermatitis

Jan. 8, 2018

AbbVie, a global research and development-based biopharmaceutical company, has announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational, once-daily oral JAK1-selective inhibitor Upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. This Breakthrough Therapy Designation is supported by positive Phase 2b results previously announced in September 2017, and marks 13 Breakthrough Therapy Designations granted to AbbVie’s investigational treatments since the company’s inception in 2013.

Novo Nordisk has proposed to acquire Ablynx for up to EUR 30.50 per share in cash, consisting of EUR 28.00 upfront and EUR 2.50 in Contingent Value Rights

January 8, 2018

Novo Nordisk has confirmed that it made a proposal to acquire Ablynx for EUR 28.00 per share in cash and one CVR with total potential cash payments over time of up to EUR 2.50 per share. This proposal implies a total equity valuation of approximately EUR 2.6 billion for Ablynx. Novo Nordisk has made a concerted and good faith effort to engage in discussions with Ablynx. This proposal is the second proposal that Novo Nordisk has made to Ablynx’s Board of Directors and represents up to approximately a 14% increase over the first proposal.

Dynavax Announces HEPLISAV-B™ is Now Available in the United States for the Prevention of Hepatitis B in Adults

January 08, 2018

Dynavax Technologies Corporation has announced that HEPLISAV-B™ [Hepatitis B Vaccine (Recombinant), Adjuvanted] is now available in the United States for the prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. HEPLISAV-B was approved by the U.S. Food and Drug Administration (FDA) on November 9, 2017. It is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults.

Thermo Fisher Scientific and Illumina Sign Agreement to Provide Research Market Broader Access to Ion AmpliSeq Technology

January 8, 2018

Illumina, Inc. and Thermo Fisher Scientific have announced that they have signed a commercial agreement that enables Illumina to sell Ion AmpliSeq technology to researchers who conduct scientific studies on Illumina’s next-generation sequencing (NGS) platforms. The best-in-class amplicon technology is highly effective in capturing DNA and RNA from minute amounts of samples for application in multiple areas of research. Under the agreement, Thermo Fisher will provide Illumina with Ion AmpliSeq technology for research use. Illumina will sell the product directly to its customers under the name AmpliSeq for Illumina. Thermo Fisher will continue to sell Ion AmpliSeq chemistry for both IVD and RUO applications to Ion Torrent NGS customers, and retains the right to make the technology available on other next-generation sequencing platforms.

Companies join forces to advance predictive and prescriptive recommendations for people with diabetes

January 8, 2018

Eli Lilly and Company and Livongo Health, a leading consumer digital health company focused on empowering all people with chronic conditions to live better and healthier lives, have announced a strategic collaboration to study real-world evidence and develop new insights to reduce the burden on people living with diabetes. The research collaboration will combine real-world behavioral studies and claims data to advance knowledge about effective interventions in diabetes care. The companies aim to contribute to medical literature in three areas:

  • Measure the impact of remote diabetes self-management education and support on clinical and healthcare cost outcomes
  • Understand drivers of healthy behaviors
  • Understand how people living with diabetes can stay more actively involved in their health
Shire announces business update at 36th Annual J.P. Morgan Healthcare Conference

January 8, 2018

Shire plc continues to progress its strategy as the leading global biotech company focused on rare diseases. The company has announced that it will create two distinct business divisions within Shire: a Rare Disease Division and a Neuroscience Division. Each division will benefit from sharper management focus, greater strategic clarity, and an increased ability to deploy resources to key growth priorities.

Axovant Announces Negative Results for Intepirdine In Phase 2b Headway and Pilot Phase 2 Gait and Balance Studies; Positive Trends in Efficacy Seen in Pilot Phase 2 Nelotanserin Study
January 9, 2018

Axovant Sciences has announced the results of the pilot Phase 2 Visual Hallucination study that the post-hoc subset analysis of patients with a baseline Scale for the Assessment of Positive Symptoms – Parkinson’s Disease (SAPS-PD) score of greater than 8.0 was misreported. The previously reported data for this population (n=19) that nelotanserin treatment at 40 mg for two weeks followed by 80 mg for two weeks resulted in a 1.21-point improvement (p=0.011, unadjusted) were incorrect. While nelotanserin treatment at 40 mg for two weeks followed by 80 mg for two weeks did result in a 1.21-point improvement, the p-value was actually 0.531, unadjusted. Based on these updated results, the Company will continue to discuss a larger confirmatory nelotanserin study with the U.S. Food and Drug Administration (FDA) that is focused on patients with dementia with Lewy bodies (DLB) with motor function deficits. The Company may further evaluate nelotanserin for psychotic symptoms in DLB and Parkinson’s disease dementia (PDD) patients in future clinical studies.

Novartis advances head-to-head superiority trials of Cosentyx® versus Humira® and proposed biosimilar adalimumab

January 9, 2018

Novartis has announced the initiation of SURPASS, a head-to-head clinical trial of Cosentyx® (secukinumab) versus proposed biosimilar adalimumab in ankylosing spondylitis (AS). SURPASS is the first head-to-head clinical trial in AS investigating superiority of Cosentyx in slowing spinal bone damage versus proposed biosimilar adalimumab. SURPASS is currently recruiting patients, with the ‘first patient first visit’ already achieved in November 2017. SURPASS and EXCEED are part of a larger rheumatology program for Cosentyx. EXCEED is a head-to-head clinical trial of Cosentyx versus Humira® (adalimumab) in psoriatic arthritis (PsA), which is already recruiting. EXCEED is the first large double-blinded head-to-head clinical trial versus Humira® in PsA investigating superiority of Cosentyx on ACR 20 at 52 weeks as the primary endpoint.

Top News from Annual J.P. Morgan Healthcare Conference 2018 last edit: 2018-01-15T10:16:01+00:00 da Luca

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