Myovant

ObsEva files uterine fibroid drug in US, chasing AbbVie, Myovant

Swiss biopharma company ObsEva has filed its oral GnRH antagonist linzagolix for the treatment of uterine fibroids in the US, hoping to expand the number of women eligible for this type of therapy. If approved, linzagolix will be the only drug in the class with a dosing regimen intended for women with uterine fibroids who …

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ViewPoints Interview: Myovant’s Dave Marek Shares Insights on the US FDA’s Approval of Myfembree in Uterine Fibroids

In an interview with PharmaShots, Dave Marek. CEO of Myovant shares insights on the US FDA’s approval of Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) in Uterine Fibroids. Shots: The US FDA has approved Myovant & Pfizer’s Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as the first once-daily …

ViewPoints Interview: Myovant’s Dave Marek Shares Insights on the US FDA’s Approval of Myfembree in Uterine Fibroids Read More »

Myovant’s Ryeqo (relugolix, estradiol, and norethindrone acetate) Receives EC’s Approval for the Treatment of Women with Uterine Fibroids

Shots: The approval is based on safety & efficacy data from the P-III LIBERTY program that consists of 2 studies i.e LIBERTY 1 & 2 evaluating Ryeqo in adult women with UF with no limitation for a duration of use. The EC’s decision is valid in all 27 member states of the EU, Iceland, Norway …

Myovant’s Ryeqo (relugolix, estradiol, and norethindrone acetate) Receives EC’s Approval for the Treatment of Women with Uterine Fibroids Read More »

ViewPoints Interview: Myovant’s Juan Camilo Arjona Ferreira Shares Insights on the Ryeqo

In an interview with PharmaShots, Myovant’s Juan Camilo Arjona Ferreira, MD, Chief Medical Officer of Myovant Sciences shares his views on the CHMP’s positive opinion for Ryeqo (Relugolix Combination Tablet). Shots: The CHMP has adopted positive opinion recommending approval of Ryeqo (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment …

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PharmaShots Weekly Snapshots (May 24 – 28, 2021)

Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug Designation,  Amyotrophic Lateral Sclerosis The US FDA’s EMDAC Supports Provention Bio’s Teplizumab in Delaying Diabetes Published: May 28, 2021 | Tags: US, FDA, EMDAC, Provention Bio, Teplizumab, Delaying Diabetes uniQure …

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FDA clears Myovant’s relugolix for uterine fibroids, setting up AbbVie clash

Myovant has chalked up a second approval for its flagship drug relugolix from the FDA, becoming the first once-daily oral drug in the US to treat heavy menstrual bleeding associated with uterine fibroids.  The drug will be sold as Myfembree (relugolix) for the uterine fibroids indication, and is already available to treat prostate cancer under …

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Pfizer/Myovant take relugolix contraceptive combination pill into phase 3

Pfizer and Myovant have begun a late-stage trial of their potential uterine fibroid drug relugolix, as part of a contraceptive combination tablet.  The FDA is already reviewing data from two phase 3 trials of relugolix as a treatment for fibroids, with a decision due on or before 1 June. Pfizer and Myovant began a collaboration …

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PharmaShots Weekly Snapshots (Feb 15- 19, 2021)

RedHill Signs a Manufacturing Agreement with Cosmo for Movantik and RHB-204  Published: Feb 19, 2021 | Tags: RedHill, Signs, Manufacturing, Agreement, Cosmo, Movantik, RHB-204 Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer Published: Feb 19, 2021 | Tags: Astellas, Seagen, Reports, Submission, …

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PharmaShots Weekly Snapshots (Jan 18 – 22, 2021)

Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC Published: Jan 22, 2020 | Tags: Takeda, Alunbrig, (brigatinib), Receives, MHLW, Approval,1L and 2L, Treatment, ALK+ Advanced or Recurrent NSCLC MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the …

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Top 20 Life Sciences Deals of 2020 by Total Deal Value

Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A, licensing, and research partnerships in 2020 Artios partnered with Merck with an option to license up to 8 oncology programs proving to be the highest valued deal of 2020 with a total deal …

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Insights+: The US FDA New Drug Approvals in December 2020

The US FDA has approved 7 NDAs and 2 BLA in Nov 2020, leading to treatments for patients and advances in the health care industry.   The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 105 novel products so far in 2020, including 9 in Dec 2020.   Additionally, last year in 2019, the US FDA has approved …

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PharmaShots Weekly Snapshots (Dec 28- 31, 2020)

Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study Published: Dec 30, 2020 | Tags: COVID-19, Interim Analysis, New Coronavirus Inactivated Vaccine, P-lll Study, reports, results, Sinopharm Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis Published: Dec 28, 2020 | Tags: CysticFibrosis, Drug, New, reports, Submission, Treatment, Trikafta, …

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Myovant Signs Agreement with Pfizer to Develop and Commercialize Relugolix in Oncology and Women’s Health

Shots: Myovant & Pfizer will jointly develop & commercialize ORGOVYX (relugolix) in advanced prostate cancer & if approved, relugolix combination tablet in women’s health in the US & Canada. Myovant will receive ~$4.2B including $650M upfront, $200M in regulatory milestones for FDA approvals for relugolix combination tablet in women’s health, and tiered sales milestones upon …

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