Pharmaceutical

Join us as we discuss today's pressing healthcare issues.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201102005244/en/

Bunny Ellerin, Director, HPM, Columbia Business School, MBA, Harvard Business School, BA, Columbia University (Photo: Business Wire)

Bunny Ellerin, Director, HPM, Columbia Business School, MBA, Harvard Business School, BA, Columbia University (Photo: Business Wire)

CO-HOSTS:

Bunny Ellerin

Director, HPM, Columbia Business School

Jing He

Biotech Analyst, Gabelli Funds

  • MBA, Harvard Business School
  • BA, Columbia University
  • MBA, Columbia Business School
  • MA, Washington University in St. Louis
  • BS, Peking University

Time

Agenda

9:00 – 9:10 AM

Welcome

  • Bunny Ellerin, Director, Healthcare and Pharmaceutical Management Program

9:10 – 10:00 AM

Vaccines & Therapeutics to Treat COVID-19

  • David Hering, Regional President, North America, Pfizer Vaccines
  • Dr. Robert Paris, Vice President, Infectious Diseases, Moderna
  • Dr. David Weinreich, Senior Vice President, Global Clinical Development, Regeneron
  • (Moderator) Jing He ‘15, Biotech Analyst, Gabelli Funds

10:10 – 11:00 AM

Health Policy & Reimbursement Trends

  • Dr. Deepa Kumaraiah, Senior Vice President, Service Lines and Chief Physician, NYP Medical Groups, NewYork-Presbyterian
  • Melissa Schulman, Senior Vice President of Government Affairs, CVS Health
  • Professor Michael Sparer, Chair, Health Policy and Management, Columbia University Mailman School of Public Health
  • (Moderator) Jeff Jonas, Portfolio Manager, Gabelli Funds

11:10 – Noon

Healthcare Delivery in a Virtual World

  • Dr. Amy Fahrenkopf, President, HSS Health and Senior Vice President, Hospital for Special Surgery
  • Jason Gorevic, CEO, Teladoc Health
  • Dr. Julie Silverstein, Divisional President, Oak Street Health
  • (Moderator) Kevin Kedra, Healthcare Analyst, G.research

Click Here to Register

Gabelli Funds, LLC is a registered investment adviser with the Securities and Exchange Commission and is a wholly owned subsidiary of GAMCO Investors, Inc. (NYSE: GBL).

Douglas R. Jamieson
914-921-5020
djamieson@gabelli.com

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Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15

  • Approximately 6,000 participants 5 years of age and older will be enrolled in Lyme disease-endemic regions in Europe and the U.S.

Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced the initiation of a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), to investigate the efficacy, safety and immunogenicity of their investigational Lyme disease vaccine candidate, VLA15.

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Pfizer to Acquire Global Blood Therapeutics for $5.4 Billion to Enhance Presence in Rare Hematology

Proposed acquisition drives growth by bringing leading sickle cell disease expertise, portfolio and pipeline to Pfizer with potential combined worldwide peak sales of more than $3 billion

Potential to address the full spectrum of critical needs in the underserved sickle cell community

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Myovant Sciences and Pfizer Receive U.S. FDA Approval of MYFEMBREE®, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis

  • Data from the Phase 3 SPIRIT program showed MYFEMBREE reduced menstrual pain and non-menstrual pelvic pain in premenopausal women with endometriosis, and a loss of mean bone mineral density of less than 1% from baseline through one year of treatment
  • Myovant and Pfizer will continue to jointly commercialize MYFEMBREE, with product available immediately
  • Myovant to host conference call and webcast on Monday, August 8, 2022, at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time

Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved MYFEMBREE ® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months. The approval is supported by one-year efficacy and safety data, including 24-week data from the Phase 3 SPIRIT 1 and SPIRIT 2 trials, which were published in The Lancet and the first 28 weeks of an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2. MYFEMBREE also is approved for heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. Myovant and Pfizer will continue to jointly commercialize MYFEMBREE in the U.S. and product is available immediately.

"Endometriosis is a painful, chronic disease with limited therapies to manage symptoms," said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. "The new MYFEMBREE indication helps advance our mission to redefine care for women by helping address a disease with high unmet need, giving women and physicians a new meaningful treatment option to manage moderate to severe pain associated with endometriosis."

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Jamieson Wellness Inc. Reports Second Quarter 2022 Financial Results

Company Increases Fiscal 2022 Guidance and Raises Second Quarter Dividend

Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX: JWEL) today reported financial results for its second quarter ended June 30, 2022. All amounts are expressed in Canadian dollars. Certain metrics, including those expressed on an adjusted basis, are non-IFRS and other financial measures. See "Non-IFRS and Other Financial Measures" below.

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LYNPARZA® Approved in the EU as Adjuvant Treatment for Patients With Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved LYNPARZA as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA 1/2 mutations (g BRCA m), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

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Merck and Eisai Provide Update on Phase 3 LEAP-002 Trial Evaluating KEYTRUDA® Plus LENVIMA® Versus LENVIMA Monotherapy in Patients With Unresectable Hepatocellular Carcinoma

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the Phase 3 LEAP-002 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, versus LENVIMA monotherapy did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). There were trends toward improvement in OS and PFS for patients who received KEYTRUDA plus LENVIMA versus LENVIMA monotherapy; however, these results did not meet statistical significance per the pre-specified statistical plan. The median OS of the LENVIMA monotherapy arm in LEAP-002 was longer than that observed in previously reported clinical trials evaluating LENVIMA monotherapy in uHCC. The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination. Merck and Eisai plan to present these data at an upcoming medical conference.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220803005211/en/

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