Selinexor FDA Submission Started for Multiple Myeloma

Selinexor FDA Submission Started for Multiple Myeloma

A rolling submission of an FDA new drug application (NDA) has been submitted for selinexor for the treatment of patients with penta-refractory multiple myeloma, according to Karyopharm Therapeutics, the manufacturer of the XPO1 inhibitor. The NDA is based on results from part 2 of the phase IIb STORM trial, in which selinexor induced an overall […]

Astellas Is Considering Selling Europe Assets to Raise Cash

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Jim Cramer: 3 Biotech Stocks Show Signs They're Ready to Climb

Jim Cramer: 3 Biotech Stocks Show Signs They're Ready to Climb

Despite President Trump circling around semi-regularly to bash the pharmaceutical industry and drug prices, biotech stocks seem to be doing pretty well. The Nasdaq Biotechnology ETF, called the IBB, is up about 17 percent so far this year. CNBC’s Jim Cramer invited in technician Bob Lang, the founder of ExplosiveOptions.net and part of TheStreet.com’s Trifecta […]

PolyU – Axis Therapeutics Joint Center for Immunotherapy Launched to Develop Innovative Cancer Treatments

PolyU – Axis Therapeutics Joint Center for Immunotherapy Launched to Develop Innovative Cancer Treatments

A memorandum of understanding (MoU) signing ceremony for setting up the PolyU-Axis Therapeutics Joint Center for Immunotherapy was held today (18 July 2018). The MoU was signed by Ir Professor Ping-kong Alexander WAI, Vice President (Research Development) of PolyU; Dr Johnson LAU, Chairman and CEO of Athenex, Inc.; and Mr YongHui WANG, Chairman and CEO […]

FDA Lays Out New Pathways for Nonprescription Drugs

FDA Lays Out New Pathways for Nonprescription Drugs

In a draft guidance released Tuesday, the US Food and Drug Administration (FDA) details two proposed approaches to making more drugs available without a prescription. Under current regulations, nonprescription drugs can come to market either by conforming to an over-the-counter (OTC) monograph or via FDA’s new drug application (NDA) process. To qualify for sale without […]

Ropes & Gray Adds Another Experienced IP Life Sciences Partner in New York, Charlotte Jacobsen

Ropes & Gray Adds Another Experienced IP Life Sciences Partner in New York, Charlotte Jacobsen

NEW YORK, July 17, 2018 /PRNewswire/ — Global law firm Ropes & Gray today announced that Charlotte Jacobsen has joined its 350-lawyer New York office as partner in the firm’s life sciences intellectual property litigation practice. Ms. Jacobsen is the second high-profile IP life sciences attorney to join the firm in New York in 2018; Filko […]

FDA Issues Guidances for Shared REMS and Waivers to Help Promote Competition and Access

FDA Issues Guidances for Shared REMS and Waivers to Help Promote Competition and Access

On May 31, 2018, the FDA announced two new guidances designed to help generic drug manufacturers to obtain access to shared Risk Evaluation and Mitigation Systems programs, thereby promoting competition and access. The first guidance, “Development of a Shared REMS” (the “Shared REMS Guidance”) describes principles and recommendations to help sponsors with developing shared REMS […]

Innovus Pharmaceuticals Reports Preliminary Q2 2018 Sales Revenue of $6.6 million to $6.8 million

Innovus Pharmaceuticals Reports Preliminary Q2 2018 Sales Revenue of $6.6 million to $6.8 million

Innovus Pharmaceuticals, Inc., (“Innovus Pharma”) (OTCQB: INNV), today announced preliminary second quarter 2018 net revenue is estimated to be between $6.6 million to $6.8 million or an approximate 47-51% increase from the first quarter of 2018 and an approximate increase of 330-340% from the second quarter of 2017. Innovus Pharma’s […]

As Aetna New (AET) Shares Rose, Water Island Capital Lifted Position; As Exelixis (EXEL) Valuation Declined, Meditor …

As Aetna New (AET) Shares Rose, Water Island Capital Lifted Position; As Exelixis (EXEL) Valuation Declined, Meditor …

July 17, 2018 – By Eric Painter Meditor Group Ltd decreased its stake in Exelixis Inc (EXEL) by 3.15% based on its latest 2018Q1 regulatory filing with the SEC. Meditor Group Ltd sold 518,600 shares as the company’s stock declined 29.43% with the market. The institutional investor held 15.97 million shares of the health care […]