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Category: News & Comments

The FDA Approves Keytruda for primary Mediastinal Large B-Cell Lymphoma (PMBCL)

–  Keytruda becomes the first anti-PD-1 therapy to be approved for PMBCL   – This is the 2nd indication for Keytruda for a hematologic malignancy. – The approval is based on tumor response rate and durability of response. The FDA...

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June 14, 2018

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Seattle Genetics Announced Impressive News as Did Celyad

Realizing the dream of approval of a small biotech’s lead drug would usually lead a small development-stage firm to either walking on the road to more achievements and growth, or walking in place doing nothing but spending its revenues while...

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October 4, 2017

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The Biotech Sector Evolution in the News

Innoviva (INVA) and GlaxoSmithKline plc (GSK) announced positive results from the pivotal Phase 3 FULFIL study of the Closed Triple combination of fluticasone furoate, umeclidinium, and vilanterol) for patients with chronic obstructive pulmonary disease (COPD). The advancement in the treatment...

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June 22, 2016

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Biotech Firms with Guaranteed Growth Potential

Good news is not always great news that makes a difference. In the drug industry, clinical trial results that demonstrate a drug has fulfilled the requirements of the trials, including the primary and secondary endpoints does not always guarantee that...

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July 7, 2016

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Why Do We Like Mannkind Now?

On November 2, 2017 Mannkind (MNKD) announced that the FDA has approved an update to its inhaled insulin product Afrezza prescribing information to include new clinical data that were presented at the American Diabetes Association's 76th Scientific Sessions in June...

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October 5, 2017

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JUNO Surged After the FDA Removed the Clinical Hold of the ROCKET Trial. See Also: Why SAGE Surged

JUNO   Juno Therapeutics (JUNO) , the CAR T developing firm that aims at revolutionizing cancer treatment has gotten the news we anticipated, but significantly faster than we expected . Indeed, the U.S. Food and Drug Administration (FDA) has removed...

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July 13, 2016

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NOVOCURE: The FDA Approves the Firm's Second Generation Non-Invasive Treatment for Glioblastoma

News about approvals or insinuations about almost guaranteed future approvals of products that promise improving the management of chronic and life-threatening diseases are always welcomed with enthusiasm. Of course some approvals are more rewarding than others, which has to be...

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July 15, 2016

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Adaptimmune EMA Privileges. Different Fate for Plummeting Stocks

EMA’s created Priority Medicines (PRIME) regulatory initiative for products which the European agency rules they are of unmet needs. PRIME makes them eligible for support, possible regulatory applications and potential accelerated reviews. PRIME has accepted Adaptimmune’s (ADAP) drug NY-ESO-targeting T-cell...

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August 1, 2016

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Why BMY News Is Not As Bad As Hysterical Investors Believed

ANOTHER MISLEADING STORY  This article was corrected after being posted. Read our apology at the end of the article . Forecasting exaggerated impact of negative-looking news has stricken  GlaxoSmithKline (GSK)  shareholders today, while enchanting  Merck’s (MRK) shareholders. GSK said that:...

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August 5, 2016

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KalVista Pharmaceuticals Signs a Lucrative Strategic Agreement with Merck

- The Agreement Covers the Development of Investigational Plasma Kallikrein Inhibitors for Diabetic Macular Edema (DME) - Upfront Fee ($37 Million).  Potential Milestone Payments. Royalties On Sales. The deal could be worth $750 million - Merck Acquires 9.9% Stake in KalVista in...

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October 11, 2017

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