Search jobs 05-Feb-2021 U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), a New CAR T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma
Breyanzi
demonstrated a 73% overall response rate and 54% complete response (CR) rate in the largest pivotal trial in 3L+ LBCL, TRANSCEND NHL 001 trial
Breyanzi
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treatment occurred in 4% and 12% of patients, respectively
PRINCETON, N.J. (BUSINESS WIRE) $BMY#BMS Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved
Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL
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NEWTON, Mass., Feb. 4, 2021 /PRNewswire/ Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that its partner Promedico Ltd., a member of the Neopharm Group, has received a principal approval letter from the Israeli Ministry of Health, Israel s regulatory agency responsible for the approval of new medicines, granting the approval of XPOVIO® (selinexor) for the treatment of patients with either multiple myeloma or diffuse large B-cell lymphoma (DLBCL). The approved indications for XPOVIO are a) in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and b) for the treatment of adult patients with relapsed or refr
Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2020
Reports Fourth Quarter Revenues of $11.1 Billion; Full-Year Revenues of $42.5 Billion Posts Fourth Quarter Loss Per Share of $4.45 and Non-GAAP EPS of $1.46; Full-Year Loss Per Share of $3.99 and Non-GAAP EPS of $6.44 Completes Acquisition of MyoKardia, Expanding Leading Cardiovascular Franchise Announces Debt Tender Offer for an Aggregate Purchase Price of Up to $4.0 Billion Delivers Positive Results from … Reports Fourth Quarter Revenues of $11.1 Billion; Full-Year Revenues of $42.5 Billion Posts Fourth Quarter Loss Per Share of $4.45 and Non-GAAP EPS of $1.46; Full-Year Loss Per Share of $3.99 and Non-GAAP EPS of $6.44 Completes Acquisition of MyoKardia, Expanding Leading Cardiovascular Franchise
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ROCKLAND, Mass., Feb. 3, 2021 /PRNewswire/ EMD Serono, the healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that the US Food and Drug Administration (FDA) has approved TEPMETKO
® (tepotinib) following Priority Review for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (
MET) exon 14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
The approval is based on results from the pivotal Phase II VISION study evaluating TEPMETKO as monotherapy in patients with advanced NSCLC with
Karyopharm Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
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NEWTON, Mass., Feb. 1, 2021 /PRNewswire/ Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the Compensation Committee of Karyopharm s Board of Directors granted stock options to purchase an aggregate of 165,500 shares of Karyopharm s common stock to 31 newly-hired employees, with a grant date of January 29, 2021. The stock options were granted as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).
Each of the stock options has an exercise price of $15.23 per share, the closing price of Karyopharm s common stock on January 29, 2021. Each stock option vests over four years, with 25% of the total number of shares underlying the stock option vesting on the one-year a