Amgen reports positive results for leukemia drug

By |March 3rd, 2017|Opinions|

Amgen Inc. ($AMGN) reported the results of the Phase 3 study of its leukemia drug Blincyto (blinatumomab). The company said that the drug almost doubled the overall survival (OS) rate in high-risk patients with B-Cell precursor acute lymphoblastic leukemia compared to chemotherapy. The data indicated that Blincyto resulted in a [...]

Premarket Biotech Digest – $VRML inks new deal, $JUNO ends cancer drug trials, $AUPH reports topline results

By |March 3rd, 2017|Digest|

Coherus BioSciences Inc. ($CHRS) reported that CHS-1420, its proposed biosimilar of adalimumab (Humira®), met the primary endpoint in a clinical pharmacokinetic (PK) bioequivalence study that compared CHS-1420 to Humira in healthy subjects. These endpoints are maximum serum concentration (Cmax), area under the time-concentration curve [...]

Exact Sciences reports positive results from lung cancer test study

By |March 2nd, 2017|Opinions|

Exact Sciences Corporation ($EXAS) reported that its collaboration with Mayo Clinics for developing a blood-based lung cancer test shows promising prospects. The study involved nearly 400 patients, which demonstrated high accuracy for detecting lung cancer at all stages. Kevin Conroy, chairman and CEO of Exact Sciences, said "Our collaboration with [...]

Premarket Biotech Digest – $AERI resubmits NDA, $OPK reports quarterly results, $OMER announces Phase 2 Data

By |March 2nd, 2017|Digest|

Roche Holding AG ($RHHBY) announced the positive results from the Phase III APHINITY study. The trial is being conducted by Roche Group firm Genentech, the Breast International Group (BIG) and Breast European Adjuvant Study Team. The study met its primary endpoint and showed that [...]

Pfizer receives warning letter from the FDA

By |March 1st, 2017|Opinions|

Pfizer Inc. ($PFE) reported that the company has received a warning letter from the FDA regarding its operations at a plant in McPherson, Kansas. The plant is used for manufacturing sterile injectable drugs. The letter stated that the company’s process at the plant was ‘out of control.’ The warning letter [...]

Premarket Biotech Digest – $SGYP reports trial results, $PRGO sells royalty stream, $ADXS inks new deal

By |March 1st, 2017|Digest|

Lexicon Pharmaceuticals Inc. ($LXRX) reported that it has received the FDA approval for its oral drug, Xarmelo, for treating carcinoid syndrome diarrhea, a condition that develops in patients with gastrointestinal tumors. The drug has been tested on patients unable to tolerate somatostatin analog therapy. [...]

ViewRay reports financial results and FDA approval

By |February 28th, 2017|Opinions|

ViewRay Inc. ($VRAY) jumped in its previous trading session as the company announced receiving the FDA approval for the MRIdian Linac system, its next generation linear accelerator-based MRI-guided radiation therapy system. The first two MRIdian Linac systems in the United States are expected to be installed at Henry Ford Hospital [...]

Premarket Biotech Digest –$LJPC provides trial updates, $ANIP acquires two products, $INCY joins S&P500 Index

By |February 28th, 2017|Digest|

ANI Pharmaceuticals ($ANIP) announced the acquisition of Inderal® XL from Cranford Pharmaceuticals, LLC and InnoPran XL® from Holmdel Pharmaceuticals LP. As a part of the deals, the company acquired the NDA and trademark for InnoPran XL® including a license to an Orange Book listed [...]

Laboratory Corp. of America Holdings to buy Pathology Associates Medical Laboratories

By |February 27th, 2017|Opinions|

Laboratory Corp. of America Holdings ($LH) announced its plans to acquire Pathology Associates Medical Laboratories LLC from Providence Health & Services and Catholic Health Initiatives. The companies expect the deal to be finalized by the early next year as the proceedings are likely to be initiated this year. Laboratory Corp. [...]

Premarket Biotech Digest – $ALIM files NDA, $MRK announces +ve results, $ABBV gets EMA nod

By |February 27th, 2017|Digest|

Merck & Co. ($MRK) announced the results for the pivotal Phase 3 clinical study of letermovir, an investigational antiviral medicine for the prevention of clinically-significant cytomegalovirus (CMV) infection in adult (18 years and older) CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant. The [...]

Boston Scientific announces recall of Lotus Valve devices

By |February 24th, 2017|Opinions|

Boston Scientific Corporation ($BSX) announced that it plans to recall its Lotus Valve devices due to reports of a premature release of a pin connecting the valve to the delivery system. The problem is most likely caused by excess tension in the pin mechanism introduced during the manufacturing process. The [...]

Premarket Biotech Digest – $PTX reports +ve results, $AOLS starts Phase I, $AGEN flunks study

By |February 24th, 2017|Digest|

OncoSec Medical Inc. ($ONCS) announced new positive clinical data from a Phase II Investigator Sponsored Trial assessing the combination of OncoSec's investigational intratumoral therapy, ImmunoPulse® IL-12, and the approved anti-PD- 1 therapy (pembrolizumab), in patients with unresectable metastatic melanoma. The results ndicated that ImmunoPulse® [...]

HealthSouth announces strong quarterly results, provides guidance

By |February 23rd, 2017|Opinions|

HealthSouth Corp ($HLS) recently reported its quarterly numbers. Its earnings for the quarter stood at $0.72 per share, beating consensus estimates of $0.63 per share in earnings. The company’s revenue for the quarter stood at $949.9 million, lagging behind estimates of $955.6 million. The company also provided results for its [...]

Premarket Biotech Digest – $PPHM stock shoots up, $AEMD reports +ve trial results, $HTGM receives delisting notice

By |February 23rd, 2017|Digest|

Aethlon Medical Inc. ($AEMD) announced the results of its study seeking to validated the in vitro capture of Cytomegalovirus (CMV), Epstein-Barr virus (EBV) and Herpes Simplex virus 1 (HSV1) by the Hemopurifier®. The results validated the ability of the Aethlon Hemopurifier® to capture latent [...]

Lantheus reports Q4 results, new deal with GE

By |February 22nd, 2017|Opinions|

Lantheus Holdings Inc. (NASDAQ:LNTH) reported its financial results for the fourth quarter and full year 2016. It also provided guidance for the current year. The company’s revenue during the fourth quarter stood at 74.4 million, compared to $71.2 million for the fourth quarter of 2015. For the full year 2016, [...]

Premarket Biotech Digest – $DCTH inks new deal, $HLS reports quarterly results, $ABT announces notes exchange

By |February 22nd, 2017|Digest|

HealthSouth Corp ($HLS) stock gained over 2 percent in its Tuesday trading session as the company reported its quarterly numbers. Its earnings for the quarter stood at $0.72 per share, beating consensus estimates of $0.63 per share in earnings. The company’s revenue for the [...]

Cellect Biotechnology reports positive results for ApoGraft trial

By |February 21st, 2017|Opinions|

Cellect Biotechnology ($APOP) shot up 14 percent in the current trading session as the company announced positive results from its clinical trial of ApoGraft™ in healthy donors. The primary objective for the study was to validate the Company's propriety method of stem cell selection by going through the process of [...]

Cellect Biotechnology reports positive results for ApoGraft trial

By |February 21st, 2017|Digest|

Cellect Biotechnology ($APOP) shot up 14 percent in the current trading session as the company announced positive results from its clinical trial of ApoGraft™ in healthy donors. The primary objective for the study was to validate the Company's propriety method of stem cell selection by going through the process of [...]

Premarket Biotech Digest – $VCEL receives FDA nod, $SRPT sells FDA voucher, $TRVN reports +ve results

By |February 21st, 2017|Digest|

Premarket Biotech Digest – $VCEL receives FDA nod, $SRPT sells FDA voucher, $TRVN reports +ve results $Digest, $VCEL, $SRPT, $TRVN Sarepta Therapeutics ($SRPT) announced selling an FDA review voucher to Gilead Sciences. The deal is expected to be worth $125 million. The company had [...]

Gilead Sciences receives Canadian approval for HIV drug

By |February 20th, 2017|Opinions|

Gilead Sciences Inc. ($GILD) announced that it has received approval in Canada for its ODEFSEY for treating HIV-1 infection. ODEFSEY is indicated in Canada as a complete regimen for the treatment of adults infected with HIV-1 with no known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) [...]

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