Pipeline updates and news over the previous week from 20 companies.

Aug 03, 2014 No Comments by

Pacira Pharmaceuticals, Inc.(NASDAQ: PCRX) noted that the FDA has set a PDUFA date of March 5, 2015 for the supplemental New Drug Application (sNDA) for a nerve block indication for EXPAREL. NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY) said that their BAYnovation trial for viral conjunctivitis has been completed and top-line results are due in mid-August 2014. Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) maintained guidance that the pre-planned […]

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Updates for GALE SCMP BLRX APPA RPTP ACOR RLYP INFI HALO ARNA CLVS SGEN ICPT GILD CUR MRK CYCC CRIS ACHN

Jan 13, 2014 No Comments by

Curis, Inc.(NASDAQ:CRIS) provided an update noting that Phase 2 data of everolimus for Operable Nodular BCC (basal cell carcinoma) are due 1Q 2014. Their submission to the FDA regarding the partial clinical hold of CUDC-427 is due shortly. A Phase 2 trial of Debio 0932 is due to be to initiated in 2H 2014. Galena Biopharma (Nasdaq:GALE) announced it has […]

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AEZS file NDA. IMGN fail Phase 2 trial. ECYT decision due Dec-Jan. ADHD data due Dec. KERX positive data + updates for STEM SGEN PTLA ISIS INSM ZGNX ITMN

Nov 06, 2013 No Comments by

Aeterna Zentaris Inc. (NASDAQ: AEZS $1.39) announced that it has submitted a NDA for AEZS-130 for adult growth hormone deficiency (“AGHD”). ImmunoGen, Inc. (Nasdaq: IMGN $13.41) announced that it will discontinue their Phase 2 trail of IMGN901 for SCLC, following the recommendation from the Data Monitoring Committee (DMC) due to a higher rate of infection and […]

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DVAX requires more safety data. AVEO CRL. CLVS offering. BDSI NDA due mid summer + SGEN EXAS AZN updates

Jun 11, 2013 No Comments

Dynavax Technologies Corporation (NASDAQ: DVAX) reported that following a meeting with the FDA regarding its Biologic License Application (BLA) for HEPLISAV,an adult hepatitis B vaccine, additional safety data would be required before they refile their BLA. This would most likely necessitate the need for a new trial. Clovis Oncology (NASDAQ:CLVS) announced that it has commenced an underwritten […]

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AFFY CEO contract terminated. ACAD RMTI offerings. SGEN PDUFA date set + TTPH LGND PTN PRMD KBIO GENT updates

May 15, 2013 No Comments

Affymax, Inc. (NASDAQ:AFFY) announced in a filing that the contract of its CEO, John Orwin, has been terminated. This follows a company-wide restructuring plan by The Brenner Group, Inc, a restructuring firm assigned by Affymax. Rockwell Medical, Inc. (Nasdaq:RMTI) announced it intends to offer shares in an underwritten public offering. ACADIA Pharmaceuticals Inc. (ACAD) also  announced it intends to offer shares […]

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Pipeline updates for ACHN BCRX BLRX CLVS RIGL INSM TRGT CBST INFI AEZS SCMP SGEN FURX EXEL FLML TSRX KERX ZIOP ISIS

May 08, 2013 No Comments

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) provided an update noting that interim RVR results from its Phase 2 ACH-3102 trials for the treatment of genotype 1 HCV are due in 3Q 2013 (-007 trial), followed by SVR results during 4Q 2013. BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) said it plans to initiate a Phase 2 trial of BCX4161 in patients with hereditary angioedema, later in 2013 […]

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AFFY reduces workforce. SGEN files sBLA + updates for MACK AGN CYTK MELA INCY INSM NVAX INO RMTI ICPT OMER

Mar 19, 2013 No Comments

Affymax, Inc. (Nasdaq: AFFY) announced in a filing that it will reduce its workforce by approximately 230 employees (or 75%) following the recall of OMONTYS.  The company is considering all possible alternatives, including further restructuring activities, wind-down of operations or even bankruptcy proceedings. If they are unable to rapidly identify and rectify the causes of the safety concerns […]

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ZIOP Phase 3 data due end of March + updates for DCTH POZN MELA VNDA BIOD SGEN CYTK OGXI IMGN

Feb 13, 2013 No Comments

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) announced that the Phase 3 (PICASSO 3) trial of palifosfamide (ZIO-201) in first-line metastatic soft tissue sarcoma has reached its target number of progression-free survival (PFS) events. Topline results from this trial will be released during the last week of March 2013. Delcath Systems, Inc. (NASDAQ: DCTH) said it continues to […]

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BIIB positive Phase 3 data. CBST pipeline update.ANTH offering + SGEN ARIA ACOR news

Jan 25, 2013 No Comments

Biogen Idec (NASDAQ: BIIB) announced that it met the primary endpoint, the annualized relapse rate (ARR) at one year, for both the two-week and four-week doses in its Phase 3 pivotal clinical trial, ADVANCE, of peginterferon beta-1a as a potential treatment for relapsing-remitting multiple sclerosis (RRMS). It also mentioned that it met the secondary endpoints of risk of 12-week […]

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DCTH PDUFA date set. CRTX CRL. Pipeline updates for IDIX CLDX THLD KERX INCY ECYT RPTP SGEN ISIS PCRX PLX

Nov 04, 2012 No Comments

Delcath Systems, Inc. (NASDAQ: DCTH) announced a PDUFA date of June 15, 2013, for the resubmission of its New Drug Application (NDA) of its chemosaturation system with melphalan hydrochloride as a treatment for patients with unresectable metastatic melanoma in the liver. Cornerstone Therapeutics Inc. (NASDAQ: CRTX) announced that it received a Complete Response Letter (CRL) for […]

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ONXX receives FDA Approval. SGEN and ASTX granted positive CHMP recommendations. ANTH and SOMX offering details + PSDV SGYP ARRY news

Jul 20, 2012 No Comments

Onyx Pharmaceuticals (Nasdaq: ONXX) today announced that it received accelerated approval from the FDA for Kyprolis (carfilzomib) for Injection, for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy. Ligand […]

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