CBST PDUFA under priority review. THLD Ph3 TH-302 timeline update. PPHM initiates Ph3 trial

Dec 30, 2013 No Comments by

Cubist Pharmaceuticals, Inc. (NASDAQ:CBST $68.27) announced that the FDA  has accepted their New Drug Application (NDA) for tedizolid phosphate, for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The PDUFA date, under priority review, is June 20, 2014. Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM 1.41) announced that enrollment has commenced in their Phase 3 SUNRISE […]

Daily News Read more

Updates for ALNY ZGNX INSV DNDN OGXI ANAC RPTP NPSP NKTR KERX APPA SRPT THLD OPXA BCRX IMUC INFI

Aug 09, 2013 No Comments by

Zogenix, Inc. (Nasdaq:ZGNX $1.52) said it continues to expect that the FDA will reach a decision regarding the Zohyrdo ER New Drug Application(NDA), during the summer of 2013. NPS Pharmaceuticals, Inc. (NASDAQ: NPSP $18.10) said that it expects to submit its Biologic License Application in 4Q 2013 for Natpara for patients with hypoparathyroidism. It also plans to initiate […]

Daily News Read more

Plenty of news from NBIX CNDO FLML PSDV MDCO ACHN MRK AVNR ONXX INSM CTIC ALNY THLD

Jul 02, 2013 No Comments by

Alnylam Pharmaceuticals, Inc.(Nasdaq: ALNY) announced positive clinical results from its Phase 2 trial of ALN-TTR02, for the treatment of TTR-mediated amyloidosis (ATTR). Interim results show that multiple doses of ALN-TTR02 led to robust and statistically significant (p<0.001) knockdown of serum TTR protein levels of up to 93%. The company also mentioned that it intends to start a […]

Daily News Read more

Pipeline updates for CLDX and OGXI. PCYC offering + JNJ files canagliflozin MAA

Mar 08, 2013 No Comments

Janssen-Cilag International NV (Janssen) today announced it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat adult patients with type 2 diabetes. Pharmacyclics, Inc. (NASDAQ: PCYC) announced that it has commenced an underwritten registered public offering of […]

Read more

FURX FDA Approval. THLD initiates Phase 3 pancreatic trial. IMGN pipeline update + ANTH

Jan 27, 2013 No Comments

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) said that Takeda Pharmaceutical Company Limited received approval from the FDA for three new type 2 diabetes therapies, NESINA (alogliptin) and the fixed-dose combination therapies, OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl), for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise. […]

Read more

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 […]

Read more

ALXA issued CRL. SGYP offering. Pipeline updates for OGXI NGSX ANTH ZIOP THLD EXEL DRRX

May 04, 2012 No Comments

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has received a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for ADASUVE. In its press release the company said the CRL was issued due to medical device deficiencies and plans to meet with the FDA to resolve the issues. Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) […]

Read more

PCRX offering. ARQL prices offering. THLD receives $20m milestone payment

Apr 11, 2012 No Comments

ArQule, Inc. (NASDAQ: ARQL) today priced its offering of 7.15m shares of its common stock at a price of $7.30 per share, for net proceeds of approximately $48.7 million, with an option to issue up to an additional 1,072,500 shares. Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) today announced that it has commenced an underwritten public offering of shares of its common stock. […]

Read more

Pipeline updates and news for SNSS IDRA THLD SYN BIOD XOMA

Mar 15, 2012 No Comments

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) gave a pipeline update noting that it expects an interim analysis of its Phase 3 VALOR trial analysing vosaroxin in patients with first relapsed or refractory AML, during 3Q 2012. Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) gave a pipeline update noting the following: Phase 2 initiation of IMO-3100 in patients with psoriasis during 2Q 2012. Phase […]

Read more

Pipeline updates for ZGNX ACHN AEZS THLD + ANX RIGL shelf filings + SNTS AMLN news

Mar 09, 2012 No Comments

ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) filed a mixed shelf allowing it to from time to time, offer up to $150m of common stock, preferred stock, debt securities, warrants to purchase common stock, preferred stock or debt securities. RIGEL PHARMACEUTICALS INC (NasdaQ: RIGL) filed a shelf allowing it to from time to time, offer up to $200m of common […]

Read more

GTXI Capesaris placed on clinical hold. RGEN PDUFA date. TRGT added to database + CHTP THLD ANTH GENT news

Feb 21, 2012 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) briefing materials are now available HERE. The meeting will be held on Thursday, February 23, 2012 to review NORTHERA for the treatment of symptomatic neurogenic orthostatic hypotension. GTx, Inc. (Nasdaq: GTXI) announced that its clinical trials evaluating Capesaris (GTx-758) for primary (first line) androgen deprivation therapy for […]

Read more