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 […]

Daily News Read more

ACST data due 3Q. OCRX offering. VTL pipeline update + THLD ACOR news

Jul 10, 2014 No Comments by

Acasti Pharma Inc. (NASDAQ: ACST) announced the completion of two trials, the Phase 2 (TRIFECTA) study of CaPre in reducing triglyceride levels in patients with mild to severe hypertriglyceridemia and the Pharmacokinetic (PK) trial. Top-line data from both trials are due at the end of September with full data in 4Q 2014. Ocera Therapeutics (Nasdaq:OCRX) announced […]

Daily News Read more

POZN resubmits NDA. Trial updates for CTIC OGXI THLD RARE

Jul 02, 2014 No Comments by

POZEN Inc. (NASDAQ: POZN) announced that it has resubmitted the NDA for PA8140/PA32540 to the FDA. They expect to hear back from the FDA within 14 days of receipt of the NDA whether or not the submission will be accepted, and if accepted, what the new PDUFA date will be. The FDA will determine whether a two month or six month review […]

Daily News Read more

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

Dec 30, 2013 No Comments

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 […]

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

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 […]

Read more

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

Jul 02, 2013 No Comments

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 […]

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