ETRM Advisory Committee results. EXAS approval decision due August. ECYT vintafolide rights returned by MRK + RCPT GALE news

Jun 18, 2014 No Comments

EnteroMedics Inc. (NASDAQ: ETRM) announced that the FDA Advisory Gastroenterology and Urology Devices Panel (GUDP) voted 8 to 1 in favour that the device is safe, 4 to 5 against its efficacy and 6 to 2 in favour, with 1 abstention, that the relative benefits outweighed the relative risk. The FDA is not bound by the GUDP’s recommendation, but will take it into consideration when […]

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FLML assigned August PDUFA date. RVNC offering. Trial updates for ATLN CLVS

Jun 17, 2014 No Comments

Flamel Technologies (NASDAQ: FLML) announced today that the FDA has assigned a PDUFA date of August 6, 2014 for its second New Drug Application (NDA). The company had received a Complete Response Letter (CRL) to its NDA on its April 28, 2014. Flamel resubmitted the NDA on June 6, 2014 and FDA classified the CRL resubmission as a Class […]

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NAVB FDA Approval. ENTA granted priority review PDUFA. KOOL offering. ENMD ticker change.

Jun 14, 2014 No Comments

Navidea Biopharmaceuticals, Inc.(NYSE MKT: NAVB) announced that the FDA has approved the Supplemental New Drug Application (sNDA) for the expanded use of Lymphoseek Injection indicated for guiding sentinel lymph node (SLN) biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity. Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA) announced that the New Drug Application (NDA) for […]

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Advisory Committee votes to not require CVOTs. HPTX Phase 3 data due 1Q 2015.

Jun 13, 2014 No Comments

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP), Progenics Pharmaceuticals (NASDAQ:PGNX) and Nektar Therapeutics (NASDAQ:NKTR) reported voting results from the Anesthetic and Analgesic Drug Products Advisory Committee of the FDA. They announced that a majority of  Advisory Committee members voted to not require cardiovascular outcomes trials (CVOTs) for PAMORAS being developed for the treatment of opioid-induced constipation in patients with chronic, non-cancer pain. The […]

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OREX PDUFA date delayed by three months. FDA lifts GERN clinical hold.

Jun 12, 2014 No Comments

Orexigen Therapeutics, Inc. (Nasdaq: OREX) announced that the FDA has extended its review of the resubmitted New Drug Application (NDA) for NB32, for weight loss. The new PDUFA date is September 11, 2014. The FDA has indicated that the review extension is needed to reach agreement on the post-marketing obligation related to the previously agreed upon evaluation of cardiovascular (CV) outcomes […]

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NPSP Adcom meeting date change. ACHN sovaprevir clinical hold lifted + ALKS news

Jun 11, 2014 No Comments

NPS Pharmaceuticals, Inc.(NASDAQ:NPSP) announced that the FDA has shifted the tentative date for the Natpara Advisory Committee Meeting from July 24 to September 12, 2014. The PDUFA date remains unchanged at October 24, 2014. Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced that the FDA has removed the clinical hold on their Phase 2 trial of sovaprevir, in […]

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RMTI PCYC PDUFA dates set. RCPT meets endpoint in Phase 2 trial. MRK to acquire IDIX. Trial initiations for KPTI ADMS + VSAR update

Jun 10, 2014 No Comments

Merck (NYSE:MRK), and Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX) announced that the companies have entered into a definitive agreement under which Merck will acquire Idenix for $24.50 per share in cash or approximately $3.85 billion. Rockwell Medical, Inc. (Nasdaq:RMTI) announced that the FDA has set a PDUFA date of January 24, 2015, for Triferic for the […]

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BDSI receives FDA Approval for BUNAVAIL

Jun 07, 2014 No Comments

BioDelivery Sciences International, Inc. (BDSI) (NASDAQ: BDSI) announced that the FDA has granted approval for BUNAVAIL (buprenorphine and naloxone) buccal film (CIII) for the maintenance treatment of opioid dependence. BDSI expects to launch BUNAVAIL late 3Q 2014. Tweet

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FLML to resubmit NDA +MDGN news.

Jun 06, 2014 No Comments

Flamel Technologies (NASDAQ: FLML) announced that it intends to resubmit their second New Drug Application (NDA), which was given a Complete Response Letter (CRL) on April 28, 2014. This follows notice from their supplier that their facility has been classified as acceptable by the FDA. They expect to make an announcement prior to the end of June 2014 […]

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