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InSite and Senju collaborate to develop and market azithromycin ophthalmic solution using DuraSite

InSite Vision Incorporated and Senju Pharmaceutical Co., Ltd. today announced that they have entered into a collaboration and license agreement to develop and market InSite's azithromycin ophthalmic solution using DuraSite® including AzaSite® 1% and AzaSite XtraTM 2% ocular antibiotics in Japan. Senju has agreed to pay InSite an upfront license fee, additional development milestones fees, and a percentage royalty on net sales.

10 Jun 2014

Alkermes initiates FORWARD-3 and FORWARD-4 efficacy studies in pivotal clinical program for ALKS 5461

Alkermes plc today announced the initiation of FORWARD-3 and FORWARD-4, two of the three planned phase 3 core efficacy studies in the pivotal clinical program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD).

10 Jun 2014

$arGEN-X partner with LLS to develop ARGX-110 for patients with refractory WM$

arGEN-X partner with LLS to develop ARGX-110 for patients with refractory WM

arGEN-X, a clinical stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today announced it has entered into a partnership with The Leukemia & Lymphoma Society (LLS) in which both parties will contribute to the funding of a Phase 2 clinical study of the Company's lead candidate, ARGX-110, in patients with refractory Waldenström's macroglobulinemia (WM).

10 Jun 2014

Combined MMRV vaccine slightly increases risk of febrile seizures in children

The combined measles-mumps-rubella-varicella (MMRV) vaccine shows a slightly increased risk of febrile seizures in children, compared with the previously separate vaccines for MMR and varicella (chickenpox) (MMR+V), according to an article in CMAJ (Canadian Medical Association Journal).

10 Jun 2014

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Pharmacyclics, Inc. today announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval.

9 Jun 2014

Celsus’ expert highlights serious side effects of topical corticosteroids

A 2013 Mayo Clinic study involving more than 140,000 patients revealed that skin disorders are the most common nonacute reason Americans seek health care.

9 Jun 2014

Antiviral therapy may prevent hepatitis B virus from developing into hepatocellular carcinoma

Researchers have found that antiviral therapy may be successful in preventing hepatitis B virus from developing into the most common form of liver cancer, hepatocellular carcinoma (HCC).

9 Jun 2014

NIDA review offers new insights into the negative health effects of marijuana

The current state of science on the adverse health effects of marijuana use links the drug to several significant adverse effects including addiction, a review reports.

9 Jun 2014

BioDelivery Sciences receives approval of NDA for BUNAVAIL from FDA

BioDelivery Sciences International, Inc. received approval of the New Drug Application (NDA) for BUNAVAIL™ (buprenorphine and naloxone) buccal film (CIII) from the U.S. Food and Drug Administration (FDA).

9 Jun 2014

Aradigm’s common shares approved for listing on NASDAQ Capital Market

Aradigm Corporation is pleased to announce that its common shares have been approved for listing on the NASDAQ Capital Market.

9 Jun 2014

Mylan launches generic version of Bristol-Myers Squibb's Paraplatin Injection

Mylan Inc. today announced that it has launched Carboplatin Injection, 50 mg/5 ml, in multi-dose vials, which is the generic version of Bristol-Myers Squibb's Paraplatin® Injection.

9 Jun 2014

Cubist Pharmaceuticals publishes positive results from Phase 3 clinical trial of SIVEXTRO

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that The Lancet Infectious Diseases published online the positive results from ESTABLISH-2, a pivotal Phase 3 clinical trial of the investigational antibiotic SIVEXTRO™ (tedizolid phosphate), which is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and complicated skin and soft tissue infections (cSSTI).

9 Jun 2014

Edison's EPI-743 receives FDA orphan drug designation for treatment of Leigh syndrome

Edison Pharmaceuticals today announced that the FDA has granted Orphan Drug status to vatiquinone for the treatment of Leigh syndrome.

9 Jun 2014

Batu Biologics reports FDA development plans for cancer immunotherapeutic vaccine ValloVax

Batu Biologics announced today FDA development plans for its patent-pending lead product, ValloVax, a cancer immunotherapeutic "vaccine" that specifically targets the tumor blood vessels (endothelium).

9 Jun 2014

Scientists develop new molecule for monitoring drug concentration

Monitoring the drug concentration in patients is critical for effective treatment, especially in cases of cancer, heart disease, epilepsy and immunosuppression after organ transplants.

9 Jun 2014

European Commission approves Boehringer Ingelheim's Pradaxa for prevention of DVT and PE

Boehringer Ingelheim today announces that Pradaxa (dabigatran etexilate) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE).

6 Jun 2014

Ocugen's OCU100 gets FDA orphan drug designation for treatment of retinitis pigmentosa

Ocugen, Inc. and the University of Colorado today announced exclusive license agreements that allow for Ocugen to continue developing two drug candidates for the treatment for ophthalmology indications, and that one of the assets, OCU100, recombinant lens epithelium derived growth factor 1-326 (LEDGF1-326), received orphan-drug status from the U.S. Food and Drug Administration for treatment of retinitis pigmentosa (RP), a rare eye disease.

6 Jun 2014

MPS&A launches pilot program to test its Adherence Performance reporting solution

McKesson Pharmacy Systems and Automation (MPS&A) has launched a pilot program to test its Adherence Performance reporting solution.

5 Jun 2014

NIH study finds that MDMA drug can be more dangerous in hot, crowded settings

A moderate dose of MDMA, commonly known as Ecstasy or Molly, that is typically nonfatal in cool, quiet environments can be lethal in rats exposed to conditions that mimic the hot, crowded, social settings where the drug is often used by people, a study finds.

5 Jun 2014

New antibiotic proves effective in treating serious bacterial skin and skin-structure infections

A study published in today's New England Journal of Medicine reports that the antibiotic dalbavancin is as effective as vancomycin, the current standard-of-care antibiotic used to treat serious bacterial skin and skin-structure infections.

5 Jun 2014

Pharmaceutical News

InSite and Senju collaborate to develop and market azithromycin ophthalmic solution using DuraSite

Alkermes initiates FORWARD-3 and FORWARD-4 efficacy studies in pivotal clinical program for ALKS 5461

arGEN-X partner with LLS to develop ARGX-110 for patients with refractory WM

Combined MMRV vaccine slightly increases risk of febrile seizures in children

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Celsus’ expert highlights serious side effects of topical corticosteroids

Antiviral therapy may prevent hepatitis B virus from developing into hepatocellular carcinoma

NIDA review offers new insights into the negative health effects of marijuana

BioDelivery Sciences receives approval of NDA for BUNAVAIL from FDA

Aradigm’s common shares approved for listing on NASDAQ Capital Market

Mylan launches generic version of Bristol-Myers Squibb's Paraplatin Injection

Cubist Pharmaceuticals publishes positive results from Phase 3 clinical trial of SIVEXTRO

Edison's EPI-743 receives FDA orphan drug designation for treatment of Leigh syndrome

Batu Biologics reports FDA development plans for cancer immunotherapeutic vaccine ValloVax

Scientists develop new molecule for monitoring drug concentration

European Commission approves Boehringer Ingelheim's Pradaxa for prevention of DVT and PE

Ocugen's OCU100 gets FDA orphan drug designation for treatment of retinitis pigmentosa

MPS&A launches pilot program to test its Adherence Performance reporting solution

NIH study finds that MDMA drug can be more dangerous in hot, crowded settings

New antibiotic proves effective in treating serious bacterial skin and skin-structure infections

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