Industry News

- Read more about Dr.Reddy's Sernivo spray gets USFDA nod
Indian drug major Dr.Reddy's Laboratories Ltd on Monday said its wholly owned US subsidiary Promius Pharma has got the USFDA for a spray to treat plaque psoriasis.

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- Read more about PhRMA hits on Indian Intellectual regime
India will be continued in priority watch list in the year 2016 as per Special 301 report submitted by PhRMA (Pharmaceutical Research and Manufacturers of America) to USTR (United States Trade Representative). PhRMA clearly reproval Indian IPR (Intellectual Property Rights) regime.
- Read more about U.S. FDA approves expanded Use of Bristol-Myers Squibb’s Daklinza (daclatasvir)
Bristol-Myers Squibb’s announced that Daklinza™ (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3.
- Read more about Amarantus requests rare pediatric disease designation from US FDA for MANF
Amarantus Bioscience Holdings Inc. a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced that it has requested Rare Pediatric Disease Designation (RPDD) from the US Food and Drug Administration (FDA) for treating retinitis pigmentosa (RP) with MANF(mesencephalic-astrocyte-derived neurotrophic factor). MANF was previously granted orphan drug designation (ODD) by the US FDA in December 2014.

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- Read more about Impax Receives Tentative FDA approval for generic version of Vytorin® (ezetimibe and simvastatin) tablets
Impax Laboratories, Inc. announced that Impax has received tentative approval from the U.S. Food and Drug Administration (FDA) for its
- Read more about U.S. FDA grants breakthrough therapy designation to Immunomedics for Sacituzumab Govitecan
Immunomedics, Inc. announced that its lead investigational antibody-drug conjugate, sacituzumab govitecan, or IMMU-132, has received Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer (TNBC) who have failed at least 2 prior therapies for metastatic disease.
- Read more about FDA approves Merck’s Single-Dose EMEND® for injection with other antiemetic agents
Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for single-dose EMEND® (fosaprepitant dimeglumine) for injection, Merck’s substance P/neurokinin-1 (NK1) receptor antagonist, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC). EMEND has not been studied for the treatment of established nausea and vomiting.
- Read more about FDA Psychopharmacologic Drug advisory committee supports the effectiveness of Brintellix® (vortioxetine)
Takeda Pharmaceutical Company Limited and H. Lundbeck A/S announced that the U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that the companies presented substantial evidence to support the effectiveness of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with Major Depressive Disorder (MDD). Earlier today, the committee also discussed that cognitive dysfunction in MDD represents an appropriate drug development target.
- Read more about SPIRIVA® RESPIMAT® now available in U.S. for maintenance treatment of Asthma
Boehringer Ingelheim announced that SPIRIVA® RESPIMAT® is now available for the treatment of asthma by prescription in U.S. pharmacies. The U.S. Food and Drug Administration (FDA) approved a once-daily dose of 2.5 µg for the long-term maintenance treatment of asthma in people ages 12 and older.
- Read more about Targovax submits a study of its adenovirus based immune therapy ONCOS-102 to the regulatory authorities in Spain
Targovax has submitted a study protocol to the regulatory authorities in Spain to assess its ONCOS-102 product in combination with chemotherapy in patients with malignant pleural mesothelioma (MPM), a rare type of lung cancer associated with exposure to asbestos.